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Old 04-30-2009, 05:00 PM   #1
Rich66
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Join Date: Feb 2008
Location: South East Wisconsin
Posts: 3,431
Might be available in compassionate use. I have no clue:





http://phx.corporate-ir.net/phoenix....953&highlight=



AVE1642 Clinical Findings Reported
The poster, "A phase I study of AVE1642, a humanized monoclonal antibody IGF-1R (insulin like growth factor 1 receptor) antagonist, in patients (pts) with advanced solid tumors (ST)" (abstract #3582), also was presented today. AVE1642 is a naked (unconjugated) antibody that was originally developed by ImmunoGen and was licensed to sanofi-aventis as part of a broader collaboration between the companies. AVE1642 works by blocking a pathway used by cancer cells to survive chemotherapy, and is intended for use with such agents. The compound is being evaluated by sanofi-aventis in combination with approved chemotherapy agents for the treatment of solid tumors and hematological malignancies in Phase I studies.
The findings presented today are from a Phase I trial that assesses AVE1642, dosed once every three weeks, in patients with solid tumors. In this study, AVE1642 is administered to patients as a single agent for the first treatment cycle, and then in combination with docetaxel (75 mg/m(2)) for all additional cycles. Increasing doses of AVE1642 are tested in new cohorts of patients to establish the dose to be evaluated in combination with an array of chemotherapy agents in upcoming solid tumor studies.
The presentation featured the results from the evaluation of three different dose levels - 3, 6, and 12 mg/kg - in cohorts of four patients each, and finds AVE1642 to be well tolerated both as a single agent and in combination with docetaxel across these doses. The authors note that a substantial and sustained biological effect is seen with AVE1642 at doses above 3 mg/kg, and select the 6 mg/kg dose, given every three weeks, for future evaluation of the compound for the treatment of solid tumors.
Encouraging evidence of anticancer activity was reported even though the study patients all had solid tumors that had failed to respond to previous treatments. Of particular note is a breast cancer patient who had previously been treated with taxanes and entered the study with skin metastases. She experienced a significant improvement in her metastases in response to treatment with docetaxel in combination with AVE1642.
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