Balance for New Cancer Clinical Trials; Second Commercial-Size Batch Now in Regulatory Testing
ORLANDO, Fla., June 15, 2018 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE American:HEB) has announced the successful completion of the first phase of its Ampligen production plan. The first commercial-sized lot of Ampligen, which completed cGMP manufacturing on April 4, 2018, has passed all required testing for regulatory release for human use. These 8,500 vials are earmarked for distribution to United States based Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) expanded access programs in Nevada and North Carolina, United States clinical trials in immuno-oncology, European expanded access programs and for certain testing and validation required for commercial launch in Argentina.
The company also reported that its cGMP contract manufacturer successfully filled and finished a second commercial-size batch production run of roughly 8,000 vials. This is the second such successful commercial sized production run in the last two months. This second commercial sized lot is currently undergoing regulatory testing for human use, a roughly two-month process.
“Our newly enlarged production capabilities were established to provide a reliable supply of Ampligen for all of our clinical and commercial programs. We are setting the stage for significant revenue expansion,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “This comes at a time of increasing scientific and medical validation of Ampligen’s potential to fill large unmet medical needs in a variety of immune-modulated illnesses. The successful release testing of our first commercial sized batch will supply the FDA-authorized AMP-511 expanded access program for ME/CFS patients in the United States and fill a 2,100-vial order for expanded early access programs in Europe and Canada for ME/CFS and pancreatic cancer. It will also be available to supply the initial requirements for additional planned clinical studies in the United States.”
The company recently announced a Memorandum of Understanding with Roswell Park Cancer Center to conduct a Phase I/II study of Ampligen in combination with checkpoint inhibitors in solid tumors. The planned program follows recent publication (Cancer Res May 31 2018 DOI:10.1158/0008-5472.CAN-17-3985) of a head-to-head study in explant culture models that pitted Ampligen against two other TLR3 agonists to measure how each individually might enhance the tumor microenvironment for checkpoint blockade therapy.
All three TLR3 agonists activated the TLR3 pathway and promoted an accumulation of killer T cells, but only Ampligen did so without causing attraction of immune suppressive elements, such as regulator T cells. This is a potentially important advantage Ampligen has over other TLR3 agonists, and Ampligen is also the only TLR3 agonist with an extensive safety profile showing it to be generally well tolerated in humans. Almost 100,000 doses of intravenous Ampligen have been administered in clinical settings.
The purpose of the planned Phase I/II study is to clinically evaluate the potential of Ampligen to enhance the immune mediated effects of checkpoint blockade technology. The goal: increasing the survival of patients with advanced solid tumors who are not responsive to checkpoint blockade therapy alone.
The second filled and finished commercial-sized lot of Ampligen, still undergoing release testing, is planned to be available to supply initial demand for the anticipated commercial launch of Ampligen in Argentina, where it is approved for the treatment of severe CFS. The Argentine commercial approval is the first-ever approval of a drug for severe CFS.
The company is continuing efforts to clarify the regulatory pathway in the United States for approval of Ampligen to treat CFS. Ampligen has been accorded Orphan Drug Product Designation by the FDA for the treatment of CFS.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. 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 believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen® in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. 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. 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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