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CuraGen Completes Enrollment in Phase II Trial of CR011-vcMMAE in Metastatic Melanoma
Date:9/11/2008

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 cell death.

iSBTc Presentation Details

Title: Phase I/II Study of CR011-vcMMAE, an Antibody-Drug Conjugate

targeting GPNMB, for the Treatment of Patients with Advanced

Melanoma

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.

About Melanoma

According to the American Cancer Society, it is expected that approximately 60,000 new cases of melanoma will be diagnosed, i
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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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