|Hemispherx Biopharma Announces First Patient Treated in Phase 2 Ovarian Cancer Clinical Trial Evaluating Ampligen in Combination with Pembrolizumab and Cisplatin|
|By: Nasdaq / GlobenewsWire - 12 Jun 2019||Back to overview list
OCALA, Fla., June 12, 2019 (GLOBE NEWSWIRE) -- (NYSE American: HEB) — Hemispherx Biopharma Inc. announced today that the first patient has been treated in the Phase 2 recurrent ovarian cancer program at the University of Pittsburgh Medical Center (UPMC) (See: https://clinicaltrials.gov/ct2/show/NCT03734692). On receipt of information from clinical sites, it is Hemispherx’ policy to provide periodic updates when a clinical study (1) is FDA authorized, (2) begins enrollment, (3) treats its first subject, (4) issues material interim reports and (5) releases final results. The company is pleased to announce this step in our clinical program, which constitutes steady progress toward Hemispherx’ clinical goals.
Under the leadership of principal investigator Robert Edwards, MD, this study is evaluating Hemispherx' experimental drug Ampligen in combination with pembrolizumab — an anti-PD-1 check-point blockade therapy — and cisplatin. This study is expected to treat 45 patients.
This is the second recurrent ovarian cancer clinical trial involving Ampligen at UPMC. A Phase 1 / 2 commenced approximately three years ago and is near completion of the Phase 1 portion (See: https://clinicaltrials.gov/ct2/show/NCT02432378). Dr. Edwards’ team has issued an interim report and is drafting a manuscript on the biological and clinical outcomes from the initial Phase 1 / 2 clinical trial in recurrent ovarian cancer.
"Our initial study indicates that Ampligen is generally well-tolerated via intraperitoneal administration, thus paving the way for this new Phase 2 study combining Ampligen and pembrolizumab. Ampligen has the potential to be clinically significant because a robust killer T-cell population in the tumor microenvironment without attracting Treg cells is important to help optimize checkpoint blockade induced tumor shrinkage," said Dr. Edwards, chair of gynecologic services at Magee-Women's Hospital of the University of Pittsburgh School of Medicine (UPMC), Professor of Obstetrics, Gynecology & Reproductive Services at UPMC, and a world-class expert in ovarian cancer and a pioneer in Ampligen research.
"This year, world-wide, ovarian cancer is projected to kill 152,000 women. With this new large-scale study funded by an industry grant, Hemispherx and the team at Magee-Women's Hospital of the University of Pittsburgh School of Medicine are focused on developing a potentially life-saving therapy to meet this critical and unmet medical need," said Hemispherx CEO Thomas K. Equels.
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