CuraGen Announces Presentation of Phase I Dose-Escalation Results on CR011- vcMMAE for Metastati...( - Initial clinical trial results sugg...),Health

- Initial clinical trial results suggesting safety and clinical activity of CR011-vcMMAE reported at the AACR-NCI-EORTC International Conference -

BRANFORD, Conn., Oct. 24 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), 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 wit
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