Kosan Presents Preclinical Data at AACR Indicating Clinical Potential of KOS-1584, Next-Generation Epothilone Drug Candidate
Monday April 18, 2:20 pm ET
HAYWARD, Calif., April 18 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today presented at the 96th Annual Meeting of the American Association for Cancer Research (AACR) in Anaheim, CA, preclinical in vivo and in vitro data describing the properties of KOS-1584 (9,10-didehydroepothilone D), a second-generation epothilone. These data showed that KOS-1584 has distinctive properties compared to KOS-862, the Company's first-generation epothilone, and led Roche and Kosan to initiate clinical testing of KOS-1584 as a potential anticancer therapeutic. KOS-1584 is currently being evaluated in a Phase I dose-escalating clinical trial in patients with advanced malignancies.
In the presentation ("KOS-1584: A Rationally Designed Epothilone D Analog with Improved Potency and Pharmacokinetic Properties," Abstract # 2535), Kosan scientists described efforts to generate and evaluate novel analogs of KOS-862 (Epothilone D) with different pharmacokinetic properties, resulting in the selection of KOS-1584. The results of in vitro cytotoxicity testing demonstrated high potency for KOS-1584 against a variety of cancer cell lines and drug-resistant cancer cell lines. Data from in vivo tests in dogs, rats, and mice and early pharmacokinetics in humans showed high tissue distribution and a long half-life for KOS-1584.
"These preclinical results demonstrate that our second-generation epothilone has unique and desirable pharmacokinetic properties. As a result, we now have two complementary epothilone drug candidates in clinical trials," stated Daniel V. Santi, M.D., Ph.D., Kosan Chairman and Chief Executive Officer. "In December 2004, we entered KOS-1584 into a Phase I clinical trial to establish its maximum tolerated dose, pharmacokinetics, pharmacodynamics, safety, and potential clinical benefit, and expect preliminary results by year end 2005."
KOS-862 continues to be evaluated in Phase II monotherapy trials in breast and prostate cancer, as well as Phase Ib combination trials with Gemzar®, Paraplatin® and Herceptin®. Clinical data for KOS-862 will be presented at the 2005 annual meeting of the American Society of Clinical Oncology in May.
KOS-862 and KOS-1584 are polyketides that inhibit cancer cell growth in vitro by a mechanism similar to paclitaxel, and preclinical models have shown both compounds to be effective against paclitaxel-resistant tumors.
Under a global development and commercialization agreement between Kosan and Roche, Roche has the worldwide exclusive right to market and sell KOS-862 and epothilone analogs owned by or licensed to Kosan for the treatment of cancer; Kosan will co-develop and has the right to co-promote Kosan/Roche epothilone products in the U.S. for the treatment of cancer.
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 .
This press release contains "forward-looking" statements, including statements with respect to the further development and potential efficacy of KOS-862 and KOS-1584 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 and uncertainties related to the clinical advancement of KOS-862 and KOS-1584 and the costs of conducting clinical studies for these product candidates; Kosan's dependence on its collaborations with Roche for development of its product candidates; Kosan's dependence on its collaboration with Roche for most of its revenues; the possibility that Kosan may require more cash than anticipated for its operating activities; and other risks detailed from time to time in the Company's SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2004, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements. |
