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Pharmacyclics Reports Financial Results for Fiscal 2010 and for Fourth Quarter 2010
Date:9/13/2010

hibitor, PCI-27483, is currently being evaluated in a multicenter Phase I/II randomized study in patients with locally advanced or metastatic pancreatic cancer. As planned, we have completed the Phase I portion of this Phase I/II trial and have successfully advanced to Phase II. In the Phase II portion of this study each pancreatic cancer patient will receive a maximum of 12 weeks of treatment with gemcitabine alone or gemcitabine plus PCI-27483. As of to date we have dosed 11 pancreatic cancer patients and the study continues enrolling in the randomized Phase II segment of the trial. We anticipate completing enrollment of 46 patients in the second half of 2011.
  • Histone deacetylase (HDAC) Inhibitor, PCI-24781, is the company's orally-bioavailable HDAC Inhibitor that disrupts DNA repair and contributes to tumor cell death. In 3 Phase I clinical trials, conducted in patients with hematologic or solid tumors, clinical response or control of tumor growth has been observed following single-agent therapy with our HDAC Inhibitor. Pharmacyclics' HDAC Inhibitor has demonstrated a good safety profile in approximately 90 patients treated so far; the main dose-limiting toxicity was a rapidly reversible thrombocytopenia, which we believe is related to the pharmacologic mechanism of action. The magnitude of thrombocytopenia can be attenuated by modification of the treatment schedule. The Phase II portion of our ongoing trial is continuing in patients with follicular and mantle cell lymphoma.  Results are anticipated in the second half of 2011. To date we have enrolled 7 follicular and 3 mantle cell patients; so far in this study 1 patient had a partial response and 4 patients have reported stable disease after 2 cycles.
  • The HDAC Inhibitor PCI-24781 has also shown synergy in preclinical testing with several approved cancer therapeutics. A Phase I/II trial in sarcoma patients is ongoing and is co-sponsored by prominent investigators at Massachuse
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