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

ign safety profile in line with our oral presentation at ASCO. As of August 31, 2010 we have completed enrollment of an additional cohort of 10 patients using a fixed, continuous dosing of 560 mg daily. Additionally, the National Cancer Institute (NCI) has dosed the first of 10 pre-typed ABC DLBCL patients. The company has submitted an abstract to the 2010 ASH annual meeting that describes the responses and the duration in all of the CLL/SLL patients dosed to date and we cannot disclose any information contained in the abstract prior to the meeting held in December.
  • Over the last 3 months the company held multiple advisory boards in the US and EU with experts in the field of lymphoma and CLL to obtain feedback to our clinical development plan. We now announce that the company is planning multiple Phase II trials in select B-cell derived malignancies (Mantle Cell in Velcade failure and Velcade naive patients, DLBCL in R-CHOP and transplant failures and CLL combination-safety trials with Bendamustine-Rituxan and Ofatumumab and other investigator initiated trials). Timelines for reportable events and regulatory interactions from these planned Phase II trials will be communicated after the ASH meeting in December.
  • A second Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-45292, is being developed for autoimmune disease; we are on track to complete IND-enabling preclinical safety studies. The company is planning to file an IND by the end of the second quarter of calendar 2011 with this molecule.
  • Factor VIIa Inhibitor, PCI-27483, is a potent and highly selective small molecule inhibitor of coagulation Factor VIIa.  Factor VIIa is best known for its role in triggering the extrinsic pathway of blood coagulation following contact and complex formation with the cell surface glycoprotein Tissue Factor.  Tissue Factor is over-expressed in pancreatic, gastric, lung, breast, colon and many other cancers of epithelial origin. FVIIa In
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