PCI-45292 has been under preclinical development for approximately 1 year as a potential new agent for the treatment of immune mediated diseases. A recent evaluation of tissues from animals dosed with PCI-45292 has revealed an undesirable target-organ effect. The effect, which was noted at all dose levels in a rat animal model, but absent in another animal model, precludes establishing a starting dose for human clinical trials.
The undesired effect observed with PCI-45292 has not been observed with our Btk Inhibitor PCI-32765 even at higher dose levels in preclinical safety studies and is not considered to be related to the inhibition of Btk. Our broad clinical development for PCI-32765 in B-cell malignancies in particular in chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma continues as outlined in our last quarterly update.
We have readily identified the portion of the PCI-45292 molecule directly responsible for these target organ changes. We have now turned our attention to evaluating a related series of molecules with the focus on eliminating the target-organ effect. Our commitment to advancing a safe and effective Btk inhibitor into the clinic for immune mediated diseases remains strong.
"While we are disappointed with the delay of the program we are pleased with the quality of the research that was able to identify this effect early in development, allowing us to make adjustments pre-clinically. We remain dedicated to developing important, new targeted therapies that are safe and effective and advance the standard of care for patients," said
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. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medial healthcare needs; and to identify promising product candidates based on scientific development expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
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