Millennium Announces FDA Selection of MLN2704 for Continuous Marketing Application Pilot 2 Program
Wednesday March 17, 7:59 am ET
Innovative Program Designed To Facilitate Scientific Exchange, Speed Review Time
# CAMBRIDGE, Mass., March 17 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the U.S. Food and Drug Administration (FDA) has selected the Company's investigational cancer therapy MLN2704 for inclusion in the Continuous Marketing Application (CMA) Pilot 2 Program. Participation in the Pilot 2 Program is limited to no more than one fast track product for each review division within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). MLN2704 is the product selected for participation by CDER's Division of Oncology Drug Products.
MLN2704 is currently being evaluated in a phase I/II multiple ascending dose clinical trial at Memorial Sloan-Kettering Cancer Center and New York-Presbyterian Hospital/Weill Cornell Medical Center for the treatment of patients with metastatic androgen-independent prostate cancer. In December 2003, the FDA granted MLN2704 fast track designation.
"We are honored to have MLN2704 selected for this innovative program and are looking forward to continuing our highly productive relationship with the FDA through increased interaction and discussions regarding this development program," said Robert Pietrusko, Pharm.D., senior vice president of worldwide regulatory affairs and pharmacovigilance, Millennium. "Our participation with MLN2704 in the Pilot 2 Program may further speed and clarify the regulatory path for this important molecule, and in turn, could help bring a much-needed treatment option to patients suffering from this advanced form of prostate cancer."
MLN2704 is an immunoconjugate consisting of the chemotherapeutic agent DM1 linked to the monoclonal antibody MLN591 targeted at PSMA. MLN2704 binds to the external portion of PSMA, is rapidly internalized, delivering a lethal dose of the chemotherapy DM1 directly to prostate cancer cells. DM1 inhibits microtubule formation, disrupting cell division and other cellular survival processes.
Unlike the enzyme PSA, which circulates in the blood, PSMA is a protein expressed on the cell surface of virtually all prostate cancer cells and its abundance on the cell surface increases as the disease progresses and becomes refractory to hormonal therapy. Selective expression of PSMA to cancer cells minimizes exposure of normal cells to drug and thus, PSMA appears to be an ideal target for an antibody-based therapeutic for prostate cancer
Robust preclinical models have indicated significant activity for MLN2704 in human prostate xenograft models. MLN2704 is currently being investigated in a Phase I/II clinical trial in prostate cancer patients.
For more information about MLN2704 clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at (800) 589-9005.
About the CMA Pilot 2 Program
Building on the current practice of interaction between the FDA and applicants, the CMA Pilot 2 program is intended to evaluate the costs and benefits of enhanced sponsor access to guidance and feedback from the FDA during the Investigational New Drug (IND) phase of new drug development of Fast Track products and determine whether such activity can improve the efficiency of the drug development and review process. Once selected, participants and FDA enter into an agreement to engage in frequent scientific feedback and interactions during the IND phase of product development. An independent expert consultant under contract with the FDA will assess the value of the program.
According to the FDA, selection of drugs or biologics for participation was based on the FDA's overall assessment of the potential value of enhanced interaction, emphasizing the potential public health benefit resulting from the development of the product; the likelihood that the concentrated scientific dialogue will facilitate the availability of a promising novel therapy; and the applicant's demonstration of commitment to product development. For more information on CMA Pilot 2, visit fda.gov. |
