CuraGen Announces Presentation of Phase I Dose-Escalation Results on CR011- vcMMAE for Metastatic Melanoma
BRANFORD, Conn., October 24, 2007 /PRNewswire-FirstCall/ -- CuraGen Corporation , a clinical-stage biopharmaceutical company focused on oncology, announced that the first Phase I clinical trial results on CR011- vcMMAE, an antibody-drug conjugate (ADC) being developed for the treatment of metastatic melanoma, were presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, CA. To date, 25 patients with unresectable Stage III or IV malignant melanoma have been treated with CR011-vcMMAE in the Phase I dose-escalation portion of the trial.
Results from the ongoing trial suggest the CR011-vcMMAE is well-tolerated at doses up through 1.88 mg/kg with no dose-limiting toxicities noted. Dose- escalation continues with patients currently being enrolled into the 2.63 mg/kg cohort. Of the 25 patients treated with doses ranging from 0.03 mg/kg to 1.88 mg/kg, six patients achieved stable disease lasting up to 11 cycles, and four of the six patients demonstrated tumor shrinkage of up to 20%. Reversible neutropenia was the only drug-related Grade 3 or 4 adverse event, and appears to be dose-dependent. Evaluation of the pharmacokinetic results also suggest that CR011-vcMMAE can be given safely to achieve human plasma concentrations in the anticipated range of activity based on data from in vivo xenograft animal models.
Upon establishing the maximum tolerated dose (MTD), the trial is expected to expand directly into a Phase II study to further assess the activity of CR011-vcMMAE in up to 32 patients with Stage III or Stage IV malignant melanoma.
"We are encouraged by these initial clinical results on CR011-vcMMAE and the suggestion of potential anti-cancer activity in patients with previously progressive disease, which support continued evaluation of this antibody-drug conjugate in the treatment of advanced melanoma. We continue to enroll patients into the trial, and look forward to further characterizing the activity of this novel therapeutic," commented Dr. Mario Sznol, co-Principal Investigator, Co-Director of the Melanoma Program at the Yale Cancer Center in New Haven, CT.
This open-label, dose-escalation study conducted at the Yale Cancer Center, New Haven, CT, MD Anderson Cancer Center, Houston, TX, and The Angeles Clinic and Research Institute, Santa Monica, CA, is evaluating the safety, tolerability and pharmacokinetics of CR011-vcMMAE for patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy. The first part of the trial will evaluate cohorts of patients receiving increasing doses of CR011-vcMMAE to determine the MTD. After determination of the MTD, up to approximately 32 additional patients will be enrolled and treated at the MTD to further define the safety and efficacy of CR011-vcMMAE.
CuraGen will host a conference call on Thursday, October 25, 2007 at 5:00 p.m. Eastern time to discuss these Phase I results on CR011-vcMMAE and the four posters discussing Phase I and Phase II clinical trial results with belinostat being presented at the AACR-NCI-EORTC International Conference.
Conference Call Details and Dial-in Information Date: Thursday, October 25, 2007 Time: 5:00 p.m. Eastern time Dial-in: 877-272-5391 (domestic) 706-758-4315 (international) Passcode: 21928842 Webcast: Access to the live webcast and presentation are available at http://www.curagen.com
A replay of the conference call will be available starting at 8:00 p.m. Eastern time on Thursday, October 25, 2007 through Sunday, November 25, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 21928842. An archive of the webcast will also be accessible at http://www.curagen.com.
CR011-vcMMAE is an 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. . 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 melanoma cells. Upon internalization into the targeted cell, CR011- vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. Preclinical studies conducted with this potential therapeutic demonstrate that CR011-vcMMAE produces strong, reproducible and durable effects against tumors in animal models of melanoma. CR011-vcMMAE is currently in a Phase I/II trial initially assessing the safety and identifying a dose to be further evaluated in the Phase II portion of the study.
Melanoma is a very serious form of skin cancer that accounts for the majority of skin-cancer related deaths each year. The number of people diagnosed with melanoma is rapidly increasing with more than 62,000 new cases expected to be diagnosed in the U.S. during 2007. While the chance of developing melanoma increases with age, it remains one of the most common cancers in young adults. This type of cancer begins in specific cells in the skin and can metastasize, or spread, throughout the body to many organ systems. Patients with Stage IV metastatic melanoma typically have a median survival of less than nine months despite current standard therapies, underscoring the need for novel therapeutics to address the unmet medical need in this patient population.
CuraGen Corporation is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer including belinostat and CR011-vcMMAE. By leveraging 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 CuraGen's CR011-vcMMAE program, including the potential of CR011-vcMMAE for metastatic melanoma and the progress and timeframe of clinical trials of 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 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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CONTACT: Glenn Schulman, PharmD, Director of Investor Relations of CuraGenCorporation, +1-888-436-6642, firstname.lastname@example.org
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Posted: October 2007