Kosan's New 17-AAG Formulation Enters Clinic
Wednesday July 14, 7:30 am ET
Phase I Trial at Dana Farber Cancer Institute to Evaluate KOS-953 in Multiple Myeloma
HAYWARD, Calif., July 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) announced today that it had initiated a company- sponsored Phase I clinical trial to investigate 17-allylamino-17-demethoxy- geldanamycin (17-AAG; designated KOS-953) in patients with relapsed and relapsed, refractory multiple myeloma. Dr. Paul Richardson, Clinical Director of The Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School, is the principal investigator. The Phase I clinical trial will evaluate the new formulation and establish the safety, pharmacokinetics and pharmacodynamics of escalating doses of KOS-953 in patients with previously treated advanced multiple myeloma. KOS-953 will be administered on a twice-weekly schedule every three weeks at the Dana Farber Cancer Institute and two other institutions, Roswell Park Cancer Institute, Buffalo, NY and Moffitt Cancer Center in Tampa, FL. This particular trial in multiple myeloma will use a variety of pharmacodynamic measurements of myeloma and peripheral blood cells to assess the biological activity of 17-AAG against client proteins considered critical in the progression of the disease. The formulation of 17-AAG developed by Kosan replaces the DMSO-egg lecithin vehicle in the original drug product with the aim to improve patient tolerability and provide greater stability.
"We are particularly enthusiastic about this study because 17-AAG is effective at inhibiting growth of multiple myeloma cells in culture and is curative as a single agent in animal models of the disease," said Dr. Kenneth Anderson, Director, Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute and Kraft Family Professor of Medicine, Harvard Medical School. "In addition, 17-AAG and bortezomib, a proteasome inhibitor and effective multiple myeloma drug, are remarkably synergistic in our cell- culture experiments."
Once an optimal dose has been established in this patient population, Kosan expects to initiate a Phase II trial at leading multiple myeloma centers to assess the efficacy of single-agent KOS-953, as well as a co-administration Phase Ib study using KOS-953 in combination with bortezomib, (Velcade(TM)) a recently approved agent to treat refractory myeloma.
The original formulation of 17-AAG is being evaluated in multiple ongoing Phase I and Phase Ib clinical trials sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) between Kosan and the NCI Cancer Therapy Evaluation Program (CTEP).
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, and others. When 17-AAG binds to Hsp90, it disrupts the Hsp90-client protein complexes, leading to their degradation.
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About Kosan
Kosan Biosciences has two lead product candidates: KOS-862 and 17-AAG, including its proprietary formulation of 17-AAG, designated KOS-953. Both compounds are derived from an important class of natural products known as polyketides. KOS-862 is in Phase II and Phase Ib clinical trials and is partnered with Roche in a global development and commercialization agreement. 17-AAG is being evaluated in multiple Phase I and Phase Ib clinical trials in collaboration with the National Cancer Institute. Kosan initiated a Phase I clinical trial of KOS-953 in July 2004. KOS-953 and 17-AAG are polyketide inhibitors of Hsp90 and interrupt several biological processes implicated in cancer cell growth and survival. By applying its expertise and proprietary technologies to generate polyketide analogs and by increasing the production yields of polyketides, Kosan has created 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.
This press release contains "forward-looking" statements, including statements relating to the potential efficacy and ongoing and further development of 17-AAG and KOS-953 in the treatment of cancer. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks related to the clinical advancement of geldanamycin analogs and other risks detailed from time to time in the Company's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, as amended, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements. |
