Pharmacyclics reported 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) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a $50-million milestone payment obligation from Janssen Biotech (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

As Pharmacyclics or Janssen initiate further Phase III trials in specific indications and enroll the fifth patient, additional milestone payments of $50 million may be triggered up to a total of $250 million. An additional Phase III trial milestone payment during calendar 2013 is anticipated.

“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., CMO, 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.”








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