StemCell Therapy

The Insight Partners recently added Genetic Engineering market Report by manufacturers, regions, type and application, forecast to 2027 in his database. This research report focus on complete assessment of market and contains future trend, growth factors, attentive opinions, facts, historical data, statistically supported and industry validated market data. Environmental concerns & regulatory guidelines regarding release of effluents through different industries. Genetic Engineering market comprehensive coverage of underlying economic and technological factors under key trend analysis.

If your Company involved in the Genetic Engineering industry or intend to be, then this study will provide you comprehensive outlook Future Industry by Analysts and know what to expect from this along with analysis By Industry Experts. Its vital you keep your market knowledge up to date segmented by In-Depth Insight of Sales Analysis, Growth Forecast and Upcoming Trends Opportunities by Applications Manufacturing, Product Types By major Manufacturers. If you have a different set of players/manufacturers according to geography or needs regional or country segmented reports we can provide customization according to your requirement globally With Expanding Future Business Scope.

Get the inside scope of the Sample report @https://www.theinsightpartners.com/sample/TIPRE00004544/

MARKET INTRODUCTION

A gene is the basic physical and function unity of heredity. Genetic engineering is the changing the structure of the genes of a living things in order to make it healthier, stronger and more useful to human. Changing DNA in cell is to understand their biology. Genetic engineering are currently used in both animal and plant cells this modifications are helps to improve performance of cell.

MARKET DYNAMICS

The genetic engineering market is expected to grow during the forecast period due to rising use of genetic engineering in the field of medical as well as in agriculture, high prevalence of infectious disease and awareness of steam cell therapy, and increasing no of genomics project due to government raising funds in genetic engineering field and more R&D. Thus, various governments are taking initiatives to create awareness amongst people about genetic engineering.

The report also includes the profiles of key Genetic Engineering Market companies along with their SWOT analysis and market strategies. In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.

Key Competitors In Market are

Integrated DNA Technologies, Thermo Fisher Scientific, Merck KGaA, Horizon Discovery Group, Transposagen Biopharmaceuticals, New England Biolabs, Genscript Biotech Corporation, Lonza Group, Origene Technologies, Sangamo Therapeutics

TOC pointsof Market Report:

Market size & shares

Market trends and dynamics

Market Drivers and Opportunities

Competitive landscape

Supply and demand

Technological inventions in industry

Marketing Channel Development Trend

Market Positioning

Pricing Strategy

Brand Strategy

Target Client

MARKET SCOPE

The Global Genetic Engineering Market Analysis to 2027 is a specialized and in-depth study with a special focus on the global market trend analysis. The report aims to provide an overview of Genetic Engineering Market with detailed market segmentation by product type, drug class, and geography. The global genetic engineering market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading genetic engineering market players and offers key trends and opportunities in the market.

Market segmentation:

Genetic Engineering Market to 2027 Global Analysis and Forecasts by Technology (CRISPR, TALEN, ZFN, Antisense, Other Technologies); By Application (Cell line Engineering, Genetic Engineering, Diagnostics & Therapeutics); By End User (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, Contract Research Organizations) and Geography

By Geography North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. And 13 countries globally along with current trend and opportunities prevailing in the region.

The target audience for the report on the market

Manufactures

Market analysts

Senior executives

Business development managers

Technologists

R&D staff

Distributors

Investors

Governments

Equity research firms

Consultants

Click to buy full report with all description:-https://www.theinsightpartners.com/buy/TIPRE00004544/

About Us:

The Insight Partnersis a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We are committed to provide highest quality research and consulting services to our customers. We help our clients understand the key market trends, identify opportunities, and make informed decisions with our market research offerings at an affordable cost.

We understand syndicated reports may not meet precise research requirements of all our clients. We offer our clients multiple ways to customize research as per their specific needs and budget

Contact Us:

The Insight Partners,

Phone: +1-646-491-9876

Email:[emailprotected]

Read more from the original source:
Genetic Engineering Market to Reflect Impressive Expansion by Integrated DNA Technologies, Thermo Fisher Scientific, Merck KGaA, Horizon Discovery...

The power of speculative fiction often lies in its ability to make us look at the world around us with fresh eyes. Mundane acts have a way of becoming extraordinarily beautiful when we are faced with the prospect of their vanishing. Here, baseball becomes a site of resistance, an emblem of humanity, an antidote to the automation and artificial intelligence that controls every other aspect of life in AutoAmerica. After all, what would be the point of automating such a thing as nine human players throwing and catching balls to the best of their physical abilities? What significance could there possibly be in a robot pitching a perfect game? We are here, one coach says late in the novel, because we believe anything can happen in a ballgame. You can get a guy and all his stats but give him a stick to swing, and you still dont know what will happen. Its a marvelously refreshing concept in a world that is otherwise dominated by algorithms.

The Resisters is a book that grows directly out of the soil of our current political moment, and much of the books unsettling pleasure lies in Jens ingenious extrapolation (or, in some cases, redescription) of contemporary problems. The book brims with EnforceBots (police robots), ThoughtCommand (next-level voice command), PermaDerms (permanent skin whitening) and SmartGuns. AutoAmerica is a nation shaped by policies like ShipEmBack, a mass deportation of immigrants, and the One Chance Policy, wherein Surplus families are permitted only one pregnancy, no matter the outcome.

Jen has such a gifted ear for the manipulative languages of tech, marketing and government that at times the sheer abundance of clever details threatens to overwhelm the stories of her characters. But perhaps this overabundance is part of the novels method, a way of swallowing the characters and the reader into AutoAmericas reality. The Resisters is aimed at many catastrophes at once: surveillance technology, government overreach, authoritarianism, automation, economic inequality, racism, sexual assault and the institutional mishandling of it, geopolitical conflict and climate change.

The central thread of the book, though, or perhaps the most lingering, is its obsession with the threats of artificial intelligence. The Resisters is full of characters who voluntarily hand over their humanity by agreeing to GenetImprovement or by mindlessly following the orders of Aunt Nettie. In one unnerving section, the narrator recounts the incremental steps that led to this all-encompassing control first, he let Aunt Nettie keep his calendar, then respond to emails on his behalf. (The Resisters might make you stop and actually read your user agreements.)

In the most devastating moment of this ultimately quite tender novel, one characters mind is surgically merged against her will with Aunt Nettie, so that the line between human and internet is no longer clear, even to herself. Crucially, it is other human beings who carry out this dreadful procedure, which suggests that even in a dystopian world dominated by artificial intelligence, people are still the ones who carry out the most atrocious acts.

We live in a moment when The Handmaids Tale is a hit television show, and Kellyanne Conways use of the term alternative facts reminded so many readers of the double talk in George Orwells classic 1984 that the novel hit the best-seller list seven decades after its original publication. The public seems to feel that the worst speculative fictions are coming true. Of course, Margaret Atwood would contend that The Handmaids Tale was true even as it was written. Perhaps Gish Jen could make a similar argument about much of The Resisters. The hope she offers, though, lies in the books title, and in the heroism of its family of Bartlebys, who resist both the lure of conveniences and the threats of the powerful, with one phrase: I would prefer not to.

Read more from the original source:
The Future Is Here, and Uncomfortably Close to Home - The New York Times

Type 2 diabetes is a condition that means insulin in the pancreas doesnt work properly. Everybody needs insulin to live and has an essential job to help keep the body healthy. Insulin allows the glucose in the blood to enter the cells and fuel the body. When a person suffers from type 2 diabetes, the impact could create a myriad of health problems. But what are the biggest symptoms to look out for when it comes to type 2 diabetes?

New research by Simplyhealth, which Dr Dawn is the ambassador of, revealed when it comes to staying healthy, only 16 percent focus on visiting the doctor when they feel unwell, while the average Briton waiting over two weeks before booking an appointment with their doctor about a minor health concerns.

This appears to be taking its toll, with one in five admitting their illnesses last longer as they cant get to the doctors due to other commitments.

For type 2 diabetes, ignoring symptoms could have a disastrous effect on ones health.

READ MORE: High blood pressure signs: The worrying symptom in your eyes that could signal your risk

Dr Harper told Express.co.uk: The biggest problems we have with type 2 diabetes is that there are literally tens of thousands of people walking around out there today with established type 2 diabetes who have no idea because they dont have symptoms.

We know that by the time an individual is diagnosed with type 2 diabetes they have about a 50 percent chance of already have started to develop some of the complications which may not have been manifested themselves but they are very serious complications with things like eye disease, kidney disease, high blood pressure, the risk of heart disease and stroke."

DONT MISS

The important issue that we have is that a lot of people wouldnt necessarily know they have type 2 diabetes," continued Dr Harper.

"One of the reasons why we are so keen that people attend things like the NHS health check to get tested because you may have no symptoms whatsoever."

When asked who is most at risk of developing type 2 diabetes, Dr Dawn replied: I think if you are a person who is putting on weight especially around your midriff then that could be a sign that you could be at risk and you need to get tested.

The NHS said: Type 2 diabetes is a common condition that causes the level of sugar in the blood to become too high.

"It can cause symptoms like excessive thirst, needing to pee a lot and tiredness.

"It can also increase your risk of getting serious problems with your eyes, heart and nerves.

"Its a lifelong condition that can affect your everyday life. You may need to change your diet, take medicines and have regular checkups. Its caused by problems with a chemical in the body called insulin.

"Its often linked to being overweight or inactive, or having a family history of type 2 diabetes.

See original here:
Type 2 diabetes warning: Dr Dawn Harper says those with condition 'may have no symptoms' - Express

A link has been found between women who have high levels of testosterone and an increased risk of type 2 diabetes, metabolic disease and cancer.

Although testosterone supplements are commonly used to treat sexual function, bone health and body composition, it is largely unknown what the long terms effects on disease risk and outcomes is. Researchers from Exeter University set out to see if there is any evidence for long term effects associated with high testosterone levels.

In their study, which involved around 425,000 people, has found evidence that females who have raised levels of the sex hormone have a 37 per cent higher risk of being diagnosed with type 2 diabetes.

Interestingly, the study revealed that for males with genetically high levels of testosterone, the risk of developing type 2 diabetes is 14 per cent lower. Although, findings suggested there was an increased chance of prostate cancer among males with high testosterone levels.

Although testosterone is usually associated with men, being the male sex hormone, women also produce small amounts of it in the ovaries and adrenal glands. This study looked at females who were genetically prone to greater testosterone levels and found, not only a higher type 2 diabetes risk, but also a 51 per cent increased risk of developing polycystic ovary syndrome a hormonal disorder that affects menstruation.

Genetics specialist Dr Katherine Ruth from Exeter University, who co-lead the study, said their findings have helped to emphasise the importance of considering men and women separately in studies, as we saw opposite effects for testosterone on diabetes.

Dr John Perry, who also worked on the trial and is from Cambridge University, added: In men, testosterone-reducing therapies are widely used to treat prostate cancer, but until now it was uncertain whether lower testosterone levels are also protective against developing prostate cancer.

The research has been published in the journal Nature Medicine.

Visit link:
High levels of testosterone linked to greater risk of type 2 diabetes in women - Diabetes.co.uk

Over the last two decades, few drugs have been approved for the treatment of AML, however increased understanding of the leukemic genome has allowed the development of targeted therapeutic agents.2,3 Between April 2017 and November 2018, eight new drugs in various different classes were approved, including: enasidenib, ivosidenib, midostaurin, glasdegib, venetoclax, and gilteritinib.4 An overview of mutations that can be targeted in AML is available on the AML Global Portal (AGP).

Some of these targeted agents are being investigated in novel combination therapies, as different lines of AML treatment, and some as monotherapy compared to standard chemotherapy. This article provides a summary of AGP content relating to novel agent-containing combinations to date and introduces the new editorial theme of Novel combination therapies using targeted agents.

The AGP were pleased to speak to Andrew Wei during the European School of Haematology (ESH) Translational Research Conference on AML, 2019, about how targeted therapies will be used in the future treatment of AML. In this interview, available below, Andrew Wei discusses whether these targeted agents should be used in combination or sequentially.

During the American Society of Clinical Oncology (ASCO) meeting in 2018, the AGP spoke to Uma Borate about how targeted therapies will impact the treatment of AML. Uma Borate discussed targeted agents, such as venetoclax, azacitidine, ivosidenib, and enasidenib.

Precision medicine may have a particular role in the treatment of older patients, since this population are often unable to receive allo-HSCT or intensive chemotherapy regimens. During the 61st American Society of Hematology (ASH) meeting, the AGP spoke to John Byrd about how precision medicine may be used to improve the outcomes of older patients with AML.

The AGP interviewed Courtney DiNardo about the treatment of elderly or frail patients with AML at the 1st National Cancer Research Institute (NCRI) AML Academy Meeting. Watch Courtney DiNardo discuss how the treatment approach for this patient group has changed in recent years with the advent of combination therapies below.

Studies have shown that epigenetic dysregulation can promote a preleukemic state that precedes leukemic transformation. Drugs targeting epigenetic dysregulation have been developed and include: azacitidine and decitabine, which are hypothesized to reverse DNA hypermethylation and reactivate repressed tumor suppressor genes; ivosidenib and enasidenib, which target IDH1 and IDH2 mutations thought to be involved in aberrant DNA hypermethylation.2 Combining these agents may improve patient outcome compared to azacitidine monotherapy.

Ivosidenib/enasidenib plus azacitidine: phase I/II study: AG221-AML-005 (NCT02677922)5,6,7

Patients with newly diagnosed AML, with either IDH1 mutations (mIDH1) or IDH2 mutations (mIDH2), were treated with azacitidine plus ivosidenib (for mIDH1) or enasidenib (for mIDH2).

Ivosidenib/enasidenib plus standard chemotherapy8

A phase III study, HOVON 150/AMLSG 29-18, is comparing enasidenib or ivosidenib (by mIDH status) plus chemotherapy (7+3) versus placebo.9 An overview of IDH inhibitors, including further information on the data from trials involving these combination therapies, is available here.

Other new targets for AML therapies are the FLT3 pathways. FLT3 is a transmembrane tyrosine kinase with two mutational subtypes: an internal tandem duplication (ITD) or point mutations in the tyrosine kinase domain (TKD).4 A third of patients with de novo AML have mutations in the FLT3 gene and patients with FLT3-ITD AML have a poor prognosis. FLT3 is therefore an attractive target for therapeutic agents, with several FLT3 inhibitors in clinical development, such as sorafenib, midostaurin, quizartinib, crenolanib, and gilteritinib.2,4

Examples of combination therapies involving FLT3 inhibitors are shown in Table 1 below. One example of a trial involving a FLT3 inhibitor is the RATIFY (NCT00651261) trial. The RATIFY trial assessed whether the addition of midostaurin to standard chemotherapy could prolong survival in newly diagnosed adult patients with FLT3-ITD AML compared to placebo + chemotherapy. The results showed midostaurin prolonged median OS and event-free survival (EFS) compared to placebo10:

However, the authors questioned if more specific FLT3 inhibitors could further improve outcomes.10

Table 1. Examples of combination therapies containing FLT3 inhibitors4,11,12

Targeted agent

In combination with/versus

Patient population

Trial name/NCT reference

Midostaurin

Induction chemo

ND AML with FLT3-ITD or TKD mutations

RATIFY

NCT00651261

Quizartinib

Induction chemo

ND AML with FLT3-ITD mutations

QuANTUM-First

NCT02668653

Crenolanib

vs midostaurin, in combination with induction chemo

ND AML with FLT3-ITD mutations

NCT03258931

Gilteritinib

Induction chemo

ND AML

NCT02310321

Sorafenib

Induction chemo

ND AML <60 years old

SORAML

NCT00893373

Learn more about FLT3 inhibitors in AML here.

During the 2019 EHA meeting, the AGP spoke to Alexander Perl about gilteritinib for the treatment of relapsed/refractory (R/R) AML.

Another example of a targeted agent for the treatment of AML is venetoclax, which is a Bcl-2 inhibitor. Venetoclax is approved by the U.S. Food & Drug Administration (FDA) for the treatment of newly diagnosed patients with AML who are not eligible for intensive induction chemotherapy, in combination with azacitidine, decitabine, or low dose cytarabine.13

Results from a phase Ib study (NCT02203773) investigating venetoclax with decitabine or azacitidine showed that these combination therapies led to a 61% complete remission or complete remission with incomplete marrow recovery rate in newly diagnosed patients with AML aged 65 and over.14 A phase III study (NCT02993523) comparing venetoclax plus azacitidine to azacitidine alone in patients with treatment-nave AML is ongoing.15

During the Acute Leukemias XVII Biology and Treatment Strategies biennial symposium, Andrew Wei gave a presentation on novel therapeutic combinations containing venetoclax for the treatment of AML.

There are a number of ongoing studies of venetoclax in combination therapies and examples of these include4:

During the 2018 ASCO meeting, the AGP spoke to Courtney DiNardo about the combination of venetoclax with hypomethylating agents (HMAs).

Subsequently, during the Society of Hematologic Oncology (SOHO) meeting in 2019, the AGP spoke to Jeffrey Lancet about the potential of venetoclax + HMAs to replace induction chemotherapy.

The AGP spoke to Marina Konopleva at the 2019 EHA meeting about Bcl-2 as a universal target in AML.

The development of targeted therapies and novel combinations holds promise for the treatment of AML, especially when compared to currently approved options. In some cases, these combinations may be more efficacious than intensive induction chemotherapy. In addition, some patients have been able to undergo allo-HSCT following treatment with a novel combination, which may indicate that the future of AML treatment will be in novel combinations and involve less chemotherapy. Additionally, these combinations appear tolerable to date.

Despite the promising results seen so far, not all patients respond equally. In order to maximize response to these therapies, it will be important to identify the right patient subgroups, with specific mutations, and may require particular combinations of agents to be used.2

Read this article:
An introduction to novel combination therapies using targeted agents in AML - AML Global Portal

Meticulous Research leading global market research company published a research report titled Medical Aesthetics Market by Product (Facial Aesthetics, Cosmetic Implants, Skin Aesthetic Devices, Thread Lift Products, Body Contouring Devices, Hair Removal Devices), End User (Hospitals, Medical Spas, Home Care Settings)Global Forecast to 2025.

According to this latest publication from Meticulous Research, the global medical aesthetics market is expected to grow at a CAGR of 11.5% from 2019 to reach $22.2 billion by 2025. The growth of this market will be driven by factors such as increasing adoption of minimally invasive and noninvasive aesthetic procedures, increasing public awareness about cosmetic procedures, and rising adoption of medical aesthetic procedures among geriatric population to improve their appearance. However, risk and complications associated with medical aesthetic procedures may hamper the growth of the market to a certain extent.

Get Inside Scoop Of The Report, Download For Free Sample PDF @https://www.meticulousresearch.com/download-sample-report/cp_id=5028(Note: Sample PDF Download with TOC, Charts, and Graphs)

Key questions answered in the report-Which are the high growth market segments in terms of products, technology, disease type, end user, and region/countries?What was the historical market for medical aesthetics market across the globe?What are the market forecasts and estimates for the period 2018-2025?What are the major drivers, opportunities, and challenges in the global medical aesthetics market?Who are the major players in the global medical aesthetics market?How is the competitive landscape and who are the market leaders in the global medical aesthetics market?What are the recent developments in the global medical aestheticsmarket?What are the different strategies adopted by the major players in the global medical aesthetics market?What are the geographical trends and high growth regions/ countries?Who are the local emerging players in the global medical aesthetics market and how do they compete with the global players?

Have Any Query? Ask Our Experts Here:https://www.meticulousresearch.com/speak-to-analyst/cp_id=5028

The global medical aesthetics market study presents historical market data in terms of values (2017 and 2018), estimated current data (2019), and forecasts for 2025- by product (facial aesthetics, cosmetic implants, skin aesthetic devices, physician-dispensed cosmeceuticals and skin lighteners, thread lift products, body contouring devices, hair removal devices, tattoo removal devices, and nail treatment laser devices), and end user (hospitals, clinics, and medical spas, beauty centers, and home care settings). The study also evaluates industry competitors and analyzes the market at a regional and country level.

On the basis of product type, facial aesthetics market segment is estimated to command the largest share of the global medical aesthetics market in 2019; whereas, cosmetic implants segment is expected to grow at the highest CAGR during the forecast period due to increasing growth of minimally invasive reconstruction surgeries, technological advancements such as injectable fillers and gummy bear breast implants, rising number of congenital face disorders, and increasing awareness about aesthetic appearance. A comprehensive range of cosmetic plastic surgery techniques and implants have been developed over the years for improving the appearance or restoring function to the human body. The implants used in cosmetic procedures are to enhance the aesthetic looks of an individual and rectify the deformities caused due to accidents, trauma, and congenital disorders.

On the basis of end user, hospitals, clinics, and medical spas segment is estimated to hold the largest share of the global medical aesthetics market in 2019. Hospitals, clinics, and medical spas are typically well-equipped with technologically advanced instruments/devices and have skilled professionals to provide effective cosmetic treatment to its patients. This has led to their greater share in the global medical aesthetics market. Hospital and medical spas design their services to improve the aesthetic procedures for patient well-being. Medical aesthetic services involve highly advanced technology that needs the combination of healthcare and beauty services. In aesthetic treatment, advanced technologies are increasingly being used to provide medical procedures designed to offer significant cosmetic change for patients. The growth of the hospitals, clinics, and medical spas segment in the market is primarily driven by the growing number of patients undergoing cosmetic procedures to enhance self-esteem, increasing healthcare expenditure on cosmetic procedures, growing geriatric population, and greater uptake of technologically advanced medical aesthetics devices in the hospitals and clinics to provide effective treatments to the patients.

Browse key industry insights spread across 195 pages with 185 market data tables & 18 figures & charts from the market research report:https://www.meticulousresearch.com/product/medical-aesthetics-market-5028/

Geograhic Review:

This research report analyzes major geographies and provides comprehensive analysis of North America (U.S., Canada), Europe (Germany, France, Italy, Spain, and U.K.), Asia-Pacific (China, India, South Korea, Japan, and Australia), Latin America, and Middle East & Africa. North America commanded the largest share of the global medical aesthetics market, followed by Europe and Asia Pacific. The largest share of North American region in the medical aesthetics market is primarily attributed to the growing healthcare sector, increasing awareness and adoption of aesthetic procedures among the population, growing healthcare expenditure, rising incidences of skin diseases, growing geriatric population, various technological advancements, and increase in the consciousness about physical appearances.

Asia Pacific region is expected to be the fastest growing geographic markets for medical aesthetics devices with countries, such as China, Japan, South Korea and India among others for being the largest contributors to the growth of the market. Additionally, rapid urbanization, increasing investments by healthcare providers towards infrastructure improvement, increasing awareness among the population, growing beauty consciousness, and availability of increasing range of advanced products and technologies is contributing to the growth of the medical aesthetics market in the Asia Pacific region.

Access Free Complete Free Sample PDF Copy Here:https://www.meticulousresearch.com/request-sample-report/cp_id=5028

Key players:

The major players operating in the globalmedical aesthetics marketare Allergan plc (Ireland), Alma Lasers (Israel), Anika Therapeutics, Inc. (US), Cutera, Inc. (US), Cynosure Inc. (US), El.En. S.P.A. (Italy), Fotona D.O.O (Solvenia& US), Galderma Laboratories, L.P. (US), Mentor Worldwide LLC (US), and Merz Aesthetics (Germany) among others.

Related Report:

Surgical Sutures Market by Product (Suture Thread (Synthetic, Nylon, Silk, Prolene, Steel), Automatic Suture Device), Application (CVD, General, Orthopedic, Gynec, Ophthalmic, Plastic, Cosmetics), End User (Hospitals, ASC, Clinic) Global Forecast to 2024

Flow Cytometry Market by Product (Cell Analyzers, Cell Sorter, Software, Reagents), Technology (Cell Based, Bead Based), Application (Drug Discovery, Stem Cell Research, Cancer, Organ Transplant, Commercial) and by End-user Global Forecast to 2027

Contact Us:Meticulous ResearchEmail-sales@meticulousresearch.comContact Sales- +1-646-781-8004Connect with us on LinkedIn-https://www.linkedin.com/company/meticulous-research

Continued here:
Medical Aesthetics Market Is Expected To Grow At CAGR Of 11.5% From 2019 To Reach $22.2 Billion By 2 - PharmiWeb.com

DetailsCategory: Small MoleculesPublished on Wednesday, 12 February 2020 17:52Hits: 446

PLEASANTON, CA, USA I February 11, 2020 I Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, today announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML. The NDA submission is based on data from the ASCERTAIN phase 3 study which evaluated the 5-day decitabine exposure equivalence of oral C-DEC and IV decitabine.

We are very pleased that the FDA has accepted our NDA for Priority Review, said Dr Mohammad Azab, MD, president & chief medical officer of Astex Pharmaceuticals, Inc. Subject to FDA review and regulatory approval, oral C-DEC may offer a new option for patients with MDS and CMML that saves them the burden of 5-day IV infusions every month during their treatment period. We are grateful to all the patients, investigators and other healthcare providers, and partner research and manufacturing organizations, who contributed to the clinical development program of oral C-DEC.

The FDA grants Priority Review to applications for drugs that, if approved, would provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions. The Priority Review designation means FDAs goal is to take action on an NDA application within six months (compared to the ten months under standard review).

Oral C-DEC is an investigational compound and is not currently approved in any country.

Astexs parent company, Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. previously announced that, subject to regulatory approvals, commercialization of oral C-DEC in the U.S. and Canada will be conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc. respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

About C-DEC (Cedazuridine 100 mg and Decitabine 35 mg) Fixed-Dose Combination

C-DEC is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase,1 with the anti-cancer DNA hypomethylating agent, decitabine.2 By inhibiting cytidine deaminase in the gut and the liver, C-DEC is designed to allow for oral delivery of the approved DNA hypomethylating agent, decitabine, at exposures which emulate exposures achieved with the approved intravenous form of decitabine administered over 5 days.3

C-DEC has been evaluated in a phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in patients with MDS and CMML (see https://www.clinicaltrials.gov NCT02103478) and a pivotal phase 3 study (ASCERTAIN) (see https://www.clinicaltrials.gov NCT03306264) conducted at investigator sites in the US and Canada and designed to confirm the results from the phase 1/2 study. The phase 3 study is now being extended to include patients with acute myeloid leukemia (AML) unsuitable to receive intensive induction chemotherapy.

In September 2019 Astex announced that C-DEC had received orphan drug designation for the treatment of MDS and CMML from the U.S. FDA.

The concept of using cedazuridine to block the action of cytidine deaminase is also being evaluated in a low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see https://www.clinicaltrials.gov NCT03502668).

About the Phase 3 ASCERTAIN Study

The study was designed as a randomized crossover study comparing oral C-DEC (cedazuridine 100 mg and decitabine 35 mg fixed-dose combination tablet given once daily for 5 days on a 28-day cycle) to IV decitabine (20 mg/m2 administered as a daily, 1-hour IV infusion for 5 days on a 28-day cycle) in the first 2 cycles with patients continuing to receive oral C-DEC from Cycle 3 onwards. The data from the ASCERTAIN study was presented at the American Society of Hematology (ASH) Meeting in Orlando, Florida in December 2019 by Dr Guillermo Garcia-Manero, MD, professor and chief of section of myelodysplastic syndromes, Department of Leukemia at The University of Texas MD Anderson Cancer Center, on behalf of the study investigators.4 The data demonstrated that the ASCERTAIN study met the primary endpoint of total 5-Day decitabine Area-Under-The-Curve (AUC) equivalence of oral C-DEC and IV decitabine. Safety findings from the study were consistent with those anticipated with IV decitabine, with no significant differences in the incidence of most common adverse events between oral C-DEC and IV decitabine in the first 2 randomized cycles. The most common adverse events of any grade >20% regardless of causality in patients in the first 2 randomized cycles who received oral C-DEC were thrombocytopenia (43.8%), neutropenia (35.4%), anemia (36.9%), and fatigue (23.8%). The ASH presentation can be downloaded from the Astex website at https://astx.com/media-center/presentations-and-publications/ASTX727 ASCERTAIN Presentation - ASH - December 2019

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.5,6 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.7 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.8 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML. CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the U.S. is approximately 1,100 new cases per year,9 and CMML may transform into AML in 15% to 30% of patients.10 The hypomethylating agents decitabine and azacitidine are effective treatment modalities for hematologic cancers and are FDA-approved for the treatment of higher-risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

About Astex Pharmaceuticals, Inc.

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

Otsuka is a global healthcare company with the corporate philosophy: Otsukapeople creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, Inc. please visit: http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: http://www.otsuka.com/en/

For more information about Taiho Pharmaceutical, please visit: https://www.taihooncology.com/

References

SOURCE: Astex Pharmaceuticals

Read this article:
Astex Pharmaceuticals Announces US Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent...

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] 10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in these patients. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

Triple-negative breast cancer is an aggressive malignancy. It is very encouraging that KEYTRUDA in combination with chemotherapy has now demonstrated positive results as both a first-line treatment in the metastatic setting with this trial, and as neoadjuvant therapy in the KEYNOTE-522 trial, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. We look forward to sharing these findings with the medical community at an upcoming congress and discussing them with the FDA and other regulatory authorities.

The KEYTRUDA breast cancer clinical development program encompasses several internal and external collaborative studies. In addition to KEYNOTE-355, in TNBC these include the ongoing registration-enabling studies KEYNOTE-242 and KEYNOTE-522.

About KEYNOTE-355

KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigators choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) compared with placebo plus one of the three chemotherapy regimens for the treatment of locally recurrent inoperable or mTNBC that has not been previously treated with chemotherapy in the metastatic setting. Part 1 of the study was open-label and evaluated the safety and tolerability of KEYTRUDA in combination with either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin in 30 patients. Part 2 of KEYNOTE-355 was double-blinded, with dual primary endpoints of OS and PFS in all participants and in participants whose tumors expressed PD-L1 (CPS 1 and CPS 10). The secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

Part 2 of KEYNOTE-355 enrolled 847 patients who were randomized to receive KEYTRUDA (200 mg intravenously [IV] on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and Area Under the Curve [AUC] 2 [carboplatin] on days 1 and 8 of each 21-day cycle); or placebo (normal saline on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and AUC 2 [carboplatin] on days 1 and 8 of each 21-day cycle).

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Original post:
Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for...

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ --Seattle Genetics, Inc.(Nasdaq: SGEN) and Astellas Pharma Inc.(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract #441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2

"Cisplatin-basedchemotherapy is the standard treatment for first-line advanced urothelial cancer; however, it isn't an option for many patients,"said Jonathan E. Rosenberg, M.D., Medical Oncologist and Chief, Genitourinary Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York."I'm encouraged by these interim results, including a median progression-free survival of a year for patients who received the platinum-free combination of PADCEV and pembrolizumab in the first-line setting."

In the study, 58 percent (26/45) of patients had a treatment-related adverse event greater than or equal to Grade 3: increase in lipase (18 percent; 8/45), rash (13 percent; 6/45), hyperglycemia (13 percent; 6/45) and peripheral neuropathy (4 percent; 2/45); these rates were similar to those observed with PADCEV monotherapy.3Eighteen percent (8/45) of patients had treatment-related immune-mediated adverse events of clinical interest greater than or equal to Grade 3 that required the use of systemic steroids (arthralgia, dermatitis bullous, pneumonitis, lipase increased, rash erythematous, rash maculo-papular, tubulointerstitial nephritis, myasthenia gravis). None of the adverse events of clinical interest were Grade 5 events. Six patients (13 percent) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. As previously reported, there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.

The data demonstrated the combination of PADCEV plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 73.3 percent (33/45; 95% Confidence Interval (CI): 58.1, 85.4) after a median follow-up of 11.5 months (range,0.7 to 19.2). Responses included 15.6 percent (7/45) of patients who had a complete response (CR)and 57.8 percent (26/45) of patients who had a partial response. Median duration of response has not yet been reached (range 1.2 to 12.9+ months). Eighteen (55%) of 33 responses were ongoing at the time of analysis, with 83.9% of responses lasting at least 6 months and 53.7% of responses lasting at least 12 months (Kaplan-Meier estimate).The median progression-free survival was 12.3 months (95% CI: 7.98, -) and the 12-month overall survival (OS) rate was 81.6 percent (95% CI: 62 to 91.8 percent); median OS has not been reached.

"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating PADCEV in this platinum-free combination in the first-line setting," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

"These additional results support continued evaluation of PADCEV in combination with other agents and at earlier stages of treatment for patients withurothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

About the EV-103 TrialEV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.

The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. Patients were dosed in a 21-day cycle, receiving an intravenous (IV) infusion of enfortumab vedotin on Days 1 and 8 and pembrolizumab on Day 1. At the time of this initial analysis, 45 patients (5 from the dose-escalation cohort and 40 from the dose-expansion cohort A) with locally advanced and/or metastatic urothelial cancer had been treated with enfortumab vedotin (1.25 mg/kg) plus pembrolizumab in the first-line setting.

The primary outcome measure of the cohorts included in this analysis is safety. Key secondary objectives related to efficacy include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). DoR,PFS and OS are not yet mature.

Additional cohorts in the EV-103 study will evaluate enfortumab vedotin:

More information about PADCEV clinical trials can be found at clinicaltrials.gov.

About Bladder and Urothelial CancerIt is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.5 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.6 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.7

The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are ineligible for cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.8

About PADCEV PADCEV (enfortumabvedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.9

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.2,9Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Seattle GeneticsSeattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people's lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.comand follow @SeattleGenetics on Twitter.

About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.

About the Astellas and Seattle Genetics CollaborationSeattle Genetics and Astellas are co-developing enfortumab vedotin-ejfv under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

Seattle Genetics Forward-Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the EV-103 and EV-302 clinical trials; clinical development plans relating to enfortumab vedotin; the therapeutic potential of enfortumab vedotin; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of enfortumab vedotin may fail to establish sufficient efficacy; that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.3 Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.4 ClinicalTrials.gov. A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103). https://clinicaltrials.gov/ct2/show/NCT03288545.5 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.6National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.7International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow. 8 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.9 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.

SOURCE Astellas

http://www.seattlegenetics.com

Here is the original post:
Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy...

Right now, Stanford University is addressing a pressing and fascinating question:

What happens to society when everyone starts living to 100? How will we stay physically fit, financially stable and mentally sharp, especially in that back half?

Exploring these questions is the goal of the Stanford Longevity Project. To answer them, theyve partnered with major brands like Wells Fargo, Instructure, and Principal to help research key elements like financial security, lifelong learning, and healthcare.

Despite Americas average life expectancy declining the past couple years due to more overdoses, suicides and alcohol-related illnesses, people are going to be able to live longer. Strong advancements have been made in cancer. This month, the U.S. saw its sharpest one year decline in cancer death rate. That will save millions of lives alone.

But this isnt just a health and wellness conversation. What this presents are multiple opportunities in multiple verticals for marketers.

One of the biggest trends at CES this month was a new generation of healthcare wearables. There were earbuds designed to detect blood pressure for those with hypertension, temporary tattoos that tell you when to get out of the sun, smart glasses that assist people with dyslexia and watches that detect sleep apnea. These technologies are all discreet, easy to use, and built in to everyday things we already use.

We are heading toward a near future in which every human body will have a functioning check engine light. You can imagine how much better healthcare will be when a sensor will tell you something needs attention, rather than panicked scrolling through WebMD.

We will have the ability to know when something is wrong and immediately trigger tests, medication and treatment. Imagine if that sensor, using the IoT, could immediately send and fill a prescription for you.

This is all coming down the pipeline, and its going to help us live longer. Its also going to change the way marketers do their jobs and open up countless new opportunities to reach new audiences.

Heres what some of those opportunities will look like.

Cincinnati has one of the best healthcare startup scenes in the country. Cincinnati Childrens Hospital is ranked #3 nationally. CincyTech has raised nearly a billion in healthcare follow-on investment over the past ten years.

The common thread these organizations share is they are tackling high-use issues in different ways. That includes everything from small, wearable, injectable devices (Enable Injections) that can be used for a multitude of conditions, to analyzing peoples sweat to ensure proper medication dosing (Eccrine Systems).

One of the most interesting might be Sense Diagnostics because their simple device addresses a huge need: stroke detection. Right now there isnt a good way to tell which kind of stroke (transient ischemic, ischemic, or hemorrhagic) someone is having in the field. An ambulance with this non-invasive device will be able to quickly diagnose which stroke is occuring, allowing them to begin the best possible treatment immediately.

As people begin living longer, well see that the traditional approach to education and work must change. A longer living workforce will be more likely to need to reskill for second and third careers.

Private equity firm Thoma Bravo is buying Instructure (makers of the popular Canvas Learning Management System) for $2 billion, precisely because of the projected growth and opportunity in education as people extend their careers.

Of course, four-year higher education will still exist. But new avenues and approaches to learning will emerge as supplemental or alternative ways of reskilling for jobs that will target people in their 60s, 70s, and 80s.

Curricula will obviously also have to adapt, becoming more flexible, personalized, and life-long. Being able to brush up every three months on relevant skills via a subscription model may be a better future model for education than entering a full-time program. Most of the marketing opportunities will be around aiding employers, because they have the budgets and the competition for retention.

Living longer changes a persons entire financial strategy.

Most standard retirement principles assume that retirement will last a maximum of 30 years. The commonly-used "4% rule" of retirement is an example of this. However, if you live to 100 or beyond, your retirement could last 35 years, 40 years, or longer, said Nathan Hamilton, director and industry analyst at The Ascent from The Motley Fool.

A deferred annuity could be worth a look. Essentially, you put some money into an annuity when you first retire (or earlier), but that won't start paying out until a certain agesay, 80 or 85. The idea is that even if your retirement nest egg is getting low as you get older, this move guarantees you a predictable income stream for life.

How we invest may also change as we look to create steady income streams that kick in throughout retirement rather than just upfront. This also may inevitably cause people to work later and longer especially as our workforce trends farther away from physical labor to more mental and creative labor.

The biggest takeaway here isnt that living longer will impact one thing. It will impact everything.

As humans, we need to think about that for ourselves and our future generations. And as marketers and entrepreneurs, we can start thinking about ways we can make that reality better, more productive, and more secure for people.

Go here to read the rest:
Marketing To 100-Year-Olds: How Longevity Will Transform Finance, Healthcare And Education - Forbes

NEW YORK, United States Nancy Pelosi has always worn Michael Kors. She told him his clothes make her feel strong, and God knows thats something she needs in Washington. Before his show on Wednesday, Kors was talking about how its more important than ever to take a stand for your principles. If youre going to do battle, youd better feel confident doing it, he said. Thats the simple truth. If youre tugging at your dress, and youre crippled in your shoes, and you cant handle your bag Kors proudly pointed out there wasnt a stiletto heel or a skintight dress in his new collection. And we dont have a bag in the show thats not hands-free. Instead, his woman was dressed for the "real" world. We need a chic security blanket, thats the reality.

His business turns 40 next year, and he claimed hes been thinking about clothing in terms of a security blanket more or less the whole time. Kors has always been ready with a raft of references for each new collection usually a Hollywood style icon but with this major anniversary approaching, hes begun to reference his own work.

There sure is enough of it. Two decades ago, Naomi Campbell modelled a cape in a Kors show, Tina Barney later photographed writer Joan Didion wearing it. We got a phone call saying Joan wanted to buy the cape and I couldnt breathe, the designer recalled. Her writing, her sense of stylishness always knocked me out. Give me Mailbu Joan Didion and Im there. Kors owns Barneys photo. I wake up to it every day. That cape is graphic, it stands the test of time, Kaia Gerber is wearing it in the show today, 21 years later.

Remember in Citizen Kane how the sled called Rosebud was a childhood memory representing all that was simple, good and true for the business titan Charles Foster Kane as he lay dying? Not wanting to sound morbid or anything, but I wondered if the cape might be Korss Rosebud, the thread that runs through his lifes work. Hes a mad movie buff, so the idea appealed to him. He certainly gave us a show that was the cinematic apotheosis of the cape, in every possible guise: Victorian detective, highwayman, Zorro, poncho, blanket. Coats and capes combined, collars flared into capelets.

The simple, good and true bit worked because what Kors was after was a sense of the cosiness and comfort of country dressing given a bit of spit and polish for city life. Now more than ever, the simple truth is that our customers dream of being able to unplug and get out of town, but thats not the way life works out.

So Kors sold the fantasy the joy of wide-open spaces as efficiently as hes always plugged his glamorous Hollywood-spiked re-visions of Americana. The escapism, the honesty of the West is one of the things you can be proud of as an American, no matter what. There was a pony print trench, and a full-on riding look in amidst all the caped cosiness.

Classics. Longevity. Kors has been brooding on them. Funny thing is, we now have a whole new generation of customers who never thought about fashion as investment, but the sustainability conversation has woken them up. They say, I dont have to buy a dress to wear twice to post on Instagram, I can actually buy something thats beautifully made and hang onto it. Intelligently, thats what Ive always thought but now were seeing a whole new generation approaching that idea for a different reason. Thats amazing.

But, honestly, is it so amazing, when youre presented with something as effortlessly, common-sensically glamorous as a slinky grey cashmere turtleneck elongated over a fishtail skirt pav-ed with subtly gleaming graphite sequins and anchored by lug-soled boots? At what stage in the devolution of humankind is that not going to look good?

See the rest here:
Michael Kors Broods on Longevity | Fashion Show Review, Ready-to-Wear Autumn 2020 | BoF - The Business of Fashion

THE WOODLANDS, TX - Larry Deckerhoff, MIM, well-known adviser to companies and entrepreneurs in The Woodlands (Texas), announced the continuation of The Woodlands Lunch Forum with a luncheon event scheduled for Friday, 28 February 2020 at Amerigos Grille, 25250 Grogans Park Drive in The Woodlands. The Forum is scheduled to start at 11:30 AM and last one and a half hours. Mr. Deckerhoff indicated,

The theme of this Lunch Forum is Advanced Health for the New Millennium, Immunotherapy and Rejuvenation. Among our featured speakers will be Ralph Fucetola JD, President of The Woodlands own Institute for Health Research - http://www.InHeRe.org. He will be joined by two experts in rejuvenation and immunotherapies. The short presentations will leave plenty of time to connect and enjoy the extraordinary cuisine at Amerigos Grille.

The Institute, founded in 1998, focuses on leading-edge, natural and nutritional support for vigorous aging and powerful immunity. The Institute President will introduce advanced approaches to health and longevity through the featured speakers who are positioned to inform and enlighten, in cooperation with NutraSpace, Health Matching Accounts and Natural Solutions Foundation.

Interested participants are requested to RSVP to stephen.contreras1@hotmail.com the requested donation of $50.00 includes a three course gourmet lunch. Donations in excess of luncheon value are tax-deductible.

The President of the Institute concluded:

We look forward to a growing presence in The Woodlands community as our alliances with local and regional companies and researchers continue to mature. Our research interests include areas as diverse as longevity nutrition, immunotherapy and autism retrieval.

Speakers:

1. Ralph Fucetola JD President, the Institute for Health Research http://www.InHeRe.org2. Bill Hayes, NutraSpace http://www.NutraSpace.com3. Elliot Gorog, HMA - http://www.HealthMatchingAccounts.com

More here:
The Woodlands Lunch Forum to Host Longevity and Health Event February 28th at Amerigo's Grille - Woodlands Online

TEMPLE, TX Baylor Scott and White doctors and researchers are teaming up with experts from across the state to improve the lives of heart failure patients.

Doctors explained to 25 News, those diagnosed with heart failure often have additional ailments, like arthritis, which often impede with the patients ability to exercise; and without exercise heart failure patients conditions often worsen.

Researchers at Baylor Scott and White are efforting a new study, conducting trails on alternative exercise regimens for their patients, by using aquatic therapy.

"The hypothesis is that compared to land based exercise they are going to have actually more mobility both before and after exercise and improve cardiac function" explained Catherine McNeal, M.D PHD Medical Director of Cardiac Rehabilitation at Baylor Scott and White.

McNeal's cohort, Albert Hicks, M.D MPH Medical Director of Heart Failure and Transplant, Baylor Scott and White, further explaining "we know that from many trails including our H.F. Action trail that heart failure patients who do cardiac rehab actually have increased survival...in the pool they have an opportunity to really not only get their heart rate up but also to do an activity that is something that they can do for the majority of the rest of their life."

The Baylor Scott and White team is collaborating with experts in aquatics at University of Texas and bio-engineers at Texas A&M University in their research.

Funded internally by the Baylor Cardiovascular Research Center, the teams efforts have all pointed towards positive results.

Awarded a small grant from the National Institutes of Health (NIH) the team looks forward to their findings and potentially positively impacting the lives of heart patients nationally.

Read the rest here:
Local News Doctors in Temple experimenting with aquatic therapy to improve longevity of heart patients Erin - KXXV News Channel 25

Anopheles arabiensis is an opportunistic malaria vector that rests and feeds outdoors, circumventing current vector control methods. Furthermore, this vector will readily feed on animal as well as human hosts. Targeting the vector, while feeding on animals, can provide an additional intervention for the current vector control activities. Agricultural animals are regularly vaccinated with recombinant proteins for the control of multiple endo- and ecto-parasitic infestations. The use of a Subolesin-vaccine showed a mark reduction in tick reproductive fitness. The orthologous gene of Subolesin, called Akirin in insects, might provide a valuable species-specific intervention against outdoor biting An. arabiensis. However, the biological function of this nuclear protein has not yet been investigated in this mosquito. The effects on An. arabiensis lifetable parameters were evaluated after Akirin was knocked down using commercial small-interfering RNA (siRNA) and in vitro transcribed double-stranded RNA (dsRNA). The siRNA mediated interference of Akirin significantly reduced fecundity by 17%, fertility by 23% and longevity by 32% when compared to the controls in the female mosquitoes tested. Similarly, dsRNA treatment had a 25% decrease in fecundity, 29% decrease in fertility, and 48% decrease in longevity, when compared to the control treatments. Mosquitoes treated with Akirin dsRNA had a mean survival time of 15-days post-inoculation, which would impact on their ability to transmit malaria parasites. These results strongly suggest that Akirin has a pleiotropic function in An. arabiensis longevity and reproductive fitness.

Read more from the original source:
Characterising the effect of Akirin knockdown on Anopheles arabiensis (Diptera: Culicidae) reproduction and survival, using RNA-mediated interference....

KEY POINTS

Lifestyle is among the determinants of how long you may live. For those who regularly go on excessive alcohol drinking, consuming diets full of trans fats, and observe many other unhealthy practices, may not expect to live long.

Scientists and health experts have found long ago that to have a healthier and longer life, you should exercise regularly and consume a healthy and balanced diet. You should also limit your alcohol intake and quit smoking.

It is not at all surprising that observing a healthy diet can help a lot in improving longevity. With thousands of information as to what can be the best diet, however, you can easily get confused as to which one to follow.

Fortunately, recent research has shed light on what could possibly be the best diet that can help improve longevity and at the same time, help prevent cancer. live healthy life vegan diet increase longevity Photo: Rita E - Pixabay

Vegans May Have an Edge

Findings of a new study that were published in The Journal of Nutrition concluded that the secret to a long life might lie in veganism. Leading scientists and health experts agree, saying that a vegan diet helps in warding off a lot of diseases, including cancer.

Researchers revealed that based on the findings of their recently concluded study, the bodies of vegans contain the most antioxidants. According to health experts, this is primarily due to the high intake of vegetables and fruits.

It was also found out that those who follow a vegan diet have considerably lower death rates compared to meat-consumers. This new study reinforces findings of past researches that found a vegetarian diet, which consists mostly of nuts, wholegrain, legumes, fruits, and vegetables, lowers the risk of developing major ailments. It also helps you live longer.

The Vegan Research

Researchers from Loma Linda University have proven that men who follow vegan diets live an average of ten years longer compared to non-vegetarian men. Women following vegan diets, on the other hand, can add six more years of a healthy life, helping them reach an average age of 85 years.

Loma Linda University researchers also comprised the same research team that came up with the groundbreaking Adventist Health Study-1, a study that examines nutrition and life expectancy.This study was regarded as a benchmark in the nutrition world because of its comprehensiveness in terms of the number of participants and the length of time conducted.

Loma Linda researchers, for fourteen long years, tracked the diets, lifestyle, and ailments among 34,000 volunteers who do not drink or smoke. They found several habits that could add years to your life.

For one, the volunteers were consuming plant-based foods and were also consuming a handful of nuts regularly. They are also physically active and maintain a healthy weight. According to the researchers, these lifestyle habits could give you an extra two to three years of a fruitful life.

Read more from the original source:
Protect Yourself Against Cancer And Increase Life Expectancy By Eating The Best Diet - International Business Times

To some longevity acolytes, stem cells promise the secret to eternal youth. For a hefty fee, you can pay a startup to extract your own stem cells and cryogenically freeze them, in the hope that they can one day be used in a treatment to help extend your life.

Other firms let you bank stem cells from your babys umbilical cord and placenta after childbirth, if youre convinced the high cost represents an insurance policy against future illness. Or you can follow the example of Sandra Bullock and Cate Blanchett and opt for an anti-ageing cream made with stem cells derived from the severed foreskins of newborn babies in South Korea.

Stem cells are the parent cells which give rise to other cells in our bodies. Since scientists first isolated human embryonic stem cells in a lab and grew them over 20 years ago, they have been mooted as a source of great hope for regenerative medical treatments, including for age-related degenerative conditions such as Parkinsons, Alzheimers, heart disease and stroke.

But apart from a few small-scale examples, the only stem cell-based medical treatment practised in clinics uses haematopoietic stem cells found in the blood and bone marrow which only produce blood cells for transplants in blood cancer patients. These cells are taken from a patients sibling or an unrelated donor, before being infused into a patients blood, or theyre taken from a patients own blood before being reinfused. The procedure has been used to treat blood malignancies for almost half a century, and recently multiple sclerosis too. So how likely is it that the predictions about stem cells' longevity-enhancing powers will become a reality?

In September 2019, Google banned ads for unproven or experimental medical techniques such as most stem cell therapy, citing a rise in bad actors attempting to take advantage of individuals by offering untested, deceptive treatments [that can often] lead to dangerous health outcomes. The decision was welcomed by the International Society for Stem Cell Research, which emphasised that most stem cell interventions remain experimental. Selling treatments before well-regulated clinical trials have been done, the body said, [threatens public] confidence in biomedical research and undermines the development of legitimate new therapies.

Its easy to see how less scrupulous companies can exploit the allure of stem cells, which seem to occupy a place in our collective consciousness as a kind of magical elixir. High hopes for stem cell-based therapies have grown since 2006, when the Japanese biologist Shinya Yamanaka created a new technology to reprogram adult cells, such as skin cells, into a similar state to embryonic stem cells, which are pluripotent, meaning they can develop into any tissue in the body. The Nobel prize-winning breakthrough was hailed as a major step in the study of stem cells without the need for controversial embryo research, and towards the use of these human induced pluripotent stem cells to regenerate damaged or diseased organs or effectively grow new spare parts which could treat the life-limiting and life-shortening illnesses associated with ageing.

Gerontologist Aubrey de Grey, whose Strategies for Engineered Negligible Senescence (SENS) research foundation aims to eliminate ageing-related diseases, thinks the chances well soon have stem cell based therapies are high. For anything that's in clinical trials, you're talking about maybe five years before it's available to the general public, he says, citing stem cell treatments for Parkinsons disease, currently being tested in phase two clinical trials, as one of the developments he thinks is likely to come soonest.

However, given that these trials involve a relatively small number of participants and most clinical trials ultimately fail, his predictions might be overly optimistic. Often described as a maverick, De Grey believes that humans can live forever and there is a 50 per cent chance medical advances of which stem cell therapies will play an important part will make this a reality within the next 17 years. Though living forever, he says, is not the ultimate goal but a rather large side effect of medicine which will successfully prevent or repair the damage that comes with ageing.

For New Jersey-based Robert Hariri, who co-founded Human Longevity Inc, which set its sights more modestly on making 100 the new 60, stem cells derived from placentas present especially exciting opportunities. A biomedical scientist, surgeon and entrepreneur, Hariri says his current venture Celularity which is focused on engineering placental cells, including stem cells, to create drugs for cancer and other conditions is not as concerned about the actual age number, but about preserving human performance as we age and treating the degenerative diseases that rob us of our quality of life.

Many of those working in the field, however, remain cautious in their optimism. Researchers have highlighted the potential risks of giving pluripotent cells to patients, whether they are induced or embryonic, as these cells can develop cancer-causing mutations as they grow.

Davide Danovi, a scientist at Kings College Londons Centre for Stem Cells & Regenerative Medicine, says the path to stem cell-based therapy is very long and full of hurdles. The supply chain involves challenges, he says. On the one hand, allogeneic treatments those with stem cells derived from one individual and expanded into big batches to create cells to treat many individuals have the advantage of being similar to the traditional pharmaceutical business models. The product is clear, its something that comes in a vial and can be scaled up and mass produced, Danovi says. But this treatment can present a greater risk of rejection from the patient, as opposed to the more bespoke autologous option which is more expensive and time-consuming as it involves extracting a patients own stem cells before reprogramming them.

Danovi is most excited by the potential of stem cells to treat age-related macular degeneration. In 2017 Japanese scientist Masayo Takahash led a team that administered transplants of artificially grown retinal cells created from induced pluripotent stem cells taken from donors to five patients with the eye condition, which can cause blindness, and theyre reported to be doing well. The eye, he says seems to be a place where immunity plays less of a role relative to other issues, so you can host cells which come from another individual with fewer problems [of rejection]. But, with other organs such as the liver, he says there are major conceptual problems with creating enough tissue. Its like the clean meat burger - you're talking about a production that is, in many cases, not easy to reach with the current technology.

Hariri believes placentas will solve some of the production challenges crucially, theyre an abundant commodity, with the vast majority thrown out after childbirth. His interest was sparked 20 years ago when his oldest daughter was in the womb: When I saw her first ultrasound in the first trimester, the placenta had already developed into a relatively sizable organ, even though she was just a peanut-sized embryo. Id been taught that the placenta was nothing more than an interface, but [if that was the case], you would expect that it would grow at the same rate as the embryo. His curiosity piqued, he began to see the placenta not as an interface but as a biological factory, where stem cells could be expanded and differentiated to participate in the development of that foetus. That intrigued me and I started to collect placentas and just, you know, basically disassemble them.

Placentas have numerous benefits, he says they dont carry the same ethical controversy as embryonic stem cells, for one thing. Scientists working on embryonic stem cells have to destroy an early embryo, and that option yields them a dozen cells, which have to be culture-expanded in the laboratory into billions of cells. In contrast, the placenta houses, billions and hundreds of billions of cells, which can be expanded as well, but you're starting out with a dramatically larger starting material.

Increasingly, scientists in the anti-ageing sphere are focusing on an approach that seems like the opposite of planting fresh stem cells into our bodies. Experts such as Ilaria Bellantuono at Sheffield Universitys Healthy Lifespan Institute are working towards creating senolytics medication that could kill off our senescent cells, the zombie cells that accumulate in tissues as we age and cause chronic inflammation. I think stem cells are very good for specific disease, where the environment is still young, Bellantuono says, but the data in animal models tells us that senolytics are actually able to delay the onset and reduce the severity of multiple diseases at the same time for example, there is evidence for osteoarthritis, osteoporosis, cardiovascular disease, Alzheimer's, Parkinson's, and diabetes. She explains that while human trials are still in their early stages, senolytics are likely to be more cost-effective than stem cell therapy and the status quo of older patients taking multiple pills for multiple diseases, which can interact with each other. Besides, she adds, they may actually work in tandem with stem-cell based therapies in the future, with senolytics creating a more hospitable environment in tissues to allow stem cells to do their work.

And as for the so-called penis facial? Its far from the only ultra-expensive stem cell skincare making bold anti-ageing claims but youre probably better off saving your money, as you are with the experimental medical treatments on offer. Stem cells are definitely exciting but theyre not the key to eternal youth. At least, not yet.

Robert Harari will be one of the speakers at WIRED Health in London on March 25, 2020. For more details, and to book your ticket, click here

Why do modern tomatoes taste so bad?

How Tesla became the world's most overvalued car company

Marvel at the incredible real-life Iron Man

How Slack ruined work

Follow WIRED on Twitter, Instagram, Facebook and LinkedIn

Get The Email from WIRED, your no-nonsense briefing on all the biggest stories in technology, business and science. In your inbox every weekday at 12pm sharp.

by entering your email address, you agree to our privacy policy

Thank You. You have successfully subscribed to our newsletter. You will hear from us shortly.

Sorry, you have entered an invalid email. Please refresh and try again.

Go here to read the rest:
Are stem cells really the key to making humans live longer? - Wired.co.uk

Global Longevity and Anti-senescence Therapy Market 2020: Research Methodology

The global Longevity and Anti-senescence Therapy Market is expected to grow at a significant pace, reports Acquire Market Research. Its latest research report, titled [Global Longevity and Anti-senescence Therapy Market Report, History and Forecast 2020-2026, Breakdown Data by Manufacturers, Key Regions, Types and Application], offers a unique point of view about the global market. Analysts believe that changing consumption patterns are expected to have a great influence on the overall market. For a brief overview of the global Longevity and Anti-senescence Therapy market, the research report provides an executive summary. It explains the various factors that form an important element of the market. It includes the definition and the scope of the market with a detailed explanation of the market drivers, opportunities, restraints, and threats.

Global Longevity and Anti-senescence Therapy Market: Segmentation

The chapters of segmentation allow the readers to understand the aspects of the market such as its products, available technologies, and applications of the same. These chapters are written in a manner to describe their development over the years and the course they are likely to take in the coming years. The research report also provides insightful information about the emerging trends that are likely to define the progress of these segments in the coming years.

Download Sample PDF of Longevity and Anti-senescence Therapy Market Report @https://www.acquiremarketresearch.com/sample-request/306097/

Top Key players Mentioned in the Global Longevity and Anti-senescence Therapy Market Research Report: CohBar, TA Sciences, Unity Biotechnology, AgeX TherapeuticsInc, PowerVision Inc.

Types covered in the Longevity and Anti-senescence Therapy industry are Hemolytic Drug Therapy, Gene Therapy, ImmunOther.

Applications covered in the report are Hospital, Medical Service Institution, Drug and Device Sales.

Global Longevity and Anti-senescence Therapy Market: Regional Segmentation

For a deeper understanding, the research report includes geographical segmentation of the global Longevity and Anti-senescence Therapy market. It provides an evaluation of the volatility of the political scenarios and amends likely to be made to the regulatory structures. This assessment gives an accurate analysis of the regional-wise growth of the global Longevity and Anti-senescence Therapy market.

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)

Global Longevity and Anti-senescence Therapy Market: Research Methodology

The research methodologies used by the analysts play an integral role in the way the publication has been collated. Analysts have used primary and secondary research methodologies to create a comprehensive analysis. For an accurate and precise analysis of the global Longevity and Anti-senescence Therapy market, analysts have bottom-up and top-down approaches.

Global Longevity and Anti-senescence Therapy Market: Competitive Rivalry

The research report includes an analysis of the competitive landscape present in the global Longevity and Anti-senescence Therapy market. It includes an assessment of the existing and upcoming trends that players can invest in. Furthermore, it also includes an evaluation of the financial outlooks of the players and explains the nature of the competition.

Grab Your Report at an Impressive Discount(with Corporate ID)! Please click here @https://www.acquiremarketresearch.com/discount-request/306097/

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Longevity and Anti-senescence Therapy marketChapter 2: Evaluating the leading manufacturers of the global Longevity and Anti-senescence Therapy market which consists of its revenue, sales, and price of the productsChapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and salesChapter 4: Presenting global Longevity and Anti-senescence Therapy market by regions, market share and with revenue and sales for the projected periodChapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Browse the full report Description, TOC and Table of Figure @ https://www.acquiremarketresearch.com/industry-reports/longevity-and-anti-senescence-therapy-market/306097/

Customization Available

With the given market data, Researchers offer customizations according to the companys specific needs. The following customization options are available for the report:

Regional and country-level analysis of the Longevity and Anti-senescence Therapy market, by end-use.

Detailed analysis and profiles of additional market players.

About us:

Acquire Market Research is a market research-based company empowering companies with data-driven insights. We provide Market Research Reports with accurate and well-informed data, Real-Time with Real Application. A good research methodology proves to be powerful and simplified information that applied right from day-to-day lives to complex decisions helps us navigate through with vision, purpose and well-armed strategies. At Acquire Market Research, we constantly strive for innovation in the techniques and the quality of analysis that goes into our reports.

Contact Us:

Sally Mach555 Madison Avenue,5th Floor, Manhattan,New York, 10022 USAPhone No.: +1 (800) 663-5579Email ID: [emailprotected]

Link:
Longevity and Anti-senescence Therapy Market 2020 Specification, Growth Drivers, Industry Analysis Forecast 2026: CohBar, TA Sciences, Unity...

The Durst Organization and The Port Authority of New York and New Jersey announced a half dozen new leases at One World Trade Center.

DADA Holdings LLC has signed a five-year lease for 4,786 s/f on the 71st floor; Princeton Longevity Center signed a 10-year lease for 11,075 s/f on the 71st floor. This will be both DADA and Princeton Longevitys first offices in New York City.

Ichnos Science Inc., moving its offices to New York City from Paramus, New Jersey, signed a seven-year and five-month lease for 10,847 s/f on the 76th floor.

Pison Stream Solutions signed a three-year lease for 10,804 s/f on the 49th floor of OWTC, making the building their global headquarters.

Also signed were two expansion deals. Symphony Communications Services has signed a one-year lease for 3,510 s/f on the 45th floor, bringing their total square footage on the floor to 12,100 s/f.

Additionally, Augustus Intelligence signed a five-year lease for 6,475 s/f on the 77th floor of OWTC, doubling their footprint with a move from the 45th floor.

We are extremely pleased with the leasing activity at One World Trade Center, said Jonathan (Jody) Durst, President of The Durst Organization.

We are beginning the year by welcoming our newest tenants DADA Holdings, Ichnos, Princeton Longevity and Pison and celebrating the success of Symphony and Augustus with their office expansions at One WTC.

Princeton Longevity Center was represented by Steven Rotter, Blake Goodman and Justin Haber of JLL.

Ichnos Sciences was represented by Cushman & Wakefields Drew Braver and Mark Zaziski.

Michael Thomas and Aidan Campbell of Colliers represented Pison. Symphony Communications Services was represented by Christopher Foerch of Savills.

And Augustus was represented by Carol Engel of CS Engel and Associates. The landlord was represented by Senior Managing Director Eric Engelhardt and Managing Director Karen Kuznick of The Durst Organization and the Newmark Knight Frank team of David Falk, Jason Greenstein, Peter Shimkin, Hal Stein and Travis Wilson.

Augustus Intelligence builds artificial intelligence products and secure infrastructure services to help enterprise clients reinvent themselves.

Pison Stream Solutions is a global leader in the research and development of chemical coatings platforms for niche markets. They implement their systems across defense, aerospace, automotive, antimicrobial, renewable energy applications, and additive platforms.

Princeton Longevity Center is a next-generation medical facility combining the most advanced technology with an integrated and individually tailored Preventive Medicine program.

A fully integrated, global biotechnology company with the spirit of a start-up, Ichnos Sciences is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology, autoimmune disease and pain.

The company, with headquarters in Paramus, N.J., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and treat patients holistically.

With a patented BEAT technology platform along with pioneering teams in Switzerland and India, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will hopefully extend and improve lives, writing a new chapter in healthcare.

Symphony offers a secure team collaboration platform that transforms the way users communicate effectively and securely with a single workflow application.

Symphony was founded in October 2014 and is headquartered in Palo Alto, CA, with offices in Hong Kong, London, New York, Paris, Singapore, Sophia-Antipolis, Stockholm and Tokyo.

One World Trade Center is the tallest building in the Western Hemisphere and home to the largest community of media and tech innovators.

The 3.1 million-square-foot LEED Gold Certified skyscraper features premier office space and some of the most spectacular views in the world.

On the 64th floor, One World Commons offers 25,000 s/f of tenant amenities including a world-class business and social hub fostering workplace creativity, collaboration, and community.

Built by The Port Authority of New York and New Jersey and The Durst Organization in a unique public-private partnership, The Durst Organization is responsible for marketing, leasing, and managing the property.

(Visited 1 times, 12 visits today)

Read this article:
Durst Organization sees flurry of new business at 1 WTC - Real Estate Weekly

Trending News: Ophthalmic Condition Linked to Blindness in Diabetes May Indicate Stroke Risk

A new phase 1 trial has demonstrated that a PRIMVAC placental malaria vaccine candidate is safe, immunogenic, and induced functional antibodies in volunteers, according to Contagion Live. The study, which marked the first in-human trial of the vaccine candidate, involved a randomized, double-blind trial in 2 staggered phase taking place between April 2016 and July 2017. Antibody titers increased with each successive dose and seroconversion was observed in all women who received the vaccination.

An ophthalmic condition linked to blindness in diabetes could serve as an additional indicator of increased stroke risk, according to HCP Live. An analysis of more than 2500 patients revealed that those who had diabetic retinopathy had an increased risk of stroke compared with patients without diabetes. The study also showed that having diabetic retinopathy was associated with a 60% higher risk of stroke compared with patients with diabetes without the ophthalmic condition. The study authors feel that more aggressive treatment for patients with a risk of stroke and who have been diagnosed with diabetic retinopathy may be warranted to reduce risk.

Visit link:
Trending News: Ophthalmic Condition Linked to Blindness in Diabetes May Indicate Stroke Risk - Pharmacy Times

Ophthalmologists announced an increase of blindness in Sudan during a workshop in Khartoum on Saturday. The reason: it is impossible to reach the marginalised areas of the country to conduct cataract operations there.

Cataract is the main cause of blindness in Sudan. It most commonly affects adults as a result of ageing.

Cataract surgery involves replacing the cloudy lens inside an eye with an artificial one. Cataracts usually get slowly worse over time. Surgery to replace the cloudy lens is the only way to improve eyesight. The operation has a high success rate.

The Sudanese ophthalmologists said that there are patients who cannot cover the costs of the operations because of poverty or dont know they can be treated.

The ophthalmologists pointed out that there are no eye hospitals in several states. Most eye operations and eye treatment are concentrated in Khartoum and the state capitals.

Radio Dabangas editorial independence means that we can continue to provide factual updates about politicaldevelopments to Sudanese and international actors, educate people about how to avoid outbreaks of infectious diseases, and provide a window to the world for those in all corners of Sudan.Support Radio Dabanga for as little as 2.50, the equivalent of a cup of coffee.

The rest is here:
Blindness from cataracts on the rise in Sudan - Radio Dabanga