Pharmacyclics, Inc.(PCYC) recently announced the completion of enrollment
in its phase III study RESONATE, which is being conducted to
evaluate ibrutinib versus Arzerra (ofatumumab) in patients with
relapsed or refractory chronic lymphocytic leukemia (CLL)/small
lymphocyctic lymphoma (SLL).
On Apr 3, 2013, Pharmacyclics completed the enrollment target of
350 patients into this study. An additional 41 patients were
screened and allowed to participate in the study.
Progression-free survival (PFS) is the primary endpoint of this
study. Pharmacyclics is likely to present data from an interim
analysis during the first quarter of 2014. If the interim analysis
shows that ibrutinib's treatment effect is statistically more
significant than that of Arzerra, then the company may pursue
discussions with the FDA and other regulatory authorities for an
early filing of the candidate.
On Aug 1, 2012, Pharmacyclics had announced the enrollment of
the fifth patient in this study which triggered a $50 million
milestone payment from Janssen Biotech, Inc., a Johnson
& Johnson ( JNJ ) company.
Pharmacyclics and Janssen's agreement dates back to Dec 2011.
The companies are collaborating for the global development and
commercialization of ibrutinib. In addition to receiving a $150
million upfront payment from Janssen, Pharmacyclics is entitled to
receive up to $825 million (of which $200 million has been earned)
on the achievement of development and regulatory milestones.
Pharmacyclics also finished enrolling 110 patients in a phase II
study, SPARK, which is being conducted to evaluate ibrutinib in
mantle cell lymphoma (MCL) patients whose disease has progressed
even after having received Velcade (bortezomib) therapy and at
least one prior Rituxan (rituximab)-containing chemotherapy
Pharmacyclics expects to file a New Drug Application (NDA) with
the US Food and Drug Administration (FDA) for the use of ibrutinib
in patients with relapsed or refractory MCL before the end of
Pharmacyclics carries a Zacks Rank #3 (Hold). Currently,
companies like QLT Inc. ( QLTI ) and
Catalyst Pharmaceutical Partners Inc. ( CPRX ) look more
attractive with a Zacks Rank #1 (Strong Buy).CATALYST PHARMA (CPRX): Free Stock Analysis
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