- Preliminary results to be presented on November 1, 2008 at 2008 iSBTc
Annual Meeting -
BRANFORD, Conn., Sept. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today announced that it has completed the enrollment of patients into its Phase II trial evaluating CR011-vcMMAE for the treatment of advanced melanoma. CuraGen also announced today that Phase II results from this trial will be presented during an oral session at the 23rd Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc), being held October 31 -- November 2, 2008, in San Diego, CA. The trial will be presented by Dr. Patrick Hwu, Co-Principal Investigator and Professor and Chairman of the Department of Melanoma Medical Oncology at The University of Texas, M.D. Anderson Cancer Center.
"We are very pleased with the clinical progress achieved with CR011-vcMMAE. Completing enrollment in this melanoma study ahead of schedule highlights the external support for this novel antibody-drug conjugate from our investigators," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "We expect that treatment of patients will still be ongoing in this Phase II trial at the time of iSBTc, and therefore look forward to presenting the first data from all treated patients in November, and anticipate that final results from the study will be available during the first half of 2009."
A total of 36 patients were enrolled in this Phase II open-label, multi-center trial evaluating the efficacy and safety of CR011-vcMMAE 1.88 mg/kg administered intravenously once every three weeks in patients with unresectable Stage III or Stage IV melanoma. Eligible patients had progressive disease at trial entry and may have received one prior cytotoxic regimen and any number of prior immunotherapies. Clinical efficacy endpoints include objective response rate, progression free rate, time to response and duration of response.
CuraGen is also continuing the Phase I portion of the trial evaluating the use of a weekly as well as a two out of every three week regimen of CR011-vcMMAE to explore the optimal dose and schedule of administration. Results from these more frequent dosing schedules are expected to be available in the first half of 2009.
In addition, CR011-vcMMAE is being studied in an ongoing Phase II trial in patients with metastatic breast cancer who have received previous chemotherapy. It is anticipated that preliminary results from the breast cancer trial will be presented in the first half of 2009.
CR011-vcMMAE targets glycoprotein NMB (GPNMB), which is overexpressed
in a variety of cancers including melanoma, breast cancer and brain tumors.
CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human
monoclonal antibody against GPNMB linked to a potent tubulin destabilizing
agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which
was licensed from Seattle Genetics, is designed to be stable in the
bloodstream and to release MMAE inside tumor cells, resulting in cancer
iSBTc Presentation Details
Title: Phase I/II Study of CR011-vcMMAE, an Antibody-Drug Conjugate
targeting GPNMB, for the Treatment of Patients with Advanced
Type: Oral presentation
Presenter: Dr. Patrick Hwu
Session: Tumor Targeting Monoclonal Antibodies
Date/Time: November 1, 2008 from 2:45 p.m. to 4:15 p.m.
According to the American Cancer Society, it is expected that approximately 60,000 new cases of melanoma will be diagnosed, including nearly 11,000 patients diagnosed with Stage III or Stage IV disease, and an estimated 8,000 people in the U.S. will die of the disease during 2008. The prognosis for patients with advanced melanoma is poor, and studies have shown that the median survival is less than nine months.
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer. 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 clinical progress of our development
programs, the timing and expected results of our clinical programs, and the
development and marketability of planned drugs, 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 CuraGen's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, 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,
CuraGen'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
Glenn Schulman, PharmD
Director of Medical Communications
|SOURCE CuraGen Corporation|
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