PipelineReview.com - Biotech News & Online Store - CuraGen Announces Top-Line Phase II Results on Velafermin

CuraGen Announces Top-Line Phase II Results on Velafermin

12 Oct 2007

CuraGen Corporation 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

BRANFORD, CN, USA | October 11, 2007 | 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.

Pipeline Update

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

About CuraGen
CuraGen Corporation (Nasdaq: CRGN) 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.

Safe Harbor
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.

SOURCE: CuraGen Corporation

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