InvestorsHub Logo
Followers 27
Posts 5261
Boards Moderated 1
Alias Born 08/02/2006

Re: surf1944 post# 63

Saturday, 10/06/2007 6:32:27 AM

Saturday, October 06, 2007 6:32:27 AM

Post# of 158
I'm still here, on the road, not able to check anything but looks like things are going well.

I tried to post a response to you about CRGN's timeline for events on Monday but ran out of time.

It was on Yahoo, august 6th PR:

http://biz.yahoo.com/prnews/070806/nem096.html?.v=10

CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
Monday August 6, 4:15 pm ET
- Enrollment completed in Phase II trial evaluating a single dose of velafermin for the prevention of severe oral mucositis -
- Continued focus to define registrational path for belinostat in the treatment of cancer -
- Conference call and webcast to be held today at 6:00 p.m. Eastern Time -

Velafermin for the prevention of severe oral mucositis (OM):

Enrollment has been completed in the Phase II randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a single infusion of velafermin for the prevention of severe OM. A total of 390 patients at 33 centers were enrolled throughout the United States. Primary safety and efficacy assessments of treated patients will be concluded at participating centers during August with preliminary, top-line efficacy results from the completed trial available in mid-October of 2007. Patients will be followed for an additional year to assess long term outcome with results available during the fourth quarter of 2008. The Phase II trial is designed to assess the reduction in the incidence of severe WHO Grade 3 or 4 OM in patients receiving high-dose chemotherapy, with or without total body irradiation (TBI), prior to autologous bone marrow transplantation (BMT). Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three doses of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT.

"We believe that the ability to recruit nearly 400 patients in 13 months speaks to the unmet need in the severe OM market, and feel there is a substantial opportunity for a product like velafermin, which could provide a convenient single dose regimen for the prevention of severe OM," commented Dr. Shannon. "We look forward to reporting top-line efficacy and safety results in mid-October, which we hope will confirm the data observed previously with 30 mcg/kg velafermin in our first Phase II trial for the prevention of severe OM."