logo
  Join        Login             Stock Quote

Gentium (GENT) To Start Clinical Development In Japan Of Defibrotide To Treat Veno-Occlusive Disease

 December 05, 2012 08:14 AM
 


(By Balaseshan) Gentium S.p.A. (NASDAQ: GENT) said it will initiate clinical development in Japan of Defibrotide to treat veno-occlusive disease (VOD), and expand named-patient program access to Asia and Japan.

The company's entry into an agreement with the National University Corporation Hamamatsu University School of Medicine (HUSM), Fukushima Medical University (FMU) and LINK Healthcare to support a clinical trial to evaluate the safety and pharmacokinetics of Defibrotide in healthy adults.

An investigational new drug application for Defibrotide to treat VOD, a potentially life-threatening condition associated with stem cell transplantation, was recently submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

[Related -Stocks Fall On Mixed Data; Tesla Motors (TSLA) Drops]

Under the terms of the agreement, Gentium will provide free drug and technical support and LINK will provide administrative and logistical support for the clinical trial conducted by HUSM.

If desired outcomes are achieved following the completion of the Phase 1 clinical trial, a Phase 2 Clinical Trial will need to be completed before submitting a marketing authorization application for Defibrotide to the PMDA.

The clinical trial is supported by a Health and Labour Sciences Research Grant (2012) and is categorized by the grant program as a study to support practical drug/medical device use during the reconstruction of disaster-hit areas in Eastern Japan.

In June 2011, the company announced the appointment of Link as exclusive distributor of Defibrotide in Australia and New Zealand.

[Related -Futures Drop After Fed Minutes; Tesla Motors (TSLA) Retreats]

Gentium and LINK intend to expand the distribution territories covered in their existing agreement to include Asia and Japan as LINK has recently established an operations and distribution facility in Singapore to serve the central Asian markets and purchased a business specializing in named-patient distribution in Japan.

Defibrotide is an investigational drug that has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD.

GENT closed Tuesday's regular session down 1.22% at $11.36. The stock has been trading between $5.31 and $11.81 for the past 52 weeks.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageChipotle Mexican Grill, Inc. (CMG) Q2 Earnings Preview: Will Higher Traffic Offset Higher Costs the Key

Chipotle Mexican Grill, Inc. (NYSE:CMG) will host a conference call to discuss second quarter 2014 read on...

article imageNetflix, Inc. (NFLX) Q2 Earnings Preview: The Ruby Month for a Reason

Netflix, Inc. (NASDAQ:NFLX) will post its second-quarter 2014 financial results and business outlook on its read on...

article imageLadenburg Thalmann Financial Services (NYSEMKT:LTS): Heavy, Durable Insider Buying

Ahh, but any worries over price levels didn’t stop multiple insiders at Ladenburg Thalmann Financial read on...

article imageInternational Business Machines Corp. (IBM) Q2 Earnings Preview: Small Beat and Pop

International Business Machines Corp. (NYSE:IBM) will host a conference call Wednesday, Jul. 16, 2014 at read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.