BOULDER, Colo.--(EON: Enhanced Online News)--Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the global ARIEL2 (Assessment of Rucaparib in Ovarian Cancer Phase 2 Trial) study of rucaparib has commenced with the dosing of the first patient at a U.S. study site. Rucaparib is the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of platinum sensitive, relapsed ovarian cancer.
“PARP inhibitors have the potential to provide meaningful clinical benefit to many women with ovarian cancer, and ARIEL2 is designed to identify the broader population of patients who likely benefit from rucaparib therapy, beyond the germline BRCA mutation carrier population.”
“I am delighted to be starting this important and timely trial,” said Professor Iain Mcneish, Professor of Gynecological Oncology, Institute of Cancer Sciences, University of Glasgow and one of the two chief investigators of the ARIEL2 study. “We have found there are many ovarian cancer patients who do not carry germline BRCA mutations yet still benefit from PARP inhibitor therapy. This study is designed specifically to help identify these women using tumor DNA sequencing, which is a viable approach since nearly all ovarian cancer patients have plentiful tumor tissue samples following de-bulking surgery. Platinum sensitivity alone may not be the best predictor of PARP inhibitor outcome and I am confident we can do much better for patients using tumor genetic analysis.”
“We are pleased to move forward with the international ARIEL clinical program, beginning with ARIEL2 today, and followed closely by our ARIEL3 pivotal study which will initiate by the end of this year,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “PARP inhibitors have the potential to provide meaningful clinical benefit to many women with ovarian cancer, and ARIEL2 is designed to identify the broader population of patients who likely benefit from rucaparib therapy, beyond the germline BRCA mutation carrier population.”
ARIEL2 is a single-arm, open-label, Phase 2 study designed to identify tumor characteristics that predict sensitivity to rucaparib using DNA sequencing to evaluate each patient’s tumor. Tumor samples from study participants will be tested for BRCA1 and BRCA2 mutations (genes that are linked to hereditary breast and ovarian cancers), as well as other biomarkers that are expected to confer sensitivity to PARP inhibitor therapy. All patients in the study will receive both rucaparib and their molecular test results (including tumor BRCA status), and be treated until their disease progresses or until they withdraw from the study.
In late 2013, the Company intends to initiate its pivotal study, ARIEL3, a randomized, double-blind, Phase 3 study that will compare the effects of rucaparib versus placebo. The study will evaluate whether rucaparib in platinum-sensitive, ovarian, fallopian tube or primary peritoneal high-grade cancer patients can extend the period of time for which the disease is controlled. The study will also prospectively test whether a patient’s BRCA mutation status or other biomarkers predict their response to rucaparib.
If the trial is successful, the Company intends to use data generated from the ARIEL studies to submit an application to the U.S. Food and Drug Administration (FDA) and other Health Authorities requesting an approval for rucaparib in all genetically-appropriate patients with relapsed, platinum-sensitive ovarian, fallopian tube or primary peritoneal high-grade cancer in a maintenance setting.
Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 in development for the treatment of ovarian cancer. Rucaparib is currently the subject of two largely complete Company-sponsored Phase I clinical studies: one to determine the MTD of oral rucaparib administered on a daily basis as monotherapy; and a second trial to determine the MTD of oral rucaparib that can be combined with intravenous platinum chemotherapy for the treatment of solid tumors. Now that the optimal dose and schedule of 600 mg BID have been established in the Phase I portion of the monotherapy study, the Company intends to initiate a Phase II expansion cohort to assess efficacy in germline BRCA ovarian cancer patients.
About Ovarian Cancer
Over 90% of ovarian cancer arises from the uncontrolled growth and replication of epithelial cells which form the surface of the ovary. Cancer involving this type of cell is known as epithelial ovarian cancer. High grade serous and endometrioid ovarian cancers are biologically related and common, accounting for approximately 75% of cases. If detected at a very early stage, ovarian cancers can usually be removed surgically and this can be potentially curative. However, there are often no clearly identifiable initial symptoms and in approximately 90% of high grade serous ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2012 and its other reports filed with the Securities and Exchange Commission.