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Pharmacyclics Reports Fourth Quarter and Fiscal 2009 Financial Results
Date:9/17/2009

he process of arranging their EU trial program, including an initial Phase I and several different Phase II's.
  • PCI-34051, Pharmacyclics' HDAC 8 Inhibitor, is currently in preclinical studies, and is planned to be developed as a unique treatment modality for autoimmune disorders. The company is anticipating further results and to conclude its preclinical work by calendar year 2010.
  • PCI-0120, Motexafin Gadelinium (MGd) is currently tested in two NCI sponsored Phase II studies. Both have extended survival as their endpoint and both completed the patient enrollment. The aggregation of the study results are dependent upon the NCI. For its pediatric pontine glioma trial Pharmacyclics is expecting results in the first half of calendar 2010. The other Phase II study in which MGd was tested in patients with newly diagnosed glioblastoma in combination with temazolamide and radiation, Pharmacyclics is expecting survival results in calendar 2011.
  • PCI-27483, a potent small molecule inhibitor of coagulation Factor VIIa, is projected to begin a multicenter Phase I/II study before the end of calendar 2009 in patients with locally advanced pancreatic cancer with gemcitabine therapy. The company has recently received FDA clearance to move ahead with this trial.
  • PCI-32765, the company's BTK inhibitor, is currently in a Phase I trial in patients with relapsed or refractory surface immunoglobulin positive B-cell Non-Hodgkin's Lymphoma (including SLL/CLL). The trial design allows for six dosing cohorts. The enrollment is anticipated to be completed during Q2 of calendar 2010, with full trial results expected in the second half of calendar 2010. At this time, the Company does not believe that all six dosing cohorts will be necessary to conclude this Phase I study.
  • An IND has been filed in August for PCI-32765 with the Allergy and Immunology Division, to allow Pharmacyclics to start a healthy volunteers study in patie
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