Genelux Initiates Phase two Clinical Trial Of GL-ONC1 at Recurrent Ovarian CancerMarketWatch #GL_ONC1October 28, 2019
SAN DIEGO, Sept. 27, 2017 /PRNewswire/ — Genelux Corporation, a privately-held biopharmaceutical company focused on the development of its proprietary oncolytic immunotherapy platform, today announced that it has treated the first patient in a Phase 2 clinical trial in recurrent ovarian cancer, with its lead clinical-stage candidate, GL-ONC1.
The Phase 2 trial, VIRO-15 (Oncolytic V accinia I mmunotherapy in R ecurrent O varian Cancer), is being conducted at Florida Hospital Cancer Institute (FHCI) in Orlando, FL and is being led by Dr. Robert Holloway, a world-renowned gynecologic oncologist with extensive clinical trial experience in gynecologic malignancies.
VIRO-15 is based on positive data of GL-ONC1 from a Phase 1b clinical study conducted at FHCI in heavily pretreated, platinum-resistant/refractory ovarian cancer patients.
Administration of GL-ONC1 as a monotherapy was shown to have clinically-significant results, including:
(i) Documented objective response and tumor-specific T-cell response;
(ii) A favorable trend of durable response; and
(iii) A quality of life benefit.
The data exceeded the futility boundary of an equivalent interim analysis for a 2-stage Simon design at the current Phase 2 dose level, supporting the continued development of GL-ONC in this patient population.
Patients who are considered platinum-resistant/refractory following front-line treatment and multiple rounds of chemotherapy have the poorest prognosis.
Robert Holloway, MD, FACOG, FACS, Medical Director of Gynecologic Oncology at the Florida Hospital Cancer Institute and Principal Investigator of the current GL-ONC1 trial in ovarian cancer, commented, “The early response and clinical benefit data achieved with GL-ONC1 are particularly impressive in this heavily pre-treated, late-stage patient population who have failed prior therapies and enrolled into our trial with documented progressive disease.”
The monotherapy treatment regimen consists of a single cycle, with GL-ONC1 being intraperitoneally administered to patients in bolus infusions on 2 consecutive days.
About Genelux Corporation Headquartered in San Diego, California, Genelux Corporation is a leader in oncolytic immunotherapy, utilizing its potent CHOICE™ discovery platform to develop a library of proprietary, oncolytic vaccinia virus-based diagnostic and therapeutic candidates.
For more information please visit www.genelux.com .
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