Hemispherx Biopharma, Inc. (NYSE: HEB) is a specialty pharmaceutical company, engaged in the clinical development of drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders.
On April 30th, HEB announced significant progress in its Ampligen recurrent ovarian cancer program at the University of Pittsburgh Medical Center (UPMC) under the leadership of the principal investigator, Robert Edwards, MD. The ovarian cancer program is being funded in part by an Ovarian Cancer Specialized Program of Research Excellence (SPORE) from the National Institutes of Health (NIH), which is supporting a Phase 1/2 study of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer.
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Recently, an interim report was received by Hemispherx that summarizes results related to some of the laboratory objectives of this study which include characterization of the local immune responses during chemo-induced cell death as measured by serial assessment of peritoneal fluid cellular phenotypes and chemokine patterns.
“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, a world-class expert in ovarian cancer and a pioneer in Ampligen research.
Recently, the company announced quarterly press release updates highlighting the progress and achievement of milestones in the Company’s ongoing clinical trials evaluating Ampligen’s ability to reprogram tumor microenvironments and increase the effectiveness of existing cancer immunotherapy, such as checkpoint blockade therapies. The Company has recently refocused its efforts to concentrate on the use of Ampligen as an immuno-therapy based on preclinical and early clinical evidence supporting the drug candidate’s potential in the fight against cancer.
On April 2nd HEB announced active initiation of a clinical trial sponsored by Roswell Park Comprehensive Cancer Center (Roswell Park) in Buffalo, N.Y. evaluating Hemispherx’ experimental drug Ampligen® (rintatolimod), a dsRNA TLR3 agonist, in combination with Merck’s Keytruda® (pembrolizumab), an anti-PD-1 check-point blockade therapy, in the treatment of metastatic triple-negative breast cancer. The study’s first participant received initial dosing this week. The phase I trial seeks to enroll at least six patients.
The company’s products include Alferon N Injection, an injectable formulation of natural alpha interferon to treat a category of genital warts, a sexually transmitted disease; and Ampligen for the treatment of chronic fatigue syndrome (CFS). It is also developing Ampligen for the treatment of CFS, Hepatitis B, HIV, and cancer patients with renal cell carcinoma and malignant melanoma.
Hemispherx Biopharma, Inc., a specialty pharmaceutical company, engages in the clinical development of drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders in the United States. The company was founded in 1990 and is headquartered in Orlando, Florida.
Stock influences and risk factors
They will require additional financing which may not be available.
If they are unable to obtain regulatory approval in a timely manner, or at all, operations will be materially harmed, and the stock adversely affected.
They may be subject to product liability claims from the use of Ampligen®, Alferon N Injection®, or other products which could negatively affect future operations. They have limited product liability and clinical trial insurance.
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