SUNNYVALE, Calif., Aug. 1, 2012 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the international Phase III randomized, multicenter, open-label clinical trial, RESONATE™ (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) initiated by Pharmacyclics has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a $50 million milestone payment obligation from Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson and the worldwide collaborator on ibrutinib in oncology. As Pharmacyclics or Janssen initiate further Phase III trials in specific indications and enroll the 5th patient, additional milestone payments of $50 million may be triggered up to a total of $250 million. We anticipate an additional Phase III trial milestone payment during calendar 2012.
"This is the first Phase III trial of a broad development plan to evaluate the potential of ibrutinib in a range of hematologic malignancies," said Bob Duggan, Chairman and CEO of Pharmacyclics. "We are very excited to have moved this molecule in such short time from first patient dosed in the spring of 2009 to now a pivotal Phase III clinical trial. The initiation of this first Phase III trial with ibrutinib is a testament to the hard work and focused efforts of the entire Pharmacyclics team, our external collaborators and the support and cooperation we enjoy with our partner Janssen. We look forward with confidence to continued progress."
"Data from patients with CLL/SLL observed in our Phase Ib/II program provide strong rationale for initiating the Phase III registration trial," said Lori A. Kunkel, M.D. Chief Medical Officer, Pharmacyclics. "CLL/SLL is an important component of our development plan to evaluate ibrutinib in B-cell malignancies. This trial complements other ongoing and planned trials for patients with unmet needs, including additional Phase III trials in relapsed or refractory CLL/SLL of ibrutinib in combination therapies, a Phase III trial of ibrutinib in frontline elderly CLL/SLL patients as a single agent and the trials in mantle cell lymphoma, all expected to start late 2012 or early 2013."
RESONATE™ Trial Design (PCYC-1112)
The RESONATE™ study is a randomized, open–label Phase III registration trial of ibrutinib as a monotherapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival in relapsed or refractory CLL/SLL patients as compared to that achieved with ofatumumab therapy. The key secondary endpoints include overall response rate, overall survival, and quality of life measures. This global study conducted by PCYC is planned to enroll 350 patients worldwide.
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