Navigation Links
Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Date:2/8/2011

CAMBRIDGE, Mass., Feb. 8, 2011 /PRNewswire/ -- Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

Vascugel, a novel endothelial cell-based therapy and Pervasis' lead development program, aims to regulate the body's healing response following surgical interventions to create vascular access points which are necessary for ESRD patients undergoing hemodialysis, reducing the need for repeat surgical interventions and improving overall patient outcomes.

FDA established Fast Track to facilitate the development and accelerate the pre-market review of treatments for serious and life-threatening conditions, so that these products can reach approval more rapidly. To receive Fast Track designation, a product must address a serious unmet medical condition, and be supported by strong results from pre-clinical or clinical testing demonstrating the product potential.

Vascugel has demonstrated clinical proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access for hemodialysis. In these trials, Vascugel exhibited an excellent safety profile and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.

"The fact that these very sick patients must endure serious complications and repeat surgical procedures so that they can continue undergoing hemodialysis represents a significant unmet medical need—one that Vascugel is uniquely able to address," stated Frederic Chereau, president and CEO of Pervasis. "Fast Track designation from the FDA further validates Vascugel's potential as a safe and effective therapy for patients with end stage renal disease, and will help accelerate the
'/>"/>

SOURCE Pervasis Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Pervasis to Present Interim Data from Phase 1/2 Clinical Study of Novel Cell Therapy Targeting Peripheral Artery Disease at International Conference on Cell Therapy for Cardiovascular Diseases
2. Pervasis Therapeutics to Develop Novel Cell-Based Approach to Target Tumor Environment, Prevent Cancer Recurrence
3. Pervasis Therapeutics Awarded Four Grants Under the Qualifying Therapeutic Discovery Project
4. Pervasis Therapeutics Receives FDA Clearance for Pivotal Phase 3 Trial of Vascugel(R)
5. Generex Oncology Receives New Patent for AE37 Immunotherapeutic Cancer Vaccine
6. China Medicine Corporation Receives Manufacturing License for rADTZ
7. Johnson & Johnson Receives Approval from European Commission
8. Mylan Receives Approval for First-to-File Generic Sular® Extended-Release Tablets
9. Boca Pharmacal Receives FDA Approval for Hydrocodone Bitartrate and Acetaminophen Tablets
10. China Sky One Medical Receives Medical Industry Awards
11. Lakewood-Amedex Inc. Receives Notice of Allowance on Three US Patent Applications Relating to Treatment of Hemolytic Uremic Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... STUDY OBJECTIVES The objective of ... an overview of the current and future characteristics ... key objective is to present a comprehensive analysis ... important tool in the treatment of various diseases. ... within the protein therapeutics market, which includes peptide ...
(Date:9/30/2014)... Mass. , Sept. 30, 2014  Decision Resources ... devices in Brazil , ... China (BRIC) will see robust ... are increasingly favored over surgical procedures. Although revenues will ... resources, reimbursement challenges, prolonged device approval times and demand ...
(Date:9/30/2014)... September 30, 2014 ... the "Glycobiology/Glycomics Market by Product [Enzymes (Glycosyltransferase, Neuraminidase, ... and Reagents], Application (Immunology, Oncology) & by ... published by MarketsandMarkets, provides a detailed overview ... current market trends, and strategies impacting the ...
Breaking Medicine Technology:Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 2Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 3Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 4Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3Glycobiology / Glycomics Market Worth $928.11 Million by 2019 2Glycobiology / Glycomics Market Worth $928.11 Million by 2019 3Glycobiology / Glycomics Market Worth $928.11 Million by 2019 4
... Coordination for the Improvement of Personnel in Higher Education ... 10th anniversary of Portal de Periodicos. CAPES will sign ... who are part of the Portal. Thomson ... its Micromedex® solutions, which include evidence-based information on drugs ...
... 9, 2010 In his recent trip to India, President ... small number of companies including GE and Boeing, as part of ... 50,000+ jobs here in the US from selling goods and services ... its sales of certified pre-owned medical equipment to India ...
Cached Medicine Technology:Higher Education Foundation in Brazil Seals Its Continued Relationship with Thomson Reuters for Academic Healthcare Content 2Skelley Medical Working with White House and President Obama in India 2
(Date:10/1/2014)... October 01, 2014 Insuranceragents.info has ... a good life insurance plan for vulnerable family members. ... vulnerable family members. Providers in the family should always ... cause financial hardships for the rest of the family. ... policies. Families can benefit more from temporary coverage or ...
(Date:10/1/2014)... ATLANTA (PRWEB) October 01, 2014 ... executive networking and relationship-marketing firm, announced today ... Security Executive® and Project of the Year ... decision makers representing organizations in financial services, ... include large-scale technology endeavors that address key ...
(Date:10/1/2014)... Between 23 million and 50 million ... to figures from the National Institutes of Health (NIH) ... many of them have something else in common: They ... disease. Gluten Free Therapeutics, makers of CeliVites ... disease by publishing a series of blog posts aimed ...
(Date:10/1/2014)... October 01, 2014 Scientists at the ... drugs that target immune system proteins has the power ... just posted details of the new study on their ... , Researchers in the UWA School of Pathology ... drugs to mice with mesothelioma with promising results. ...
(Date:10/1/2014)... Woodland Hills dental implants ... of dental specialists who treat full mouth implant cases ... Oviedo. Dr. Reshad of the Anacapa Dental Art Institute, ... two continents, will give a full-day presentation Oct. 4 ... , “These specialists want to improve their skills and, ...
Breaking Medicine News(10 mins):Health News:Life Insurance for Families - Clients Can Compare Affordable Rates Online! 2Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 2Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 3Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 4Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 5Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 6Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 7Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 2Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 3Health News:New Mesothelioma Study Says Mice Cured by Immuntherapy “Cocktail”, Reports Surviving Mesothelioma 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 3Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 4
... Angeles Superior Court accuses sunscreen makers of exposing millions ... on their products.// ,The suit, which ... manufacturers like Coppertone, Banana Boat, Hawaiian Tropic, Bullfrog and ... protection against skin cancer, these companies are putting consumers ...
... that you are strong and muscles are workings would actually ... team which asked 30 subjects to do biceps //curls and ... the muscles were doing. ,The method was to ... of electrical activity in their biceps and asked them to ...
... village in Bihar was left for herself to cremate the body ... up// give a helping hand. The widow dragged his body to ... ,Grief-stricken Dhanua Devi (named changed), a 36-year-old resident of Khaira ... thatched hut to console her. ,A mother of three, ...
... expecting bird flu arrive at the U.S. West Coast this ... United States of the deadly virus. // The deadly H5N1 ... to Africa. This announcement was made by California Health and ... a state bird flu pandemic preparedness meeting. ,Officials said ...
... waiting lists. He said that they can take their health care ... guaranteed that one can open the door to legal action if ... , By this the framework in place is maintained and ... that is essential. Clement said this while, speaking at a conference ...
... been long regarded to be a chronic and unremitting condition. ... or short-lived condition // from which affected individuals can recover ... same thing about alcohol. But now I think that we ... compulsive gambling is - for some people it is something ...
Cached Medicine News:Health News:Bird Flu Expected To Hit U.S. This Summer 2Health News:Compulsive Gambling Not A Chronic Addiction Always: Research 2
... Clareon to practices that require an increased ... efficacy. The versatility of the Clareon System ... of treatments that would typically require multiple ... worry about obsolescence because the Clareon is ...
Standard Lipo-tubing...
... Donor Screening, Supplemental Confirmatory (Western Blot): The ... HIV-1 antigens on their surface. The cells ... IFA glass slide. Fixed, uninfected T-cells are ... or plasma sample with HIV- I antibodies ...
Perfect for physicians who prefer a Heavier and Longer tubing, permitting them maximum access around the OR table. 12 feet in length Sizes availabe to fit any vacuum canisters...
Medicine Products: