StemCell Therapy

This article was originally published here

Indian J Palliat Care. 2020 Oct-Dec;26(4):506-511. doi: 10.4103/IJPC.IJPC_233_19. Epub 2020 Nov 19.

ABSTRACT

AIM: Chemotherapy-induced peripheral neuropathy (CIPN) is a long-term neurological health issue in patients diagnosed with multiple myeloma (MM). The aim of this study was to assess CIPN symptoms and health-related quality of life (HRQOL) among MM patients.

METHODS: A cross-sectional survey was conducted among patients diagnosed with MM in a tertiary care hospital using a self-reported Arabic questionnaire, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire for CIPN scale (QLQ-CIPN20). The HRQOL was assessed using EORTC multiple myeloma module (QLQ-MY20). Categorical variables were reported in frequency tables and percentages. Age and duration of MM diagnosis were reported as mean and standard deviation. Survey responses were presented using descriptive statistics.

RESULTS: In total, 62 patients had participated. Males were 60%. The average age was 58.74 11.49 years. On sensory scale, 20% reported quite a bit/very much tingling in fingers/hands, 23% in toes/feet, 39% numbness in fingers/hands, 37% in toes/feet, and 43% reported trouble standing or walking. On motor scale, 40% reported trouble walking and 60% had difficulty in climbing stairs/standing up from chair. On autonomic scale, 27% reported orthostatic hypotension and only 13/37 (46%) males reported erectile dysfunction. For HRQOL, 50% reported bone aches/pain, 42% reported back pain, 57% reported feeling ill, 33% reported lost hair, 35% had been thinking about their illness, whereas 28% were worried about future health and 22% had reported being worried about dying.

CONCLUSION: MM patients encounter CIPN symptoms with impaired HRQOL. Capturing CIPN as a patient-reported outcome needs to be considered in routine clinical practice.

PMID:33623313 | PMC:PMC7888416 | DOI:10.4103/IJPC.IJPC_233_19

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Chemotherapy-Induced Peripheral Neuropathy and its Impact on Health-Related Quality of Life among Multiple Myeloma Patients: A Single-Center...

The research report focuses on target groups of customers to help players to effectively market their products and achieve strong sales in the global Diabetic Peripheral Neuropathy Treatment Industry Market Market. It segregates useful and relevant market information as per the business needs of players. Readers are provided with validated and revalidated market forecast figures such as CAGR, Diabetic Peripheral Neuropathy Treatment Industry Market market revenue, production, consumption, and market share. Our accurate market data equips players to plan powerful strategies ahead of time. The Diabetic Peripheral Neuropathy Treatment Industry Market report offers deep geographical analysis where key regional and country level markets are brought to light. The vendor landscape is also analysed in depth to reveal current and future market challenges and Diabetic Peripheral Neuropathy Treatment Industry Market business tactics adopted by leading companies to tackle them.

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Our impartial and unbiased approach toward Diabetic Peripheral Neuropathy Treatment Industry Market market research is one of the major benefits offered with this research study. While internal analysis holds great importance in market research, secondary research helps guide changes during the preparation of a Diabetic Peripheral Neuropathy Treatment Industry Market research report. We dont simply take the word of third parties, we always look for justification and validation before using their data or information in our research study. We have attempted to give a holistic view of the global Diabetic Peripheral Neuropathy Treatment Industry Market market and benchmark almost all important players of the industry, not just the prominent ones. As we focus on the realities of the global Diabetic Peripheral Neuropathy Treatment Industry Market market, be rest assured that you are on the right path to receiving the right information and accurate data.

In Chapter 4 and 14.1,on the basis of types, the Diabetic Peripheral Neuropathy Treatment market from 2015 to 2025 is primarily split into:AntimunocelASP-8477BNV-222CapsaicinCBX-129801Others

In Chapter 5 and 14.2, on the basis of applications, the Diabetic Peripheral Neuropathy Treatment market from 2015 to 2025 covers:HospitalClinicOthers

Competitive Landscape

Key players of the global Diabetic Peripheral Neuropathy Treatment Industry Market market are profiled on the basis of various factors, which include recent developments, business strategies, financial strength, weaknesses, and main business. The Diabetic Peripheral Neuropathy Treatment Industry Market report offers a special assessment of top strategic moves of leading players such as merger and acquisition, collaboration, new product launch, and partnership.

Companies Includes

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Table of Contents

Market Overview: In this section, the authors of the report provide an overview of products offered in the global Diabetic Peripheral Neuropathy Treatment Industry Market market, market scope, consumption comparison by application, production growth rate comparison by type, highlights of geographical analysis in Diabetic Peripheral Neuropathy Treatment Industry Market market, and a glimpse of market sizing forecast.

Manufacturing Cost Analysis: It includes manufacturing cost structure analysis, key raw material analysis, Diabetic Peripheral Neuropathy Treatment Industry Market industrial chain analysis, and manufacturing process analysis.

Company Profiling: Here, the analysts have profiled leading players of the global Diabetic Peripheral Neuropathy Treatment Industry Market market on the basis of different factors such as markets served, market share, gross margin, price, production, and revenue.

Analysis by Application: The Diabetic Peripheral Neuropathy Treatment Industry Market report sheds light on the consumption growth rate and consumption market share of all of the applications studied.

Diabetic Peripheral Neuropathy Treatment Industry Market Consumption by Region: Consumption of all regional markets studied in the Diabetic Peripheral Neuropathy Treatment Industry Market report is analysed here. The review period considered is 2014-2019.

Diabetic Peripheral Neuropathy Treatment Industry Market Production by Region: It includes gross margin, production, price, production growth rate, and revenue of all regional markets between 2014 and 2019.

Competition by Manufacturer: It includes production share, revenue share, and average price by manufacturers. Diabetic Peripheral Neuropathy Treatment Industry Market market analysts have also discussed the products, areas served, and production sites of manufacturers and current as well as future competitive situations and trends.

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Diabetic Peripheral Neuropathy Treatment Industry Market Market Go Advanced and Next Generation South Florida Theater Review - South Florida Theater...

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

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

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

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

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

Major information from the Diabetic Neuropathy market report:

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Diabetic Neuropathy Market segments covered in the report:

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

Product types:

Applications spectrum:

Competitive outlook:

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

Key Highlights Questions?

Table of Content:

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

Neuropathy Pain Treatment Market Forecast (2020-2029):

The most recent exploration report on the worldwide Neuropathy Pain Treatment market covers late patterns found in the overall market. This study rotates around the latest events, for example, the mechanical enhancements, item improvements, and their results in the worldwide Neuropathy Pain Treatment market. The industry contains data gathered from different fundamental and helper sources. This information has been approved by business specialists and experts, accordingly giving gigantic pieces of information to the partners, inspectors, administrators, and industry pioneers.

The Neuropathy Pain Treatment Market report also covers a detailed comprehension of the major geographies present in the market along with the key segments and sub-segments. The report focuses on regional development status, which includes the market size, share, and volume. Additionally, this report covers the manufacturers data, including business distribution, cost and price, margin, and gross revenue. This allows a reader to understand consumers behaviour and a better understanding of the leading competitors operation in the market.

Key players in the market include Pfizer, Depomed, Eli Lilly, Endo, Grnenthal Group, Arbor Pharmaceuticals

Major Types includes

Calcium Channel Alpha 2-Delta Ligands

Serotonin-Norepinephrine Reuptake Inhibitors

Others

Major Applications includes

Retail Pharmacies

Hospitals

Others

The Neuropathy Pain Treatment Industry research reveals insight into a top to bottom investigation of the subjective and quantitative perspectives by various industry experts and key assessment pioneers, to introduce a nitty-gritty examination into the Neuropathy Pain Treatment market and industry standards. Further, the report gives a thorough knowledge of the recorded and present market scene, incorporating future gauge concerning the specialized headways, request and supply investigation, miniature and full-scale efficient variables, administering elements, and improvement designs on the lookout. The report reveals insight into the key procedures embraced by the main parts on the lookout.

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Neuropathy Pain Treatment Market In-Depth Analysis, Growth Strategies and Comprehensive Forecast to 2029 KSU | The Sentinel Newspaper - KSU | The...

The research report on global Neuropathy Pain Treatment market by OrbisPharmaReports comprises of the study of all the dynamics associated with the market. The comprehensive analysis of potential customer base, market values and future scope is included in the global Neuropathy Pain Treatment market report. Along with that the research report on the global market by OrbisPharmaReports holds all the vital information regarding the latest technologies and trends being adopted or followed by the vendors across the globe.

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The up-to-date information of the factors like profitability, product knowledge, revenue, industry growth, end users, etc. included in the research report provide great help to vendors in the industry to expand the boundaries of their businesses in the market. The research report covers all the necessary data regarding the market patterns of the growth in the market and the factors providing momentum to this growth. The research report by OrbisPharmaReports offers detailed study of an important microscopic view of the industry to define manufacturers footprints by awareness of manufacturers worldwide sales and costs, and manufacturers production over the forecast era. Leading and dominant players in the global Neuropathy Pain Treatment market are intrinsically analyzed on the basis of key factors in the competition analysis portion of the study. The study includes a detailed overview and reliable athlete sales estimates for the forecasted timeframe.

Neuropathy Pain Treatment Market Top Manufactures Details Here:

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

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By the product type, the market is primarily split into

Calcium Channel Alpha 2-delta Ligands, Serotonin-norepinephrine Reuptake Inhibitors, Others, etc.

By the application, this report covers the following segments

Neuropathy Pain Treatment has been segmented into Retail Pharmacies, Hospitals, Others, etc.

The research report also covers the study of another major market aspect which is the regional study. The research report on the global Neuropathy Pain Treatment market by OrbisPharmaReports includes an insightful data on the size and volume of each region in market terms. The report gives the numerical data stating the share in the market per region. Some of these regions are Asia Pacific, Africa, North America, Middle East, Europe, South America, etc. The research report also holds crucial information regarding the segments of the global Neuropathy Pain Treatment market. The segments included in the report by OrbisPharmaReports are types, region, application, etc. The research report offers the study of major investments, operational business decisions, collaborations, mergers, etc. in the industry over the recent years.

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At Orbispharma we curate the most relevant news stories, features, analysis and research reports on the important challenges undertaken by the pharmaceutical and related sectors. Our editorial philosophy is to bring you sharp, focused and informed perspective of industries, the end users and application of all upcoming trends into the pharma sector. Orbispharma believes in conversations that can bring a change in one of the most crucial economic sectors in the world. With these conversations we wish our customers to make sound business decisions with right business intelligence.

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Global Neuropathy Pain Treatment Market 2021 by Company Regions Type and Application Forecast to 2027 : Pfizer, Endo, Depomed, Eli Lilly, Arbor...

The Latest Released Neuropathy Pain Treatment market study has evaluated thefuture growth potential of Neuropathy Pain Treatment marketand provides information and useful stats on market structure and size. The report is intended to provide market intelligence and strategic insights to help decision makers take sound investment decisions and identify potential gaps and growth opportunities. Additionally, the report also identifies and analyses changing dynamics, emerging trends along with essential drivers, challenges, opportunities and restraints in Neuropathy Pain Treatment market. The study includes market share analysis and profiles of players such as Pfizer, Depomed, Eli Lilly, Endo, Grnenthal Group, Arbor Pharmaceuticals.

If you are a Neuropathy Pain Treatment manufacturer and would like to check or understand policy and regulatory proposal, designing clear explanations of the stakes, potential winners and losers, and options for improvement then this article will help you understand the pattern with Impacting Trends.Click To get SAMPLE PDF (Including Full TOC, Table & Figures)

Major Highlights of the Neuropathy Pain Treatment Market report released by HTF MI

Market Breakdown by Applications: Retail Pharmacies, Hospitals & Others

Market Breakdown by Types: , Calcium Channel Alpha 2-delta Ligands, Serotonin-norepinephrine Reuptake Inhibitors & Others

Revenue and Sales Estimation Historical Revenue and sales volume is presented and further data is triangulated with top-down and bottom-up approaches to forecast complete market size and to estimate forecast numbers for key regions covered in the report along with classified and well recognized Types and end-use industry.

SWOT Analysis on Neuropathy Pain Treatment PlayersIn additional Market Share analysis of players, in-depth profiling, product/service and business overview, the study also concentrates on BCG matrix, heat map analysis, FPNV positioning along with SWOT analysis to better correlate market competitiveness.

Demand from top notch companies and government agencies is expected to rise as they seek more information on COVID-19. Check Demand Determinants section for more information.

Regulation Analysis Local System and Other Regulation: Regional variations in Laws for the use of Neuropathy Pain Treatment Regulation and its Implications Other Compliances

Have Any Query? Ask Our Expert @:https://www.htfmarketreport.com/enquiry-before-buy/3088088-neuropathy-pain-treatment-market-1

FIVE FORCES & PESTLE ANALYSIS:

In order to better understand Market condition five forces analysis is conducted that includes Bargaining power of buyers, Bargaining power of suppliers, Threat of new entrants, Threat of substitutes, Threat of rivalry.

Political (Political policy and stability as well as trade, fiscal and taxation policies) Economical (Interest rates, employment or unemployment rates, raw material costs and foreign exchange rates) Social (Changing family demographics, education levels, cultural trends, attitude changes and changes in lifestyles) Technological (Changes in digital or mobile technology, automation, research and development) Legal (Employment legislation, consumer law, health and safety, international as well as trade regulation and restrictions) Environmental (Climate, recycling procedures, carbon footprint, waste disposal and sustainability)

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Heat map Analysis, 3-Year Financial and Detailed Company Profiles of Key & Emerging Players:

Geographically, the following regions together with the listed national/local markets are fully investigated: APAC (Japan, China, South Korea, Australia, India, and Rest of APAC; Rest of APAC is further segmented into Malaysia, Singapore, Indonesia, Thailand, New Zealand, Vietnam, and Sri Lanka) Europe (Germany, UK, France, Spain, Italy, Russia, Rest of Europe; Rest of Europe is further segmented into Belgium, Denmark, Austria, Norway, Sweden, The Netherlands, Poland, Czech Republic, Slovakia, Hungary, and Romania) North America (U.S., Canada, and Mexico) South America (Brazil, Chile, Argentina, Rest of South America) MEA (Saudi Arabia, UAE, South Africa)

Some Extracts from Neuropathy Pain Treatment Market Study Table of Content

Neuropathy Pain Treatment Market Size (Sales) Market Share by Type (Product Category) [, Calcium Channel Alpha 2-delta Ligands, Serotonin-norepinephrine Reuptake Inhibitors & Others] in 2020Neuropathy Pain Treatment Market by Application/End Users [Retail Pharmacies, Hospitals & Others]Global Neuropathy Pain Treatment Sales and Growth Rate (2015-2025)Neuropathy Pain Treatment Competition by Players/Suppliers, Region, Type and ApplicationNeuropathy Pain Treatment (Volume, Value and Sales Price) table defined for each geographic region defined.Supply Chain, Sourcing Strategy and Downstream Buyers, Industrial Chain Analysis..and view more in complete table of Contents

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Neuropathy Pain Treatment Market is Thriving Worldwide with Pfizer, Depomed, Eli Lilly, Endo The Bisouv Network - The Bisouv Network

This report is presented in a clear and concise way to help you better understand market structure and dynamics. Recent trends and developments in the Diabetic Neuropathy Drugs Market have been analyzed. Opportunities leading to market growth have been analyzed and stated. The report focuses on the global market and provides answers to the most important questions that stakeholders are facing today in the world. Information on the size of the market raises the issue of expanding competitiveness and hindering market-leading sectors and market growth.

The report provides an overview of the Diabetic Neuropathy Drugs market in several key countries spread across different geographic regions around the world. The report focuses on identifying various market trends, dynamics, growth drivers and factors restraining the market growth. Further, the report provides detailed insights into various growth opportunities and challenges based on various types of products, applications, end users and countries, among others. The global Diabetic Neuropathy Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX% during 2021-2026.

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The Key manufacturers that are operating in the global Diabetic Neuropathy Drugs market are:Daiichi Sankyo Company, Limited Johnson & Johnson Services, Inc. Novartis AG Pfizer Inc. Eli Lilly and Company

Report Scope:

Report Overview:

This study was conducted with a global perspective in terms of the various segments in the Diabetic Neuropathy Drugs market. Market sizing and forecast have been conducted for 5 geographic regions: North America, Latin America, Europe, Middle East and Africa (MEA), and Asia-Pacific. All market sizing data is provided in US$ with historic data for the years 2018 and 2019, along with estimations and forecast for the period from 2020 to 2025.

The ongoing COVID-19 pandemic has had a significant impact on the overall international trade and businesses. This report provides the latest insights into the Diabetic Neuropathy Drugs market factoring in various effects of the industry disruptions and halts caused by COVID-19.

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Market Segmentation:Diabetic Neuropathy Drugs Market, by Type:

Diabetic Neuropathy Drugs Market, by Application:

Diabetic Neuropathy Drugs Market, by Geography:

Benefits of Buying Reports:

Table of Contents:

Part 01:Executive Summary

Part 02:Scope of the Report

Part 03:Research Methodology

Part 04:Market Landscape

Part 05:Pipeline Analysis

Part 06:Market Sizing

Part 07:Five Forces Analysis

Part 08:Market Segmentation

Part 09:Customer Landscape

Part 10:Regional Landscape

Part 11:Decision Framework

Part 12:Drivers and Challenges

Part 13:Market Trends

Part 14:Vendor Landscape

Part 15:Vendor Analysis

Part 16:Appendix

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Diabetic Neuropathy Drugs Market Key Drivers, Applications, Challenges and Opportunities, 2021-2028 - The Courier

The latest survey on the Global Diabetic Neuropathy Market is conducted covering various organizations of the industry from different geographies to come up with a 100+ page report. The study is a perfect mix of qualitative and quantitative information highlighting key market developments, challenges that industry and competition are facing along with gap analysis and new opportunity available and trend in the Diabetic Neuropathy Market.

Initially, the report provides a basic overview of the industry including definitions, classifications, applications, and industry chain structure. The Diabetic Neuropathy market analysis is provided for the international markets including development trends, competitive landscape analysis by leading company profiles like Pfizer, Janssen Pharmaceuticals, Eli Lilly and Company, ACTAVIS, Cephalon, MEDA Pharma & Co. KG, etc., and key regions development status.

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This report looks at the current economic impact of COVID-19. This outbreak fundamentally changed the global economic situation. The current scenario of an ever-evolving corporate sector, as well as current and future impact assessments, are also discussed in the report.

Major highlights of Diabetic Neuropathy market report:

The Top Players Profiled in Diabetic Neuropathy Research study are:

Global Diabetic Neuropathy Market: Product Type Segment Analysis

Global Diabetic Neuropathy Market: Application Segment Analysis

Global Diabetic Neuropathy Market: Regional Segment Analysis

The Diabetic Neuropathy industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.

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CHAPTERS COVERED IN THIS REPORT ARE AS FOLLOW:

Chapter 1: Diabetic Neuropathy Market Overview, Product Overview, Market Segmentation, Market Overview of Regions, Market Dynamics, Limitations, Opportunities and Industry News and Policies.

Chapter 2: Diabetic Neuropathy Industry Chain Analysis, Upstream Raw Material Suppliers, Major Players, Production Process Analysis, Cost Analysis, Market Channels and Major Downstream Buyers.

Chapter 3: Value Analysis, Production, Growth Rate, and Price Analysis by Type of Diabetic Neuropathy.

Chapter 4: Downstream Characteristics, Consumption, and Market Share by Application of Diabetic Neuropathy.

Chapter 5: Production Volume, Price, Gross Margin, and Revenue ($) of Diabetic Neuropathy by Regions (2014-2020).

Chapter 6: Diabetic Neuropathy Production, Consumption, Export and Import by Regions (2014-2020).

Chapter 7: Diabetic Neuropathy Market Status and SWOT Analysis by Regions.

Chapter 8: Competitive Landscape, Product Introduction, Company Profiles, Market Distribution Status by Players of Diabetic Neuropathy.

Chapter 9: Diabetic Neuropathy Market Analysis and Forecast by Type and Application (2020-2026).

Chapter 10: Market Analysis and Forecast by Regions (2020-2026).

Chapter 11: Industry Characteristics, Key Factors, New Entrants SWOT Analysis, Investment Feasibility Analysis.

Chapter 12: Market Conclusion of the Whole Report.

Chapter 13: Appendix Such as Methodology and Data Resources of This Research.

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Research Objective Diabetic Neuropathy Market Research:

The report is useful in providing answers to several critical questions that are important for the industry stakeholders such as manufacturers and partners, end-users, etc., besides allowing them in strategizing investments and capitalizing on market opportunities.

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Market Assessment of Diabetic Neuropathy Industry including Top Players like Pfizer, Janssen Pharmaceuticals, Eli Lilly and Company, ACTAVIS,...

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

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

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

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

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

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

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

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

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

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

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

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

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Top Key Players Profiled in this report are:

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

The key questions answered in this report:

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

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

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

The report provides insights on the following pointers:

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

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

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

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

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

Table of Contents

Global Neuropathy Pain Treatment Market Research Report 2021 2027

Chapter 1 Neuropathy Pain Treatment Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

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

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

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Neuropathy Pain Treatment Market Forecast

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

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

Athenexs Oral Paclitaxel for Metastatic Breast Cancer

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

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

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

Blueprint Medicines Pralsetinib for Thyroid Cancer

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

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

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

CorMedix Defencath for Bloodstream Infections Associated with Catheters in Hemodialysis Patients

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

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

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

Sanofis Libtayo for Advanced Non-Small Cell Lung Cancer

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

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

KemPharms KP415 for ADHD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The study was published in Oncology and Therapy.

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

Novartis and the Bill and Melinda Gates Foundation are joining forces to discover and develop a gene therapy to cure sickle cell disease with a one-step, one-time treatment that is affordable and simple enough to treat patients anywhere in the world, especially in sub-Saharan Africa where resources may be scarce but disease prevalence is high.

The three-year collaboration, announced Wednesday, has initial funding of $7.28 million.

Current gene therapy approaches being developed for sickle cell disease are complex, enormously expensive, and bespoke, crafting treatments for individual patients one at a time. The collaboration aims to instead create an off-the-shelf treatment that bypasses many of the steps of current approaches, in which cells are removed and processed outside the body before being returned to patients.

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Sickle cells cause is understood. The people it affects are known. But its cure has been elusive, Jay Bradner, president of the Novartis Institutes for BioMedical Research, told STAT.

We understand perfectly the disease pathway and the patient, but we dont know what it would take to have a single-administration, in vivo gene therapy for sickle cell disease that you could deploy in a low-resource setting with the requisite safety and data to support its use, he said. Im a hematologist and can assure you that in my experience in the clinic, it was extremely frustrating to understand a disease so perfectly but have so little to offer.

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Sickle cell disease is a life-threatening inherited blood disorder that affects millions around the world, with about 80% of affected people in sub-Saharan Africa and more than 100,000 in the U.S. The mutation that causes the disease emerged in Africa, where it protects against malaria. While most patients with sickle cell share African ancestry, those with ancestry from South America, Central America, and India, as well as Italy and Turkey, can also have the hereditary disease.

The genetic mutation does its damage by changing the structure of hemoglobin, hampering the ability of red blood cells to carry oxygen and damaging blood vessels when the misshapen cells get stuck and block blood flow. Patients frequently suffer painful crises that can be fatal if not promptly treated with fluids, medication, and oxygen. Longer term, organs starved of oxygen eventually give out. In the U.S., that pain and suffering is amplified when systemic and individual instances of racism deny Black people the care they need.

Delivering gene therapy for other diseases has been costly and difficult even in the best financed, most sophisticated medical settings. Challenges include removing patients cells so they can be altered in a lab, manufacturing the new cells in high volume, reinfusing them, and managing sometimes severe responses to the corrected cells. Patients also are given chemotherapy to clear space in their bone marrow for the new cells.

Ideally, many of those steps could be skipped if there were an off-the-shelf gene therapy. That means, among other challenges, inventing a way to eliminate the step where each patients cells are manipulated outside the body and given back the in vivo part of the plan to correct the genetic mutation.

Thats not the only obstacle. For a sickle cell therapy to be successful, Bradner said, it must be delivered only to its targets, which are blood stem cells. The genetic material carrying corrected DNA must be safely transferred so it does not become randomly inserted into the genome and create the risk of cancer, a possibility that halted a Bluebird Bio clinical trial on Tuesday. The payload itself mustnt cause such problems as the cytokine storm of immune overreaction. And the intended response has to be both durable and corrective.

In a way, the gene delivery is the easy part because we know that expressing a normal hemoglobin, correcting the mutated hemoglobin, or reengineering the switches that once turned off normal fetal hemoglobin to turn it back on, all can work, Bradner said. The payload is less a concern to me than the safe, specific, and durable delivery of that payload.

For each of these four challenges delivery, gene transfer, tolerability, durability there could be a bespoke technical solution, Bradner said. The goal is to create an ensemble form of gene therapy.

Novartis has an existing sickle-cell project using CRISPR with the genome-editing company Intellia, now in early human trials, whose lessons may inform this new project. CRISPR may not be the method used; all choices are still on the table, Bradner said.

Vertex Pharmaceuticals has seen encouraging early signs with its candidate therapy developed with CRISPR Therapeutics. Other companies, including Beam Therapeutics, have also embarked on gene therapy development.

The Novartis-Gates collaboration is different in its ambition to create a cure that does not rely on an expensive, complicated framework. Novartis has worked with the Gates Foundation on making malaria treatment accessible in Africa. And in October 2019, the Gates Foundation and the National Institutes of Health said together they would invest at least $200 million over the next four years to develop gene-based cures for sickle cell disease and HIV that would be affordable and available in the resource-poor countries hit hardest by the two diseases, particularly in Africa.

Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings, Trevor Mundel, president of global health at the Gates Foundation, said in a statement about the Novartis collaboration. Its about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought.

Asked which is the harder problem to solve: one-time, in vivo gene therapy, or making it accessible around the world, David Williams, chief of hematology/oncology at Boston Childrens Hospital, said: Both are going to be difficult to solve. The first will likely occur before the therapy is practically accessible to the large number of patients suffering the disease around the world.

Williams is also working with the Gates Foundation, as well as the Koch Institute for Integrative Cancer Research at MIT, Dana-Farber Cancer Institute, and Massachusetts General Hospital, on another approach in which a single injection of a reagent changes the DNA of blood stem cells. But there are obstacles to overcome there, too, that may be solved by advances in both the technology to modify genes and the biological understanding of blood cells.

Bradner expects further funding to come to reach patients around the world, once the science progresses more.

There is no plug-and-play solution for this project in the way that mRNA vaccines were perfectly set up for SARS-CoV-2. We have no such technology to immediately redeploy here, he said. Were going to have to reimagine what it means to be a gene therapy for this project.

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Novartis, Gates Foundation pursue a simpler gene therapy for sickle cell - STAT

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Novartis and the Bill & Melinda Gates Foundation have partnered on a single-dose, in vivo gene therapy for sickle cell disease (SCD). The Foundation will offer funding for development of the therapy.

Existing gene therapy approaches to sickle cell disease are difficult to deliver at scale and there are obstacles to reaching the vast majority of those affected by this debilitating disease, said Jay Bradner, a hematologist and president of the Novartis Institutes for BioMedical Research (NIBR). This is a challenge that calls for collective action, and we are thrilled to have the support of the Bill & Melinda Gates Foundation in addressing this global unmet medical need.

The announcement comes only a day after bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension. The cause is a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).

HGB-206 is the companys ongoing Phase I/II trial of LentiGlobin for SCD. It includes three cohorts, A, B and C. In Group C, a refined manufacturing process designed to increase vector copy number was used.

Group C also received LentiGlobin for SCD manufactured from hematopoietic (blood) stem cells (HSCs) collected from peripheral blood after mobilization with plerixafor, instead of by way of bone marrow harvest, which was the method used in Groups A and B.

HGB-210 is their ongoing Phase III single-arm open-label trial. It is evaluating efficacy and safety of LentiGlobin for SCD in patients between two years and 50 years of age with sickle cell disease.

Which underlines that even though gene therapy is making headway, it is still a cutting-edge technology.

SCD is a hereditary blood disease that affects millions of people globally, with more than 300,000 born with it each year. It primarily affects people of African descent, and sub-Saharan Africa bears about 80% of the disease burden. It affects the structure of red blood cells, causing a distinct sickle shape, which decreases the ability of red blood cells to transport oxygen efficiently.

Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings, said Trevor Mundel, president of Global Health at the Gates Foundation. Whats exciting about this project is that it brings ambitious science to bear on that challenge. Its about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought. It also holds the promise of applying lessons learned to help develop potentially curative options for other debilitating diseases affecting low-income populations, such as HIV.

Novartis also announced today that the U.S. Food and Drug Administration (FDA) approved the expanded indication for Entresto (sacubitril/valsartan) to decrease the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure. The biggest benefit was for patients with left ventricular ejection fraction (LVEF) below normal.

The expansion was based on data in the PARAGON-HF Phase III trial.

This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced, said Scott Solomon, professor of Medicine at Harvard Medical School and Brigham and Womens Hospital, and PARAGON-HF Executive Committee co-chair. We can now offer a treatment to a wider range of patients who have an LVEF below normal.

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Charles River Laboratories will acquire Cognate BioServices, a cell and gene therapy contract development and manufacturing organization, in an $875 million cash deal that will significantly expand the companys capabilities in the high-growth cell and gene therapy sector.

In addition to expanding Charles Rivers capabilities in the cell and gene therapy space, the company said the acquisition of Memphis, Tenn.-based Cognate will also establish a comprehensive solution from discovery and non-clinical development through CGMP manufacturing in advanced drug modalities. Cognate has a global presence with more than 500 employees. In January, Cognate announced plans to significantly expand cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities, and increase office support at its facilities inthe United StatesandEurope.

The company has extensive experience producing various cell types and technologies used in cellular immunotherapy and immuno-oncology, regenerative medicine and advanced cell therapy. Its primary area of expertise is in CGMP cell therapy manufacturing, which processes a variety of cellular products and other starting materials to develop and produce allogeneic (donor-derived) and autologous (patient-derived) cell therapies. Cognate also produces plasmid DNA, which is a foundational tool used in the development of gene-modified cell therapies and gene therapies, as well as other CDMO inputs, Charles River said.

James C. Foster, president and chief executive officer of Charles River Labs, said Cognate provides a synergistic fit for Charles River. He said bringing Cognate under the companys umbrella presents a unique opportunity to expand the companys capabilities and also enhance its offerings to clients in emerging areas of scientific innovation.

Additionally, Charles River said the addition of Cognate will complement its existing Biologics Testing Solutions business. Cognates capabilities will enable clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner, enabling them to achieve their goal of driving greater efficiency, the company said.

The addition of Cognate is also expected to provide a significant financial boost to Charles River. Cognate is expected to generate annual revenue of approximately $140 million in 2021, and is expected to grow at least 25% annually over the next five years, the company said.

This acquisition will be an exceptional strategic fit, adding to our comprehensive suite of early-stage research and manufacturing support solutions and enabling us to achieve our goal of establishing a single scientific partner to provide biopharmaceutical clients with an integrated solution to help accelerate their cell and gene therapy programs from discovery and non-clinical development through commercialization, Foster said in a statement. Because of the synergistic fit with Charles River, the market growth potential, and the emerging role of advanced drug modalities as treatments for oncology and rare disease, we believe Cognate will meaningfully enhance our long-term revenue and earnings growth potential.

The acquisition is expected to move quickly. Charles River anticipates the closing of the deal by the end of the first quarter of 2021. Based on the anticipated completion of the acquisition by the end of the first quarter, Cognate is expected to add approximately $110 million to Charles Rivers 2021 consolidated revenue for the partial year.

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Charles River Dives Deep Into Cell and Gene Therapy With Cognate BioServices Acquisition - BioSpace

Two Kolon Life Science executives were acquitted Friday of involvement in the company's allegedly fraudulent report on a key ingredient in its gene therapy drug.

The Seoul Central District Court handed down the ruling to the drugmaker's two executives, surnamed Cho and Kim, who were indicted on charges that included fraud related to the company's suspected illegalities in the development and sales of Invossa, a cell and gene therapy for osteoarthritis.

But the court separately ordered Cho, a senior director at the company's clinical development team, to pay a fine of 5 million won ($4,500) for bribing an official at the Ministry of Food and Drug Safety in seeking favors in the company's drug development process.

They were suspected of having been involved in submitting fraudulent documents on purpose to the ministry to get approval for Invossa.

While acknowledging that the company submitted some false data, the court said the ministry seemed to have failed to perform due diligence in verifying the submitted documents.

The court also found them not guilty of fraud and other charges for having received a state subsidy of 8.2 billion won based on allegedly fraudulent documents.

Kolon Life Science, a unit of Kolon Group, initially received the approval for Invossa in 2017. But it was revoked in May 2019 after it was revealed that a key material used in Invossa came from a kidney cell, instead of from cartilage as stated in the document submitted for approval.

The company acknowledged that a substance in the joint pain treatment drug had been mislabeled, but claimed no one has suffered from any medical complications from the drug use.

Later in the day, however, the Seoul Administrative Court ruled against the drugmaker, dismissing its plea to reinstate the license for Invossa.

Having submitted false data was "a grave fault as drugs can have a significant effect on people's lives and health," the court said, even though it was hard to confirm with the evidence presented that the company intentionally committed any wrongdoing.

"There is no illegality with the ministry's decision to revoke the license since it did not seem to be aware of data that could raise suspicions about the drug's safety," the court ruled. (Yonhap)

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Kolon Life executives acquitted of falsifying data of gene therapy drug - The Korea Herald

HOUSTON, Feb. 16, 2021 /PRNewswire/ -- Avance Biosciences Inc., a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today that its Houston facility, which successfully passed an inspection by the U.S. Food and Drug Administration in Oct 2018, is undergoing major expansion to handle rapidly growing demand for their services.

The new facility, expected to be completed by Q3 2021, is located adjacent to the current facility and will expand the Houston campus by an additional 5,500 square feet. The new facility will be devoted to cell-based assay services and enable Avance to better address the specific needs of their GMP clients. Additionally, Avance is expanding their mammalian cell culture related assay capabilities including: mycoplasma testing, adventitious agents testing, sterility, potency, and others.

As a provider of genomics and biological testing services, Avance Biosciences offers a broad range of molecular biology and microbiology assays in compliance with current Good Manufacturing Practices (21 CFR Parts 210 & 211) and Good Laboratory Practices (21 CFR Part 58) to support its clients' regulatory submissions.

Avance's CEO, Dr. Xuening Huang commented, "We take a partnership approach with our clients and that means an extended relationship; from discovery to development to clinical testing and on to manufacturing. Our most recent expansions will ensure that we can keep pace with our customer's increased needs when ramping up development and manufacturing activities. Our primary goals are to deliver world-class service and complete customer satisfaction."

Avance's Vice President of Sales and Marketing, Cal Froberg commented, "It's clear there is tremendous growth in the development of cell and gene therapies and we're proactively managing resources to handle increased market demand for related support services. The industry is expanding rapidly and Avance is positioned well to address the specific needs of these customers."

This most recent expansion comes on the heels of another 7,500 square foot expansion completed in 2020 which has significantly increased Avance's NGS and ddPCR capabilities. This facility has been pivotal in addressing gene therapy development support needs such as: edited gene testing, gene integration assays, and DNA/RNA biodistribution studies.

Recently, Avance Biosciences was recognized as a top 10 Genomics Solutions Company for 2020. Current and future expansion plans will serve to solidify this position among the premier providers in this space.

About Avance Biosciences

Avance offers cGMP/GLP compliant genomics biological testing services in support of drug development and manufacturing. Its leading scientists have designed, validated, and tested thousands of assays under cGMP/GLP regulations for the FDA, EPA, and European and Japanese regulatory agencies. Avance's team has extensive knowledge and experience working with scientists, QA/QC professionals and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

Contact

Xuening Huangxuening.huang@avancebio.com877-909-52109770 West Little York RoadHouston, TX 77040 USA

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Avance Biosciences Expanding Houston Campus in Support of Cell and Gene Therapy Drug Development - BioSpace

Theres news today that Bluebird has suspended its gene therapy work on sickle cell disease because of two cases of cancer in its treatment population. Another had been reported in 2018, so that takes us to two cases of myelodysplastic syndrome and one case of myeloid leukemia (which can be a sequel of MDS in some cases). This isnt good. Youll note that all of these are diseases of the bone marrow, and the marrow is where a good deal of the action in this sort of gene therapy takes place.

There are several companies working in this space, and its no coincidence. Sickle cell anemia is the absolute prototype of a genetically linked disorder, famously first identified in 1949 by Linus Pauling and co-workers. That paper termed it a molecular disease, and Pauling certainly deserves the credit he gets as a founder of molecular biology. Both sickle cell and the conceptually related beta-thalassemias are defects in the production of hemoglobin, and it has been obvious for decades that if you could somehow yank the defective gene out of the patients and replace it with a normal sequence that they simply wouldnt have these conditions any more.

There are by now plenty of other genetic disorders that fall into the same category, but these blood-cell based ones have a unique feature that has put them into the forefront of actual attempts at gene therapy. In these cases, all the relevant cells come from the same tissue, the bone marrow. And we actually have ways to kill that off and to swap in new tissue of our choosing: a bone marrow transplant. It is a tough procedure to go through, for sure, but not as tough as living a life of acute sickle cell attacks (or being killed off early by rampaging leukemia, to pick another application).

Contrast that with so many other gene-linked disorders take Huntingtons, for example. We know the gene for that one, and the protein it codes for, and it is equally obvious that if you could magically yank out that gene from a patient and insert the normal one for the Htt protein that they would no longer have the disease. But there is no analogous procedure for killing off the basal ganglia of the brain and replacing it with new neuronal tissue. Not quite. No, bone marrow based disorders are a unique opportunity, and thats why so much effort has gone into this area.

Its a similar situation to the way that therapeutic RNAs have been aimed at liver disorders. In that case, youre not wiping out the old cell population but rather trying to overwhelm it in situ, and the liver is chosen because we dont really know how to make i.v. dosed RNA species accumulate anywhere else. So we make do with what we have and turn the Liver Problem into the Liver Advantage. If we ever get to the point of treating Huntingtons at a genetic level, its surely going to be via a similar rework-things-in-situ method as well, but figuring out to do that in only the desired regions of the brain without causing trouble elsewhere is quite a challenge youve lost the Liver Advantage.

Now, Bluebird. They have been using a lentivirus vector to rewrite the bone marrow transplant tissue, and theres a solid reason for that. Lentiviruses (of which HIV is the most famous/infamous example) insert their genetic payloads into the host cells DNA. Its their key step, and they can do it even on non-dividing cells. Now, when a person hears viral vector these days, the thought is immediately of vaccines, and that takes us to the worry that the vaccines aimed at the COVID-19 pandemic will do things to our DNA. But were not using lentiviruses for the viral-vector vaccines were using adenoviruses, because those explicitly do not work by inserting genes into host DNA. Thats also a feature of the mRNA vaccines: messenger RNA is not incorporated into our DNA. Those two species are constantly working in close proximity in living cells and theres a huge pile of optimized protein machinery to keep them from getting crossed in that fashion. Nor does a messenger RNA sequence get turned back into DNA and inserted that way. Every cell has hundreds of thousands of mRNA molecules in it at any given time, and things would come to a catastrophic halt if these started getting reversed back into DNA sequences. (Our cells do have some RNA-to-DNA machinery in them, but it doesnt work like that).

But for gene therapy, the opposite considerations apply you most certainly want to insert new genes into human DNA, and you want it done quickly, efficiently, and right where you tell it to go. That last part is always the worry with any gene-insertion technique, be it some variety of CRISPR, zinc-finger nucleases, lentivirus vectors or what have you. This is one of the main reasons the human-editing experiment in China was so amazingly irresponsible, because our control over such things in a human embryo is just not acceptable yet. Not even close.

In fact, its tricky enough just in the stem cells pulled out of bone marrow. Thats one possibility for what Bluebird is seeing that when they treated the patients extracted cells with their lentivirus vector, that some of the hemoglobin genetic data got mishandled and plopped into the wrong stretch of DNA, demolishing some other important genes function in the process. You can be sure that theyre sequencing the abnormal blood cells from these patients now to see if this shows up. The MDS patient from 2018 turned out not to have this problem, so its possible that these two just reported dont, either. So whats the problem, if not that?

Well, as mentioned, bone marrow transplantation is a grueling process no matter what. The process of (either mostly or completely) wiping out a persons bone marrow stem cells involves severe treatments mixing chemotherapy with radiation, and one of the compounds used (and used by Bluebird) is called busulfan. The organic chemists in the crowd will find that one interesting: its the bis-mesylate of 1,4-butanediol, nothing more and nothing less, and if the thought of taking a reactive small molecule like that intravenously gives you the shivers, well, welcome to chemotherapy and get ready for some stuff thats even worse. The thing is, busulfan itself is a Class I carcinogen (as one would expect from its structure). Many older chemotherapy agents are. They are destructive to cells, and the only way you would take any of them is if you have a population of cells that you actually want to see destroyed, and you are willing to take your chances that you can bear up under the collateral damage of doing that. So its certainly possible that the leukemia seen in Bluebirds patients is at least partly driven by the bone marrow transplantation procedure rather than the gene alteration part. In case youre wondering, this could well be happening with some bone marrow transplant patients who undergo this whole procedure to treat leukemia itself, in which case it lands silently in the relapsed category. No, you only do bone marrow transplants when theres no alternative.

As that first link in todays post (Adam Feuerstein at STAT) mentions, though, theres ongoing research to make that part of the process less risky. Survival rates for bone marrow transplants in general have steadily improved over the years, and everyone knows that one of the rough parts is the pre-treatment. But that problem might or might not get solved in time to help out Bluebird (or to quell the worries that other gene-therapy outfits might have who are also targeting that hematopoietic tissue). If indeed its the problem in the first place. . .

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Cancer and Gene Therapy | In the Pipeline - Science Magazine

The new gene therapy target,GJB2 coding for the Connexin 26 protein, has been added to Sensorions development portfolio: with the target the third candidate to emerge from the R&D collaboration with Institut Pasteur. It represents the largest gene therapy opportunity for the French biotech to date.

The GJB2 program will focus on major new markets with an estimated patient population of 300,000 children and adults in Europe and the US alone.

Sensorion, a French clinical-stage biotech based in Montpellier, was founded in 2009 to develop novel therapies to restore, treat and prevent hearing loss disorders.

The GJB2 program draws on new research from Institut Pasteur which shows that the same genes that underly congenital deafness are also involved in severe forms of presbycusis (age-related hearing loss). These forms of presbycusis appearing to be monogenic types of hearing loss that can be potentially treated by gene therapy.

Although the types ofGJB2mutations in children and adults may differ, Sensorion says gene therapy could potentially provide a solution to both.

Mutations inGJB2are believed to alter a gap junction protein widely expressed in the inner ear, disturbing intercellular exchanges of molecules and leading to hearing loss that is severe-to-profound in a majority of cases.

Institut Pasteur research now shows three pathologies related to GJB2 mutations: congenital deafness;age-related hearing loss in adults; and progressive forms of hearing loss in children. Sensorion will prioritize the latter two forms, saying it is the first company to address these needs and offering the potential of large market opportunities.

The emergence of a new gene therapy target candidate validates our conviction that long-term solutions for restoring hereditary hearing loss will arise from an in-depth analysis of the "genetic landscape" of hearing loss," saidNawal Ouzren, CEO of Sensorion.

"It was clear that mutations in the GJB2 gene are important in severe to profound childhood hearing loss. However, the new discovery made by our collaborators at Institut Pasteur shows that alteration of this gene in adults offers new opportunities for Sensorion. It marks significant potential expansion of our pipeline and supports our goal of becoming a global leader in the field of gene therapies for hearing loss disorders.

Sensorions collaboration with Institut Pasteur initiated in 2019 has already led to gene therapy candidate programs in two other indications. Its USHER-CT gene therapy development program aims to restore inner ear function for patients suffering from Usher Syndrome Type 1 by providing a healthy copy of the USH1G gene coding for the SANS protein.

Meanwhile, the OTOF-GT gene therapy development program seeks to restore hearing in people with Otoferlin deficiency, one of the most common forms of congenital deafness.

Both of these have been proved in concept in preclinical studies.

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Sensorion and Institut Pasteur announce new gene therapy collaboration - BioPharma-Reporter.com