NEWS & COMMENTS

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MEMORY PHARMACEUTICALS (MEMY): The FDA lifted its hold on clinical trials of the company's MEM3454 Alzheimer's drug candidate, following a review of the firm’s investigational new drug application. Memory plans to begin its mid-stage clinical trial for the drug in Alzheimer's disease during the first quarter of 2007.

The story: In October, the FDA requested more information on revisions that were made to toxicology reports filed with the initial new drug application. The FDA concerns revolved around manufacturing process and potential impurities in the drug. The start of mid-phase trials  were delayed.

This is good news.

KOSAN BIOSCIENCES (KOSN): Phase 1 trials of the firm’s second generation Hsp90 inhibitor, alvespimycin HCl (KOS-1022) have demonstrated encouraging signs of anti-leukemia activity in a highly refractory patient population and tolerable toxicity.

The data were presented in a poster session on Sunday, December 10, 2006, at the American Society of Hematology (ASH) 48th Annual Meeting and Exposition, held in Orlando, Florida. Data were presented by Jeffrey Lancet, M.D., H. Lee Moffitt Cancer Center, Tampa, FL in a presentation entitled, "Phase 1, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Intravenous Alvespimycin (KOS-1022) in Patients with Refractory Hematological Malignancies."

Some insight

From the Company

A Broad Therapeutic Potential: "Alvespimycin's ability to induce clinical responses in AML patients with highly refractory disease and the compound's tolerability suggests broad therapeutic potential," said Dr. Lancet. "We strongly support continued development of alvespimycin in an expanded clinical setting." Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer said that the firm plans  to explore the full potential of this exciting and promising compound in later-stage trials in a variety of tumor types.

The Drug

      Hsp90 inhibitors are a new class of compounds that work through a novel mechanism of action. Hsp90 is a protein chaperone that binds to several sets of 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, Raf, ErbB2 and other kinases, as well as steroid hormone receptors. Disruption of the Hsp90-client protein complexes leads to proteasome-mediated degradation of client proteins and cell death. Alvespimycin is a second-generation Hsp90 inhibitor that has enhanced pharmaceutical properties compared to Kosan's first-generation Hsp90 inhibitor. It is three-to-five times more potent and has a half-life of about 30 hours, allowing for less frequent dosing. Alvespimycin is orally bioavailable, making oral dosing possible. It is water soluble and can easily be formulated in both an intravenous and oral forms.

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