AstraZeneca And Pharmacyclics Enter Clinical Trial Collaboration To Evaluate Imbruvica In Hematologic Cancers

 AstraZeneca and Pharmacyclics, Inc.

today announced that they have entered into a clinical trial collaboration to evaluate novel combination therapies targeting a number of hematologic cancers. The collaboration will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors in combination with IMBRUVICA^® (ibrutinib), Pharmacyclics' oral Bruton's tyrosine kinase inhibitor, for the treatment of patients with relapsed or refractory Diffuse Large B-cell Lymphomas. Preclinical evidence suggests that the combination of IMBRUVICA with these investigational medicines may enhance their effects. Under the terms of the agreement, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple studies may be considered and conducted. The studies will be led by AstraZeneca. The Phase I element of each study is expected to establish a recommended safe and tolerable dose and schedule for the combination, and the Phase IIa element will assess its safety and efficacy in an expanded patient population. The financial terms of the agreement have not been disclosed. The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted. Susan Galbraith, Head of AstraZeneca's Oncology Innovative Medicines Unit said, "There is a clear and significant unmet need in the treatment of hematologic malignancies, an area of increasing focus for AstraZeneca. Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes." "We are optimistic that combining our oral once-per-day IMBRUVICA with other agents has the potential to enhance efficacy and duration across the landscape of hematologic cancers," said Bob Duggan, Chairman & CEO, Pharmacyclics. IMBRUVICA is being developed and commercialized jointly by Pharmacyclics and Janssen Biotech, Inc.