SUNNYVALE, Calif., Oct. 15, 2012 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the international, randomized Phase III clinical trial (CLL3001) of ibrutinib (PCI-32765) in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a third $50 million milestone payment obligation from Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies, worldwide collaborator on ibrutinib in oncology and sponsor of this CLL3001 trial.
"This is our first Phase III study in which we use ibrutinib in a combination setting. Together with Janssen we are making good progress exploring ibrutinib's potential in a multitude of diseases and across different disease stages as a single agent and now in combination. Over time, we will continue to initiate further studies to complement a broad clinical development program for ibrutinib." said Bob Duggan, Chairman and CEO of Pharmacyclics. "We are pleased with our clinical progress and the cooperation with our partner. We look forward to providing a material update in December at the American Society of Hematology Annual Meeting."
Quarterly Financial Update and Conference Call
We are planning to release on November 5, 2012, our fiscal, first quarter financial results from quarter ending September 30, 2012. This financial release will also contain a summary of the abstracts accepted for presentation by the American Society of Hematology (ASH), which will be published on that day on the ASH website ( www.hematology.org). The clinical presentations during ASH's annual meeting, December 8-11, 2012 ( Atlanta, GA) will provide significant updates regarding our clinical studies of the efficacy and safety of ibrutinib (PCI-32765) in chronic lymphocytic leukemia, mantle cell lymphoma, multiple myeloma, diffuse large B-cell lymphoma and follicular lymphoma. The company will not hold a conference call on November 5 th but will instead hold a conference call following the ASH presentations in December.Trial Design (CLL3001) This is a randomized, multi-center, international Phase III, double blinded, placebo controlled trial of ibrutinib in combination with bendamustine and rituximab versus bendamustine and rituximab alone in relapsed/refractory CLL/SLL patients who received at least one line of prior systemic therapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival. The key secondary endpoints include overall response rate, overall survival and other measures of clinical benefit. This combination study conducted by Janssen plans to enroll 580 patients worldwide and may enable registration in this population.