Kosan Initiates Phase I Clinical Trial of Second-Generation Hsp90 Inhibitor KOS-1022 in Hematologic Cancers
Monday June 6, 7:30 am ET
Company Also Announces Grant of U.S. Patent Covering KOS-1022
HAYWARD, Calif., June 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) announced today that it has initiated a company-sponsored multicenter Phase I clinical trial of KOS-1022 (DMAG) in patients with advanced hematologic malignancies. The Company also announced that the U.S. Patent & Trademark Office has granted patent No. 6,890,917 B2, entitled "Geldanamycin Derivative and Method of Treating Cancer Using Same," covering the KOS-1022 composition of matter and its use for treating a range of cancers. The Company is the exclusive licensee of the patent in these fields and others. KOS-1022 is a second-generation Hsp90 inhibitor that is highly potent and water soluble, with good bioavailability.
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"The rationale for testing KOS-1022 in these hematologic cancers is particularly compelling. Preclinical data have demonstrated that KOS-1022 reduces the levels of several client proteins, such as Flt3, Akt, and Bcr-Abl, which may be important targets in leukemias," stated Daniel V. Santi, M.D., Ph.D., Kosan Chairman and Chief Executive Officer. "This Kosan-sponsored trial expands the clinical development program for KOS-1022, which is currently in Phase I testing through our collaboration with the National Cancer Institute. We are also pleased by the grant of this patent, which will accord us important intellectual property protections as we continue our work in this area."
The Phase I clinical trial will assess the safety, pharmacokinetics and pharmacodynamics of escalating doses of KOS-1022 in patients with acute myelogenous leukemia, acute lymphocytic leukemia, or chronic myelogenous leukemia. According to the Phase I trial design, KOS-1022 will be given by one-hour infusion on a twice-weekly schedule every three weeks. In addition, the pharmacodynamics of KOS-1022 in leukemic blast cells will be investigated in order to determine the biological activity of KOS-1022 against client proteins critical to the progression of leukemia. The clinical trial will be conducted at leading cancer centers in the United States.
In addition to the Phase I study announced today, KOS-1022 is being evaluated in Phase I clinical trials in advanced solid tumors 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, a first-generation Hsp90 inhibitor, as well as KOS-953, Kosan's proprietary formulation of 17-AAG, are also currently being investigated in multiple Phase II single-agent and Phase Ib combination clinical trials in a variety of tumor types. In 2004, Kosan obtained orphan drug designation for 17-AAG from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of multiple myeloma and chronic myelogenous leukemia.
About Hsp90 Inhibitors
KOS-1022, 17-AAG, and KOS-953 inhibit Hsp90 (heat shock protein 90), a protein found in high levels in tumor cells. Hsp90 is a protein "chaperone" that maintains the stability of numerous "client proteins" implicated in tumor growth and metastasis, including protein kinases and transcription factors. By blocking the activity of Hsp90, Kosan's geldanamycin analogs disrupt the Hsp90-client protein complexes, leading to the degradation of the client proteins. By targeting multiple growth-signaling pathways involved in cancer, these compounds may have potential use in a variety of tumor types, both as single agents and in combination with other signal transduction inhibitors and cytotoxic drugs.
About Kosan
Kosan Biosciences has two first-in-class anticancer agents in Phase II and Phase Ib clinical trials: KOS-862 (Epothilone D) and 17-AAG, a geldanamycin analog and Hsp90 inhibitor. KOS-862, the Company's lead drug candidate, has a mechanism of action similar to taxanes and is partnered with Roche in a global development and commercialization agreement, along with a follow-on compound, KOS-1584, currently in Phase I testing. 17-AAG targets multiple pathways required for tumor growth and is being developed in collaboration with the National Cancer Institute, in addition to a second-generation geldanamycin analog, KOS-1022 (DMAG), now in Phase I trials. Kosan's proprietary formulation of 17-AAG, KOS-953, is in Phase I and Phase Ib trials. Kosan has generated a pipeline of potentially significant products for cancer, infectious disease and other therapeutic areas based on its proprietary technologies for discovering, developing and manufacturing polyketide analogs. Polyketides are an important class of natural products that have yielded numerous pharmaceuticals for the treatment of cancer, infectious diseases, high cholesterol, transplant rejection and other diseases. For additional information on Kosan Biosciences, please visit the Company's website at kosan.com . |
