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.

(PARP Inhibitors News) Merrill J. Egorin, MD an acclaimed PARP Inhibitors and cancer researcher died on August 7, 2010 at the age of 62. Dr. Egorin’s death came five years after being diagnosed with multiple myeloma, which is a cancer of the plasma cells in bone marrow. Dr. Egorin had been a professor of medicine and pharmacology at the University of Pittsburgh Cancer Institute. Last year he won a prestigious $500,000 award from the American Society of Clinical Oncology (ASCO) for his outstanding cancer research. The award money is to be used to further the training of translational research-focused oncologists.

Dr. Egorin was passionate about the effectiveness of PARP inhibitors, predicting a year ago that the publicity and popularity of PARP inhibitors would explode. PARP inhibitors have shown promise in killing cancer cells in certain breast cancer and ovarian cancer patients undergoing chemotherapy. PARP inhibitors help stop cancer cell DNA from repairing itself after chemotherapy. Studies have shown great promise. Dr. Egorin has been pushing for the expansion of the research of PARP inhibitors because of the promise they showed and because of its gain in popularity. Many news organizations, in June 2009, dubbed PARP inhibitors as “the wonder cancer drug” even though a lot of research and studies are still needed before PARP inhibitors can be used on a mass scale. Current research is mainly targeting breast and ovarian cancer, but it’s widely believed that PARP inhibitors will be effective in the treatment support of other cancers.

ASCO describes its $500,000 Translation Research Professorship Award as:

The Translational Research Professorship is awarded to physicians who are full-time professors at academic medical centers and have made significant contributions to the field of cancer research. This year’s recipient will receive $500,000 over five years to support continued efforts to bring advances in basic sciences into the clinical arena, and will also serve as a mentor for other translational researchers.

Since Dr. Egorin died one year after receiving the five-year award, it is unknown at this time how the rest of the award/program will be handled. However, ASCO did put out the following statement after learning of the death:

The ASCO Cancer Foundation® is deeply saddened by the passing of one of our Translational Research Professors, Dr. Merrill Egorin. Dr. Egorin was a world-class scientist, a wonderful colleague, and a truly inspired and dedicated teacher and mentor. He will be missed by the entire oncology community. Many of our staff had the honor to work with him while he taught our Grants Writing Workshops, actively performed TACF-funded research, was interviewed for our video series, and mentored many young investigators on their first grants. We saw first-hand what an inspiration he was and our hearts go out to his family and colleagues in this difficult time. We are confident that his legacy of passionate teaching and mentorship will live on through the many physician-scientists that he trained and we are glad that we were able to support him in these endeavors.

Dr. Egorin will be greatly missed with the PARP Inhibitors community, especially with his push to expand the research within this field.