CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma- RECIST-defined objective response supports expansion of Simon 2-Stage designed trial -
BRANFORD, Conn., June 11, 2008 /PRNewswire-FirstCall/ -- CuraGen Corporation , a clinical-stage biopharmaceutical company focused on oncology, announced today that its Phase II Trial evaluating CR011-vcMMAE for the treatment of patients with unresectable Stage III or Stage IV melanoma has met the efficacy criteria for advancement to the second stage of enrollment. Of the first six evaluable patients in this Phase II trial one patient has had a confirmed objective response, as measured by RECIST criteria. As part of the Simon 2-Stage design the trial will now expand to enroll a total of 32 patients.
"We are very encouraged by the emerging clinical efficacy of CR011-vcMMAE. We believe that this objective response confirms the initial activity observed in the Phase I trial, the results of which were reported earlier this month at ASCO," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "This trial is enrolling well, and we expect the data to quickly mature allowing us to provide further updates from the study later in the second half of this year."
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented, "There remains a substantial unmet need for patients with advanced melanoma. As we continue to evaluate CR011-vcMMAE 1.88 mg/kg given once every three weeks in this ongoing Phase II trial, we are also looking to further optimize the activity of CR011-vcMMAE by actively exploring alternative dosing schedules including more frequent intravenous administration of this novel agent."
This ongoing open-label, multi-center Phase II study evaluating CR011- vcMMAE in patients with advanced melanoma utilizes a Simon 2-Stage design with a primary endpoint of objective response rate. Patients enrolled in the study may have received no more than one prior cytotoxic regimen, but may have received an unlimited number of prior cytokine, immune or vaccine therapies. Enrollment in the study is expected to be completed by the end of 2008.
CR011-vcMMAE targets a protein known as GPNMB, which has been shown to be overexpressed in melanoma, breast cancer and brain tumors. Based on the clinical activity observed in the treatment of melanoma, CuraGen anticipates initiating a Phase II trial evaluating CR011-vcMMAE for the treatment of patients with metastatic breast cancer in the third quarter of 2008. Furthermore, CuraGen is conducting preclinical research to determine the optimal approach for utilizing CR011-vcMMAE as a potential treatment of brain tumors, including glioblastoma multiforme.
CR011-vcMMAE is an antibody-drug conjugate (ADC) comprised of a fully- human monoclonal antibody against glycoprotein NMB (GPNMB) attached to a potent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. GPNMB is a novel, selective target that plays a role in the ability of cancer cells to invade and metastasize. CR011-vcMMAE contains an enzyme-cleavable linker designed to be stable in the bloodstream and to release MMAE after internalization into tumor cells that express GPNMB, resulting in cancer cell death.
The number of people diagnosed with melanoma is rapidly increasing. It is expected that approximately 60,000 new cases of melanoma will be diagnosed 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 is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer. 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 effectiveness of antibody-drug conjugates and CuraGen's CR011-vcMMAE program, including the use of CR011-vcMMAE for metastatic melanoma, breast cancer and gliomas, and the timeframe of initiating clinical trials and presenting results on CR011-vcMMAE 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 period ended March 31, 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 otherwise.
Contacts: Glenn Schulman, PharmD Director of Medical Communications firstname.lastname@example.org (888) 436-6642 CRGN-P
CONTACT: Glenn Schulman of CuraGen Corporation, PharmD, Director ofMedical Communications, +1-888-436-6642, email@example.com
Web site: http://www.curagen.com/
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Posted: June 2008