Molecular Insight Pharmaceuticals, Inc. Receives European Medicines Agency Approval To Proceed With Phase 3 Development Of OnaltaTM

Main Category: Pancreatic Cancer
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 15 May 2009 - 0:00 PDT

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Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced that the European Medicines Agency (EMEA) has approved its Phase 3 protocol for Onalta (Yttrium-90 edotreotide). Onalta is the Company's lead radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. The proposed Phase 3 trial will confirm that administration of Onalta results in stabilization, regression or complete remission of the carcinoid tumor, and improves carcinoid-related symptoms when compared to a high-dose regimen of the current standard therapy for this disease, Sandostatin®. With EMEA's approval of its proposed Phase 3 protocol in hand, Molecular Insight can proceed with the final clinical trial that will position Onalta for marketing authorization in the EU.

EMEA notified Molecular Insight that its Onalta Phase 3 protocol is acceptable, including the plan to assess and manage renal tolerance, that the endpoints and measures are appropriate, and that the number of patients proposed to be presented in support of safety for the future Marketing Authorization Application (MAA) is acceptable.

John W. Babich, Ph.D., Executive Vice President, Chief Scientific Officer and President of Research and Development of Molecular Insight, said that, "This is a significant Company milestone that allows us to proceed with a pivotal trial for Onalta in Europe. A successful trial would mean an innovative and well-understood therapy could be made available to thousands of patients whose lives are being cut short and who suffer from the debilitating symptoms that accompany this disease.

"The notification by EMEA comes on the heels of our Special Protocol Assessment (SPA) agreement with FDA allowing us to proceed to a pivotal phase 2 trial for Azedra™ Ultratrace™ (Iobenguane I-131) in another neuroendocrine cancer, pheochromocytoma. Azedra is also currently being evaluated for treatment of neuroblastoma. These drug candidates represent significant opportunities to provide neuroendocrine cancer patients with innovative therapies. Molecular Insight has selected Progression Free Survival (PFS) as the primary endpoint for the proposed Phase 3 study and overall survival will be assessed as a key secondary endpoint. The regulatory progress in Europe will hopefully be followed by regulatory progress in the USA."

According to Dr. Val Lewington, Consultant Physician, Royal Mardsen NHS Foundation Trust, "EMEA approval of this Phase 3 protocol represents a landmark in radionuclide therapy. The potential of this approach is well-recognized in Europe but this will be the first opportunity to evaluate this peptide-based radiotherapy in a major, multi-center, randomized clinical trial. It is difficult to overstate the importance of this step in the development of innovative therapies for inoperable neuroendocrine tumors which so often prove refractory to other treatment options. News of the EMEA decision will be welcomed enthusiastically both by clinicians and by patients with neuroendocrine disease."

The proposed Phase 3 protocol will evaluate 194 patients with metastatic, progressive, somatostatin receptor-positive, carcinoid cancer, receiving either Onalta or the standard of care. Carcinoid cancer is a rare, serious and life-threatening condition that affects a group of patients with few treatment options. Once the disease has metastasized, the patients' prognosis is poor: the best five-year survival rate is reported to be 20 - 30 percent.

Onalta is intended to complement Azedra™, Molecular Insight's other clinical stage radiotherapeutic candidate for the treatment of neuroendocrine tumors. In 2007, Molecular Insight acquired Onalta from Novartis Pharma AG, which had conducted three Phase 1 and three Phase 2 clinical trials involving more than 300 patients.

About Onalta

Molecular Insight has been developing Onalta as a treatment for metastatic pancreatic neuroendocrine and carcinoid tumors in patients whose symptoms are not controlled by current somatostatin analogue therapy. Neuroendocrine tumors are a type of cancer that arises from neuroendocrine cells and can occur in different parts of the body. A somatostatin analogue is a synthetic compound, in this case a peptide, which functions in the body in a manner similar to the hormone somatostatin, which regulates a variety of other metabolic hormonal functions. Onalta binds selectively to tumor cells that have receptors for the peptide hormone somatostatin on their surface and serves as a carrier for targeted delivery of a lethal dose of radiation to the cancer cells through the radioactive decay of yttrium-90. The compound has been used to treat patients in Europe on an investigative basis for more than 10 years. There are no approved treatments in the U.S. for metastatic neuroendocrine tumors.

Source
Molecular Insight Pharmaceuticals, Inc.