CuraGen Announces Top-Line Phase II Results on Velafermin
BRANFORD, Conn., Oct. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation , 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, 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 http://www.curagen.com.
A replay of the conference call will be available starting at 12:00 p.m. Eastern time on Thursday, October 11, 2007 through Sunday, November 11, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 20509852. An archive of the webcast will be available for 30 days at http://www.curagen.com.
Upcoming Presentations at the AACR-NCI-EORTC 2007 International Conference on Molecular Targets and Cancer Therapeutics, October 22-26, 2007, in San Francisco, CA: Belinostat Title: Phase II Multicenter Trial of Belinostat (PXD101) in Combination with Carboplatin and Paclitaxel (BelCaP) for Patients (pts) with Relapsed Ovarian Cancer Date: Thursday, October 25, 2007 Poster Board: C223 Session: Poster Session C: Other Small Molecule Therapeutic Agents Title: A Phase I Study of Oral Belinostat (PXD101) in Patients with Advanced Solid Tumors Date: Wednesday, October 24, 2007 Poster Board: B134 Session: Poster Session B: Epigenetic Targets Title: A Phase 1 Study of Belinostat (PXD101) in Combination with Bortezomib in Patients with Advanced Solid Tumors and Lymphoma Date: Tuesday, October 23, 2007 Poster Board: A149 Session: Poster Session A: Clinical Trials Title: A Phase II Trial of the Histone Deacetylase Inhibitor Belinostat (PXD101) in Patients with Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors. A Trial of the PMH Phase II Consortium Date: Tuesday, October 23, 2007 Poster Board: A160 Session: Poster Session A: Clinical Trials CR011-vcMMAE Title: A Phase I and Pharmacokinetic Study of CR011-vcMMAE, an Antibody Toxin Conjugate Drug, in Patients with Unresectable Stage III /IV Melanoma Date: Wednesday, October 24, 2007 Poster Board: B47 Session: Poster Session B: Biological Therapeutic Agents Title: Pharmacologically Enhanced Expression of the Melanoma-Associated Target, GPNMB, Increases the Sensitivity of Melanoma Cells to the CR011-vcMMAE Antibody-Drug Conjugate Date: Tuesday, October 23, 2007 Poster Board: A68 Session: Poster Session A: Biological Therapeutic Agents Upcoming Presentations at the 2007 ASH Annual Meeting, December 8-11, 2007 in Atlanta, GA: Belinostat Title: Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma: Results of a Phase II Study Date: Monday, December 10, 2007 Poster Board: 2607 Session: Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Diffuse Large Cell Lymphoma and T-Cell Lymphoma Velafermin Title: A Randomized Placebo Controlled Phase II Trial of Prevention of Severe Oral Mucositis Using Single Dose Velafermin in Patients Receiving Myeloablative Therapy and Autologous Hematopoietic Stem Cell Transplant (AHSCT) Date: December 10, 2007 Time: 4:00 p.m. Eastern Time Session: Clinical Care: Transplantation Regimen Toxicities and Engraftment-Regimen-Related Toxicities
CuraGen Corporation is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer including belinostat and CR011-vcMMAE. By leveraging the drug development strengths cultivated over the years, CuraGen expects to make a difference by advancing its promising therapeutics to address the unmet medical needs of cancer patients. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the advancement of the belinostat and CR011- vcMMAE programs and the projected timing for updates on the CuraGen's clinical trial results may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGen's stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Posted: October 2007