SUNNYVALE, Calif., Aug. 20, 2012 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a second $50 million milestone payment obligation from Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, worldwide collaborator on ibrutinib in oncology and sponsor of this MCL trial. As Pharmacyclics or Janssen initiate specific clinical trials and enroll the 5th patient, additional milestone payments of $50 million may be triggered up to a total of $250 million.
"We formed this partnership with Janssen, with the intention to broadly expand and propel the clinical development of ibrutinib. The speed at which we have moved into important clinical trials in CLL and now MCL is a validation of this joint venture's ability to convert plans into actualities," said Bob Duggan, Chairman and CEO of Pharmacyclics. "We are satisfied with the early progress this partnership is generating and we look forward to providing a material update in December, during the American Society of Hematology Meeting."
SPARK Trial Design (MCL2001)
The SPARK study is a single-arm, multi-center Phase II trial of ibrutinib in MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. The key secondary endpoints include overall survival rate, progression-free survival rate, and pharmacokinetic data of ibrutinib. This global study conducted by Janssen is planned to enroll 110 patients worldwide.Further information about this trial can be found at www.clinitrials.gov: NCT01599949 – "A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy"