In the news release, Pharmacyclics® Triggers Significant Milestone Payment and Provides Clinical Program Update, issued 01-Aug-2012 by Pharmacyclics, Inc. over PR Newswire, we are advised by the company that the first paragraph, last sentence, should read "calendar 2012" rather than "calendar 2013" as originally issued inadvertently. The complete, corrected release follows:
Pharmacyclics® Triggers Significant Milestone Payment and Provides Clinical Program Update
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. Further information about this trial can be found at www.clinitrials.gov:NCT01578707 – "A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumamb in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE ™)" Ibrutinib Development Update
Clinical Trial Initiations planned in second half of 2012 / first quarter 2013:Pharmacyclics and Janssen plan to initiate three additional Phase III studies over the next 6 - 9 months. These studies include:
- Phase III combination study of bendamustine/rituximab plus ibrutinib versus bendamustine/rituximab plus placebo in relapsed or refractory CLL/SLL patients.
- Phase III frontline study of single agent ibrutinib versus a comparator in elderly CLL/SLL patients.
- Phase III study outside the US of ibrutinib versus temsirolimus in subjects with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior chemotherapy regimen.
Clinical Updates planned at a medical meeting by the end of 2012:
- PCYC-1104, Phase II study of single agent ibrutinib in patients with relapsed or refractory MCL, including cohorts of subjects either previously treated with bortezomib or naive to bortezomib treatment.
- PCYC-1102, Phase Ib/II study of single agent ibrutinib in patients with relapsed or refractory CLL/SLL.
- PCYC-04753, Phase I study of single agent ibrutinib in patients with recurrent B-cell malignancies. The update will focus on the cohort of evaluable patients with follicular lymphoma.
- PCYC-1106, Phase II study, of ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients were enrolled with two genetically distinct subtypes of DLBCL, the activated B-cell (ABC) subtype and the germinal center (GC) subtype.
- PCYC–1111, a Phase II study of ibrutinib in subjects with relapsed/refractory multiple myeloma (MM).
Clinical Updates planned by mid-year 2013:
- The Company's ongoing Phase II studies of single agent ibrutinib in DLBCL and MM are expected to mature with continued enrollment in both histologies over the next 12 months. By mid-year 2013 the Company intends to provide a meaningful update on the clinical development plans in non-Hodgkin's lymphoma and MM.
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