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Pharmacyclics Identifies Functional Biomarkers for its Novel HDAC,Inhibitor and Demonstrates Preclinical Anti-Tumor Activity with,Bruton's Tyrosine Kinase Inhibitors

SUNNYVALE, Calif. and LOS ANGELES, April 18, 2007 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. today announced data from two preclinical studies, one identifying a functional biomarker for its novel histone deacetylase (HDAC) inhibitor and another demonstrating preclinical anti-tumor activity with its Bruton's tyrosine kinase (BTK) inhibitor compounds. The data were presented at the American Association for Cancer Research (AACR) 2007 Annual Meeting being held this week in Los Angeles.

Results of an in vitro study (Abstract #1966) demonstrate that Pharmacyclics' HDAC inhibitor, PCI-24781 inhibits homologous recombination, a cellular mechanism of DNA repair, by both down-regulating RAD51 gene expression, and by affecting the ability of the cell to form RAD51 foci at the site of the lesion. The RAD51 gene provides instructions for making a protein that is essential for the repair of damaged DNA. These data suggest that PCI- 24781 could be used successfully in combination with other cancer therapies that generate lesions repaired by homologous recombination, such as gamma- irradiation, cisplatin, and oxaliplatin, and show the usefulness of using RAD51, an enzyme, as a biomarker to predict clinical efficacy. Researchers observed that PCI-24781-treated cells are more sensitive to DNA damaging cancer agents, suggesting that it may act in part by inhibiting DNA repair. PCI-24781 is currently in Phase 1 clinical trials evaluating its safety and effectiveness in both solid and hematological malignancies.

"Not only have we further elucidated the mechanism by which our HDAC inhibitor may kill cancer cells, we have also identified a biomarker that may predict its efficacy in cancer patients," stated Richard A. Miller, M.D., president and CEO of Pharmacyclics. "We have filed patents based on this new information, and are moving this promising compound forward in clinical trials incorporating use of this bioma
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