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Archive for the ‘Neuropathy’ Category

The News Journal Baptist Health Wound Care offers help with winter wounds – The News Journal

Wednesday, March 3rd, 2021

With severe winter weather upon us, outdoor activities can result in wounds for an unfortunate few.

Precipitation, such as snow, sleet and freezing rain, can make sidewalks and parking lots dangerous. Falls are much more prevalent during these weather conditions and can result in skin tears and painful abrasions. Sitting close to fireplaces, space heaters or other heat sources can cause burns on the extremities. Many diabetics experience neuropathy keeping these burns from even being noticed, leading to an increased risk of infection.

Megan Barton, APRN, of the Wound Care Center cautions, One of the most common, but often underestimated conditions during this winter season is frostbite.

Frostbite occurs when your skin freezes during exposure to cold weather or water, causing either visible or invisible damage to your cells and soft tissues. Frostbite usually affects your extremities (fingers, toes and ears) first, but can also affect your cheeks, chin or any other exposed skin.

Too much time outdoors in the cold, particularly for those with diabetic neuropathy, can lead to frostbite. Symptoms can include numbness, swelling, blisters, redness or blackened skin.

If you have exposed skin during extremely cold temperatures, you are at risk of developing frostbite. You also are at a higher risk if you take medicine for high blood pressure, have diabetes, suffer from poor circulation, or have been drinking alcohol or taking drugs.

Timely diagnosis and treatment from experts is essential to maximize tissue salvage and achieve the best results, stresses Barton.

Winter weather can be fun for some, tedious for others, but can be dangerous for all. Dress appropriately. Be extremely aware of your extremities, if you have neuropathy. Limit your exposure to the bitter temperatures, and if you are concerned about a wound or frostbite injury, you can call Baptist Health Wound Care at (606) 526-4565 or visit BaptistHealthCorbin.com/wound. Physician referral not required.

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Impact of COVID-19 on Neuropathy Pain Treatment Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | Pfizer, Depomed, Eli Lilly,…

Wednesday, March 3rd, 2021

Neuropathy Pain Treatment Market research report is the new statistical data source added by A2Z Market Research.

Neuropathy Pain Treatment Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Neuropathy Pain Treatment Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Top Key Players Profiled in this report are:

Pfizer, Depomed, Eli Lilly, Endo, Grnenthal Group, Arbor Pharmaceuticals.

The key questions answered in this report:

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Neuropathy Pain Treatment market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Neuropathy Pain Treatment markets trajectory between forecast periods.Regions Covered in the Global Neuropathy Pain Treatment Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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Regions Covered in the Global Neuropathy Pain Treatment Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Neuropathy Pain Treatment Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration: Comprehensive information on the product portfolios of the top players in the Neuropathy Pain Treatment market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Neuropathy Pain Treatment market.

Table of Contents

Global Neuropathy Pain Treatment Market Research Report 2021 2027

Chapter 1 Neuropathy Pain Treatment Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Neuropathy Pain Treatment Market Forecast

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FDA Action Alert: Athenex, Blueprint, CorMedix and More – BioSpace

Wednesday, March 3rd, 2021

The end of February and beginning of March is a busy time for the U.S. Food and Drug Administration (FDA), with a number of PDUFA dates on the calendar. Read on for more.

Athenexs Oral Paclitaxel for Metastatic Breast Cancer

Athenexhas a target action date of February 28, 2021, for its New Drug Application (NDA) for Oral Paclitaxel for metastatic breast cancer, under Priority Review. The submission was built on topline data released in August 2019 for its Phase III trial.

On December 9, 2020, the company presented updated Phase III progression-free survival (PFS) and overall survival (OS) data on the clinical benefits in efficacy and tolerability of oral paclitaxel versus intravenous paclitaxel (IVP) in patients with metastatic breast cancer. The median PFS data demonstrated a benefit for oral paclitaxel compared to IVP, 8.4 versus 7.4 months, respectively, and median OS data was 23.2 months compared to 16.3 months, respectively.

The oral paclitaxel regimen appears to overcome some of the limitations of IV therapy, particularly in terms of reducing the risk of neuropathy, said Gerardo Antonio Umanzor Funez, lead investigator and medical oncologist at Centro Oncologico Integral, working with DEMEDICA of San Pedro Sula, Honduras. The lessened burden of neuropathy, the ability to manage GI side effects with prophylactic treatments, and the convenience of home-based administration, could be transformational in the treatment of metastatic breast cancer, especially in the current environment.

Blueprint Medicines Pralsetinib for Thyroid Cancer

Blueprint Medicines had a target action date of February 28 for its NDA for pralsetinib for patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. It was accepted for review under the agencys Real-Time Oncology Review (RTOR) pilot program. Its designed to assess a more efficient review process. It was approved on December 1, 2020, and will be marketed as Gavreto (pralsetinib).

The approval expanded the labeled indications for Gavreto to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, if radioactive iodine was appropriate.

Gavreto is a once-daily oral therapy that potently and selectively targets RET alterations that drive multiple tumor types. It is jointly commercialized in the U.S. by Blueprint and Genentech, a Roche company.

CorMedix Defencath for Bloodstream Infections Associated with Catheters in Hemodialysis Patients

CorMedix has a target action date of February 28 for its NDA for Defencath for the treatment of life-threatening bloodstream infections associated with the use of central venous catheters in patients receiving chronic hemodialysis. It has been designated by the FDA as a Fast Track and Qualified Infectious Disease Product, which offers an additional five years of marketing exclusivity.

On November 18, 2020, the company announced that the FDA had decided to cancel the Antimicrobial Drug Advisory Committee meeting that had been tentatively scheduled for January 14, 2021, to discuss the NDA.

Defencath is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL. Taurolidine is an amino acid derivative that has broad antimicrobial activity against gram-positive and -negative bacteria, including antibiotic resistant strains, in addition to mycobacteria and clinically relevant fungi including Aspergillus. The company also is working to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients.

Sanofis Libtayo for Advanced Non-Small Cell Lung Cancer

Sanofihad a target action date of February 28 under Priority Review of Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with 50% PD-L1 expression. Libtayo is a fully human monoclonal antibody that targets the PD-1 immune checkpoint receptor on T-cells. On February 22, 2021, the FDA approved Libtayo for this indication. The patients must either have metastatic or locally advanced tumors that are not candidates for surgery or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations. The PD-L1 expression level is determined by an FDA-approved test.

The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease, said Naiyer Rizvi, Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center. Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation.

KemPharms KP415 for ADHD

KemPharmhas a target action date of March 2 for the NDA for KP415 for treatment of attention deficit hyperactivity disorder (ADHD). The drug is made up of serdexmethylphenidate (SDX), the companys prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. It is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action, longer duration of therapy, and avoiding unnecessary spikes in d-MPH concentrations.

On December 2, 2020, after a Late-Cycle Communication Meeting with the FDA, company president and chief executive officer Travis Mickle stated, The late-cycle review meeting with the FDA continued a series of productive meetings with the agency, and sets the stage for the next phase of the NDA review process, including the potential for confidential discussions of the KP415 product label.

Gilead and Kites Yescarta for R/R Follicular Lymphoma and Marginal Zone Lymphoma

Gilead Sciencesand Kite Pharma, a Gilead company, have a target action date of March 5 for their Yescarta (axicabtagene ciloleucel) for the treatment of follicular lymphoma (FL) and marginal zone lymphoma (MZL). The results from the ZUMA-5 clinical trial was the basis for the supplemental Biologics License Application (sBLA).

On December 5, 2020, the companies announced results from the primary analysis of ZUMA-5, a Phase II trial of Yescarta in adults with r/r indolent non-Hodgkin lymphoma (iNHL) after at least two previous lines of therapy. In the trial 92% of iNHL patients responded, including 76% with a complete response (CR) at a median follow-up of 17.5 months. The drug had previously been granted a Breakthrough Therapy Designation (BTD) by the FDA for FL and MZL.

It is encouraging to see this level of response to CAR T-cell therapy in a heavily pretreated and multiply relapsed patient population, in whom response duration to other available therapies is expected to be short, said Caron A. Jacobson, medical director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School.

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BR Retains its Role in Frontline Waldenstrm Macroglobulinemia Despite the Utility of BTK Inhibitors – OncLive

Wednesday, March 3rd, 2021

The treatment landscape of Waldenstrm macroglobulinemia (WM) is becoming increasingly complex with second-generation BTK inhibitors; however, the combination of bendamustine and rituximab (Rituxan; BR) remains the frontline standard of care for this patient population, said Morie A. Gertz, MD, in a virtual presentation during the 25th Annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma, an event hosted by Physicians Education Resource, LCC.

BR remains the frontline standard of care for patients with WM based on data from a phase 3 trial (NCT00991211) showing improved progression-free survival (PFS), less toxicity, and fewer relapses with BR vs R-CHOP [rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone] in patients with WM (n = 41), said Gertz, a consultant in the Division of Hematology, Department of Internal Medicine, and a professor of medicine at Mayo Clinic.1

To build upon this regimen, rituximab was evaluated as maintenance therapy in the phase 3 StiL NHL-2008 MAINTAIN trial. The study randomized 218 patients who responded to BR induction therapy to rituximab maintenance or observation. The 2-year course of rituximab maintenance led to a numerical improvement in PFS of 101 months compared with 83 months with observation in this patient population; however, the difference in PFS was not statistically significant (HR, 0.80; 95% CI, 0.51-1.25; P = .32).2 As such, rituximab maintenance is not indicated for patients with WM who respond to BR induction, said Gertz.

Other treatment options for patients with WM include bortezomib (Velcade) in combination with dexamethasone and rituximab. This regimen induced an overall response rate (ORR) of 96% in patients (n = 23) and a median time to response (TTR) of 1.4 months.3

Similarly, carfilzomib (Kyprolis) plus rituximab and dexamethasone led to an ORR of 87.1% in patients (n = 31) and a median TTR of 2.1 months.4 Moreover, responses were not affected by MYD or CXCR4 mutational status, and the combination did not cause higher than grade 1 peripheral neuropathy, explained Gertz.

Carfilzomib is less neurotoxic than bortezomib, Gertz said. Neurotoxicity is a real issue in patients with IgM monoclonal proteins [because] they have high peripheral neuropathy rates with bortezomib.

In addition to these therapies, BTK inhibitors have led to a paradigm shift in WM, said Gertz.

In 2015, ibrutinib (Imbruvica) was granted a breakthrough therapy designation by the FDA as monotherapy for the treatment of patients with WM.5 Updated results of the pivotal study that led to the approval reported an ORR of 90.5% and a major response rate of 79.4% at a median follow-up of 59 months.6 Improvement in immunoglobulin M serum (IgM), bone marrow disease involvement, and hemoglobin were also observed.

Grade 3 or greater adverse effects (AEs) included neutropenia (15.9%), thrombocytopenia (11.1%), and pneumonia (3.2%). Notably, a 12.7% rate of atrial arrhythmia was observed with ibrutinib.

Atrial fibrillation in this elderly population raises issues of anticoagulation, rate control, and ablation. It is a serious complication in this group, said Gertz.

In 2018, the FDA expanded the label for ibrutinib to include its use in combination with rituximab to treat patients with WM based on findings from the phase 3 iNNOVATE trial.7

In December 2020, the prescribing information for ibrutinib was updated to include efficacy and safety data from the final analysis of the iNNOVATE trial, which demonstrated significantly higher rates of PFS with ibrutinib/rituximab (n = 75) compared with placebo/rituximab (n = 75) in patients with treatment-nave and relapsed/refractory disease.8

At Mayo Clinic, we still use BR as our first-line [regimen], with the exception of central nervous system lymphoplasmacytic lymphoma, or so-called Bing-Neel Syndrome. In this situation, bendamustine does not cross the blood-brain barrier, but ibrutinib does, said Gertz.

Additionally, the second-generation BTK inhibitor acalabrutinib (Calquence) was evaluated in a phase 2 trial in patients with treatment-nave (n = 14) or relapsed/refractory (n = 92) WM.9 Findings from the study demonstrated an ORR of 93% in both cohorts of patients. Moreover, a lower rate of severe atrial fibrillation was observed with acalabrutinib (1%) compared with what had been reported with ibrutinib.

Another second-generation BTK inhibitor, zanubrutinib (Brukinsa) was compared with ibrutinib in the ASPEN trial, wherein the rate of complete response plus very good partial response was 28.4% with zanubrutinib compared with 19.2% with ibrutinib (P = .09).10 Notably, the 12-month PFS and 12-month overall survival rates in the overall and relapsed/refractory populations were numerically improved with zanubrutinib vs ibrutinib.

Additionally, regarding safety, zanubrutinib was associated with lower rates of atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, pneumonia, and AEs leading to treatment discontinuation or death compared with ibrutinib.

Although the efficacy improvements in the ASPEN trial were not considered statistically significant, the lower rates of toxicity suggest that zanubrutinib could have clinical utility for patients with WM, said Gertz.

Taken collectively, these data provide a potential treatment algorithm for patients with WM. At Mayo Clinic, current practice dictates that patients with IgM monoclonal gammopathy of undetermined significance with less than 10% lymphoplasmacytic infiltration, asymptomatic/smoldering WM, and patients with no cytopenias can be safely observed without therapeutic intervention. Single-agent rituximab should be given to those with IgM-related neuropathy, WM-associated hemolytic anemia, or symptomatic cryoglobulinemia. Finally, 4 to 6 cycles of BR without rituximab maintenance should be given to those patients with bulky disease, profound cytopenias, constitutional symptoms, and/or hyperviscosity symptoms, Gertz said.

Patients who had a response to previous therapy lasting 3 or more years could be considered for retreatment with their original therapy. Conversely, patients whose response was less than 3 years should be considered for zanubrutinib, acalabrutinib, or ibrutinib monotherapy if not previously used, bortezomib plus dexamethasone and rituximab if preexisting peripheral neuropathy is less than grade 2, rituximab plus dexamethasone and cyclophosphamide, or BR alone if not previously used.

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BR Retains its Role in Frontline Waldenstrm Macroglobulinemia Despite the Utility of BTK Inhibitors - OncLive

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Daratumumab Monotherapy Safe in Heavily Treated Relapsed or Refractory Multiple Myeloma – DocWire News

Wednesday, March 3rd, 2021

An early access treatment protocol (EAP) found that daratumumab monotherapy was safe in a population of patients with heavily treated relapsed or refractory multiple myeloma (RRMM).

Collectively, this EAP provides additional evidence of the favorable safety profile of daratumumab in patients with heavily pre-treated RRMM and the associated maintenance of patient-reported health-related quality of life (HRQoL), the researchers concluded.

Patients who were previously treated with at least three lines of therapy including a including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or who were double refractory to a PI and IMiD were given intravenous daratumumab 16 mg/kg.

Final analysis included 293 patients who received at least one dose of daratumumab. A third of patients were from the UK, a quarter each from Spain and Italy, and 17.1% from Russia. The median age was 64 years (range, 32-85 years); 13.7% of patients were aged 75 years or older. Most patients were male (56.7%), White (93.5%), and had a baseline Eastern Cooperative Oncology Group performance status of 0 or 1 (88.7%).

Patient histories included vascular disorders (38.9%); surgical and medical procedures (31.1%); musculoskeletal and connective tissue disorders (22.9%); metabolism and nutrition disorders (20.8%); and benign, malignant, and unspecified (including cysts and polyps) neoplasms (15.0%). Comorbidities affecting more than 5% of patients included hypertension (31.4%), peripheral neuropathy (6.8%), anemia (6.8%), hypercholesterolemia (5.8%), deep vein thrombosis (5.5%), back pain (5.5%), and pulmonary embolism (5.1%).

The median duration of daratumumab exposure was 4.2 months (range, 0.03-24.1 months), and median number of infusions was 13 (range, 1-37). The overall response rate was 33.1%. Progression-free survival was 4.63 months. Overall, 60.1% of patients experienced grade 3 or 4 treatment-emergent adverse events (AEs), the most common being thrombocytopenia (18.8%), anemia (11.9%), and neutropenia (11.6%); serious AEs most commonly reported were pneumonia (4.4%) and pyrexia (4.1%).

Overall, the study yielded no new safety signals, and patients maintained their HRQoL, the study authors reported.

The study was published in Oncology and Therapy.

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Daratumumab Monotherapy Safe in Heavily Treated Relapsed or Refractory Multiple Myeloma - DocWire News

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Global Chemotherapy Induced Peripheral Neuropathy Treatment Market Industry Perspective, Comprehensive Analysis, and Forecast 2028||Nemus Bioscience,…

Sunday, February 14th, 2021

Global chemotherapy induced peripheral neuropathy treatment marketis expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and huge investments in research and development are the factors responsible for the growth of this market.

The analysis covered in the Chemotherapy Induced Peripheral Neuropathy Treatment marketing report gives an assessment of various segments that are relied upon to witness the quickest development amid the approximated forecast frame. The numerical and statistical data has been denoted in the graphical format for a clear understanding of facts and figures. This market report contains historic data, present market trends, environment, technological innovation, upcoming technologies and the technical progress in the related industry. It not only identifies the emerging trends along with major drivers, challenges and opportunities in the market but also analyses them efficiently.

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The major players covered in the chemotherapy induced peripheral neuropathy treatment market are Metys Pharmaceuticals, Nemus Bioscience, Sun Pharmaceutical Industries Pvt Ltd., PledPharma, Mylan N.V., GlaxoSmithKline, plc., Regenacy Pharmaceuticals, Pfizer, Inc., Asahi Kasei Pharma, Apexian Pharma, Solasia Pharma, Immune Pharmaceuticals, DermaXon, Krenitsky Pharmaceuticals among other domestic and global players.

Global Chemotherapy Induced Peripheral Neuropathy Treatment Market Scope and Market Size

The chemotherapy induced peripheral neuropathy treatment market is segmented on the basis of treatment, drug class, drug type, end-users and distribution channel. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

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Chemotherapy Induced Peripheral Neuropathy Treatment Market Country Level Analysis

The chemotherapy induced peripheral neuropathy treatment market is analysed and market size information is provided by country, treatment, drug class, drug type, end-users and distribution channel as referenced above.

The countries covered in the chemotherapy induced peripheral neuropathy treatment market report are U.S., Canada, Mexico in North America, Brazil, Argentina, Peru, Rest of South America, as part of South America, Germany, France, U.K.,Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific, Saudi Arabia, U.A.E, Egypt, Israel, Kuwait, South Africa, Rest of Middle East and Africa, as a part of Middle East and Africa.

On geographical estimation, North America accounts the largest market share due to the presence of high healthcare expenditure and favourable reimbursement policies for the treatment. Europe accounts the second largest market share due to increased genetic disorders and presence of refined medical facilities. Asia-Pacific is expected to account for the largest market share over coming years for the chemotherapy induced peripheral neuropathy treatment market due to constant rise in the incidence of cancer with increased demand for cost-efficient therapeutics.

Table of Contents:

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Microalbuminuria Is Higher in Patients With Uncontrolled Diabetes – MD Magazine

Sunday, February 14th, 2021

Urine spot for albumin:creatinine ratio (UACR) values are higher in patients with uncontrolled type 2 diabetes (T2D) and in patients with a longer duration of disease, according to new research.

The findings bolster the case for annual UACR tests as a routine part of care, the authors concluded, since the tests can identify early signs of diabetic nephropathy.

Diabetic nephropathy is a complication of diabetes that is linked with chronic kidney disease leading to end-stage renal disease. Early detection of nephropathy can be a key factor in clinical outcomes. The presence of albumin in urine is associated with diabetic neuropathy. The American Diabetes Association recommends yearly screening for microalbuminuria. UACR is a more efficient method of testing for albumin, replacing the older standard of 24-hour urine collection.

Corresponding author Ayesha Malik, of Hameed Latif Hospital, in Pakistan, and colleagues noted that strict glycemic control can prevent microalbuminuria. The investigators sought to better understand how common microalbuminuria is among patients with T2D and the extent to which it correlates with diabetic control.

Malik and colleagues recruited 133 patients for their study, and recorded data such as body mass index, duration of diabetes, and hemoglobin A1C levels. The patients were given morning, mid-stream UACR tests, which were then evaluated for albumin.

The study population was mostly male (60.9%) and had an average age of 54.5 years. The mean duration of diabetes in the group was 6.29 years, and mean A1C was 8.99%.

Overall, 30.1% of patients had diabetic neuropathy, and 25.6% had microalbuminuria. In addition, 4.5% had macroalbuminuria.

The investigators then performed a Pearson product-moment correlation coefficient, which showed that high UACR correlated with a higher likelihood of uncontrolled diabetes and a longer duration of diabetes.

Some of the factors that influence kidney disease development include genetics, blood sugar control, and blood pressure, the authors said. The impact of strict diabetic control on prognosis is most pronounced in patients microalbuminuria. We found a significant correlation between higher HbA1c level and presence of microalbuminuria.

The investigators noted that T2D is growing in prevalence around the world, and they said local studies in the South Asian region have shown rates of microalbuminuria among patients with T2D that align with this new study.

However, due to poor healthcare infrastructure and lack of education, people are not routinely screened in developing or underdeveloped countries and end up presenting late in the disease course, they wrote.

Limitations of the study included the small sample size and the fact that the investigators did not take into account patients detailed drug histories or their histories of dietary protein intake prior to UACR. These factors could potentially alter UACR values.

Still, the investigators said their data show routine UACR testing can be an important component of kidney disease prevention.

Both early detection and progress of the disease can be determined by sensitive markers like the UACR, they concluded. In addition, our study shows that poorly controlled diabetes is associated with higher UACR. Involvement of the UACR in routine practice should be considered for all diabetic patients.

The study, "Prevalence of Microalbuminuria in Type 2 Diabetes Mellitus," was published online in Cureus.

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Microalbuminuria Is Higher in Patients With Uncontrolled Diabetes - MD Magazine

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Chemotherapy Induced Peripheral Neuropathy Treatment Market Size 2021 | Covid-19 Impact Analysis | Business Outlook, Growth, Trends and Forecasts 2027…

Sunday, February 14th, 2021

Fort Collins, Colorado: Chemotherapy Induced Peripheral Neuropathy Treatment Market Research is a precise analysis of the historical, current, and future phases of the market. The report was released specifically for business owners, executives, policymakers, and Chemotherapy Induced Peripheral Neuropathy Treatment stakeholders to determine likely market conditions. A few key aspects are highlighted in the Chemotherapy Induced Peripheral Neuropathy Treatment market report including raw materials, market strategies, production volumes, sales, and CAGR.

The report also sheds light on key market characteristics such as dynamics, viable market structure, global price volatility, supply and demand, market restraints, restraints, and growth drivers. The report also covers other important aspects like demand ratio, Chemotherapy Induced Peripheral Neuropathy Treatment price violations, strict rules, and unpredictable market fluctuations. It also highlights several growth drivers that may increase market returns in the near future.

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In-depth study of major segments of the Chemotherapy Induced Peripheral Neuropathy Treatment market:

The Chemotherapy Induced Peripheral Neuropathy Treatment market report also highlights the adverse effects of Covid-19 globally as well as at all levels of the Chemotherapy Induced Peripheral Neuropathy Treatment market and offers key projections for 2027. In addition to the impact of pandemic, the Chemotherapy Induced Peripheral Neuropathy Treatment market is growing. develops rapidly. CAGR stable over the past decade. The market is also expected to grow more strongly during the forecast period. The market keeps pace with active research and development, technological advancement and rapid industrialization.

Chemotherapy Induced Peripheral Neuropathy Treatment Market also provides key insights into market segments that help players develop sound business strategies and deliver accurate products and services to their customers. He also helps market players and Chemotherapy Induced Peripheral Neuropathy Treatment business owners identify their potential buyers and grow their existing customer base so that they can better serve their customers. It also allows readers to plan specific directions and stay ahead of their competition.

Chemotherapy Induced Peripheral Neuropathy Treatment Market Segmentation, By Type

Chemotherapy Induced Peripheral Neuropathy Treatment Market Segmentation, By Application

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Leading Companies on the Chemotherapy Induced Peripheral Neuropathy Treatment market:

The study also highlights the details and estimates of major manufacturers of Chemotherapy Induced Peripheral Neuropathy Treatment operating in the Chemotherapy Induced Peripheral Neuropathy Treatment market. It helps gamers to analyze how their competitors have performed in the market over the past few years and how they will perform in the near future. The report provides an important analysis of financial metrics, revenue patterns, sales volume, average annual expenses, profitability and CAGR, along with a study of their organizational, financial and productive details, business strategies, product launches and promotions., Quantities and production capacity.

Market Segments by Major Manufacturers:

Geographical scenario:

The geographical analysis of the Chemotherapy Induced Peripheral Neuropathy Treatment market has been done by examining different global regions such as North America, Latin America, Middle East, Asia-Pacific, and Africa on the basis of different parameters. The primary target for the Chemotherapy Induced Peripheral Neuropathy Treatment market is the Chemotherapy Induced Peripheral Neuropathy Treatment countries. The Chemotherapy Induced Peripheral Neuropathy Treatment market has broadly compiled through extensive research and analysis techniques such as qualitative and quantitative analysis. Furthermore, it offers a blend of SWOT and Porters five techniques to analyze the data of the global market. Moreover, this report offers a complete analysis of different business perspectives such as the ups and downs of the global market shares. To expand the market at the global level, it makes use of different techniques and sales methodologies for achieving the outcomes of the businesses.

Collectively, this research repository encapsulates data of Chemotherapy Induced Peripheral Neuropathy Treatment market to offer strategic decision-making abilities to various investors, business owners, decision-makers as well as policymakers.

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Following major key questions are addressed through this global research report:

1. What will be the Chemotherapy Induced Peripheral Neuropathy Treatment market size over the forecast period?2. What are the demanding regions for making significant growth in the upcoming future?3. What are the challenges in front of the Chemotherapy Induced Peripheral Neuropathy Treatment market?4. Who are the key vendors in Chemotherapy Induced Peripheral Neuropathy Treatment market?5. What are the effective sales patterns and methodologies for boosting the performance of the Chemotherapy Induced Peripheral Neuropathy Treatment market?6. What are the different ways to find out potential customers as well as global clients?7. Which factors are hampering the Chemotherapy Induced Peripheral Neuropathy Treatment market?8. What are the outcomes of SWOT and porters five techniques?9. What are the demanding trends of the Chemotherapy Induced Peripheral Neuropathy Treatment market?

Key strategic developments in the Chemotherapy Induced Peripheral Neuropathy Treatment market:

This global study also includes the key strategic developments of the Chemotherapy Induced Peripheral Neuropathy Treatment market including the new product launchings, partnerships and collaboration among the key players functioning at the global level.

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Chemotherapy Induced Peripheral Neuropathy Treatment Market Size 2021 | Covid-19 Impact Analysis | Business Outlook, Growth, Trends and Forecasts 2027...

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Impact Of Covid-19 On Leber’s Hereditary Optic Neuropathy Drug Market 2020: Remarking Enormous Growth With Recent Trends | Alkeus Pharmaceuticals,…

Sunday, February 14th, 2021

Industry Growth Insights (IGI) recently published a report entitled, the Lebers Hereditary Optic Neuropathy Drug Market, describing the crucial aspects of the market by conducting an in-depth analysis of the current trend, emerging threats, and future market assessment. This report takes into account the adverse impact of the COVID-19 pandemic on the market for the period of 2020-2020 and provides a detailed information about how the market will perform during the forecast period, 2020-2027. Our research team presents the report in a simplistic manner supported by fact and actual figures that will assist clients to arrive an informed decision about their investment plans and business strategies.

Request Free Exclusive Sample on Lebers Hereditary Optic Neuropathy Drug Market Report @ https://industrygrowthinsights.com/request-sample/?reportId=198426

The report provides a holistic view of the market offering key insights of the market behavior over last four years and key assessment of the future market performance. It includes a systematic analysis of historical data for the period, 2015-2020 and draws upon assessment of the market performance for the forecast period, 2020-2027 by observing 2020 as the base year. With the reference to the available data, it provides vital insights on key factors such as drivers, restrains, trends, challenges, and opportunities of the Lebers Hereditary Optic Neuropathy Drug market growth.

This report provides a comprehensive outlook on the key segments and sub-segmentations that includes the complete information about the product types, applications, end-users and regions. It offers latest information regarding the growth rate, volume, and size of the market in respect to each segment and also explains the market performance of these segments in the respective five regions. Moreover, it discusses a wide range of the emerging market scope and potential drawbacks present in the segments.

Lebers Hereditary Optic Neuropathy Drug Market Report Includes:

The Global Lebers Hereditary Optic Neuropathy Drug Market Report is segmented into:

By Types:

ElamipretideGS-011IXC-201KH-176Others

By Applications:

HospitalClinicOthers

By Regions:

For More Information on This Report Visit: https://industrygrowthinsights.com/enquiry-before-buying/?reportId=198426

The report covers the competitive landscape of various major global players, their current market positions, and key business strategies adopted to mark their major footprint in the market. This includes information about the product launch, expansion of the production facilities or plants, adoption of new technologies, latest merger & acquisition, partnership, and collaboration of the key players. It furthers provides concrete information about the existing market scope for the new entrants and the current competitive levels and scenario for the emerging players in the global market.

The Lebers Hereditary Optic Neuropathy Drug Market Report Covers the Following Companies:

Alkeus Pharmaceuticals, Inc.Biovista Inc.GenSight Biologics S.A.Ixchel Pharma, LLCKhondrion BVSpark Therapeutics, Inc.Stealth BioTherapeutics Inc.

Industry Growth Insights (IGI) also offers customized report for a particular product, application, and region as per the requirement of clients and provides additional companies profiles as per the clients request.

Regarding the methodology, the report is prepared by relying on primary and secondary sources including interviews of the company executives & representatives and accessing official documents, websites, and press release of the companies related to the Lebers Hereditary Optic Neuropathy Drug market. It also includes comments and suggestions from the experts in the market especially the representatives from government and public organizations as well as international NGOs. The report prepared by Industry Growth Insights (IGI) is known for its data accuracy and precise style, which relies on genuine information and reliable data source. Moreover, customized report can be available as per the clients wishes or specific needs. It takes into account of various research tools and methods including predictive analysis, Porters 5 force analysis, SWOT analysis, and real-time analytics.

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This report includes the estimation of market size in terms of value (USD) and volume (K MT), with applying top-down and bottom-up approaches to estimate and validate the overall scope of the market. The report is presented with a group of graphical representations, tables, and figures that shows a clear picture of the developments of the products and its market performance over the last few years. With this precise report, it can be easily understood the growth potential, revenue growth, product range, and pricing factors related to the Lebers Hereditary Optic Neuropathy Drug market. This report includes information on the latest government policies, norms, and regulations that can affect the dynamics of the market.

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This report provides a complete guideline for the clients to arrive an informed business decision since it offers a comprehensive market outlook that will help the clients to understand better of the current & future market situation.

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Impact Of Covid-19 On Leber's Hereditary Optic Neuropathy Drug Market 2020: Remarking Enormous Growth With Recent Trends | Alkeus Pharmaceuticals,...

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What everyone should know about cancer and cold weather – Yahoo News

Sunday, February 14th, 2021

Cold weather can create health issues for many people, but some are more susceptible than others. In particular, cold can be especially difficult for cancer patients.

"Cancer, in general, puts a lot of stress on the body, and when we have stress on the body, we have trouble regulating other parts of our normal physiology," Dr. Nicholas Rohs, an oncologist at Mount Sinai in New York City, told AccuWeather.

Rohs said advising his patients about problems that can arise during cold weather is a regular part of his treatment routine.

It's not necessarily cancer itself that causes cold sensitivities -- it's therapies and side effects, Rohs said, that create problems, although cancer stresses out the entire system which puts a patient at a higher risk in general.

"People with really advanced cancers that are taking a really big toll on their body can have trouble regulating their own temperature," Rohs explained. "Inflammatory markers are flying around that can adjust how we are able to accommodate to our surroundings."

Chemotherapy and cold weather can be dangerous

Cold impacts can vary depending on the type of drug a patient is receiving. "Oxaliplatin is a very common chemotherapy medication we give," Rohs said. "That medication has a side effect called cold-induced neuropathy."

Patients being treated with Oxaliplatin who suffer cold-induced neuropathy can experience "numbness, tingling in their fingers, toes and even other parts of their bodies," Rohs said, adding that the condition "can get so bad they can be numb so they may not sense cold as well. But Oxaliplatin has this cold-induced neuropathy where when I give it to my patients they have hypersensitivity to cold to even a level where my patients say, 'I grabbed a sort of cold spoon and I couldn't hold it. I went to open my fridge and I couldn't.' And if it's really bad, people can be in an air-conditioned room and feel super uncomfortable because of it."

Story continues

Neuropathy is when the nerves malfunction, causing numbness or weakness. These patients experience cold temperatures, which can cause numbness, tingling, pain and muscle weakness. Neuropathies frequently start in the hands and feet but can affect other parts of the body as well. Rohs says this can cause them to be more prone to frostbite because they might not realize how cold their hands and fingers are getting in cold weather.

"If you have bad neuropathies -- and I actually have neuropathies not related to chemotherapy in my feet, I could go walk around in the snow for five or 10 minutes and not feel it the same way that a normal person would -- that can be really dangerous. If you can't sense the danger, you can't get away from it, so for people who have really significant neuropathies, they definitely need to be really thoughtful about wearing good cold-weather gear."

Rohs advises his patients to wear gloves and layers, so they can adjust to temperatures as they go in and out of buildings and different settings.

Julene Diedrich, a Marshfield Clinic nurse practitioner in Oncology tells Shine365, "We even tell these patients to avoid cold drinks or ice."

Cancer patients at higher risk of flu, cold, pneumonia and other viruses and infections

Chemotherapy can also compromise the immune system, making a patient extremely vulnerable to viruses or infections, which means common illnesses like the cold, flu or pneumonia can be life-threatening.

Rohs said someone who is not receiving chemotherapy might "easily fend off" a case of the common cold or flu, but "somebody who has a low blood count [a side effect of chemotherapy] might not be able to do the same. Patients receiving chemotherapy can also be susceptible to bacterial infection," he said. "They can get really robust pneumonia and things like that that they can't easily fight off."

One of the most common side effects of chemotherapy is that it attacks quickly dividing blood cells. Those cells include white and red blood cells. After a chemo treatment, patients often have lower white blood cell counts, particularly neutrophils, which are the first cells to arrive on the scene when someone experiences a bacterial infection. That's what lowers a patient's immunity. Having low red blood cell counts can make people feel colder and be more susceptible to cold.

"You don't have those red blood cells to circulate everything that you need and your body. If it's more anemic, your blood vessels in your peripheral part of your body -- the outsides of your body -- will clamp down more, so you can have more blood in your central areas because those are clearly more critical to us," Rohs said. "Our lungs, our heart -- all of these things are in the middle of our body."

So if the body is going into a state in which it's really cold, the circulatory system is going to shunt blood to the middle of our body, Rohs continued. "So when we're anemic, our body will try and keep most of the blood pool where it's most critical so you're likely to have cold fingers, toes, things like that."

Some patients can also be prone to cold-induced asthma, which occurs when lungs react to the temperature by narrowing, making it tougher to breathe.

"Patients who already have breathing issues, going out into the cold can be particularly irritating to their lungs and cause them to feel like their more short of breath and actually make them more short of breath because they can't breathe as well," Rohs said.

Cancer patients more prone to serious injury from an icy fall

In addition to treatment-induced issues, cancer patients often lose large amounts of weight, Rohs told AccuWeather. "Things like 20, 30 pounds for months so that's our biggest insulator," he said, adding that bodies that have lost a lot of weight due to chemotherapy can "have a lot of trouble regulating temperature."

Weight isn't just an insulator; it's padding that protects bones at a time when they are at their most fragile. Many cancer treatments cause bone loss also. Hormonal therapies often used to treat breast cancer can strip bone density, which is called osteoporosis. Osteopenia occurs when the body doesn't make new bone as quickly as it reabsorbs old bone. Both conditions put cancer patients at a high risk of becoming seriously injured when slipping and falling on ice. Rohs says a bone fracture can be devastating for a cancer patient whose body is already under tremendous stress.

"People have trouble adjusting to such an abrupt change in their physical health so they'll say, 'Well, I can still walk out to the street. Oh, it's a little icy, I do that all the time,' and they're more likely to fall and also when we talk about those neuropathies ...You might not be able to feel as steady on your feet, so you're more likely to slip and fall."

He added,"[If] we're having a snowstorm in New York I say. 'Hey -- stay home!' It's not the end of the world for many of my patients."

Bottom line, if you or someone you know is undergoing chemotherapy or other cancer treatments, pay particular attention to the weather forecast, so you can dress appropriately for the temperature.

"I tell my patients, you know, wear gloves, bring layers so that you can adjust to temperatures as you go in and out of buildings, or just different settings."

Keep checking back on AccuWeather.com and stay tuned to the AccuWeather Network on DirecTV, Frontier, Spectrum, Fubo, and Verizon Fios.

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What everyone should know about cancer and cold weather - Yahoo News

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FHN Health Column: Be careful in the cold protect your skin from frostbite – Freeport Journal-Standard

Sunday, February 14th, 2021

Journal Standard

Cold enough for you? This typical Midwest winter greeting pretty much sums up this weeks weather, but it should serve as a reminder, too it can be too cold.

As the temperature plunges and cold winds blow, so does the risk of frostbite. Skin exposed to extreme cold can develop frostbite in as little as five minutes, said FHN Podiatrist Roland Tolliver. Fingers in gloves and toes in boots can develop frostbite, too.

Though frostbite can happen to anyone, some conditions can make a person more susceptible: if you have diabetes, take blood thinners or smoke, your circulatory system may not work as efficiently or you may suffer from neuropathy, which means you have lost some feeling in your extremities. Poor circulation and neuropathy put you at higher risk for developing frostbite.

Skin that is cold and wet, like fingers in damp gloves and toes in wet socks, is even more susceptible to frostbite.

Danger Signs

Dr. Tolliver said one of the first signs of frostbite can be skin that is itchy, burnsor is numb. The skin also may turn white or greyish yellow, and as more damage occurs, feel waxy or hard. At its most severe, frostbite can cause blistering and even gangrene.

If you notice any of the signs of frostbite, go inside or get warmed up as quickly as possible.

Once you are in where its warm, remove any wet clothing and look closely at the affected area. You might see red skin and feel some pain or numbness. As you warm up, you may notice the area feels tingly that means the circulation is returning.

You can help speed the warming process by soaking the affected area in lukewarm not hot water. (The water temperature should be between 105-110 F.) Soak the area until the skin is back to its normal color and you dont feel any numbness.

A warm beverage like tea or cocoa can help you feel warmed up, too, but avoid any alcoholic beverages while your body is recovering from the cold. If you are feeling pain, an over-the-counter pain reliever may help.

If your pain increases or your skin doesnt return to its normal color, bundle up (in dry clothes leave the soggy gloves and boots behind) and head for the emergency department for medical attention.

Warm and dry

If youre planning to spend a lot of time outside in the cold, you probably know to wear long underwear and a turtleneck to help keep you warm.

Well-planned layers can help prevent frostbite, too: wear a thin pair of socks to pull moisture away from your feet underneath a thicker pair of socks for warmth. If you know youll be handling wet snow, wear waterproof gloves or layer pairs to keep your fingers as dry as possible.

Hand warmers and other gadgets to tuck in your pockets or shoes are easy to find this time of year, but people with poor circulation or who have lost some feeling in their extremities should be cautious using these items: if you cant feel your fingers or toes getting too cold, you likely wont be able to tell if they get too warm, either, and that can cause tissue damage, too.

The key to staying safe from frostbite, Tolliver said, is just to be aware of any signals your body may be sending. Take a warm-up break from shoveling or sledding when you need one with these temperatures, the snow isnt going anywhere!

Roland Tolliver, DPM, FACFAS, is a podiatrist at FHN. Hear more of his Dial-a-Doc interview on this topic at http://www.fhn.org/newsradio.asp.

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FHN Health Column: Be careful in the cold protect your skin from frostbite - Freeport Journal-Standard

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

Thursday, February 11th, 2021

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

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

Thursday, February 11th, 2021

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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.

Why buy Neuropathy Pain Treatment Market Report?

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

Thursday, February 11th, 2021

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

Thursday, February 11th, 2021

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.

DOWNLOAD FREE SAMPLE REPORT: https://www.marketquest.biz/sample-request/9018

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)

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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.

Customization of the Report:

This report can be customized to meet the clients requirements. Please connect with our sales team (sales@marketquest.biz), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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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

Thursday, February 11th, 2021

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:

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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.

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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

Thursday, February 11th, 2021

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.

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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:

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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

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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

Thursday, February 11th, 2021

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

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

Thursday, February 11th, 2021

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.

Read more from the original source:
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

Thursday, February 11th, 2021

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

)

Read more from the original source:
Prothena Reports Fourth Quarter and Full Year 2020 Financial Results, and Provides Financial Guidance and R&D Update - Yahoo Finance

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