And speaking of both Fast Track and MLNM:
Wednesday June 5, 8:45 am Eastern Time
Press Release
SOURCE: Millenium Pharmaceuticals, Inc.
FDA Grants Millennium's MLN341 and MLN518 Fast Track Status
Phase II Multiple Myeloma and Phase I Acute Myeloid Leukemia (AML) Studies are Designed to Evaluate Patients With Unmet Medical Needs
CAMBRIDGE, Mass., June 5 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Food and Drug Administration (FDA) has granted two of Millennium's investigational cancer therapies, MLN341 (formerly known as LDP341 and PS341) and MLN518 (formerly known as CT53518) fast track designation. MLN341 is currently in Phase II clinical trials for the treatment of relapsed and refractory multiple myeloma, and MLN518 is currently in Phase I clinical trials for the treatment of acute myeloid leukemia (AML).
"We are pleased that the FDA has recognized the critical situation shared by those who suffer from multiple myeloma as well as AML," said John Maraganore, senior vice president, strategic product development at Millennium Pharmaceuticals. "Relapsed and refractory multiple myeloma remains one of the deadliest forms of cancer and is generally considered incurable. AML is an equally serious disease with an often-fatal outcome. Millennium remains committed to help alleviate the unmet needs of patients with potential new treatment options for both of these forms of cancer."
Under the FDA Modernization Act of 1997, designation as a fast track product indicates that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition. Specifically, this allows for the FDA to accept on a rolling basis portions of a marketing application for review prior to the completion of a final document.
MLN341 is designed to specifically inhibit the proteasome, which is an enzyme complex in the cell responsible for breaking down a variety of proteins, including many that regulate cell division. Laboratory studies suggest that by inhibiting the proteasome, MLN341 in cancer cells disrupted regulating proteins and ultimately induced apoptosis (programmed cell death). MLN341 is currently the only proteasome inhibitor in clinical trials for oncology indications.
MLN518 is a novel, small molecule specifically designed to inhibit the Flt-3 receptor tyrosine kinase (RTK). Approximately 30 percent of AML patients have a mutation in their Flt-3 gene, called internal tandem duplication (ITD), which may be implicated in the growth and survival of this leukemia. In preclinical studies, MLN518 selectively killed human Flt-3/ITD-positive AML leukemia cells.
For more information about MLN341 or MLN518 clinical trials, patients and physicians can contact Millennium's Medical Information Center at (800) 589-9005.
About Multiple Myeloma
Multiple myeloma is a cancer of the blood in which white blood cells called plasma cells, normally responsible for the production of antibodies (proteins that fight infection and disease), are overproduced in the bone marrow -- the tissue inside the bone that manufactures all blood cells. The proliferation of these abnormal plasma cells, known as myeloma cells, causes decreased production of normal red and white blood cells, and of normal disease-fighting antibodies, as well as the growth of tumors that spread to "multiple" sites -- hence the term multiple myeloma. The decreased white blood cell production damages the immune system while the myeloma tumors cause bone destruction that manifests as pain and fractures.
Multiple myeloma is the second most common cancer of the blood and although the disease is predominantly a cancer of the elderly (the peak age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. About 11,200 Americans (5,800 men and 5,400 women) are expected to die of multiple myeloma this year. The disease is about twice as common in males as females. Among African Americans, multiple myeloma is one of the top 10 leading causes of cancer death.
About Acute Myeloid Leukemia (AML)
Leukemia is a cancer of the blood that is characterized by the uncontrolled growth of developing cells in the bone marrow -- the tissue inside the bone that manufactures all blood cells. Acute myeloid leukemia (also known as acute myelogenous leukemia) is a rapidly progressing disease that results in the accumulation of immature cells in the marrow and blood. The proliferation of these abnormal cells causes decreased production of normal red and white blood cells, and of normal disease-fighting antibodies.
According to the American Cancer Society, AML represents 90% of all adult acute leukemias, with an estimated 10,600 new cases annually in the United States. The overall five-year survival rate for AML is 14%, and approximately 7,400 Americans are expected to die from AML this year. AML is usually treated by a combination of cytotoxic drug therapies and in some cases, bone marrow transplantation.
Millennium's Oncology Franchise
Millennium is committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds in addition to MLN341 and MLN518, MLN591, an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer and MLN576 (XR11576), a small molecule with DNA-targeting activity in phase I trials for solid tumors. The Campath® (alemtuzumab) monoclonal antibody, a therapeutic developed from a former joint venture of Millennium and ILEX Oncology, Inc., is commercially available in both the United States and a number of European countries. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin®, a melastatin detection product for melanoma developed through our predictive medicine efforts.
Maybe this will provide a lift today.
On another topic, an interesting release from VPHM that indicates that Picovir might not be dead after all... (in which case the stock is a screaming bargain).
Peter |
