On January 4, 2018 Genelux Corporation, a privately-held biopharmaceutical company focused on the development of its proprietary oncolytic immunotherapy platform, is reported that Gynecologic Oncology Associates/Women’s Cancer Research Foundation (GOA/WCRF) in Newport Beach, California has been added as a clinical site for its Phase 2 VIRO-15 Study: Oncolytic Vaccinia Immunotherapy in Recurrent Ovarian Cancer (Press release, Genelux, JAN 4, 2018, View Source [SID1234532452]).
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GOA/WCRF, a renowned gynecologic oncology care & research center, is now actively enrolling patients. The Principal Investigator at the site is Alberto A. Mendivil, MD, FACOG, FACS, with the following sub-investigators:
Lisa N. Abaid, MD, MPH
Tiffany L. Beck, MD, MPH
John V. Brown, MD
Kristina M. Mori, MD
Adding GOA/WCRF will accelerate the clinical development timeline of GL-ONC1 and completion of this important Phase 2 study.
Thomas Zindrick, Genelux CEO, said, "We are pleased to welcome one of the largest and most well-respected gynecological practices in the country to the VIRO-15 Study. We look forward to working with GOA/WCRF, especially given the investigators’ expertise in the conduct of ovarian cancer clinical research."
GOA/WCRF joins Florida Hospital Cancer Institute as participating sites in the study. These geographically diverse sites will drive enrollment and bring a convenient trial location to western United States.
John P. Micha, MD, President/Founder/Board Member of WCRF and founder of GOA, commented, "GL-ONC1 immunotherapy is one of the most exciting and promising gynecologic oncology treatment modalities to come along in recent years for late stage ovarian cancer. Our patients and staff have renewed hope that we will be able to improve clinical outcomes in the not too distant future."
About the Study
The open label, Phase 2 study (NCT02759588) is currently recruiting participants with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It is expected to enroll up to a total of 40 patients in two cohorts. Patients will receive GL-ONC1 as a monotherapy treatment regimen, consisting of intraperitoneal bolus infusions on 2 consecutive days. The study’s primary endpoint is progression-free survival, and secondary endpoints include incidence of adverse events, anti-tumor response, objective response, disease control rate, and overall survival.
About GL-ONC1
GL-ONC1, Genelux’ lead product candidate, is an attenuated therapeutic vaccinia virus, a non-pathogenic virus, modified by Genelux to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in over 100 subjects treated in Genelux studies have shown GL-ONC1 is well tolerated with documented antitumor activities and clinical benefits.
About Gynecologic Oncology Associates (GOA) & Women’s Cancer Research Foundation (WCRF)
Founded in 1985, GOA is the largest gynecologic oncology practice on the West Coast. WCRF is a nonprofit organization. The physicians from the WCRF have been pioneers in clinical research to improve cure rates for women with ovarian, uterine, endometrial, cervical and other gynecological cancers. WCRF designs, conducts and publishes research on leading-edge medical advances. WCRF has developed collaborative research relationships with many prominent pharmaceutical and biotech companies. GOA/WCRF physicians have received many honors in recognition of their excellence in cancer care, including Best Physicians in Orange County, America’s Best Oncologists, ACOG/Ortho National Research Award and many other honors for teaching and clinical care