Hemispherx Reports Positive Safety and Survival Data in Phase 1 Stage 4 Ovarian Cancer Clinical Study Using Ampligen®
OCALA, Fla., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE American: HEB) announced today that the University of Pittsburgh Medical Center (UPMC) has issued a final report supporting the safety of using Ampligen in combination therapy for the treatment of recurrent ovarian cancer in its Phase 1 trial using Ampligen with Intron A and celecoxib. The research team, led by Drs. Robert Edwards, Anda Vlad and Brian Orr, found that Ampligen was well tolerated on an intraperitoneal basis and as a combination therapy.
"This concludes that these drugs can be given in this combination with no major toxicities noted and no evidence of added toxicity when adding the immunomodulators to cisplatin as most of the grade 3 toxicities listed above are common with cisplatin," wrote Dr. Orr in the Phase 1 report.
"The Phase 1 study, in addition to generating excellent safety data, has also produced positive survival data with regard to the stage 4 ovarian cancer patients participating in the recently completed Recurrent Ovarian Cancer Phase 1 Study," said Dr. Edwards. See: ClinicalTrials.gov.
Based on the above Phase 1 study results, a new Phase 2 recurrent ovarian cancer clinical study has already begun at UPMC treating stage 4 patients with Ampligen, cisplatin and pembrolizumab. The 45 subject Phase 2 trial in combination with pembrolizumab is designed to test the combinational synergy with checkpoint blockade therapy where Ampligen is administered by injection in the peritoneal cavity where the tumor is located. See: ClinicalTrials.gov.
Hemispherx CEO Thomas K. Equels acknowledged the importance of these events, stating that "The positive results regarding the safety and survival using Ampligen, as evidenced in these first stage 4 patients treated in the Phase 1/2 study, are extremely encouraging in our quest to expand horizons in immuno-oncology, facilitating a path toward greater efficacy for checkpoint blockade therapies. The results are consistent with foundational research Hemispherx obtained in animals, as well as in clinical trials in humans with melanoma and renal cell carcinoma, where Hemispherx Chief Medical Officer Dr. David Strayer was the Principal Investigator, that support the impact Ampligen has in making the tumor more susceptible to host immunosurveillance and more susceptible to destruction by a host immune response in the presence or absence of additional immune or chemotherapeutic agents."
Go here for a full report on Hemispherx's ongoing Ampligen clinical trials, its Early Access Program for pancreatic cancer in Europe and its Expanded Access Program for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in the United States.
About Hemispherx Biopharma Hemispherx Biopharma, Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Cautionary Statement Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. Among other things, no assurance can be given as to whether the ongoing or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities of the Cancer Centers sponsoring these trials. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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