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news.Pharmacyclics has enrolled fifth patient for the clinical trial SPARK (MCL2001) of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).
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The enrolment will lead to second $50m milestone payment obligation to Pharmacyclics from Janssen Biotech, a worldwide collaborator on ibrutinib in oncology and sponsor of the MCL trial.
The additional milestone payments of $50m may be advanced up to a total of $250m.
Pharmacyclics chairman and CEO Bob Duggan said Pharmacyclics formed the partnership with Janssen, with the intention to 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," Duggan added.
"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.”
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.
As part of the study, Janssen will enrol 110 patients across the globe.