ORLANDO, Fla., April 04, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, said it amended its agreement with Netherlands-based myTomorrows to include management of a Special Access Programme (SAP) in Canada for patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
myTomorrows, Hemispherx’s exclusive service provider for early access programs in Europe and Turkey, will now also perform special access activities in Canada to include managing the supply of Ampligen® for the treatment of ME/CFS, for which there is currently no approved product in Canada. Ampligen is approved only in Argentina for severe ME/CFS. Hemispherx has a NDA on file with the U.S. FDA and is developing a protocol for a confirmatory Phase 3 trial.
The first commercial size batch of Ampligen, which will contain ~8,300 vials, is anticipated to be available in May. This is the first of several lots scheduled over the next 18 months. We have recently received a stock order from myTomorrows for 2,100 vials that will be allocated from the first lot of Ampligen produced.
The Canadian SAP will be supported by Millions Missing Canada, a non-profit organization advocating for ME/CFS research funding and treatment access in Canada, which is working with Hemispherx to establish a pathway for government approval of Ampligen for ME/CFS in Canada.
“This is long overdue, and we are delighted myTomorrows is expanding its role with us into Canada to provide a greatly needed option for Canadians suffering the debilitating effects of ME/CFS,” said Thomas K. Equels, CEO of Hemispherx. “Millions Missing Canada brings a strong advocacy and outreach to this program as an invaluable partner in advancing treatments for ME/CFS patients.”
Scott Simpson, an ME patient and advocate with Millions Missing Canada said, "With over 580,000 Canadians diagnosed with ME, and experiencing the highest rates of unmet health care needs according to Health Canada, access to Ampligen is our greatest hope for treatment. For over 3 decades there have been millions of dollars missing from ME research and treatment in Canada, now Canadians living with ME may have a treatment option through the Special Access Program and we are keen to collaborate with Hemispherx and myTomorrows to make that opportunity become a reality. We may get our health, and lives, back."
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.
Cautionary Statement
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.
Contact
Hemispherx Biopharma, Inc.
Phone Number: 800-778-4042
Email: IR@hemispherx.net