US Oncology, Biomarin Announce Collaboration to Launch PARP Inhibitor Phase III Study in BRCA Metastatic Breast Cancer Patients

US Oncology Research, one of the nation's largest research networksspecializing in Phase I through IV oncology clinical trials, announced todayit is collaborating with BioMarin Pharmaceutical Inc. to offer agroundbreaking Phase III study to investigate the use of BMN 673, a PARPinhibitor, in metastatic breast cancer patients who test positive for BRCA1 orBRCA2 gene mutations. The study will investigate the effectiveness and safetyof BMN 673, adding to the promising data currently being analyzed from ongoingPhase I and II studies of the drug. Thirteen US Oncology Research affiliatedpractices with 56 locations will participate in the study.“We are excited to collaborate with BioMarin on this important study that canlend more insight into the potential of PARP inhibitor BMN 673 in a metastaticbreast cancer setting,” said Joanne L. Blum, M.D., medical oncologist anddirector, Hereditary Cancer Risk Program, Texas Oncology-Baylor Charles A.Sammons Cancer Center and a principle investigator for the study. “This is anopportunity for patients who have a BRCA1 or BRCA2 gene mutation withmetastatic breast cancer to receive an investigational PARP inhibitor to seeif it will help control the metastatic disease compared to standardchemotherapy. Eligible patients have the possibility of receiving a promisingnovel therapy not available elsewhere while participating in a world-classstudy that may change patients' lives in the future,” she noted.According to the National Cancer institute (NCI), the strongest knownpredictive risk factor for breast cancer is a positive family history for thedisease. Hereditary breast cancer, which can occur generation after generationin some “cancer families,” can often be explained by specific mutations in theBRCA1 or BRCA2 genes that belong to a gene class known as tumor suppressors.Women who have a mutation in one of these genes have a greatly increased riskof developing breast and/or ovarian cancer during their lifetimes, and menwith these mutations also face an increased risk of breast cancer.During the past decade, great strides have been made in understanding geneticsand its link to various cancers. Several years ago researchers concluded polyADP-ribose polymerases (PARPs) play a critical role in certain pathways thatrepair DNA damage, and several recent studies have been investigatinginhibiting the activity of PARPs in tumor cells as a therapeutic approach tocancer, including PARP inhibition in BRCA-mutated breast cancer.“We are thrilled to collaborate with US Oncology Research and leverage theirvast network and clinical expertise in the execution of BioMarin's Phase IIItrial in patients with metastatic breast cancer with gBRCA mutations,” saidHank Fuchs, M.D., chief medical officer of BioMarin. “We look forward toconducting a world-class study in collaboration with some of the finestclinical investigators to evaluate the safety and efficacy of BMN 673 in thissetting.”A Phase III, open-label, randomized, parallel, 2-arm, multi-center study ofBMN 673 versus physician's choice in germline BRCA mutation subjects withlocally advanced and/or metastatic breast cancer, who have received no morethan 2 prior chemotherapy regimens for metastatic disease will investigate thedrug's effectiveness, evaluate its safety, and compare it to commonly usedtreatments. The trial is currently screening patients for enrollment.“Thanks to the exemplary performance of our Research Regulatory Team led onthis project by Regulatory Affairs Specialist Jessica Stabler, we were able toget this study up and running in just eight weeks,” explained Lauren Steckel,B.S., project manager of Research Operations for US Oncology Research who wasin charge of this project. “With a staff that is deeply committed to ourmission and our large affiliated network of research sites already equipped tohandle complex trials, we can open studies at a rapid pace, especially forrare patient populations like this one. It is very rewarding to play a role inbringing these potentially life changing agents to this very special group ofpatients as soon as possible,” she noted.“We are committed to collaborating with others in the cancer community to helpdevelop promising new treatments for patients battling these rare geneticcancers,” said Stephen Jones, M.D., medical director for US Oncology Researchand associate chair of its Breast Committee. “With our large network ofaffiliated community-based cancer centers, we are uniquely positioned torapidly identify and enroll eligible participants in these vital studies thatmay eventually improve outcomes and quality of life for these rare patientpopulations that are battling these difficult diseases,” he concluded.