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Pharmacyclics, Inc. Reports Interim Safety and Clinical Data from a Phase I/II Clinical Trial of its Oral HDAC Inhibitor PCI-24781 in Lymphoma at the American Society of Hematology Annual Meeting
Date:12/6/2009

NEW ORLEANS and SUNNYVALE, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim results from a Phase I/II study showing safety and clinical activity in patients with relapsed / recurrent non-Hodgkin's Lymphoma (NHL) treated with its HDAC inhibitor PCI-24781 as a single agent. The data were presented today at the 51st ASH Annual Meeting being held in New Orleans, LA (Abstract # 2726).

PCI-24781 is an oral pan-HDAC inhibitor which is currently in multiple clinical trials for solid and hematological malignancies (PCYC-0401 single center, solid tumor cancer patients IV administered drug; PCYC-0402 multi-center, solid cancer patients orally administered; PCYC-0403 multicenter, lymphoma cancer patients orally administered). This compound, which has been optimized for the best combination of potency and pharmacokinetics (PK), has potent anti-tumor activity in a variety of preclinical tumor models (Buggy et al Mol Cancer Ther 5:1309-1317, 2006) and has also demonstrated safety and clinical benefit in human solid tumors (Undevia et al, ASCO 2008).

In a review of the clinical data at the end of the Phase I dose-escalation portion of the current lymphoma trial, it was revealed that PCI-24781 has shown strong signs of efficacy with minimal toxicity as a single agent in lymphoma, with 1 Complete Response (follicular lymphoma), 4 Partial Responses (2 follicular lymphoma, 1 diffuse large B-cell lymphoma, 1 mantle cell lymphoma) and 6 Stable Disease in 16 patients evaluated for response (after 2 cycles). Partial Response is defined as a 50% reduction in tumor size. The Overall Response Rate (Partial and Complete Response) has been 31%, with responses being observed in each of the four cohorts. Of 4 follicular lymphoma patients evaluated in this trial, 3 had objective response
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