Orphan Drug Designation Granted to Kosan's 17-AAG for the Treatment of Chronic Myelogenous Leukemia (CML)
Tuesday October 26, 7:30 am ET
HAYWARD, Calif., Oct. 26 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today announced that the U.S. Food and Drug Administration has granted its anticancer compound 17-allylamino-17-demethoxy- geldanamycin, or 17-AAG, an analog of the polyketide geldanamycin, orphan drug status for the treatment of Chronic Myelogenous Leukemia (CML). 17-AAG is being evaluated for the treatment of multiple cancer indications in Phase II, Phase I, and Phase Ib clinical trials, including a Phase Ib trial with Gleevec(TM) as a combination therapy in CML. These trials are being conducted in collaboration with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) between Kosan and the NCI Cancer Therapy Evaluation Program (CTEP).
"This is the second orphan drug designation granted in the U.S. to Kosan and the NCI, and is a significant achievement for the collaborative geldanamycin analog clinical program," said Robert G. Johnson, Jr., M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer, Kosan Biosciences. "This designation strengthens Kosan's position in this highly visible area of clinical development and can afford important marketing advantages to Kosan in the future."
17-AAG inhibits Hsp90 (heat shock protein 90), a protein chaperone that binds to signaling proteins, known as "client proteins." These client proteins include a "who's who" list of cancer-relevant targets such as mutated p53, Bcr-Abl, Her2, Akt, Raf-1, B-Raf, and others. When 17-AAG binds to Hsp90, it disrupts the Hsp90-client protein complexes, leading to degradation of the client proteins.
Chronic myelogenous leukemia, or CML, often referred to as chronic myeloid leukemia is a cancer of the blood system in which too many white blood cells (WBCs) are produced in the bone marrow. CML has three distinct phases. The chronic phase can be insidious in onset and last several years. This is followed by an accelerated phase, accompanied by a more rapid growth rate of the malignant WBCs. Finally, CML patients enter into a "blast crisis" stage associated with a rapid rate of cell growth and a survival of only a few months on average. The American Cancer Society estimates that 4,300 new cases of chronic myelogenous leukemia will be diagnosed this year in the United States. CML usually occurs in people in their 40s and beyond, although it can occur in younger patients.
About Orphan Drug Designation
Orphan drug designation is granted by the U.S. Food and Drug Administration to products that treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation provides eligibility for a special seven-year period of market exclusivity after marketing approval, potential tax credits for research, grant funding for research and development, possibly reduced filing fees for marketing applications, and assistance with the review of clinical trial protocols.
About Kosan
Kosan Biosciences has two first-in-class anticancer agents in Phase II clinical trials. KOS-862 (Epothilone D) is in Phase II and Phase Ib clinical trials and is partnered with Roche in a global development and commercialization agreement. 17-AAG, Kosan's lead geldanamycin analog, is in Phase II and Phase Ib clinical trials, and DMAG, its second-generation geldanamycin analog, is in Phase I. Both compounds are being developed in collaboration with the National Cancer Institute. Kosan's proprietary formulation of 17-AAG, designated KOS-953, is in Phase I. 17-AAG and DMAG are polyketide inhibitors of Hsp90 and interrupt several biological processes implicated in cancer cell growth and survival. Kosan's focus is on an important class of natural products known as polyketides. Polyketides are a class of natural products that have yielded numerous important pharmaceuticals for the treatment of cancer, infectious diseases, high cholesterol, transplant rejection and other diseases. Kosan applies its expertise and proprietary technologies to generate polyketide analogs and increase the production yields of polyketides, resulting in a robust pipeline of potentially significant products for cancer, as well as for infectious disease and other therapeutic areas. For additional information on Kosan Biosciences, please visit the Company's website at www.kosan.com. |
