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CuraGen Announces Preliminary Data from Ongoing Phase II Study Showing Clinical Activity of CR011-vcMMAE in Patients with Metastatic Melanoma
Date:11/3/2008

nically 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 for
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SOURCE CuraGen Corporation
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Related medicine technology :

1. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
2. CuraGen and TopoTarget Initiate Phase I/II Clinical Trial of Belinostat (PXD101) Combination Therapy for Acute Myeloid Leukemia
3. CuraGen Announces Top-Line Phase II Results on Velafermin
4. CuraGen Announces Presentation of Phase I Dose-Escalation Results on CR011- vcMMAE for Metastatic Melanoma
5. CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference
6. CuraGen and TopoTarget Announce Presentations on Belinostat at the Upcoming American Society of Hematology 49th Annual Meeting
7. CuraGen Advances CR011-vcMMAE into Phase II
8. CuraGen Announces Data From Ongoing Phase I/II Trial Showing Clinical Activity of CR011-vcMMAE in Metastatic Melanoma
9. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma
10. CuraGen Announces Initiation of Phase II Trial of CR011-vcMMAE in Patients with Advanced Breast Cancer
11. CuraGen Reports Second Quarter 2008 Financial Results and Clinical Progress of CR011-vcMMAE
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