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Pharmacyclics Reports Updated Clinical Results from its Phase IA Trial of its First in Human Btk-Inhibitor PCI-32765
Date:12/7/2010

>(3/11)Mantle Cell Lymphoma (MCL)9

3

4

1

178%

(7/9)

78%

(7/9)

75%

(3/4)Diffuse Large B Cell Lymphoma (DLBCL)72

1

429%

(2/7)

29%

(2/7)

17%

(1/6)Marginal / Malt41

1

1

125%

(1/4)

33%

(1/3)

33%

(1/3)Waldenstrom42

1

01

50%

(2/4)

67%

(2/3)

N/ATotal56

5

20**

11

10

6

2

45%

(25/56)**

52%

(25/48)**

49%

(17/35)*** Too Early Too Evaluate (TETE), are patients who are currently on study and have not had their tumor assessment. Not evaluable (NE) are patients who have not completed two cycles of treatment and/or had a least one tumor assessment done. Other abbreviations:  Complete response (CR); Partial response (PR); Stable disease (SD); Progressive disease (PD)

**2 additional evaluable patients had a nodal response with lymphocytosis and are excluded in the response categories listed in this ASH table above but were included in the totals from ASCO 2010 (far right column)

With longer-term follow-up of this Phase I trial, PCI-32765 continues to be well tolerated. As reported previously, only two patients of the enrolled 56 patients have experienced a dose limiting toxicity (DLT) on this trial (drug hypersensitivity and delay in dosing due to neutropenia for 7 days). The overall rate of grade >3 adverse events continues to be low, and significant hematologic toxicities have been uncommon (<5% incidence of grade >3 neutropenia or thrombocytopenia). No adverse events related to liver or renal function have been reported. To date, there appears to be no dose-toxicity relationship, and there is no evidence of cumulative toxicity in patients receiving treatment for >6 months. There have been only t
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SOURCE Pharmacyclics, Inc.
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