Pharmacyclics, Inc. announced the signing of a five-year Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the development of PCI-32765, a first-in-class, small molecule inhibitor of Bruton's tyrosine kinase (Btk) for the treatment of haematologic malignancies (blood cancers). Under the Agreement, the NCI's Division of Cancer Treatment and Diagnosis (DCTD) plans to sponsor phase I and phase II trials of PCI-32765 in various haematologic malignancies, including Non-Hodgkin Lymphoma (NHL) and multiple myeloma.

“We are very pleased to be collaborating with the NCI on the development of PCI-32765,” said Eric Hedrick, MD, vice president, Oncology Development of Pharmacyclics. “This CRADA represents a major achievement for the company, and allows us to broaden our knowledge of PCI-32765 based on clinical trials to be performed by leading investigators in the field of haematologic malignancies.”

“The attainable goal of dramatically reducing the burden of cancer and improving the lives of cancer patients is a postulate Pharmacyclics holds in common with the NCI,” said Bob Duggan, chairman and CEO of Pharmacyclics. “We will continue to work tirelessly until this goal is achieved.”

PCI-32765 is an orally active small molecule inhibitor of Bruton's tyrosine kinase that Pharmacyclics is developing for the treatment of patients with B-cell lymphomas or leukaemias. B-cell maturation is mediated by B-Cell Receptor (BCR) signal transduction and Btk is an essential part of the signalling pathway. Recent studies indicate that some B-cell lymphomas depend on chronic active signals from the BCR, and that suppression of this signalling by PCI-32765 can induce apoptosis and inhibit cell migration. Similarly, BCR signalling is thought to promote malignant cell expansion and survival in chronic lymphocytic leukaemia. Pharmacyclics is currently evaluating its Btk Inhibitor, PCI-32765, in several phase II clinical trials.

The NCI leads the National Cancer Programme and the National Institutes of Health (NIH) effort to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers.

Pharmacyclics is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases.