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World Symposium Orchard leads the crop of Hurler syndrome hopefuls – Vantage

February 11th, 2021 8:49 am

Gene therapy companies have been under pressure lately, but Orchard Therapeutics got a lift yesterday from promising early data with its mucopolysaccharidosis type I candidateOTL-203.

The company is seeking to supersede the current standard of care, enzyme-replacement therapy or bone marrow transplant. But other gene therapy contenders are not too far behind, notablyRegenxbio, which in December started a proof-of-concept study of its rival project, RGX-111.

Good IDUA

Both projects seek to deliver the -l-iduronidase (IDUA) gene, which is mutated in MPS-I, leading to a deficiency of the IDUA enzyme. This enzyme usually breaks down glycosaminoglycans (GAGs), so in MPS-I patients these build up, causing tissue and organ damage. Symptoms of MSP-I, also known as Hurler syndrome, include cognitive impairment and skeletal deformity; if left untreated, patients rarely survive beyond the age of 10.

And both OTL-203 and RGX-111 are designed as one-time therapies, whereas the current enzyme replacement, Biomarin/Sanofis Aldurazyme, is given intravenously once a week.

However, the gene therapy candidates go about restoring IDUA enzyme activity in different ways. OTL-203 uses hematopoietic stem cells taken from the patient, then genetically modified using a lentiviral vector to express the IDUA gene, before being reinfused.

RGX-111, meanwhile, uses an adeno-associated viral vector to deliver the gene directly to the brain, getting around a central problem with Aldurazyme, which cannot cross the blood-brain barrier.

Getting into the brain should not be a problem for OTL-203 either, Orchards head of medical affairs, Leslie Meltzer, told Evaluate Vantage. She explained that hematopoietic stem cells naturally cross the blood-brain barrier and, once in the CNS, differentiate into a microglial-like cell.

This claim appears to be supported by the latest data, which admittedly come in just a handful of subjects. The eight-patient phase I/II trial, presented at the World Symposium yesterday, found increases in the IDUA enzyme in patients blood and cerebrospinal fluid. There was also a decrease in GAGs in the CSF and urine.

Encouragingly, this activity appears to have translated into a clinical benefit: all eight patients showed stable cognitive scores and stable motor function versus baseline, as well as growth in the normal range for patients age.

Its a progressive disease, so youd expect these things to worsen over time, but the fact they continued to be stable is very promising, Ms Meltzer said.She admitted that the data were early, with only around a year of follow-up on most of the clinical endpoints.

Orchard plans to start a registrational study by the end of this year.Ms Meltzer would not give any details ondesign, saying this would be finalised after feedback from regulators.

Regenxbios proof-of-concept study of RGX-111 is due to complete in November, putting the project about a year behind OTL-203.

One candidate that will go no further is Sangamos SB-318. The company reported disappointing data with the in vivo zinc finger nuclease genome-editing project two years ago, and has since said it would focus on second-generation zinc finger projects.

Still, even two gene therapies might be too many for an ultra-rare disease like MPS-I, which affects just one in 100,000 people. Asked whether this market could support more than one gene therapy, Ms Meltzer said newborn screening recently implemented in countries including the UScould lead to a revision of that estimate.

But, as in other rare disorders that have attracted several gene therapy players, a battle over a limited patient pool could be shaping up.

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AGTC Executives Awarded First Place in the BioProcess International Reader’s Choice Awards, Cell & Gene Therapies Category – GlobeNewswire

February 11th, 2021 8:49 am

Article reflects Companys leadership and innovation in scalable, reproducible manufacture of adeno-associated virus (AAV)-based gene therapies

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company focused on developing adeno-associated virus (AAV) based gene therapies for the treatment of rare inherited diseases, announced that Sue Washer, President & Chief Executive Officer and Dave Knop, Vice President of Process Development, have been awarded first place in the BioProcess International (BPI) magazine inaugural Readers Choice Awards program, cell and gene therapies category, for their article, Viral-Vectored Gene Therapies: Harnessing Their Potential Through Scalable, Reproducible Manufacturing Processes.

High-productivity approaches to AAV manufacturing processes, like AGTCs HSV-helper based platform, will be crucial if we are to address the unmet clinical need growing across a variety of indications, said AGTC President and CEO, Sue Washer. There is no question that investing in the manufacturing process is imperative and our early commitment in this area has put AGTC in a strong position with respect to the purity and quality needed for late stage development and commercialization.

Concentrating on articles published from September 2019 through June 2020, and using rankings based on views, engagement, and download rates, BioProcess International identified the four most popular articles within each of its six pillars of bioprocessing coverage. The AGTC authors article received the highest number of votes from BPI readers, who ranked the nominees in terms of their innovativeness, presentability and applicability.

The eBook featuring the first-place article by Washer and Knop, as well as summarized versions of the second- and third-place articles, are available by visiting: https://bioprocessintl.com/wp-content/uploads/2020/11/18-11-eBook-RCA-CellGeneTherapies.pdf.

About AGTCAGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. The Companys most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Its preclinical programs build on the Companys industry-leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders.

IR/PR CONTACTS:David Carey (IR) or Glenn Silver (PR)Lazar FINN PartnersT: (212) 867-1768 or (646) 871-8485david.carey@finnpartners.com or glenn.silver@finnpartners.com

Corporate Contact:Bill SullivanChief Financial OfficerApplied Genetic Technologies CorporationT: (617) 843-5728bsullivan@agtc.com

Stephen PotterChief Business OfficerApplied Genetic Technologies CorporationT: (617) 413-2754spotter@agtc.com

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AGTC Executives Awarded First Place in the BioProcess International Reader's Choice Awards, Cell & Gene Therapies Category - GlobeNewswire

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Actinium Showcases Targeted Conditioning Program with 2 Oral Presentations Highlighting Iomab-B and Pivotal Phase 3 SIERRA Trial at 2021…

February 11th, 2021 8:49 am

NEW YORK, Feb. 11, 2021 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today highlighted its presence at the 2021 Transplantation & Cellular Therapy (TCT) Annual Meeting, which is being held virtually from February 8th 12th. The TCT meeting organizes thousands of transplant professionals from over five hundred transplant centers worldwide and is a seminal event for Actinium given its focus on targeted conditioning for bone marrow transplant (BMT), CAR-T and other adoptive cell therapies and gene therapy. At TCT, Actinium's pivotal Phase 3 trial SIERRA trial for Iomab-B was featured in 2 oral presentations, as well as CME event focused on AML and BMT and in investigator interactions led by Actinium's clinical development and medical affairs teams.

Dr. Mark Berger, Actinium's Chief Medical Officer, said, "TCT is the ideal venue to showcase Actinium's Iomab-B and Iomab-ACT targeted conditioning programs given the concentrated audience of thought leaders in these fields that TCT brings together. The timing of TCT is also ideal as it follows shortly after ASH resulting in a data rich period for Actinium that drives investigator interest. This is particularly the case this year as we have built strong momentum in SIERRA following positive data from 75% enrollment featured in 2 oral presentations at ASH and now in 2 oral presentations at this year's TCT, which has driven high levels of investigator and referring physician interactions. We have coupled this with bolstered outreach efforts, which will continue beyond TCT, that have resulted in new site activation despite the advanced stage of SIERRA and robust enrollment rates that give us great confidence in completing SIERRA enrollment rapidly."

Summary data presented in TCT oral presentations include:

-100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician's choice of salvage therapy on the control arm- 79% of all patients enrolled on SIERRA were able to proceed to BMT despite being a patient population not considered eligible for BMT with standard approaches-Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events

TCT Oral Presentation: Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered

Phase 3 SIERRA 75% Enrollment Results

Baseline Characteristics

Iomab-B Arm(N=56)

Conventional Care (CC) Arm(N=57)

Age (yrs, median, range)

63 (55-77)

65 (55-77)

Cytogenetic and Molecular Risk1, 2

Favorable: 4%Intermediate: 35%

Adverse: 61%

Favorable: 5%

Intermediate: 32%

Adverse: 63%

% TransplantedIntent-to-Treat Group

88% (49/56)

18% (10/57)

64% (30/47)

Results

Underwent Iomab-B based Conditioning and HCT (N=49)3

Achieved CR and received standard of care HCT (N=10)

Randomized to Conventional Care and Crossed Over to Iomab-B with HCT (N=30)4

Cross-over Rate

n/a

n/a

Received Therapeutic Dose of Iomab-B (N=30)

Transplanted (N=30)

64% (30/47)

% Transplanted

100% (49/49)

18% (10/57)

100% (30/30)

% Marrow Blast @ randomization (median, range)

29% (4-95)5

20% (5-97)

28% (6-87)

Days to ANC Engraftment

14 (9-22)6

17 (13-83)7

14 (10-37)8

Days to Platelet Engraftment

18 (4-39)6

22 (8-35)7

19 (1-38)8

Days to HCT (Post Randomization)

30 (23-60)

67 (52-104)

62 (36-100)9

Myeloablative Dose Delivered to Bone Marrow

14.7 (4.6-32) Gv

n/a

15.5 (6.3-42) Gv

592 (313-1013) mCi

646 (354-1027) mCi

100-day non-Relapse Transplant-Related Mortality

4%

(2/45 Evaluable)

20%

(2/10 Evaluable)

10.7%

(3/28 Evaluable)

1) Iomab-B arm: data unavailable (4) and patient was excluded (1)

2) Per NCCN guidelines version 3. 2020

3) No therapy dose (7) due to: declining KPS (4), Infusion reaction (1), unfavorable biodistribution (1), post- randomization eligibility (1). Two (2) did not receive DI and five (5) received DI without proceeding to TI.

4) Thirteen (13) patients ineligible for crossover due to: hospice care/progression (4), declined/ineligible for HCT (5), died pre-crossover (4). Additionally, four (4) patients were eligible for crossover and did not receive Iomab-B due to declining KPS.

5) One (1) patient with 4% blasts in the marrow had circulating AML blasts

6) ANC engraftment data not available (4), platelet engraftment data not available (7)

7) ANC and platelet engraftment data not available (1)

8) ANC engraftment data not available (1), platelet engraftment data not available (2)

9) One (1) patient at 161 days had delayed transplant due to infection & respiratory failure, received Iomab & transplant when stable, not included in range

https://tct.confex.com/tct/2021/meetingapp.cgi/Paper/16878

TCT Oral Presentation: Myeloablative Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Spares the GI Tract and Has Low Incidence of Severe Mucositis, Febrile Neutropenia and Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Adverse Event

Iomab-B Arm (N=56)

Conventional Care Arm (N=57)

Received Iomab-B/HCT

(N=49)1

Achieved CR and received Std HCT (N=10)

No CR Crossed over to Iomab-B/HCT (N=30)

Sepsis

% (N)

4.2 (2)*

30.0 (3)

23.3 (7)

Febrile Neutropenia Gr 3-4

% (N)

41.7 (20)

50.0 (5)

40.0 (12)

Mucositis Gr 3-4

% (N)

10.4 (5)

30.0 (3)

16.7 (5)

Day +100 Non-Relapse Mortality3

2/45(4.4%)

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VM202 Is Safe and Effective for Painful Diabetic Peripheral Neuropathy – Clinical Pain Advisor

February 11th, 2021 8:49 am

VM202, a plasmid DNA that expresses 2 isoforms of hepatocyte growth factor, is both safe and effective in providing long-lasting pain relief in painful diabetic peripheral neuropathy (DPN), according to results of a phase 3-1b study published in Clinical and Translational Science.

Following positive efficacy and safety data results from phase 1 and 2 studies, researchers conducted a large scale, double-blind, placebo-controlled phase 2 study of VM202 for painful DPN. The study was conducted in 2 parts: the main study took place over 9 months (DPN 3-1; ClinicalTrials.gov identifier NCT02427464; N=500 participants), followed by a noninterventional 3-month safety and efficacy extension that included a subset of later-enrolling main study participants (DPN 3-1b; ClinicalTrials.gov identifier NCT04055090; n=101).

Researchers hypothesized that VM202 administration would reduce the average daily diabetic peripheral neuropathy pain scores more than placebo. The primary efficacy endpoint was the mean 24-hour numerical rating scale pain score, recorded in a daily pain and sleep diary at 3 months.

In both studies, most participants were White (74.4% and 80.2%) with an overall mean age of 61.5 years. Many participants had comorbid conditions, including hypertension, dyslipidemia, and obesity.

Between-group demographic and baseline characteristics were similar. At the time of randomization, roughly half of the participants were not receiving either pregabalin or gabapentin to manage DPN.

Researchers assessed safety based on incidence of treatment-emergent adverse events, serious adverse events, and adverse events of special interest (injection site reactions, ophthalmologic or acute cardiac events, foot ulcers, and symptoms of central nervous system depression).

In DPN 3-1, 72.6% of those treated with VM202 and 68.9% of those treated with placebo reported at least 1 treatment-emergent adverse event. The most common adverse events were infections and infestations, which were similar between groups.

Adverse events of special interest occurred in 17.2% and 16.8% of VM202 and placebo patients, respectively. The most common adverse events were diabetic retinopathy, peripheral edema, and skin ulcers. The incidence of these events that were deemed related to the study drug was low, with no difference between groups.

Serious adverse events were reported in 9.6% of the VM202 group and 9.9% of the placebo group. In the VM202 group, adenocarcinoma and vitreous hemorrhage were deemed possibly related to the study drug. Three myocardial infarctions were deemed not related to the study drug due to patients medical history.

In DPN 3-1b, 15.4% and 22.2% of VM202- and placebo-treated patients, respectively, experienced treatment-emergent adverse events. Adverse events of special interest were experienced by 3.1% and 2.8% of VM202- and placebo-treated patients, and included peripheral edema, chest pain, and angina pectoris. One participant in the VM202 group and 2 in the placebo group reported serious adverse events, but all 3 of these participants had relevant medical histories.

DPN 3-1 failed to meet the primary endpoints, with between-group differences that were not statistically significant for any endpoint measure. When the participants who were not receiving concurrent gabapentinoids were analyzed separately (n=251), endpoints remained statistically nonsignificant compared with placebo.

In DPN 3-1b, efficacy data differed strikingly, despite similar participant demographic and baseline characteristics. Although there was no significant pain severity difference at baseline, there were significant reductions in the primary efficacy endpoints at 12 months in the VM202 group compared with placebo. Significant pain reductions were also noted at 6 and 9 months, and greater pain reductions were identified in patients who were not taking gabapentin or pregabalin during the 12-month study, which was consistent with Phase 2 study results.

The researchers stated, To our knowledge, this is the first Phase 3 gene therapy study for pain that has ever been done. VM202 did not meet efficacy endpoints in the fullpopulation, but VM202 demonstrated long-term, clinically significant reductions in pain in [DPN 3-1b], particularly in [participants] not on gabapentinoids

They concluded, Given the excellent safety profile of VM202, the potential for disease modifying effects, and the high unmet medical needs of the DPN patient population not on gabapentinoids, further study is warranted.

Disclosure: This clinical trial was supported by Helixmith Inc. Please see the original reference for a full list of authors disclosures.

Kessler JA, Shaibani A, Sang CN, et al; for the VM202 Study Group. Gene therapy for diabetic peripheral neuropathy: a randomized, placebo-controlled phase 3 study of VM202, a plasmid DNA encoding human hepatocyte growth factor. Published online January 19, 2021. Clin Transl Sci. doi:10.1111/cts.12977

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Ischemic Optic Neuropathy Treatment Market is Driven by Increased Use of Intravitreal Implants for Treating Ophthalmology Diseases KSU | The Sentinel…

February 11th, 2021 8:49 am

Global Ischemic Optic Neuropathy Treatment Market: Overview

Technological progress made in the treatment of ischemic optic neuropathy coupled with the availability of alternative drugs is expected to boost the growth of the global ischemic optic neuropathy treatment market over the period of analysis, from 2020 to 2030. Ischemic optic neuropathies (IONs) are one of the major reasons for seriously impaired vision or blindness usually amongst the elderly and middle-aged people. However, the disease can affect anyone and no human age is immune to it. Increased prevalence of the disease is anticipated to propel expansion of the global ischemic optic neuropathy treatment market in the years to come.

Ischemic optic neuropathies (IONs) come in two types, namely posterior ischemic optic neuropathy (PION) and anterior ischemic optic neuropathy (AION). Inflammation of the arteries that supply blood to the optic nerve causes anterior ischemic optic neuropathy and reasons other than inflammation cause non-anterior ischemic optic neuropathy. However, anterior ischemic optic neuropathy is more commonly found in people than posterior ischemic optic neuropathy. Immediate treatment is needed in case of anterior ischemic optic neuropathy to prevent loss of vision in the affected eye as it also causes damage in the other eye in a span of just 5 to 10 days.

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Hypercholesterolemia, diabetes, and hypertension are some of the causes of the disease. In addition, other medical conditions such as failure of autoregulation, severe anemia, vasospasm, nocturnal hypotension, sleep apnea, and hypoperfusion are likely to cause ischemic optic neuropathies.

Disease type, treatment type, end user, and region are the four important parameters based on which the global ischemic optic neuropathy treatment market has been classified. The thorough evaluation of the market comes with the objective of providing stakeholders with a detailed and clear analysis of the global ischemic optic neuropathy treatment market.

Global Ischemic Optic Neuropathy Treatment Market: Notable Developments

One of the significant developments that give a quick view of the dynamics pertaining to the global ischemic optic neuropathy treatment market is mentioned as below:

In July 2019, Pfizer Inc. acquired US-based pharmaceutical company, Array BioPharma Inc. This acquisition is estimated to strengthen innovative biopharmaceutical business and assist in the meeting the unmet medical needs of diseases like cancer and other rare diseases.

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Some of the prominent organizations in the global Ischemic optic neuropathy treatment market comprise the below-mentioned:

Global Ischemic Optic Neuropathy Treatment Market: Key Trends

The global ischemic optic neuropathy treatment market is characterized by the presence of the following restraints, drivers, and opportunities.

Increased Demand from Various End Use Sectors to Fuel Market Growth

The development of the global ischemic optic neuropathy treatment market is anticipated to register high growth rate over the tenure of assessment. The increased use of intravitreal implants for treating ophthalmology diseases is expected to open new avenues of growth for the global ischemic optic neuropathy treatment market over the forecast period, from 2020 to 2030. Many of the leading drug manufacturing and pharmaceutical companies from the developed countries are making high investment in the research and development activities so to develop better and advanced solutions and reduce the burden of vision and eye-related diseases. Increased spending in infrastructure and new, advanced technologies in ophthalmology therapeutics are likely to account for a larger share of the market in the years to come.

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For patients suffering from ischemic optic neuropathy, corticosteroid is considered as the first choice of therapy, particularly in countries like Russia, France, Germany, and the US. However, several patients have developed resistance to anti-VEGF, which is likely to boost growth of the global ischemic optic neuropathy treatment market over the period of analysis, from 2020 to 2030.

Global Ischemic Optic Neuropathy Treatment Market: Geographical Analysis

North America is estimated to exert dominance over the global ischemic optic neuropathy treatment market and the region is likely to retain its prominence throughout the period of analysis, from 2020 to 2030. Availability of advanced healthcare infrastructure together with increased spending on the research and development activities in the field of ophthalmology is expected to propel growth of the global ischemic optic neuropathy treatment market in the years to come.

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Neuropathy Pain Treatment Market Size | Latest COVID19 Impact Analysis | Demand, Growth, Trends, Segmentation and Forecasts to 2027 – NeighborWebSJ

February 11th, 2021 8:49 am

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New Jersey, United States,- Verified Market Reports has recently published a market research report titled, Neuropathy Pain Treatment Market Size, Status and Forecast 2021-2027. Analysts have used primary and secondary research methodologies to determine the path of the market. The data includes historic and forecast values for a well-rounded understanding. It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the Neuropathy Pain Treatment market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the Neuropathy Pain Treatment market.

This report includes the assessment of various drivers, government policies, technological innovations, upcoming technologies, opportunities, market risks, restraints, market barriers, challenges, trends, competitive landscape, and segments which gives an exact picture of the growth of the Neuropathy Pain Treatment market.

Competitive analysis:

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides an in-depth analysis of the competition in the Neuropathy Pain Treatment market.

The report covers the following key players in the Neuropathy Pain Treatment Market:

Pfizer Depomed Eli Lilly Endo Grnenthal Group Arbor Pharmaceuticals

Segmentation of Neuropathy Pain Treatment Market:

The Neuropathy Pain Treatment market report has been segmented into Types, Applications, and End-users. It provides the market share of each segment participating in the Neuropathy Pain Treatment market. Companies operating in this market have a thorough understanding of the fastest-growing segment. That way, they can identify their target customers and allocate their resources wisely. Segment analysis helps create the perfect environment for engagement, customer loyalty, and acquisition. This section will help companies operating in the Neuropathy Pain Treatment market identify key areas of intervention while making their strategic investments.

By the product type, the market is primarily split into:

Calcium Channel Alpha 2-delta Ligands Serotonin-norepinephrine Reuptake Inhibitors

By the application, this report covers the following segments:

Retail Pharmacies Hospitals

Neuropathy Pain Treatment Market Report Scope

Regional analysis:

The Neuropathy Pain Treatment market report covers the analysis of various regions such as North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Market trends change by region and result in changes due to their physical environment. The report, therefore, covers key regions with sales, revenue, market share and growth rate of Neuropathy Pain Treatment in these regions from 2020 to 2027. It analyzes the region with the highest market share as well as the fastest growing region of the Neuropathy Pain Treatment market. The report by region is then broken down into analyzes at the country level. For example, North America is divided into the United States and Canada. Europe includes the UK, France, and Germany, followed by APAC, which includes countries like China, India, and Japan. Latin America is made up of countries like Mexico and Brazil, and the MEA countries included in the Neuropathy Pain Treatment market are the GCC countries and South Africa.

Research methodology:

The research methodology used to aggregate the Neuropathy Pain Treatment market report involves a combination of primary and secondary research approaches. The research team starts desk research from various sources to collect data on the Neuropathy Pain Treatment market. The report combined its data from reliable secondary sources such as company annual reports, industry publications, news, government websites and more. In addition, the primary research includes interviews to get first-hand market intelligence. Our analysts interviewed several C-level executives, decision-makers, board members, key opinion leaders, industry veterans and other stakeholders in the Neuropathy Pain Treatment market. All of the data is then combined and presented in a report to enable a deep understanding and analysis of the Neuropathy Pain Treatment market.

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The Neuropathy Pain Treatment market report provides a comprehensive overview of the current market and forecast till 2020-2027. It helps to identify the opportunities associated with the market in the near future. This gives our users a clear idea of ??where to use their resources. The report also includes industry dynamics such as drivers, restraints, and market opportunities that are significantly influencing the growth of the Neuropathy Pain Treatment market. In-depth study of general market expansion that helps users make product launch and asset development decisions. The report covers recent developments and changing market trends with the aim of making the appropriate decisions.

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Neuropathy Pain Treatment Market Size | Latest COVID19 Impact Analysis | Demand, Growth, Trends, Segmentation and Forecasts to 2027 - NeighborWebSJ

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Global Neuropathy Pain Treatment Market 2020 2025 Business Statistics of Report that Emphasizes the impact of COVID-19 FLA News – FLA News

February 11th, 2021 8:48 am

Global Neuropathy Pain Treatment Market 2020 by Company, Regions, Type and Application, Forecast to 2025 presents a point of view for the existing market trends, metrics, drivers, and restrictions, and all the important segments. The report specializes in an in-depth study of the global Neuropathy Pain Treatment market with a focus on the global market trend. The report is suitably segmented and sub-segmented so that it can shed light on every aspect of the market such as type of product, application, and region. The research contains key statistics on the market status of the leading market players and offers key trends and opportunities in the market. The report prophesies future revenue, growth, and trend of the market on the basis of recent developments and past data. Then the research emphasizes faster-growing segments and emerging trends in the market.

The report has extracted a systematic analysis of actual and projected market data. Key points covered are Drivers, restraints, opportunities, market revenue, trends shares, vendor profiling, manufacturers or players. The report layouts the global Neuropathy Pain Treatment market segments by defining and evaluating them, and forecast the global market size. The report identifies various developments, broad opportunities, and market growth factors. The study covers current status, market share, future patterns, development rate, SWOT examination, sales channels, to anticipate growth scenarios for the years 2020-2025. It aims to recommend analysis of the market with regards to growth trends, prospects, and players contribution in the market development.

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NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

Exploring Growth Rate Over A Period:

This report contains data regarding the rise in sales within a given consumer base for the forecast period, 2020 to 2025. With this precisely documented report, business owners can scale up their business. Product owners can use this information along with the driving factors such as demographics and revenue generated from other products discussed in the report to get a better analysis of their products and services. Besides, the research analysts have compared the global Neuropathy Pain Treatment market growth rate with the product sales to assist business owners to determine the success or failure of a specific product or service.

Leading companies covered in this research report: Pfizer, Endo, Depomed, Eli Lilly, Arbor Pharmaceuticals, Grnenthal Group

Market segmentation by product types: Calcium Channel Alpha 2-delta Ligands, Serotonin-norepinephrine Reuptake Inhibitors, Others

Market segmentation by applications: Retail Pharmacies, Hospitals, Others

Key regions and countries covered in this research report: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), MENA (Saudi Arabia, UAE, Turkey and South Africa)

ACCESS FULL REPORT: https://www.marketquest.biz/report/9018/global-neuropathy-pain-treatment-market-2020-by-company-regions-type-and-application-forecast-to-2025

Reasons To Buy A Full Report:

Moreover, the report will help the industry players in deciding the investment feasibility and development status across the globe. The analysis of global Neuropathy Pain Treatment market share, revenue, pricing analysis, SWOT analysis is covered for all the key market players. All the product segments and sub-segments are studied in detail in this report.

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Global Neuropathy Pain Treatment Market 2020 2025 Business Statistics of Report that Emphasizes the impact of COVID-19 FLA News - FLA News

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Recent Study on Neuropathy Pain Treatment Market 2021 Including Key Players, Applications, and Growth Size By 2026 NeighborWebSJ – NeighborWebSJ

February 11th, 2021 8:48 am

According to the new market research report Neuropathy Pain Treatment Market Strategic recommendations, Trends, Segmentation, Use Case Analysis, Competitive Intelligence, Global and Regional Forecast (to 2026), published by In4Research, the global Neuropathy Pain Treatment Market size in the post-COVID-19 scenario is projected to grow significantly by 2026.

Study Objectives of Global Neuropathy Pain Treatment Market:

Request for a sample copy of the report to get extensive insights into Neuropathy Pain Treatment market at https://www.in4research.com/sample-request/53942

Research Coverage of Neuropathy Pain Treatment Market:

The market study covers the Neuropathy Pain Treatment market size across different segments. It aims at estimating the market size and the growth potential across different segments, including application, type, organization size, vertical, and region. The study further includes an in-depth competitive analysis of the leading market players, along with their company profiles, key observations related to product and business offerings, recent developments, and market strategies.

Major Key Players Covered in The Neuropathy Pain Treatment Market Report include

Neuropathy Pain Treatment Market Segmentation by Type, Application, and Region as follows:

By Type:

By Application:

Geographically, this report is segmented into several key Regions along with their respective countries, with production, consumption, revenue, and market share and growth rate of Neuropathy Pain Treatment in the following regions:

For more Customization, Connect with us at https://www.in4research.com/customization/53942

Valuable Points Covered in Neuropathy Pain Treatment Research Study are:

Moreover, the analyst who has authored the report has completely estimated the market potential of the key applications and recognized the future opportunities. The top players in the global Neuropathy Pain Treatment market are covered based on their market size, served market, products, applications, and regional growth. The report comprises the industry deliverables such as market size, sales volume, valuation forecast, etc. The report focuses on the upstream raw material analysis, downstream analysis, manufacturing base, and import-export details.

Any Questions/Queries or need help? Speak with our analyst https://www.in4research.com/speak-to-analyst/53942

Key Topics Covered in Neuropathy Pain Treatment Research Study are:

Introduction

Value Chain Analysis

Porters Five Forces Analysis

Pricing Analysis

And more

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Recent Study on Neuropathy Pain Treatment Market 2021 Including Key Players, Applications, and Growth Size By 2026 NeighborWebSJ - NeighborWebSJ

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Diabetic Neuropathy Market Outlook, Strategies, Manufacturers, Countries, Type and Application, Global Forecast To 2026 – AlgosOnline

February 11th, 2021 8:48 am

Market Study Report, LLC, has recently added a report on ' Diabetic Neuropathy market' which offers a comprehensive synopsis of revolving market valuation, market size, SWOT analysis, revenue estimation and geographical spectrum of the market. The report further elucidates primary business obstacles and growth prospects within the forecasted timeline, while examining the current competitive sphere involving key players of the ' Diabetic Neuropathy market'.

The research analysis of Diabetic Neuropathy market provides a broad perspective of the major development trends, limitations, and restraints as well as growth opportunities, which are slated to define the industry growth rate in the subsequent years.

Request a sample Report of Diabetic Neuropathy Market at:https://www.marketstudyreport.com/request-a-sample/3171246?utm_source=Algosonline.com&utm_medium=Ram

According to the report, the Diabetic Neuropathy market is predicted to witness a y-o-y growth rate during the analysis timeframe (2021-2026) and generate lucrative returns by the end of the forecast duration.

The advent of COVID-19 pandemic is expected to have some modifications to the growth of this business vertical. Various organizations operating in this industry landscape are compelled to revisit their respective budgets in order to establish a proper profit trajectory for the ensuing years. Thus, the study offers an in-depth analysis regarding the impact of the COVID-19 pandemic on the overall industry remuneration.

Apart from this, the document also highlights the various segmentations and their individual contribution towards the overall market outlook.

Major information from the Diabetic Neuropathy market report:

Ask for Discount on Diabetic Neuropathy Market Report at:https://www.marketstudyreport.com/check-for-discount/3171246?utm_source=Algosonline.com&utm_medium=Ram

Diabetic Neuropathy Market segments covered in the report:

Regional segmentation: North America, Europe, Asia-Pacific, South America, Middle East and Africa

Product types:

Applications spectrum:

Competitive outlook:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-diabetic-neuropathy-market-2021-by-company-regions-type-and-application-forecast-to-2026

Key Highlights Questions?

Table of Content:

Read More Reports On: https://www.marketwatch.com/press-release/monodose-packaging-for-probiotics-and-nutraceutical-market-share-growth-statistics-by-application-production-revenue-forecast-to-2026-2021-02-05

Contact Us:Corporate Sales,Market Study Report LLCPhone:1-302-273-0910Toll Free:1-866-764-2150Email:[emailprotected]

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Diabetic Neuropathy Market Outlook, Strategies, Manufacturers, Countries, Type and Application, Global Forecast To 2026 - AlgosOnline

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North America to Stand in a Better Stead in the Neuropathic Pain Market between 2020 and 2030 – Industry Today

February 11th, 2021 8:48 am

Pipeline strategies by manufacturers are focused on introducing advanced drugs with minimum side effects to increase market share. For instance, Pfizer sponsored drug Pregabalin, effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma that is in phase 3 clinical trials. Increasing research and development activities to develop medications for indications such as post-herpetic neuralgia are creating significant opportunities for manufactures to flourish in the market.

Reaching the revenues of overUS$ 6 Bnat the end of 2019, the globalneuropathic pain management marketis projected for a healthy CAGR during the forecast period (2019 2029). Increasing prevalence of neuropathic pain disorders and growing awareness about pain medication are boosting the demand for pain management drugs.

Want a sneak peek into the Neuropathic Pain Market? Access the Table of Content of Neuropathic Pain Market report! @https://www.persistencemarketresearch.com/market-research/neuropathic-pain-market/toc

Pipeline strategies by manufacturers are focused on introducing advanced drugs with minimum side effects to increase market share. For instance, Pfizer sponsored drug Pregabalin, effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma that is in phase 3 clinical trials. Increasing research and development activities to develop medications for indications such as post-herpetic neuralgia are creating significant opportunities for manufactures to flourish in the market.

Get going with a sample of Neuropathic Pain Market report!@https://www.persistencemarketresearch.com/samples/4149

Company Profiles

Key Takeaways Neuropathic Pain Management Market Study

Increasing prevalence of diabetic neuropathy and availability of approved neuropathy pain medications have significantly added to the opportunities for market growth, thereby fostering the rate of adoption of neuropathic pain management drugs.

Increasing R&D Spending by Pharmaceuticals Companies Shaping Future

One of the key factors observed to impact the neuropathic pain management market growth is the development of new drugs for treatment of neuropathic and chronic pains. Companies are focusing on clinical trials to develop drugs for efficient treatment of neuropathic pain. For instance, Eli Lilly and Company developed Duloxetine (LY248686) for Diabetic Peripheral Neuropathic Pain (DPNP) that is under phase 4 clinical trial.

At the same time, companies are focused on expanding therapeutic applications of drugs such as opioids and steroids for neuropathic pain management without causing any serious side effects to patients. Currently, more than 100 clinical trials are been carried out for pain management. Among those clinical trials, nearly half of the clinical trials are for various indications of neuropathic pain such as diabetic neuropathy and post-herpetic neuralgia.

What Does the Report Cover?

The neuropathic pain management market, a new study from Persistence Market Research, provides unparalleled insights on evolution of the neuropathic pain management market during 2014 2018 and presents demand projections during 2019 2029 on the basis of drug class (tricyclic anti-depressants, anticonvulsants, SNRIs, capsaicin cream, local anesthesia, opioids, steroids, and others), indication (diabetic neuropathy, trigeminal neuralgia, post-herpetic neuralgia, chemotherapy-induced peripheral neuropathy and others), distribution channel (retail pharmacies, hospital pharmacies, and online pharmacies) across prominent regions (North America, Latin America, Europe, Asia Pacific and MEA).

About UsPersistence Market Research (PMR), as a 3rd-party research organization, does operate through an exclusive amalgamation of market research and data analytics for helping business ride high, irrespective of the turbulence faced on the account of financial/natural crunches.Contact Us:Persistence Market Research (PMR)Address 305 Broadway, 7th Floor, New York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales sales@persistencemarketresearch.com

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Diabetes symptoms: Sign in your legs of high blood sugar – the ‘pain’ you shouldn’t ignore – Express

February 11th, 2021 8:48 am

Diabetes is a common condition that affects around five million people in the UK. But a lot of people may not even know that they have diabetes. You could be at risk if you develop a subtle pain in your legs.

Diabetes is a life-long condition, and 90 percent of all cases are caused by type 2 diabetes.

Type 2 diabetes is where the body struggles to produce enough of the hormone insulin.

Insulin helps the body to convert sugar in the blood into useable energy.

But if your body isn't getting enough insulin, the amount of sugar in your blood starts to rise, which can lead to diabetes.

READ MORE: Type 2 diabetes symptoms - 'dark adaption' could be a warning sign

"Diabetic neuropathy is a type of nerve damage that can occur if you have diabetes," said the Mayo Clinic.

"High blood sugar can injure nerves throughout your body. Diabetic neuropathy most often damages nerves in your legs and feet.

"Depending on the affected nerves, diabetic neuropathy symptoms can range from pain and numbness in your legs and feet to problems with your digestive system, urinary tract, blood vessels and heart.

"Some people have mild symptoms. But for others, diabetic neuropathy can be quite painful and disabling."

Meanwhile, other common symptoms of diabetes include passing more urine than normal, and feeling unusually tired.

Some people also find that they're always feeling thirsty, despite drinking plenty of fluids.

Speak to a doctor if you're worried about the signs of diabetes.

Diagnosing the condition early could help to lower your risk of diabetes complications, including strokes or heart disease.

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Diabetes symptoms: Sign in your legs of high blood sugar - the 'pain' you shouldn't ignore - Express

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Prothena Reports Fourth Quarter and Full Year 2020 Financial Results, and Provides Financial Guidance and R&D Update – Yahoo Finance

February 11th, 2021 8:48 am

DUBLIN, Ireland, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, today reported financial results for the fourth quarter and full year 2020. In addition, the Company provided 2021 financial guidance and an update on its R&D programs.

We continue to see positive momentum in our pipeline with the recent announcement of the confirmatory, registration-enabling Phase 3 AFFIRM-AL study of birtamimab in AL amyloidosis and positive clinical findings reported in 2020 from both the Phase 2 study of prasinezumab in Parkinsons disease and Phase 1 study of PRX004 in ATTR amyloidosis, said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. We are particularly pleased that our unique protein dysregulation platform has now resulted in the translation of our preclinical findings into clinical benefit for patients across multiple programs in our portfolio. We look forward to a number of significant milestones in 2021, with the planned initiation of 3 late-stage clinical studies, including the birtamimab AFFIRM-AL study, the prasinezumab Phase 2b study and the PRX004 Phase 2/3 study. In addition to these late-stage programs, we have also advanced the three targets under our global neuroscience collaboration with Bristol-Myers Squibb and expect to file an IND for PRX005 this year. Our strong cash position and potential partner payments provide a foundational capital position to fund the company through value-creating milestones as we transition to a fully integrated commercial company.

Story continues

Full Year 2020 and Recent Developments:

Birtamimab, a potential treatment for AL amyloidosis, is a humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Based on significant survival benefit observed in the previous VITAL study in Mayo Stage IV patients (HR=0.413, p=0.025, over 9 months) and multiple in-depth discussions with the U.S. Food and Drug Administration (FDA), Prothena announced plans in February 2021 to advance birtamimab into the confirmatory Phase 3 AFFIRM-AL study in Mayo Stage IV patients with AL amyloidosis. AFFIRM-AL is a global, registration-enabling Phase 3 study that will be conducted with a primary endpoint of all-cause mortality at p0.10 under a Special Protocol Assessment (SPA) agreement with FDA.

Prasinezumab, a potential treatment for Parkinsons disease, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

Presented results from Phase 2 PASADENA study showing prasinezumab significantly slows progression on pre-specified clinical measures of Parkinsons disease in September 2020 at the International Parkinson and Movement Disorder Societys 2020 Congress. Prasinezumab is the first potentially disease-modifying, anti-alpha-synuclein antibody to demonstrate signals of efficacy on multiple pre-specified secondary and exploratory clinical endpoints in patients with early Parkinsons disease.

Announced that Roche and Prothena will advance prasinezumab into a late-stage Phase 2b study in patients with early Parkinsons disease. The study will be designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinsons disease on stable levodopa therapy. Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage development.

PRX004, a potential treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein

Reported results from the Phase 1 study of PRX004, the first anti-amyloid immunotherapy designed to deplete amyloid to demonstrate efficacy in ATTR amyloidosis. In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels.

PRX012, a potential treatment for Alzheimers disease, is monoclonal antibody targeting key epitopes within the N-terminus of A

Multi-immunogen vaccine, for the potential prevention and treatment of Alzheimers disease, is a multi-immunogen A-tau vaccine

Presented data on a multi-immunogen vaccine that targets key A and tau epitopes, the two main pathological proteins involved in the cause and progression of Alzheimers disease, at the CTAD Conference in November 2020

Corporate

Appointed Brandon Smith as Chief Business Officer, responsible for leading Prothenas business development activities, portfolio strategic planning and alliance management activities. Mr. Smith joined Prothena after serving as Chief Operating Officer at Iconic Therapeutics

Upcoming Milestones:

Birtamimab

Prasinezumab

New pre-specified exploratory subgroup analyses from Part 1 of the Phase 2 PASADENA study to be presented at the 15th International Conference for Alzheimers and Parkinsons Diseases in March 2021 (ADPD 2021)

$60 million clinical milestone payment to be achieved upon first patient dosed in late-stage Phase 2b study in patients with early Parkinsons disease; further details expected in 2Q 2021

Results from Part 2 of the PASADENA study expected to be presented at an upcoming medical conference

PRX004

PRX005

Preclinical data to be presented in March at ADPD 2021

IND filing expected 3Q 2021

$80 million potential payment from Bristol-Myers Squibb upon exercising their US license option in 2021

PRX012

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

H.C. Wainwright Global Life Sciences Conference on Tuesday and Wednesday, March 9-10, 2021, virtual presentations will be available on demand both days

Oppenheimer 31st Annual Healthcare Conference on Wednesday March 17, 2021 at 10:00 AM ET

Stifels 3rd Annual CNS Day on Thursday April 1, 2021 at 8:00 AM ET

Fourth Quarter and Full Year of 2020 Financial Results and 2021 Financial Guidance

For the fourth quarter and full year of 2020, Prothena reported a net loss of $30.7 million and $111.1 million, respectively, as compared to a net loss of $21.6 million and $77.7 million for the fourth quarter and full year of 2019, respectively. Net loss per share for the fourth quarter and full year of 2020 was $0.77 and $2.78, respectively, as compared to a net loss per share of $0.54 and $1.95 for the fourth quarter and full year of 2019, respectively.

Prothena reported total revenue of $0.4 million and $0.9 million for the fourth quarter and full year of 2020, respectively, primarily due to license revenue in the fourth quarter and collaboration revenue for the full year as compared to total revenue of $0.3 million and $0.8 million for the fourth quarter and full year of 2019, respectively, primarily due to Roche collaboration revenue.

Research and development (R&D) expenses totaled $20.8 million and $74.9 million for the fourth quarter and full year of 2020, respectively, as compared to $15.5 million and $50.8 million for the fourth quarter and full year of 2019, respectively. The increase in R&D expense for the fourth quarter and full year of 2020 compared to the same periods in the prior year was primarily due to higher manufacturing costs primarily related to our PRX005, birtamimab and PRX012 programs and to a lesser extent PRX004, higher collaboration expense with Roche related to the prasinezumab program and higher R&D consulting expense. R&D expenses included non-cash share-based compensation expense of $2.1 million and $8.2 million for the fourth quarter and full year of 2020, respectively, as compared to $2.0 million and $8.1 million for the fourth quarter and full year of 2019, respectively.

General and administrative (G&A) expenses totaled $9.9 million and $38.7 million for the fourth quarter and full year of 2020, respectively, as compared to $8.1 million and $35.7 million for the fourth quarter and full year of 2019, respectively. The increase in G&A expenses for the fourth quarter and full year of 2020 compared to the same periods in the prior year was primarily related to higher costs for our director and officer insurance premiums. G&A expenses included non-cash share-based compensation expense of $3.2 million and $13.8 million for the fourth quarter and full year of 2020, respectively, as compared to $3.3 million and $15.5 million for the fourth quarter and full year of 2019, respectively.

Total non-cash share-based compensation expense was $5.2 million and $22.0 million for the fourth quarter and full year of 2020, respectively, as compared to $5.3 million and $23.6 million for the fourth quarter and full year of 2019, respectively.

As of December 31, 2020, Prothena had $298.1 million in cash, cash equivalents and restricted cash and no debt.

As of February 5, 2021, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company expects the full year 2021 net cash used in operating and investing activities to be $51 to $74 million, which includes an expected $60 million milestone payment from Roche upon first patient dosed in the late-stage Phase 2b study of prasinezumab and expects to end the year with approximately $235 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2021 net cash used in operating and investing activities is primarily driven by an estimated net loss of $79 to $111 million, which includes an estimated $20 million of non-cash share-based compensation expense.

Conference Call Details

Prothena management will discuss these results and its 2021 financial guidance during a live audio conference call today, Thursday, February 11, 2021, at 8:30 AM ET. The conference call will be made available on the Company's website at http://www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company's website for at least 90 days.

To access the call via dial-in, please dial (877) 887-5215 (U.S. and Canada toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 5677514. A replay of the call will be available until February 25, 2021 via dial-in at (855) 859-2056 (U.S. toll free) or (404) 537-3406 (international), Conference ID Number 5677514.

About Prothena

Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothenas pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimers disease, Parkinsons disease and a number of other neurodegenerative diseases. For more information, please visit the Companys website at http://www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; our goal of building a protein dysregulation platform; the treatment potential and proposed mechanisms of action of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and multi-immunogen A-tau vaccine; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; amounts we might receive under our collaborations with Roche and Bristol-Myers Squibb; the expected timing of reporting data from prior clinical studies of birtamimab, the Phase 2 clinical study of prasinezumab, and preclinical studies of PRX005; our anticipated net cash burn from operating and investing activities for 2021 and expected cash balance at the end of 2021; and our estimated net loss and non-cash share-based compensation expense for 2021. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the Risk Factors sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2020, discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC, and our Annual Report on Form 10-K to be filed with the SEC for our fiscal year 2020. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

PROTHENA CORPORATION PLCCONSOLIDATED STATEMENTS OF OPERATIONS(unaudited - amounts in thousands except per share data)

Three Months EndedDecember 31,

Twelve Months EndedDecember 31,

2020

2019

2020

2019

Collaboration revenue

$

121

$

256

$

564

$

814

License revenue

239

289

Total revenue

360

256

853

814

Operating expenses:

Research and development

20,760

15,471

74,884

50,836

General and administrative

9,908

8,059

38,703

35,736

Restructuring (credits)

(61

)

Total operating expenses

30,668

23,530

113,587

86,511

Loss from operations

(30,308

)

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Diabetic Foot Ulcer Therapeutics Market Overview 2021: Top Companies Analysis, Outlook, Market Share, Trends and Segmentation KSU | The Sentinel…

February 11th, 2021 8:48 am

Diabetic Foot Ulcer Therapeutics Market is valued at USD 2549.3 Million in 2018 and expected to reach USD 4397.4 Million by 2025 with a CAGR of 8.1% over the forecast period. Increasing geriatric population across the globe is anticipated to drive growth of Global Diabetic Foot Ulcer Therapeutics Market.

Diabetic foot ulcers are a common complication of poorly controlled diabetes, forming as a result of skin tissue breaking down and exposing the layers underneathThere is a more possibility that people with diabetes can develop foot ulcers but good foot care can help prevent them. Theyre most common under the big toes and the balls of feet, and they can affect the feet down to the bones. The risk of developing a diabetic foot ulcer increases with in time. The major causes of diabetic ulcers includes; poor circulation, high blood sugar, nerve damage and irritated or wounded feet. A majority of non-infected foot ulcers are treated without surgery; however, if this treatment fails, surgical management may be appropriate. Major surgical procedures to remove the pressure on affected area majorly include the correction of various deformities such as hammertoes, bunions, or bony bumps and shaving or excision of bone. Healing time depends on a variety of factors which includes; wound size and location, pressure on the wound from walking or standing, blood glucose levels, swelling, circulation, wound care and others. Healing may require few weeks or several months. The top priority in treating the diabetic foot syndrome is to avoid a major amputation.

Get Sample Copy of The Report@https://brandessenceresearch.com/requestSample/PostId/308

Global diabetic foot ulcer therapeutics market report is segmented on the basis of product type, ulcer type, end-user and region & country level. Based upon product type, global diabetic foot ulcer therapeutics market is classified into wound care dressings, therapy devices, biologics, antibiotic medications and others. Based upon ulcer type, global diabetic foot ulcer therapeutics market is divided into neuropathic ulcers, neuro-ischemic ulcers and ischemic ulcers. Based on end-user, the diabetic foot ulcer therapeutics market is classified into hospitals, ambulatory surgical center, specialty clinics and others.

The regions covered in this Global Diabetic Foot Ulcer Therapeutics Market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, the market of diabetic foot ulcer therapeutics is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, Middle East Asia (UAE, Saudi Arabia, Egypt) GCC, Africa, etc.

Some major key players for global diabetic foot ulcer therapeutics market are Acelity L.P. Inc., 3M Healthcare, ConvaTec, Inc., Medline Industries, Inc., Medtronic Plc., Coloplast A/S, Smith & Nephew Plc., B. Braun Melsungen AG, Molnlycke Health Care AB, Organogenesis, Inc., BSN Medical GMBH and others.

Increasing Geriatric Population Coupled with the Increasing Prevalence of Diabetes Worldwide Drives Global Diabetic Foot Ulcer Therapeutics Market

The major factor driving the growth of global diabetic foot ulcer therapeutics market is increasing incidences of foot ulcers coupled with the increasing prevalence of diabetes. For example; As per National Center for Biotechnology Information; The prevalence of diabetic foot ulcer among diabetic patients in Gondar University Referral Hospital was found to be high. Residence, higher BMI (overweight and obesity), types of diabetes, neuropathy, and foot self-care practice were factors significantly associated with diabetic foot ulcer. In addition, increasing inclination towards the avoidance of surgeries and amputation is also supplementing the growth of diabetic foot ulcer market. Furthermore, increasing geriatric population is also fostering the market growth as this population is more prone to diabetes. However, high cost of ulcer treatments may hamper the market growth. In spite of that, increasing advancements in and adoption of innovative ways of treatments can provide various opportunities for the further growth of the market.

North America is Expected to Dominate the Global Diabetic Foot Ulcer Therapeutics Market

The global diabetic foot ulcer therapeutics market is segmented into North America, Europe, Asia-Pacific Latin America and Middle East & Africa. North America is expected to dominate the global diabetic foot ulcer therapeutics market within the forecast period attributed to large diabetic patient pool due to the an aging population and the growth of minority populations are expected to add to the diseases prevalence. For example; Centers for Disease Control and Prevention; In the United States, Currently, 1 in 10 Americans has Type 2 diabetes and if current trends continue then 1 in 3 people will have Type 2 diabetes by 2050. But if new cases develop as estimated then its prevalence could double or triple over the next 40 years. In addition, highly developed healthcare infrastructure and increasing adoption of wound care devices are also supplementing the growth of diabetic foot ulcer therapeutics market in this region.

Asia Pacific is anticipated to witness a lucrative growth in global diabetic foot ulcer therapeutics market owing to the increasing geriatric population which is more prone to diabetes. The aging of the population in China and India will bring with it an increase in the burden of chronic disease. The number of people with diabetes in China is projected to increase 103.4 percent, from 20.8 million to 42.3 million, between 2000 and 2030. In comparison, the rate of diabetes in India is expected to increase 150.5 percent, from 31.7 million to 79.4 million, over the same period.

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Key Benefits Market Report

Market Segmentation:-

By Product Type:

By Ulcer Type:

By End-User:

By Regional & Country Level:

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Most Painful Cancer: What to Know about Pain and Treatment – Healthline

February 11th, 2021 8:48 am

Pain is a common cancer symptom. In fact, its estimated that approximately 66 percent of people with cancer will experience pain as a symptom at some point.

Cancer pain can have several causes. These can include the cancer itself or the effects of various treatments or surgeries that are used to treat the cancer.

While all cancers can cause pain, some, such as those affecting the bones or pancreas, are more frequently associated with pain. Regardless of the type of cancer, its important that remember that cancer pain can often be treated.

Continue reading below to learn more about cancer and pain, how this pain can be managed, and more.

All cancers have the potential to cause pain. The amount of cancer pain you may experience can depend on many different factors, including:

According to the National Cancer Institute, younger individuals are more likely to experience cancer pain and people with advanced cancer tend to experience more severe pain.

When the cancer itself causes pain, its often due to a tumor thats pressing on other organs, bones, or nerves. Tumors can also spread to other areas, such as the spinal cord and bones, leading to pain as well.

Below, well discuss some types of cancer that are commonly associated with pain and why the pain may occur. As we do so, its important to keep in mind that even severe cancer pain can be treated.

Bone cancer is when cancer occurs in your bones. Cancer that originates in the bone, which is called primary bone cancer, is actually quite rare in adults. In fact, it makes up only 0.2 percent of all cancers.

Many times, when someone has bone cancer, its actually due to cancer thats spread to the bones from another location in the body. This can happen with many types of cancer, such as those of the breast, lung, and prostate.

Pain is one of the main symptoms of cancer in the bones. The presence of cancer cells can interfere with the normal maintenance of bone tissue, making your bones weaker. A growing tumor may also press on nerves around the bone.

The pain from bone cancer often begins as a dull pain that comes and goes and is typically worse at night. Eventually, the pain can become constant. Because bone tissue has become weak, its also prone to breaking.

Pancreatic cancer is cancer that develops in your pancreas. The pancreas is an organ that produces enzymes that are important for digestion. It also helps to regulate your blood sugar.

In its early stages, pancreatic cancer can be asymptomatic. Because of this, about 80 percent of pancreatic tumors are detected at more advanced stages. When symptoms are present, they can include abdominal or back pain, jaundice, and weight loss.

Pain from pancreatic cancer can be severe. It can be due to a tumor that presses on surrounding nerves, the spine, or organs in your abdomen like your liver or intestines.

Head and neck cancers are those that start in your:

The symptoms of head and neck cancer can depend on their specific location but often include pain. Like other types of cancer, pain is often due to a tumor that presses on surrounding nerves and structures.

Cancer pain can be exacerbated in the head and neck because the area has a high number of nerves. Additionally, your head and neck contain many structures that are situated within a relatively small space.

A tumor in your head or neck can also cause discomfort by interfering with various body functions. These can include things like eating, swallowing, or breathing.

Your brain and spinal cord make up your central nervous system (CNS). The CNS collects, processes, and responds to sensory information collected from your body and your environment. Think of it as your bodys control center.

Tumors around your brain or spinal cord can put pressure on the surrounding nerves and structures, leading to pain. This can also cause other symptoms like seizures, trouble with movement, and sensory problems.

The most common symptom of a brain tumor in adults is headache. These headaches often become more frequent and severe as time passes.

Pain from a tumor affecting the spinal cord can be characterized as burning, sharp, or tingling. It can happen at a specific location and may also radiate out to other areas of the body. It can be severe and may become constant as time passes.

Lung cancer is cancer that starts in your lungs. Its one of the most common cancers in the world.

Similar to pancreatic cancer, lung cancer has few symptoms in its early stages. Because of this, many times it isnt diagnosed until more advanced stages.

As lung cancer grows and spreads, it can put pressure on your lungs and chest wall. This can lead to chest pain that gets worse when you breathe, cough, or laugh.

Additionally, tumors may partially or completely block some airways. This can also lead to discomfort and can cause distressing symptoms like shortness of breath and wheezing.

There are many different ways to help manage cancer pain. Lets take a deeper dive into some of them below.

Many times, medications are prescribed to help ease cancer pain. Your doctor will select a medication based on whether your pain levels are mild, moderate, or severe.

Some examples of medications that can be given for cancer pain are:

In addition to medications, there are other ways to help manage cancer pain. These can include:

In addition to pain thats caused from the cancer itself, the various types of cancer treatments can also potentially lead to pain. Lets explore this further.

Surgery may be used to remove a tumor from your body. If you have surgery for cancer, its normal to experience postoperative pain in the days or weeks after your procedure.

Pain from surgery is typically treated using medications. Its possible youll need to use stronger pain medications right after your surgery and then switch to less strong medications in the following days.

In some cases, you may experience phantom pain following surgery. This is pain or discomfort that feels like its coming from an area of your body thats been removed. It may happen if youve had a breast or limb surgically removed.

There are several treatment methods that may work for phantom pain. These include medications, TENS, or physical therapy.

Chemotherapy uses strong medications to kill cancer cells. However, it can also lead to side effects that can be painful. One of these is chemotherapy-induced peripheral neuropathy (CIPN), which can cause pain, numbness, and tingling.

According to the National Cancer Institute, studies on medications and natural products to help relieve pain due to CIPN have had mixed results. Some examples of medications that may be used include:

Alterative treatment methods for CIPN are also being explored. Some examples of these include acupuncture and relaxation therapy.

Mouth and throat sores may also develop as a side effect of chemotherapy. While these often go away on their own eventually, you can ease discomfort by applying a topical pain medication and avoiding foods that may irritate the sores.

Radiation therapy utilizes high amounts of radiation to kill cancer cells. Like chemotherapy, it may also cause painful side effects. These can include:

Treatment for the side effects of radiation therapy can depend on the symptoms youre experiencing. They may include pain medications, steroids for inflammation, or antiseizure medications for nerve pain.

Other types of cancer treatments, such as immunotherapy and targeted therapy may cause pain as a side effect as well.

Medications are used to help ease these side effects as you receive treatment. Side effects typically go away once your treatment ends.

Cancer pain can be effectively managed using a variety of methods, helping to ease this symptom and improve your quality of life. Because of this, talk with your doctor if you have cancer and experience pain that:

When you see your doctor, be sure to tell them:

Its likely that youll be asked to rate your pain on a scale. For example, this may be done on scale of 1 to 10, where 1 would mean that youre experiencing little pain and 10 would mean that youre experiencing very severe pain.

Your doctor and care team can use this information as well as your medical history to help develop a plan to better manage your pain.

If youve recently been diagnosed with cancer, you may feel scared or worried. There are resources that can help you to cope with these feelings.

One of these resources is support groups. Support groups are made up of people whose lives have been touched by cancer. These can include other people with cancer, their loved ones, and cancer survivors.

In these groups, you can discuss your experience with cancer, learn about new treatments, and receive support and encouragement from others. Some resources for finding a support group near you are:

Its also possible that you may not be ready to talk about your feelings in a group setting. This is completely normal.

If youre feeling distressed, anxious, or depressed about your diagnosis, it may be beneficial to speak to a mental health professional like a psychologist or psychiatrist. Your doctor can recommend one near you that has experience working with people with cancer.

Pain is a common symptom of cancer. It can be caused by the cancer itself, by the methods used to treat cancer, or both.

Some cancers are associated with more pain than others. These can include those of the bones, pancreas, and head and neck. However, pain can happen with all cancers.

Its always important to keep in mind that cancer pain is treatable. In fact, there are many methods that may be used to manage cancer pain.

Speak to your doctor if you have new pain, pain that doesnt go away, or pain that happens even when you take your current pain medications. They can work with you to adjust your pain management plan to help alleviate cancer pain.

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Most Painful Cancer: What to Know about Pain and Treatment - Healthline

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Type 2 diabetes symptoms: Do you experience ‘dark adaption’? It could be a warning sign – Express

February 11th, 2021 8:48 am

Blood sugar - the main type of sugar you get from eating food - supplies the body's cells with energy. However, consistently high levels can unleash destruction on the body. If you have type 2 diabetes, you are prone to high blood sugar levels because the main regulating force - insulin production - is impaired.

The effects of high blood sugar levels often constitute the first perceptible warning signs of type 2 diabetes.

Some of the most acute symptoms stem from autonomic neuropathy - damage to nerves that control your internal organs.

As the National Institute of Diabetes and Digestive and Kidney Diseases (NIH), high blood sugar in the blood from diabetes can damage your nerves and the small blood vessels that nourish your nerves, leading to autonomic neuropathy.

Struggling to adjust your eyes in a dark room is a warning sign of autonomic neuropathy.

READ MORE:Diabetes type 2 symptoms: The alternating toilet habits that signal high blood sugar

NIH explains: "Damage to the nerves in your pupils may make them slow to respond to changes in light and darkness."

The health body adds: "Your eyes may take longer to adjust when you enter a dark room. You may have trouble seeing the lights of other cars when driving at night."

This is otherwise known as 'dark adaptation', which refers to how the eye recovers its sensitivity in the dark after exposure to bright lights

Other signs of autonomic neuropathy include problems with:

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According to the NHS, you should see a GP if you have any of the symptoms of type 2 diabetes or you're worried you may have a higher risk of getting type 2 diabetes.

"You'll need a blood test, which you may have to go to your local health centre for if it cannot be done at your GP surgery."

The earlier diabetes is diagnosed and treatment started, the better.

As the NHS explains, early treatment reduces your risk of other health problems.

Lifestyle changes are usually recommended to bring blood sugar levels down to keep the risks of diabetes at bay.

There are two key components to blood sugar control - eating a healthy, balanced diet and regular exercise.

A common misconception about type 2 diabetes is that you need to avoid eating certain foods.

There's technically nothing you cannot eat if you have type 2 diabetes, but you'll have to limit certain foods.

The worst offenders are carbohydrates because carbs are brown down into glucose relatively quickly - this causes spikes in blood sugar.

There are some general dietary principles that can help you to manage type 2 diabetes.

According to the NHS, you should:

Physical exercise helps lower your blood sugar level - you should aim for 2.5 hours of activity a week, advises the health body.

"You can be active anywhere as long as what you're doing gets you out of breath," it adds.

Originally posted here:
Type 2 diabetes symptoms: Do you experience 'dark adaption'? It could be a warning sign - Express

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How the law will change in 2021 – Lexology

February 11th, 2021 8:47 am

The changes brought by the COVID-19 pandemic have had an impact across society, and courts and IP offices are no exception. As part of our series of articles looking at what to expect in 2021, Kilburn & Strode attorneys discuss some of the legal developments on the horizon.

Its not just business meetings, webinars and Christmas quizzes that are suited to Zoom; court and IP office hearings are increasingly conducted virtually too.

At the EPO, oral proceedings in examination and oppositions will be heldonlineunless there are exceptional circumstances until September 2021 (at least). Board of Appeal hearings are heading the same way. While some practitioners have been sceptical about these changes, at Kilburn & Strode we see video conferencing as a hugely powerful and accessible medium for getting to a good decision quickly.

This is good news for SMEs, who may now be able to afford to fight cases they couldnt otherwise, says associate Rosie Carrie. But, she adds, the long-term implications are hard to predict: Will parties be more likely to be confrontational when not seeing each other in person? Will they pursue arguments more strongly? Will the opportunity to resolve issues in an informal setting be missed?

At the EUIPO, there may be changes too. Areformin 2019 overlooked by many people at the time means that the CJEU now accepts appeals from the EU General Court only where they raise an issue that is significant with respect to the unity, consistency or development of EU law. In practice, this means the General Court is now the final arbiter for most cases involving EU trade marks and registered Community designs. That may lead to the EUIPO Boards of Appeal holding more oral hearings between parties, something that until now has been extremely rare.

Patent priorities

With normal routines disrupted and the opportunity to reflect, the pandemic has led many people to consider their values and priorities getting fit, learning new hobbies or their social and political values. Policy debates about the balance between competition and innovation, between access and reward; or between control and free speech have always been part of IP. In this new environment, will we see them become even more prominent?

In patents, for example, partnerNick Bassilsays he increasingly sees morality issues being raised regarding patents for stem cells, gene therapy etc, arising from the ordre public (public policy) and morality exception in Article 53(a) of the EPC: This will become more and more relevant with genetic medicine. More generally, debates about access to medicine, the role of patents, pricing mechanisms and sourcing of drugs are gaining attention as the pandemic increases awareness (if not understanding) of the role of medicine (see our separate article on political and social trends).

On your marks

In trade marks, meanwhile, debates are continuing about the proper scope of protection and whether making broad and/or multiple related trade mark applications should be discouraged (including on the grounds of bad faith). These issues were not fully resolved in last yearsSkyKickdecision from the CJEU, but should be addressed further in the MONOPOLY case pending before the EU General Court.

Trade mark partnerIain Stewartsays: These debates reflect wider concerns about the cluttering of trade mark registers. One view is that unlike in the US where there are strict use requirements, in Europe there are too many marks that are registered but not used. It means clearance searches in the EU are becoming a nightmare. Sometimes the results run to dozens of pages, explains Iain. As well as being a practical challenge for those seeking to apply for trade marks, particularly internationally, cluttering raises questions about the accessibility of the trade mark system and its ability to serve all users, especially SMEs.

UPC or not UPC?

The end of 2020 saw Germany take important steps towards ratifying the Unified Patent Court (UPC) Agreement, raising the possibility that it could theoretically come into effect, though significant legal challenges remain (meaning ratification by Germany and implementation in 2021 is unlikely).Gwilym Robertssays: The UPC was always a lofty ideal and the simplification it offers remains attractive. But with the continuing legal challenges it faces one wonders if its time to look at alternative multilateral arrangements bringing the same benefits.Whatever comes out Kilburn & Strode will continue to be a part of it as we continue to expand our European presence.

Read article three here

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How the law will change in 2021 - Lexology

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Writing is the best medicine – The London Economic

February 11th, 2021 8:47 am

In addition to carving out a distinguished medical career, Dr Cliff Bacchus has built a reputation as a novelist unafraid to tackle challenging social issues, most recently the practice of intermarriage between cousins.

By the time they reach their sixties, most people would be looking forward to retiring and taking things easier. For medical doctor Dr Cliff Bacchus, however, it marked the launch of a second career as a novelist.

Now aged 78, Dr Bacchus has published three critically-acclaimed novels within the last 15 years, with the latest gripping psychological thriller Curses of Cousins just released.

For the Bahamas-based author, who also runs two busy pain management clinics in the country, writing is a much-needed creative escape from the pressures of the day job.

Since 1974, he has served the medical needs of the Bahamian island that has been his adopted home since he left his native Guyana to study medicine in what was then Communist Russia.

During all that time, he has consulted the rich, the famous, and the less fortunate with equal attention, and care for all, initially as a senior medial officer working for the government before going into private practice in the early 2000s.

His standing as a physician also led him to be cast as a doctor in 2007 Bahamas-set Hollywood film Bad Girl Island after he conducted the medical examinations for the director, Stewart Raffill, and crew.

Perhaps somewhat unsurprisingly, Dr Bacchus draws heavily upon his training and experiences for his novels also including his literary debut, 2007s A Doctor and a Gentleman and 2011s Do No Harm in the sense that they are all fundamentally driven forward by a thought-provoking consideration of contemporary medical issues or ethics.

In the case of Curses of Cousins, the narrative is wrapped around an exploration of intermarriage between cousins.

It is a practice that goes on not only in certain communities within the Bahamas but around the world, including the UK. While perfectly legal, it is a semi-taboo subject within society, hardly spoken of.

The problem is that this practice also carries with it a serious risk of genetic defects in any resulting offspring. Indeed, it is believed that two children born from such unions die in the UK from resultant genetic abnormalities every single week.

In the novel, the protagonist, teacher Brooklyn Watts, sets out to find out why her family, and many other families on the fictional Bahamian island of Sigatoo, suffer chronic, incurable illnesses.

In her case, it is alopecia and multiple sclerosis (MS), and, as she quickly comes to learn, her and others ill-health, previously attributed to a curse, is in fact a direct result of the traditional island practice of cousin marriage.

Despite the pain she suffers daily from her debilitating condition, she sets out on a quest to educate the population about the risks that such marriages carry to the next generation.

For Dr Bacchus, who was named Physician of the Year by the Government of the Bahamas in 2000, it is a vitally-important health issue to address.

I got the idea for Curses of Cousins as I have had several patients with genetic-based conditions that resulted from intermarriage between cousins, he says.

Im not calling for the practice to be banned outright, but there needs to be an open acknowledgment that children of such marriages run a significant risk of inheriting genetic defects that could impact their quality of life.

With this awareness then, at least, those who still wish to enter into such relationships can understand the importance of carrying out genetic counselling and blood tests to ensure a healthy progeny.

The novel is also notable for another battle that Brooklyn must face while trying to confront ignorance, superstition, and traditionalism within her society: a war between the literal forces of good and evil for control of her mind.

I always include a metaphysical aspect to my novels, explains Dr Bacchus who, in additional to a medical degree and membership of the American Association of Family Physicians and the American Association of Anti-Aging Medicine, holds a degree in metaphysical science and is the Worshipful Master of his islands Masonic lodge.

I do believe that beyond the physical we are all attuned to a higher, cosmic consciousness.

In Curses of Cousins this war between the personifications of good and evil adds a deeper level to the readers understanding of Brooklyn, and also another perspective on the obstacles she must overcome from certain parts of society in bringing about positive change.

As well as praising his latest novel for its originality and daring to broach the pressing issue of cousin marriage, reviewers have also highlighted Dr Bacchuss realistic depiction of a female lead a rare achievement for a male author.

This, however, is something that he attributes as much to his environment as his writing skills.

He says: All my life Ive been in the company of women. My children were all girls and in all my years of practice I have worked alongside female nurses.

Its given me a better understanding of the female mind than most men, I think, and it is wonderful that readers and reviewers concur.

Brooklyn was a fascinating character to create, being independently-minded, courageous and determined to protect future generations so that they wouldnt suffer in the same way that she does.

Some readers have called her inspirational, and that makes the whole writing process more than worthwhile.

I always intended to highlight the issue of intermarriage through fiction because it stands a much better chance of reaching the widest audience, compared to a dusty old academic paper that will never be read by anyone save other doctors.

But a novel stands or falls on whether the central character engages with readers, so it looks like all those years in almost exclusively female company has paid off.

As to the future, Dr Bacchus is already working on his next novel, which will be focused on another global issue world poverty.

Writing keeps my young, he adds. Its far more relaxing the medicine while also providing the opportunity to communicate with the world.

Curses of Cousins by Cliff Bacchus is out now on Amazon , priced 9.07 in paperback and 3.02 as an eBook.

EXCLUSIVE INTERVIEW WITH DR CLIFF BACCHUS

Dr Cliff Bacchus discusses his new novel, psychological thriller Curses of Cousins, and what motivates him as an author.

Q. What was your motivation for becoming an author?

A. To expand my outreach to people around the world.

Q. Your latest novel deals with a very grave subject: the risk of genetic abnormalities from intermarriage. Why did you feel it better to cover this subject through fiction than nonfiction?

A. Through fiction, I can reach more people, and generate more interest through theme, plot structure, unique characterisation, and suspense.

Q. What do you hope readers get from reading your new novel, Curses of Cousins?

A. I want them to grasp the theme: that cousins marrying cousins may not be the best for the children you give birth to. However, this is not a concrete rule. There are many who intermarry because of custom and religion, but it is time to reflect on the subject. If it works for you, fine! It is my point of view, based on experience as a medical doctor for nearly five decades.

Q. How did you get the idea for your latest novel?

A. From my medical experience over many decades.

Q. Describe a typical day in your life

A. I rise early, write for two hours until clinic time, 8 am to 11 am. Then its clinic again from 3 pm to 5 pm, followed by a walk and watching BBC news, CNN and talk shows, or a spot of painting on canvas. Bedtime is by 12 midnight.

Who are your literary inspirations, and why?

A. Shakespeare, Jane Austin, and Sidney Sheldon. Inspirational!

Q. All your novels include a metaphysical element. Can you explain why you feel it important to weave this into your stories?

A. Metaphysics deals with abstract concepts such as being, knowing, identity, time, and space. My novels are just about that. My novels must have meaning!

Q. If you could offer one piece of advice to somebody wanting to become an author, what would it be?

A. Be prepare to work hard and love it. Be prepared to accept the lonely life and love it. Be prepared to do research and love it.

Q. What satisfaction does writing bring you?

A. Knowing that I can communicate the truth and hope for the acceptance of it.

What can readers expect next from you?

A. Another work of fiction as I hone the craft for better and better.

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Writing is the best medicine - The London Economic

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Misleading glyphosate-cancer study Part 2: ‘Symptom of a widespread problem’Concerns about ideological activism in science research and communications…

February 11th, 2021 8:47 am

For the better part of five years, a coalition of environmental groups and tort lawyers (aided by the mainstream press) has relentlessly asserted that the weedkiller glyphosate poses a serious cancer risk. A team of respected epidemiologists poured gasoline on this already raging fire in 2018, when they published a meta-analysis (which Ill refer to as the Zhang paper after the first author) that found a significant association between glyphosate exposure and the risk of non-Hodgkins lymphoma (NHL).

In part one of this series, I detailed how the authors of what appeared to be an important paper made some highly questionable decisions in order to reach their conclusion, namely selecting certain data points and excluding others from the studies they considered. Despite the serious defects that I and a few other scientists pointed out soon after the paper appeared online, the papers conclusion that relatively heavy exposure to glyphosate was associated with a 41 percent increased risk of NHL ensured that it would get widespread publicity.

But there were still other indications of bias in the paper that provide insight into the authors thinking. In this follow-up piece, I want to examine some of the other instances of bias, then address three crucial questions. How could this paper, flawed as it is, have passed peer review and largely escaped serious criticism in the two years following publication? What does the Zhang paper reveal about the authors mindset, and about standards of scholarship in the field of environmental epidemiology? And, finally, what are the implications for efforts to produce reliable science that can guide policy makers and consumers?

Well before I got to the heart of the Zhang paper, I picked up signals that put my critical antennae on guard. On page three, the authors stated, GBHs [glyphosate-based herbicides] have recently undergone a number of regional, national, and international evaluations for carcinogenicity in humans [20-23], resulting in considerable controversy regarding glyphosate and GBHs overall carcinogenic potential.

In order to support their claim of considerable controversy, the authors provided two references to agencies that found that glyphosate is not a health concern (US Environmental Protection Agency, EPA; Joint FAO/WHO Meeting on Pesticide Residues, JMPR) and two that found it to be a probable carcinogen (The International Agency for Research on Cancer, IARC; and Californias Office of Environmental Health Hazard Assessment, OEHHA), thus implying that opinion is evenly divided and balanced.

In fact, roughly a dozen national and international agencies have found glyphosate to be safe and non-carcinogenic (EPA, Health Canada, the European Food Safety Authority, the European Chemicals Authority, the UNs Food and Agriculture Organization, and the health agencies of France, Germany, Australia, New Zealand, Japan, and Brazil). The fact is that IARC is the only major agency that has found glyphosate to be problematic, and its analysis has been deemed defective by many independent experts. As for OEHHA, it mechanically follows IARC in its designation of carcinogens under Californias Proposition 65, a byzantine law approved by voters in 1986 that has led the Golden State to list garlic bread and, for a time, coffee as possible carcinogens.

Whatever controversy over glyphosate there is, then, is the product of political and legal considerations, not evidence that the weedkiller causes cancer. However, the assertion that there is considerable controversy is important to the Zhang authors because, in their telling, it is what motivated their meta-analysis, as the following sentence makes clear: Hence, addressing the question of whether or not GBHs are associated with NHL has become even more critical (emphasis mine).

Throughout the paper, there are other similarly one-sided characterizations of the evidence on specific topics.

First, in their introduction, the authors emphasized the amount of glyphosate used in the past decade and noted that it has been detected in various foods and baby formula, concluding that glyphosate may be considered ubiquitous in the environment. However, they omitted that glyphosate has relatively low acute and chronic toxicity compared to other pesticides and that the levels detected in foods are well below the level at which any adverse effects would be expected.

They observed that use of glyphosate increased roughly 16-fold between 1992 and 2009, but they failed to note that the incidence of NHL has remained unchanged over the past thirty years.

Second, they articulated criticisms of the Agricultural Health Study (AHS) at length based on secondary considerations, but failed to note its strengths. The AHS is, in fact, the best epidemiological investigation of glyphosates cancer-causing potential, and it poses a significant challenge to Zhangs conclusion. It is striking that the authors failed to note the much more serious problems with the case-control studies they inappropriately combined with the AHS (Read part one for a full analysis of this issue).

Third, to supplement the results of the meta-analysis of human studies, Zhang et al. summarized the results of studies of lymphomas in mice following the administration of glyphosate, which they interpreted as providing additional evidence of the carcinogenicity of glyphosate. However, the evidence appears mixed and, where increasing trends were seen in the tumor yield with increasing doses of glyphosate, they were modest. Researchers have evaluated glyphosate rodent studies for all tumor sites and found more instances of tumor decreases with increasing glyphosate exposure levels than tumor increases.

Finally, the authors pointed to a number of biological mechanisms that may play a role in the development NHL in humans and of lymphoma in animals. While such mechanisms are worthy of study, it is generally recognized that the results of laboratory studies are less directly relevant to risk assessment than epidemiologic studies and, secondarily, animal experiments.

Thus, there is a pattern throughout the Zhang paper of what I call motivated reasoning. Rather than evaluating the evidence on its merits, the authors constructed a narrative designed to support their a priori hypothesis. In other words, their critical faculties served to imprison them in their motivated thinking, always a danger in science thatphysicist Richard Feynman addressed in his 1974 commencement address at Caltech titled Cargo Cult Science. Feynman emphasized that when you formulate a hypothesis, you must list all the observations and facts that support it, but you must also list all of the observations and facts that do not agree with it. This is the only way not to fool yourselfand, Feynman added, you are the easiest person to fool.

Given the Zhang papers unjustified assumptions and methodological flaws, how did it survive peer review? Peer review is a lottery, by which I mean the quality of the review depends very much on the individuals who perform the review, as well as the editor who oversees the review. Some reviewers are tough minded and the study author senses they miss nothing in evaluating a paper.

At the other extreme, reviewers who are less alert or less methodologically astute may feel that the authors have made a convincing case. I would argue that Zhang et al. wrote their paper with an emphasis on justifying their choices and judgments rhetorically, if not scientifically. One almost feels snowed by their arguments. And their style of argumentation appears to have been very effective. What is clear is that neither the editors nor the reviewers noticed the pattern of motivated reasoning, selective attention to facts, and unsupported assumptions that I have described.

The fact that the Zhang paper was published in Mutation Research, a publication with a broad focus on genetic toxicology, rather than in an epidemiology journal may have increased the likelihood of an inadequate review of a paper reporting on a meta-analysis of observational epidemiology studies.

The authors response to substantive criticism has been revealing. Rather than acknowledging criticism and presenting valid arguments to support their position or modifying it, they doubled down on their hypothesis and tried to divert attention from the key issues, while asserting the transparency and quality of their work. In addition, they implied that their critics must have some conflict of interest.

I will give just one example among many. In her February 2020 Forbes piece, responding after a full year to my critique published in February 2019, Lianne Sheppard, the Zhang papers senior author, wrote that cherry-picking of data to achieve particular results is never acceptable scientific practice, and in the case of our meta-analysis, this claim is not true. But, based on her a priori hypothesis, she defended her selection of the one relative risk out of five from the AHS (relative risk 1.12) that ensured a statistically significant result.

This was not the main analysis presented by the AHS researchers in their paper that was the unlagged relative risk of 0.87. And, as I made clear in part one, there are two glaring facts that should have motivated Sheppard to reconsider her choice. First, the AHS, by far the largest and most careful study, showed no support for her a priori hypothesis that the highest exposure group would show the strongest association and demonstrated this point in all five analyses! Second, as the Zhang authors themselves acknowledged, the latency period for NHL to develop is uncertain, and could be as short as two years, although their conclusion is based on the assumption that it is 20 years. Recognition of both these facts should have made the authors reconsider the justification for their analysis.

After this evasion of the science, Sheppard went on to raise further diversions, arguing that publications in the popular media are not appropriate for the serious business of evaluating risks scientifically. Only the sacred precincts of academic journalswhere my colleagues and I have recently published a thorough critique of the Zhang paper are suitable venues for such discussion. Sheppard seems unaware of the flourishing, real-time discussions of critical issues in science and medicine by the likes of Eric Topol, Peter Hotez, Vinay Prasad, and many others on Twittter. True scientists are happy to engage with an interested audience, whatever the forum.

I have devoted time to examining this paper because I believe it is symptomatic of a state of mind that is prevalent in environmental and lifestyle epidemiology. This area is challenging due to the difficulty of measuring human exposure to low-level environmental agentsoften measured at a single point in timeand gauging their long-term health effects against the background of exposures that are often orders of magnitude stronger (smoking, alcohol consumption, diet, body mass index, postmenopausal hormones, etc). Nevertheless, numerous papers continue to be published examining the association of self-reported exposures to trace levels of chemicals in urine or blood with risk of some chronic disease.

There are those working in this area who appear to feel that, in spite of the limitations of the studiesor, perhaps, because of these limitationsone has to take seriously results that are suggestive of an association. In a sense, because of the difficulty of documenting low-level exposures, scientists may feel that they have to give them the benefit of the doubt. Given the limitations of the data, the findings of such studies need to be interpreted with an allowance for the fact that the studies cant tell us what we want to know.

The science policy scholar Daniel Sarewitz has used the term trans-science to refer to the study of complex questions that cant be answered by present-day science. In the absence of definitive data, what seems to be most important to these people is their interest in the question regarding the effects of a particular chemical agent. This is how results from weak studies that appear to point to a risk can be seized on, and this is what appears to have happened in the Zhang paper. What is lacking in high-quality evidence is compensated for by ideological and moral zeal.

Researchers are keenly aware that the media, the public, and even journal editors and reviewers are sensitive to findings that appear to implicate a common exposure in chronic disease. Where strong data are lacking but the issue is one that will resonate with the public and the media, scientists know that their message will get picked up and get traction. Weve seen many examples of this in research on electromagnetic fields, endocrine disrupting chemicals and BPA, DDT and other pesticides, e-cigarettes, and many other issues.

A number of agencies and institutions have been associated with this type of motivated sciencethe International Agency for Research on Cancer (IARC) regarding glyphosate, cell phones, and other exposures; the National Institute for Environmental Health Sciences (NIEHS) regarding BPA; and the Endocrine Society regarding endocrine-disrupting chemicals generally.

In contrast to the kind of science exemplified by the Zhang paper, there are examples of sober and careful work by scientists who are trying to advance knowledge in their field by building on firm results and framing new hypotheses. This work, however, is unlikely to attract media attention.

A recent paper by Moubadder et al. has reviewed environmental exposures in relation to NHL. With regard to environmental exposures, they noted that several infectious agents have been causally linked to NHL. However, with regard to chemical exposures, they concluded that numerous studies have attempted to link NHL risk to chemical exposures, but in spite of many reported associations, causality has not been established.

Commenting on the Zhang meta-analysis, they had this to say:

A recent meta-analysis that included the 2018 Agricultural Health Study (AHS), a cohort of pesticide applicators that have been followed prospectively, and five casecontrol studies found the relative risk of NHL to increase by 41% among those highly exposed to glyphosate-based herbicides [meta-risk ratio (RR) = 1.41; 95% CI, 1.131.75; ref. 20]. However, studies on the AHS population alone, which includes 515 incident NHL cases, have consistently observed no association between reported glyphosate exposure and NHL risk, regardless of the latency period (i.e., 5-, 10-, 15-, and 20-year lag times; refs. 21, 22).

Taking a broad view of the role of environmental exposures in the etiology of NHL, Moubadder considered glyphosate specifically, but still came to the conclusion that causality has not been shown for any chemical.

In contemplating the contrast between the Moubadder paper and the Zhang paper, I was reminded of interviewing the reproductive expert Richard Sharpe about the huge amount of fruitless research that had been devoted to BPA as a cause of adverse reproductive events. In the early 1990s Sharpe had been one of the originators of the so-called environmental estrogen hypothesis and had seen it grow into a huge academic bandwagon, which he dissociated himself from. Sharpe shifted his attention to studying the effects of pharmaceuticals taken by pregnant women on the fetus and the developing child, as well as other exposures. The shift away from studying trace exposures to BPA to more significant exposures has already led to evidence of real effects.

Explaining why he went his own way, he said, I was lucky that the question that drove me was what causes these disorders? not how do EDCs [endocrine disrupting chemicals] cause these disorders? Such a simple difference, but it takes your thought processes in a very different direction.

Geoffrey Kabat is a cancer epidemiologist and the author ofGetting Risk Right: Understanding the Science of Elusive Health Risks. Find Geoffrey on Twitter@GeoKabat

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Misleading glyphosate-cancer study Part 2: 'Symptom of a widespread problem'Concerns about ideological activism in science research and communications...

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Kat Wests husband, Jeff West, sentenced to 16 years in wifes death – AL.com

February 9th, 2021 8:55 pm

Shelby County Judge William Bostick III on Monday ordered 47-year-old Jeff West to serve 16 years in prison for the death of his wife, Kat West.

In November, Jeff West was convicted of reckless manslaughter in the death of 42-year-old Kat West, a Calera mother and online exhibitionist.

Kat West died from a blow to the head from a Lucid Absinthe bottle wielded by her husband, a jury deemed. He has maintained his innocence for more than three years, contending she died as the result of a drunken, accident fall.

Jeff West addressed the court before sentencing. He talked of all hes missed while jailed over the past three years. He never mentioned his wife by name or her death, only saying I lost my best friend.

Bostick said he took into consideration Kat Wests familys pleas of leniency. He said he gave less weight to the testimony of Nancy Martins request, however. Martin, Kat Wests mother, has supported her son-in-law throughout the entire criminal process. The judge said, In my opinion, shes ignored the evidence in this case.

He said he also considered Jeff Wests military history, his lack of criminal record and his strong ties to the community.

We dont drag people into courts of law and try them for who they are. We drag people into courts of law and try them for what they did,' Bostick said. Our laws designed to punish people not for who they are but for what they do. In this case the the jury found you to be responsible for your wifes death. They imposed that responsibility on you. You were afforded the opportunity to accept responsibility for causing your wifes death. You have, for your own reasons, taken the position that you dont intend to do that. So the jury had to do that for you.

I know there were some versions of the evidence that may say Kat was responsible for her own death, or her drinking. She contributed to her demise, but I dont consider that mitigating at all in this case,' the judge said. Domestic violence always follows according to a pattern. Kats death was foreseeable I dont believe you woke up the morning that this offense occurred and decided todays the day Im going to kill her. I dont believe the happened. But I do believe this could have been avoided, I do believe it was foreseeable and I do believe with the jury that it is your reckless acts that caused her death.

West will receive credit for the nearly three years hes already served. He will appeal.

The case was prosecuted by assistant district attorneys Daniel McBrayer and Ben Fuller. Joined by District Attorney Jill Lee, they spoke following Mondays sentencing. Obviously we would have preferred a 20-year sentence just as we would have preferred a murder verdict,' McBrayer said. We respect the judges sentence and the jurys verdict. We are glad he will see the inside of a prison for this killing. We think thats important.

Prior to the start of last years trial, Jeff West was offered a plea deal that would have allowed him to be released immediately for time served. He turned down that deal. That is our standard practice. Here in this case we did make an offer that was within the voluntary guidelines but that was premised on the defendant accepting responsibility for this crime and he didnt,' McBrayer said. So thats why you see a difference in what we offered in the case and the ultimate sentence we asked for.

McBrayer was asked for his reaction to Jeff Wests statement in which he only barely mentioned his wife. It struck me that he mentioned very little other than himself,' he said.

McBrayer described Jeff West as calculating. I think he was very thoughtful and deliberative about every action and every word that he said in this case,' he said. The jury found this was a reckless act but it was backed up by intentional actions, whether it was moving the body , what he said to police, and when he said it.

Fuller said Jeff West has refused to accept any responsibility. Its been consistent throughout the trial. That was our point he bears responsibility from start to finish and he just refuses to accept that,' he said.

Jeff Wests attorney, John Robbins, said he was expecting a 20-year sentence. I appreciate we didnt get the full maximum sentence. My position has been that even though he was convicted of manslaughter,' he said, I think this was a case that probation would have been appropriate, especially after serving almost three years on this so far.

He said he asked Jeff West if he was sorry he did not take the plea deal. He still satisfied with that position that hes taken since Day 1,' Robbins said. Im not at liberty to tell you exactly what he said, but you can read between the lines.

Im sorry the prosecution wants him to come out and say I did this. Since Day 1 he has denied it and thats his position. It wasnt going to change,' he said. He had an opportunity to take that position and go home. He refused to admit to something that he didnt do. You have to respect the person for that.

Robbins talked about how much weight is given to a victims family and their wishes in criminal cases. Usually, the victims family does not take the side of the defendant which is what happened in this case.

Still, Robbins said, the same amount of equity should be given to the wishes of Kat Wests family. You cant take into consideration only when its convenient for you,' Robbins said. Thats what the prosecution did. Its convenient when the family wants to jump up and down and want vengeance. On the other hand, when the family wants leniency and mercy, we want to ignore that.

Here is full coverage of the death of Kat West

Kat West was killed Friday, Jan. 12, 2018.

Her body was found about 5 a.m. the following day by a 19-year-old neighbor who was on her way to work at a fast-food restaurant. The victim was wearing only a sports bra. A cell phone was nearby with a green bottle on top of it, which witnesses said appeared staged.

Kat West touted herself on social media as a stay-at-home mom but also had a subscription-only website, where she went by the name Kitty Kat West. Her Twitter and Instagram accounts, also under the name of Kitty Kat West, featured revealing photos of West, and directed viewers to her paid adult website, which cost $15.99 per subscription.

Jeff West, a former Birmingham Southern College campus security officer and U.S. Army veteran, has been held in the Shelby County Jail since his arrest three years ago. The couple had a daughter, Logan, who also goes by Lola, who is a teen.

During Mondays sentencing hearing, the couples 15-year-old daughter, a student at Calera High School, testified on behalf of her father, asking a judge to release him. She said she grew up in a loving home. Her father, she said, never spanked her nor was he ever loud or abusive. Instead, she described him as always calm.

He has always been my shield against the world,' Logan told the judge. Please give me my father back as soon as possible.

During a recess, Logan hugged her father for nearly two minutes.

Both Jeff Wests mother, Sue West, and mother-in-law, Nancy Martin, also testified on his behalf. The two families have presented a united front since the 2018 death and Jeff Wests arrest.

Martin, the only witnesses for the defense at last years trial, said she was shocked that he was convicted in the death of her daughter. He has always been a kind and caring person,' Martin said. He is a good man.

The Martins have custody of Logan but share the responsibility with Jeff Wests parents. We are a family,' she said.

Sue West, speaking for herself and her husband, Jerry West, broke down while talking about her son. He has always been empathetic and kind,' she said. He tries to see the good in everyone and every situation. He is the most forgiving person I know.

I need my child back,' Sue West said. Logan needs her dad back. This has been an absolute nightmare.

Jeff West (Shelby County Jail)

Also in Mondays sentencing hearing, McBrayer and Fuller again presented a photo of Kat West as she was found that Saturday morning, face down, bloodied and wearing only a pink bra.

They also played audio of a portion of his interview with police during which Jeff West was asked if the couple had arguments. He said it was nothing out of the ordinary but that they argued over her drinking. I dont like her drinking,' he told them.

Asked why they bought liquor that night, he said, I love her and she said she could control it.

In closing arguments, McBrayer said that Jeff West is a trained crime scene investigator who clearly knew what he was doing that night. He said even as recently as last week, Jeff West refused to take responsibility for the crime. He is what he always was, calculating,' McBrayer said.

He said Jeff West is a trained crime scene investigator who knew what he was doing when he staged the Lucid Absinthe bottle on top of the cell phone. Those two things, her drinking and her social media use, were what drove Jeff West to kill her, he said. He said evidence also showed that Jeff West moved his wifes body after he killed her to make it look like she had been hit by a vehicle.

The killing, and the consequences, merit a tougher sentence than the minimum guidelines call for. McBrayer asked that Jeff West get 20 years in prison.

Robbins, in his sentencing closing statements, said its been a difficult case on everyone involved. Not every person is the same, not every crime is the same and he said the judge should consider that when imposing Jeff Wests sentence, especially his 21 years of service in the U.S. Army during which he saw combat. He has no criminal record, and strong family times to the community.

He was not convicted of an intentional act,' Robbins said.

Robbins asked for no more than time served plus one additional year. He asked that the judge consider the familys feelings. Theyre pleading for mercy,' Robbin said.

The week-long trial took place in November 2020 at which time prosecutors said they believed Jeff West was motivated to kill his wife over her excessive drinking and frequent use of social media to promote her adult website.

In the hours leading up to the killing, the couple had shared a date night dinner and drinks out and a stop at a liquor store after where they bought Jameson whiskey and the bottle of Absinthe.

They both drank a lot and then Jeff West took two photos of his wife, who posed in a pink bra, pink multi-colored panties and pink stiletto shoes.

At some point, prosecutor Daniel McBrayer said, an argument erupted. He is tired and fed up with this Instagram stuff, McBrayer said. He grabs her phone and chunks it out the front door where it lands in the street. Prior testimony showed that Kat Wests phone was cracked.

Kat West went outside to retrieve her phone. She was wearing only the pink bra no pants or panties or shoes. McBrayer has said he believes Jeff West grabbed the liquor bottle, followed her outside and, holding the bottle in an inverted position, delivered the fatal blow to her head.

This marriage was not in a good place, McBrayer said during last years trial. This (was) a relationship on the rocks.

Jeff West carefully placed the Absinthe bottle on top of her cell phone and went back inside, leaving the front door open, McBrayer said. Jeff West then waited for somebody to find his wifes dead body in the street.

Shes dead. He doesnt know what to do because hes got a body outside of his (home) McBrayer said.

Crime scene photos and autopsy photos shown to the jury throughout the trial showed her head and upper body lying in the gutter and asphalt while her legs were in a neighbors grass. A couple of feet from her body was a large pool of blood and a blood trail flowing downhill.

A crime analyst testified that Jeff Wests left thumb and left ring finger fingerprints were found on the Lucid Absinthe bottle in an inverted position. In other words, the prints indicated the bottle was held upside down and by the bottles throat rather than its base.

Jeff Wests attorney, however, said he didnt believe Kat West was killed. She fell and hit her head, Robbins said. Theres no murder here.

A state medical examiner called by the prosecution testified that the wound to Kat Wests skull was so significant that it was not likely to have been caused by a fall.

Alabama Department of Forensic Sciences pathologist Dr. Stephen Boudreau said the laceration to Kat Wests skull was two inches long with the skin split open and contusions surrounding the wound.

The force of the blow and subsequent brain bleed, Boudreau said, pushed the brain down to the stem with deadly results.

It was a considerable amount of force to cause an injury like that, the doctor said. Kat West would likely have lost consciousness immediately, he said. Scalp wounds bleed like mad...its (the brain) a very vascular structure.

Asked if it was possibly to get that type of injury from a fall, Boudreau said it wasnt likely, especially at her height of 5-feet, 2-inches. The doctor said Kat West died from blunt force trauma. Whatever it was had an edge, but it wasnt sharp, he said of the object he believes caused her death.

Boudreau also testified that Kat Wests blood alcohol content was .23, nearly three times the legal limit to drive, and said urine and eye fluid toxicology testing indicated that at some point that night her alcohol levels would have been significantly higher.

Kat West had some bruises on her right leg in varying stages of healing that werent likely due to whatever incident caused her death, Boudreau testified. She also had a fresh injury to her toe that probably happened in the same time frame of the fatal head injury.

Home of Jeff and Kat West on Greenwood Circle in Calera.

Robbins said while the couple had arguments, like most married couples do, there was no discord or threat of violence in the marriage -- especially not that night.

Both sides discussed frequent text messages between the two. While the prosecution pointed out frequent arguments via text mostly one-sided with Kat West being the verbal aggressor Jeff Wests attorney also tried to use them to his advantage.

In December, about three weeks before Kat Wests death, she accused her husband via text of throwing away 14 years of marriage. Another text read, Im never doing this holiday again with you.

But text messages exchanged between the two on the day of the killing showed them making plans for that night and using terms of endearment with one another. The couple had matching tattoos on their wrists that read 4Life and often ended their texts with 12345 meaning I love you for life or 123, meaning I love you.

Jurors also heard testimony about forensics found on Kat Wests phone, which included the phones Health App, showing the number of steps she took, or where her phone was, the night authorities believe she was killed. The last time her phone moved, according to the data, was at 1054 p.m. and recorded 87 steps.

Data from the ADT alarm system showed the front door to the West home opened at 10:53:01 p.m. on Jan 12, 2018 and closed at 10:53:11 p.m. It opened again at 1:51:46 a.m. and remained open until 5:12:45 a.m., at which time it closed.

Jeff West had told investigators he fell asleep about 10:30 p.m. and didnt wake up again until 5:15 a.m. when he was awakened by his dogs barking at the fleet of police vehicles outside of his home. Though he said he went to bed at 10:30 p.m., testimony from his Health App phone data showed he took 18 steps from 11:03 p.m. until 11:10 p.m.

Robbins pointed out that that no blood or DNA was found on Jeff Wests clothes or his hands. And, Robbins said, no hair or scalp or brain tissue was found on the Lucid Absinthe bottle. Theres no suggestion of a struggle or fight in the house, Robbins said.

Jeff West, the attorney said, cooperated with police throughout the entire interrogation, voluntarily giving them permission to search the couples phones. He addressed the observation that Jeff West showed little to no emotion in the lengthy videotaped interview with police.

People deal with stressful situations, trauma, in different ways,' Robbins said. Not everybody stands there and cries. Hes a trained soldier. Soldiers are trained to keep their emotions in check.

Jeff West initially was expected to take the stand in his defense. However, he later spoke with his family and told the judge he would instead stay silent.

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Kat Wests husband, Jeff West, sentenced to 16 years in wifes death - AL.com

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Harnessing the Potential of Cell and Gene Therapy – OncLive

February 9th, 2021 8:54 pm

Excitement took wing in the scientific community in the early 1990s, when the first gene therapy trial showed significant success, only to crash at the end of the decade with a patients tragic death.

Twenty years later, the excitement is back and greater than before. Although safety remains a concern, investigators are breaking ground in cell and gene therapy, and many believe that ultimately, a string of cured cancers will follow.

In 2017, the excitement over these therapies returned in spades when the FDA signed off on a cell-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for patients with B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then-FDA commissioner, in announcing the groundbreaking approval.

Gottlieb was not exaggerating. The growth in CAR T-cell research is exploding. Although only a handful of cell and gene therapies are on the market, the FDA predicted in 2019 that it will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells.

Community oncologists will need to be increasingly familiar about the various products, including their immediate and longer-term risks, Bo Wang, MD, and Deepu Madduri, MD, recently wrote in OncologyLive.1 It is key to understand the optimal time for referring these patients to an academic institution, as well as how to manage the requisite post CAR T-cell therapy in the community setting. Madduri is an assistant professor of medicine, hematology and medical oncology, as well as associate director of cellular therapy service, and director of clinical operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai in New York, New York. Wang is a third-year clinical fellow in hematology/oncology at Mount Sinai.

Early referral to academic centers and hospitals equipped to deliver therapies is crucial for patients eligible for therapy. However, as advances continue in the field, community practices may be called upon to administer therapies in their clinic.

The Community Oncology Alliance (COA) envisions a broader role for the settings in which CAR T-cell therapies can be administered. When the Centers for Medicare & Medicaid Services (CMS) was considering coverage for CAR T-cell therapies in 2019, COA officials argued against limiting approvals to hospitals.

It is important to understand that there are state-of-the-art community oncology practices that have significant experience and capabilities in administering highly complex treatments, COA officials wrote in a letter to CMS. For example, stem cell transplants, which are similar in complexity to CAR T therapy, are performed successfully in the community oncology practice setting.2

Broader use of gene therapies depends on several factors, including navigating the logistics of gene therapies, addressing the high costs, and managing toxicities.3

Autologous CAR T-cell therapies involve a manufacturing process that requires coordination between the treating facility and the processing facility. Following leukapheresis, patients may require maintenance therapy to control disease progression during the manufacturing time, which can take 3 to 5 weeks.

In terms of cost, gene and cell therapies can cost from $375,000 to $475,000 per dose and they may face coverage restrictions from payers. Approvals could take weeks to obtain.3,4

Because of cytokine release syndrome and neurotoxicities associated with CAR T-cell therapy, the FDA mandates risk evaluation and mitigation strategy training for centers.

Further, providers may find that real-world experiences with gene therapies are different from those seen in the clinical trial setting, according to Ankit J. Kansagra, MD.

In a presentation at the 2020 American Society of Clinical Oncology Virtual Education Program, Kansagra, an assistant professor of medicine and Eugene P. Frenkel, MD, Scholar in Clinical Medicine at Harold C. Simmons Comprehensive Cancer Center in Dallas, Texas, said that in practice patients may be older and have more aggressive disease, with double- and triple-hit lymphomas.4

Specifically, Kansagra noted that medications such as steroids and/or tocilizumab (Actemra) to prevent or treat cytokine release syndrome or other toxicities were more frequently used in the real-world setting than what had been seen in clinical trials.

As it stands now, only a fraction of eligible patients are receiving CAR T-cell therapies, Kansagra said. Potentially, 9750 patients a year may be eligible for CAR T-cell therapies in approved and upcoming hematologic indications. From 2016 to 2019, a total of 2058 patients received CAR T-cell infusion.4

Next steps for transplanting these novel therapies to clinical practice will require changes in key areas, Kansagra said, such as supply chain management, patient support, and financial systems (Figure).4

Figure. Next Steps for Effective Delivery of Gene and Cell Therapies4

Meanwhile, multiple myeloma experts advise providers to be ready for change. As commercially available myeloma CAR T-cell therapies are approved, it will be even more important for community oncologists to better understand these therapies so they can offer them to their patients, Wang and Madduri wrote.1

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector [AAV] gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by 2015 Giants of Cancer Care winner in immuno-oncology Carl H. June, MD, and others in CAR T-cell therapy. Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed/ refractory mantle cell lymphoma.

Another CD19-directed therapy under FDA review for relapsed/refractory large B-cell lymphoma, is lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application for ide-cel seeks approval for the B-cell maturation antigendirected CAR therapy to treat adult patients with multiple myeloma who have received at least 3 prior therapies.5

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials. gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.6 Natural killer (NK) cells are the research focus of Dean A. Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital in Columbus, Ohio. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA investigational new drug application. Lee is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His efforts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio (NPR) did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.7

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.8

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off-the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

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Harnessing the Potential of Cell and Gene Therapy - OncLive

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