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Ongoing Phase I Monotherapy Study Of Rucaparib In Patients With Solid Tumors Demonstrates Clinical Activity, Establishes Dose And Schedule

Clovis Oncology (NASDAQ:CLVS) today announced updated results from an ongoing Phase I/II monotherapy study of rucaparib, the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of ovarian cancer. Data from the Phase I dose-escalation portion of this Phase I/II study are being presented today at a poster session during the European Cancer Congress 2013 in Amsterdam.

"We’ve seen significant clinical activity with one complete response in breast cancer and six partial responses in ovarian, breast and pancreatic cancers to date, and a disease control rate in patients with germline BRCA mutant ovarian (platinum-sensitive and platinum-resistant) cancer of 100% and 63% at 12 and 24 weeks, respectively. I am pleased to be participating in the Phase II and pivotal Phase III trials (ARIEL2 and ARIEL3) which aim to build on the clear activity of rucaparib in BRCA-mutant ovarian cancer and prospectively identify and test other genetic mutations associated with sensitivity to PARP inhibition in ovarian cancer. This approach has the potential to broaden applicability of PARP inhibitor treatment for ovarian cancer as well as other solid tumors and hopefully benefit many patients,” said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist UCLH and UCL Cancer Institute in London.

“These data demonstrate that rucaparib is both well-tolerated and predictably absorbed, and provides meaningful clinical benefit to certain ovarian cancer patients,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Now that we have identified the recommended Phase II dose, we plan to commence our late-stage development program in platinum-sensitive ovarian cancer. This includes a now-open biomarker study known as ARIEL2 (the Assessment of Rucaparib in Ovarian Cancer Phase 2 Trial) which will refine the definition of patients beyond those with BRCA mutations who may benefit from rucaparib. By the end of 2013 we expect to initiate a Phase III pivotal trial known as ARIEL3 in a broad set of ovarian cancer patients with a stratified efficacy analysis in genetically-defined groups, including somatic and germline BRCA mutations as well as a population with mutations beyond BRCA, utilizing insights from the ARIEL2 study.”

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