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Clovis Oncology will develop Pfizer's PF-01367338 PARP Inhibitor under a development and licensing agreement announced today worth $255 million. Pfizer's oral and IV Poly (ADP-ribose) polymerase (PARP) inhibitor, PF-01367338 is currently in Phase 1/2 development for solid tumors. PF-01367338 is a novel, orally active, small molecule inhibitor of PARP and will be developed by Clovis as both a monotherapy and in combination with chemotherapeutic agents for the potential treatment of select cancer patients.
"We are pleased to add PF-01367338 to our pipeline and appreciate Pfizer's belief in our organization and in the development plans we have for the drug," said said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "It has long been evident that inhibiting PARP may provide significant benefit to patients with many tumor types. We are particularly attracted to this compound because its profile suggests not only that it could be used in combination with chemotherapy but could potentially be used as monotherapy for the long term management of disease."
PF-01367338 is currently in a Phase 1 clinical trial examining the maximum tolerated dose of oral PF-01367338 that can be combined with intravenous platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing trials, currently using the IV formulation: a Phase 1/2 study in gBRCA breast and ovarian cancer and a Phase 2 study in the adjuvant treatment of triple negative breast cancer. Clovis Oncology intends to replace the IV formulation with the oral formulation in these studies.
"This drug is a very potent PARP inhibitor. It has already demonstrated very encouraging activity as an IV formulation and now we know that the oral formulation is also active. This potentially opens up many exciting opportunities for long-term treatment for cancer patients," said Professor Hilary Calvert, Director of Cancer Drug Discovery and Development at University College London, UK, and a pioneer in the field of human cancer therapy with PARP inhibitors.
PARP inhibitors are considered a breakthrough for the treatment of certain types of cancer, although ongoing studies still measure its overall effectiveness.