- Data presented at the 2008 iSBTc Annual Meeting -
- Conference call to be hosted today at 11:00 a.m. ET to discuss results -
BRANFORD, Conn., Nov. 3 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) announced today preliminary data from an ongoing Phase II trial of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, for the treatment of patients with unresectable Stage III or Stage IV melanoma. 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, presented the data during an oral session at the 2008 International Society for Biologic Therapy of Cancer (iSBTc) Annual Meeting.
Thirty-six patients were enrolled into this Phase II open-label, multi-center trial that is evaluating the efficacy and safety of CR011-vcMMAE 1.88 mg/kg administered intravenously once every three weeks. Eligible patients had progressive disease at trial entry and may have received one prior cytotoxic regimen and any number of prior immunotherapies. Of the patients enrolled, 94% had Stage IV disease of which two-thirds were classified as M1c, the poorest risk group.
At the time of the data cutoff for this analysis (19 Sept 2008), 31 patients had at least one efficacy assessment available, and 18 patients were continuing to receive ongoing treatment in the study. The median overall progression-free survival (PFS) to date was approximately 4.5 months. RECIST-defined partial responses were reported in 3 patients, 2 ongoing, and an unconfirmed partial response in 1 patient. Nineteen patients had stable disease, 14 ongoing, with tumor shrinkage observed in 12 of these patients.
"PFS is a clinically meaningful and important regulatory endpoint. The apparent prolongation in PFS of 4.5 months, compared to a historical expectation of 1.7 months, combined with clear objective responses and tumor reduction in the majority of patients, suggests that CR011-vcMMAE has the potential to become an important novel therapy in this patient population," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen.
As expected based upon the expression of GPNMB and as observed in Phase I, dermatologic adverse events consisting of rash, alopecia, and pruritus were the most common toxicities in this study. A preliminary exploratory analysis assessing the relationship of rash and PFS was performed and showed a trend toward longer PFS in patients that developed Grade 2 or higher rash (n=13). Other adverse events included fatigue, diarrhea, anorexia and nausea. Grade 3 or 4 neutropenia was observed in 7 patients (22%).
"The target of CR011-vcMMAE, GPNMB, is a protein that is believed to be over expressed in a variety of tumors and also present in some normal tissue including the skin. The preliminary data which may suggest a correlation between the development of rash and clinical efficacy is very intriguing and we will continue to assess its potential role in helping to identify those patients who may best respond to treatment with CR011-vcMMAE," commented Dr. Ronit Simantov, Chief Medical Officer at CuraGen. "We would like to thank our investigators for their enthusiasm, which we believe is highlighted by their ability to fully enroll this Phase II trial in just 6 months, and we look forward to reporting the final data from this Phase II trial during the first half of 2009."
"Targeting GPNMB with this antibody-drug conjugate represents a potentially novel way to treat this disease, and based on these preliminary Phase II results, CR011-vcMMAE appears to be clinically active against unresectable melanoma in some patients. We look forward to further evaluating the correlation between rash and clinical activity, as well as alternate dosing schedules of CR011-vcMMAE," commented Dr. Hwu.
CuraGen is currently enrolling patients into a Phase I portion of this trial to evaluate more frequent dosing schedules of CR011-vcMMAE, including a weekly and a two out of every three-week regimen, to explore if more frequent administration can provide additional activity in patients with metastatic melanoma. CR011-vcMMAE is also being studied in an ongoing Phase II trial in patients with metastatic breast cancer who have received previous chemotherapy. CuraGen anticipates providing updated data from the ongoing melanoma and breast cancer studies in the first half of 2009.
"While we continue to finalize data from this study, develop data from more frequent dosing in patients with metastatic melanoma and from the Phase II study in patients with breast cancer, we will be engaging in discussions with potential partners as we develop plans for the advanced stages of development," added Dr. Shannon. "The goal of a partnership will be to support the financial, development and commercial resources that will be required in advanced development, improving the risk profile to CuraGen shareholders while maintaining upside potential."
In addition to M. D. Anderson, other sites participating in the melanoma trial include Yale Cancer Center, New Haven, CT; The Angeles Clinic and Research Institute, Santa Monica, CA; and New York University Medical Center, New York, NY.
Reprints of the presentation will be made available on CuraGen's website at http://www.curagen.com or can be requested by emailing firstname.lastname@example.org.
A replay of the conference call will be available starting at 2:00 p.m. Eastern time on Monday, November 3, 2008 through Wednesday, December 3, 2008 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 71190212. An archive of the webcast will be available for 30 days at http://www.curagen.com.
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by CuraGen that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. (Nasdaq: SGEN). The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and gliomas. Upon internalization into the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. CR011-vcMMAE is currently in two Phase II trials assessing the safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.
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.
About CuraGenCuraGen Corporation (Nasdaq: CRGN) is a clinical-stage biopharmaceutical company developing promising 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 CuraGen's development program for CR011-vcMMAE, including CuraGen's ability to advance CR011-vcMMAE through Phase II clinical trials for melanoma and metastatic breast cancer, explore additional doses and schedules of this antibody-drug conjugate, explore the potential of CR011-vcMMAE in a patient population in need of new therapies, and intention to engage in discussions with potential partners with respect to 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 CuraGen's pursuit of partnership opportunities will not proceed as planned or 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, as well as risk associated with 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 ability to comply with Nasdaq listing requirements, 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 under the section "Risk Factors" in CuraGen's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed with the Securities and Exchange Commission 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.
Conference Call Details and Dial-in Information Date: Monday, November 3, 2008 Time: 11:00 a.m. EDT Dial-in: 877-272-5391 (domestic) 706-758-4315 (international) Passcode: 71190212 Webcast: Access available at http://www.curagen.com
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