Molecular Insight (MIPI) Said Azedra Study Demonstrates Positive Safety Profile and Durable Objective Tumor Responses

October 5, 2009 9:12 AM EDT

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) reported one-year follow-up data from a Phase I dose-escalation clinical study of Azedra(TM) demonstrating a positive safety profile and durable objective tumor responses in patients with neuroendocrine cancers, pheochromocytoma and paraganglioma.

The study was designed to evaluate the safety and identify the maximum tolerated dose (MTD) of Azedra, as well as to collect clinical data on efficacy. These data were presented on October 2, 2009, at the North American Neuroendocrine Tumor Society (NANETS) 2009 Neuroendocrine Tumor Symposium in Charlotte, North Carolina. Azedra (Ultratrace� iobenguane I 131) is Molecular Insight's lead oncology targeted radiotherapeutic using the Company's proprietary radiolabeling technology platform.

In 12-month data reported today, a single dose of Azedra was shown to be well tolerated by patients, and toxicities were predictable and manageable. Additionally, Azedra demonstrated clinical benefit, stabilizing or reducing tumor volumes in a majority of patients. Twenty-one patients were treated at escalating dose levels from 6 to 9 mCi/kg. Objective tumor response according to Response Criteria in Solid Tumors (RECIST) was obtained every three months. Best confirmed overall response per RECIST was partial response (PR) for three patients (14%), stable disease for 14 (67%), progressive disease for two (10%), and not evaluable for two (10%) who had no follow-up scans. All three patients with PR demonstrated this response at the first post-therapy visit at three months and sustained the response through 12 months.

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