Fate Therapeutics (FATE) Granted FDA Orphan Drug Status for ProTmune
- Wall Street falls with financials, other post-election gainers
- The FTC Confirms Antitrust Charges Against Qualcomm (QCOM) for Monopolizing Semiconductor Device Used in Cell Phones
- United Airlines (UAL) Tops Q4 EPS by 5c
- Obama shortens sentence of Manning, who gave secrets to WikiLeaks
- After-Hours Stock Movers 01/17: (SHLO) Higher; (GIMO) (AFAM) (CSX) Lower (more...)
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
Fate Therapeutics, Inc. (NASDAQ: FATE) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for ProTmune™, the Company’s lead product candidate that is currently undergoing Phase 1/2 clinical investigation. The FDA designation is for “prevention of graft-versus-host disease in patients undergoing allogeneic hematopoietic cell transplantation” and broadly covers diseases, including blood cancers and genetic disorders, for which the procedure is performed.
“The granting of both orphan drug and Fast Track designations for ProTmune validates the product candidate’s unique therapeutic potential to address life-threatening complications and improve the curative potential of allogeneic HCT,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “Graft-versus-host disease is a significant cause of morbidity and mortality in patients undergoing allogeneic HCT and there are no FDA-approved therapies to prevent its occurrence. Through our development of ProTmune, we seek to transform the allogeneic HCT paradigm by providing immunocompromised patients a therapeutically-optimized donor graft containing immune cells with reduced alloreactivity and enhanced infection-fighting and anti-tumor properties.”
Graft-versus-host disease (GvHD) is a severe immunological complication that arises when newly-transplanted donor immune cells attack the patient’s tissues and organs, resulting in a potentially fatal immune system reaction. Despite the use of protocols to prevent its occurrence, up to 50 percent of patients experience GvHD. Additionally, GvHD is treated systemically with immunosuppressive agents, with only about half of patients responding to treatment. The systemic use of these agents increases a patient’s risk of severe infection from bacteria, viruses and fungi as well as cancer relapse, further compromising the curative potential of allogeneic HCT.
The FDA provides orphan designation to drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States. Orphan drug designation would provide seven years of market exclusivity in the United States, with certain exceptions, if market approval is granted for ProTmune. Orphan designation also qualifies a company for various development incentives, including tax credits for qualified clinical testing and a waiver of PDUFA filing fees.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Eli Lilly & Co. (LLY), Incyte (INCY) Announce FDA Extends Review Period for Baricitinib
- McKesson (MCK) Confirms $150M DoJ Settlement
- Neurocrine Biosciences (NBIX) Reports Results from Phase II Clinical Study of VMAT2 Inhibitor INGREZZA
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!