- Published: 26 February 2018
- Written by Editor
Hemispherx To Supply Ampligen for Pancreatic Cancer Patients in Canada Under Special Access Program
ORLANDO, Fla., Feb. 26, 2018 -- Hemispherx Biopharma, Inc. (NYSE American:HEB) said it is expanding its partnership with myTomorrows to supply Ampligen® for pancreatic cancer patients in Canada under a Special Access Program (SAP).
Amsterdam-based myTomorrows, an international leader in providing physicians access to experimental medicines, is conducting a similar program with Ampligen in Europe, where it is called an EAP, or Early Access Program.
In clinical trials in a variety of indications, approximately 100,000 doses of the experimental drug Ampligen have been administered, IV or intranasally, resulting in one of the most comprehensive safety profiles of a Toll-like receptor agonist. Toll-like receptors (TLRs) are a class of proteins that play a key role in activating the innate immune system.
As a selective activator of the TLR3 pathway, Ampligen stimulates important components of the immune system. It has been tested as a vaccine adjuvant, and it is in late-stage development for ME/CFS. In recent cancer studies, combinational use of Ampligen has been shown to make certain cancers more responsive to immuno-oncology agents such as checkpoint inhibitors.
The program is expected to be in place as of May 2018. Physicians who participate in the program will use their clinical judgment in choosing whether to use Ampligen as a stand-alone immuno-therapy agent or in combination with other drugs or with surgery.
Thomas K. Equels, CEO of Hemispherx, noted that the growing popularity of checkpoint blockade therapy has broadened the potential of Ampligen in immuno-oncology beyond single-agent use, with new data helping to define its potential role as a combinational agent in promoting killer T cell accumulation in the tumor microenvironment.
“Data presented last month by Dr. Pawel Kalinski of the Roswell Park Cancer Institute at the Immuno-Oncology Frontiers Conference showed that combination Ampligen had a positive modulating effect on the PD-1/PD-L1/PD-L2 system in human ovarian and colorectal cancers. Pancreatic cancer is an extremely lethal malignancy with a 95% mortality rate. Therefore, this unmet medical need is a top priority for team Hemispherx,” Mr. Equels said.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc., is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
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. Among other uncertainties, Ampligen’s® ability to treat or assist in the treatment on pancreatic cancer, while promising, significant additional testing will be required and no assurance can be given that Ampligen® will prove effective in such treatment. 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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