OCALA, Fla., Aug. 13, 2018 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, is pleased to announce it mailed a letter to stockholders on August 11, 2018 detailing recent developments, including financial results and new business opportunities.
- A strategic decision to prioritize Ampligen’s potential in combination therapeutic treatments in immuno-oncology. Synergistic anti-tumor activity and/or increased median survival has been observed when Ampligen was added to other anti-cancer agents in three pre-clinical studies. As a result, we are now working with several major cancer research centers to initiate Phase 1 and Phase 2 clinical trials combining Ampligen with FDA-approved checkpoint blockade therapies;
- Completion of the initial phase of the Ampligen commercially-scaled production plan to support these trials plus current and anticipated commercial orders from (1) Argentina, where Ampligen was recently approved for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); and (2) existing U.S. and international ME/CFS early access programs, such as AMP-511;
- Continuation of our program to secure U.S. FDA approval for Ampligen for the treatment of ME/CFS. In the meantime, we have expanded the Treatment Protocol/Expanded Access Programs for ME/CFS in the U.S. to new enrollees;
- Price increase approved by the FDA for U.S. programs from $75 per vial to $200 per vial, with sales commencing this quarter and volume of sales projected to increase over the next six months;
- Amending of our agreement with myTomorrows to include management of two Special Access Programs in Canada, one for patients with pancreatic cancer, the other for patients suffering from ME/CFS;
- Progress toward legal access to Ampligen in other countries where early access programs exist for serious diseases with unmet medical need;
- Initiation of plans to change our corporate name to Amplified Immune Modulation Inc., d/b/a A.I.M. Immuno-pharma, with a corresponding reservation of the ticker symbol AIM, to more accurately reflect the Company’s prioritizing of immuno-oncology.
To read the letter to stockholders in full, please visit: http://ir.hemispherx.net/Annual_Stockholder_Meeting.
“We remain optimistic about Ampligen’s prospects as we move closer to its commercialization, especially as we approach its commercial launch pursuant to approval in Argentina,” said Thomas K. Equels, the Chief Executive Officer of Hemispherx. “Our top priority is validating Ampligen’s role in enhancing the performance of current immunotherapeutic drugs.”
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. 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. 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.
Hemispherx Biopharma, Inc.
Phone Number: 800-778-4042