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

hed that starting with cohort 2, PCI-32765 fully occupied the target kinase. Examining response in fully occupied dose cohorts the response rate ("RR") was 56% in the evaluable patient population and 48% in the ITT patient population. Including disease control in the form of stable disease in our assessment of evaluable patients, the disease control rate was 78% (10% CRs, 41% PRs and 27% SDs). Of note, the median tumor reduction from base line in our objective responding patients was 75% as of August 31, 2010.  
  • As of August 31, 2010, 23 patients continue to remain on study. This compares with 25 patients on study as of the ASCO presentation on June 4, 2010.  Median duration of response has not yet been determined in this ongoing study. The company has submitted an abstract describing the duration of response to the American Society of Hematology (ASH) in Orlando, FL on December 4-7, 2010; consistent with ASH's guidelines, we will not be disclosing these data prior to our ASH presentation.
  • PCI-32765 appears to be well tolerated through the initial exposure even in its highest dosing cohort (including 12.5 mg/kg). Only 2 patients of the enrolled 47 patients have experienced a dose limiting toxicity (DLT) on this trial (drug hypersensitivity and delay in dosing due to neutropenia for 7 days). No other DLTs have been observed. Thirteen of the 47 patients had 1 or more serious adverse events, but only 2 were considered drug related by investigators.
  • As previously announced we have initiated a Phase Ib trial in CLL/SLL patients studying 2 populations. One population is relapsed or refractory patients at 420 mg (24 patients with fixed dosing). The second population is elderly naive patients at 420 mg (12 patients with fixed dosing). Enrollment commenced end of May and as of to date we have dosed 30 patients (22/24 in the 420 mg relapsed or refractory dosed arm and 8/12 elderly naive patients). Amongst all patients dosed we maintain a ben
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