CAMBRIDGE, Mass. & BOULDER, Colo.--(BUSINESS WIRE)--Foundation Medicine, Inc. and Clovis Oncology, Inc. (Nasdaq:CLVS) announced today that they have entered into a diagnostic collaboration. The goal of the collaboration is to develop an in-vitro diagnostic (IVD) to identify biomarkers to select cancer patients most likely to respond to Clovis' product candidate rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor currently in Phase I/II clinical development.
"We are pleased to collaborate with Foundation Medicine," said Patrick J. Mahaffy, president and CEO of Clovis Oncology. "This continues our commitment to developing targeted therapies with companion diagnostics to identify the patients most likely to benefit from our therapeutics. Foundation Medicine's leadership in next generation sequencing and genomic analysis make them an ideal partner to work with us on our rucaparib program."
Foundation Medicine and Clovis Oncology will analyze the genomic alterations found in tissue samples from patients to evaluate the feasibility of developing an IVD method to identify patients who have tumors more likely to respond to rucaparib.
In particular, the goal of the collaboration is to identify the additional genetic mutations beyond those in germ-line and somatic BRCA that are associated with defective DNA repair and may define appropriate tumor targets for rucaparib. In high-grade serous ovarian cancer, for example, this study has the potential to increase the percentage of ovarian cancer patients potentially eligible for rucaparib therapy from the 15 percent typically found to have germ-line mutations of BRCA to an estimated 40 to 50 percent who have DNA repair deficiencies caused by somatic mutations in a variety of genes.
"Foundation Medicine's core capability is the translation of genomic insights into clinically actionable information," said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. "But even the most in-depth genomic profile for a patient is only as actionable as the available and relevant targeted therapies. Therefore, we are working to help expand the universe of targeted therapeutic options. Clovis Oncology, a recognized leader in patient-specific oncology drug development, is an ideal partner in this mission."
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.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's initial clinical product, FoundationOne™, is a fully informative genomic profile to identify a patient's individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.foundationmedicine.com.
Clovis Oncology Forward-Looking Statement: 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 our clinical development programs for rucaparib, the corresponding development strategies for companion diagnostics for our product candidates, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
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