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Biotech / Medical : CuraGen (CRGN) -- Ignore unavailable to you. Want to Upgrade?

To: Mike McFarland who wrote (474)	10/11/2007 8:28:34 AM
From: nigel bates	Respond to of 478

CuraGen Announces Top-Line Phase II Results on Velafermin Thursday October 11, 7:00 am ET - Conference call to be hosted today at 8:30 a.m. Eastern Time - BRANFORD, Conn., Oct. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that its Phase II dose-confirmatory clinical trial (CLN-12) evaluating a single dose of velafermin for the prevention of severe oral mucositis demonstrated that velafermin was safe and well-tolerated but did not meet its primary endpoint. Based on these results, the Company is discontinuing the development of velafermin, and will continue to focus its resources on belinostat, a Phase II histone deacetylase (HDAC) inhibitor for the treatment of solid tumors and hematologic malignancies, and CR011-vcMMAE, a Phase I/II antibody-drug conjugate for the treatment of metastatic melanoma. "While we are disappointed that the primary endpoint was not met in this study, on behalf of everyone at CuraGen, I would like to thank all of the patients and investigators who took part in the velafermin development program," commented Timothy Shannon, President and Chief Executive Officer of CuraGen. "We continue to aggressively focus on our goal of advancing the belinostat and CR011-vcMMAE programs toward initiation of Phase III development in 2008, and we look forward to presenting updated clinical trial results on these programs in October at the AACR-NCI-EORTC conference, and in December at the ASH Annual Meeting." CLN-12 was a randomized, double-blind, placebo-controlled study designed to assess a reduction in the incidence of severe Grade 3 or 4 oral mucositis in patients receiving high-dose chemotherapy followed by autologous bone marrow transplantation (BMT). The trial enrolled 390 patients at 33 centers in the United States. Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three dose levels of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT. The primary endpoint was a decrease in the incidence of severe oral mucositis in patients receiving 30 mcg/kg velafermin compared to placebo. Secondary endpoints evaluated included duration of oral mucositis, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition. The complete results from CLN-12 will be presented in December at the American Society of Hematology (ASH) 2007 Annual Meeting in Atlanta, GA. CuraGen will host a conference call today at 8:30 a.m. Eastern Time. Dial-in and webcast information are provided below. Dial-in and Webcast Information Date: Thursday, October 11, 2007 Time: 8:30 a.m. EDT Dial-in: 877-272-5391 (domestic) 706-758-4315 (international) Passcode: 20509852 Webcast: Access to the live webcast is available at curagen.com.