Print
Email
Print Edition Stories
MHT's Efrain Viscarolasaga: Soldier tech heads to Afghanistan
MHT's Marc Songini: Mass. bio firms prep for lifting of stem cell ban
The U.S. Food and Drug Administration has accepted a new drug application for the oncology drug Onrigin from New Haven-based Vion Pharmaceuticals Inc.
Vion (OTC Bulletin Board: VION), in an announcement this past week, explained that Onrigin—laromustine is its lead oncology treatment. The company had announced the filing of the new drug application with the FDA in February 2009. The application presents data for Onrigin as a single agent for remission induction treatment for patients 60 or older with de novo poor-risk acute myeloid leukemia.
The application is based on the results of an international multi-center pivotal Phase 2 trial of 85 patients 60 or older with de novo poor-risk acute myeloid leukemia. This was supplemented with data from 55 patients in a previous Phase 2 trial in elderly acute myeloid leukemia. Eighty-six percent of these 140 patients had two or more risk factors indicating a poor prognosis.
This FDA acceptance is an “important milestone” for Vion, stated Alan Kessman, CEO, in a press release.
Vion develops and commercializes new oncology drugs and has two agents in clinical trials, Onrigin injection and Triapine, which is an inhibitor of a key step in DNA synthesis. Triapine is being evaluated in clinical trials sponsored by the National Cancer Institute.
The company reported a net loss of $29.8 million for 2008, compared with a net loss of $34 million for 2007. Vion reported it ended the year with $38 million in cash and cash equivalents.
Comments
If you are commenting using a Facebook account, your profile information may be displayed with your comment depending on your privacy settings. By leaving the 'Post to Facebook' box selected, your comment will be published to your Facebook profile in addition to the space below.
RSS Feeds
