Hemispherx Biopharma Announces Collaboration with Millions Missing Canada to Bring Medication to Canadians for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Advocacy Organization to Work with Health Canada with the Goal to Gain Approval
PHILADELPHIA, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) has announced that on Thursday, August 3, 2017 it participated in a meeting in Toronto, Canada with Canadian advocates for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The meeting was lead by Millions Missing Canada and a Canadian physician representing Canadian patients with ME/CFS, in support of a collaborative effort to advance ME/CFS research and potential treatments in Canada. http://www.millionsmissingcanada.ca/links-and-resources/ This joint effort, which includes Dr. Ian Hyams, a leading physician specializing in ME/CFS management is the next step to bringing Ampligen® to Canadians suffering from the disease.
One year ago, Ampligen® became the first drug therapy approved in the world for ME/CFS, receiving government approval from the Republic of Argentina. Applications for Early Access Programs (EAP) in Europe and elsewhere are planned in the coming year. In the United States, Hemispherx has completed a pivotal Phase 3 clinical trial in ME/CFS, where it is the only late-stage drug in the pipeline for this disease. The U.S. FDA has advised that potential approval for commercial sale in the U.S. will require the conduct and review of a follow up confirmatory clinical trial. Ampligen® is also currently being used in patients with pancreatic cancer in an EAP in Europe.
Dr. Hyams is the medical director of the chronic fatigue and pain clinic in West Vancouver, British Columbia ("BC"), specializing in ME/CFS and fibromyalgia management as well as the management of similar disorders. Dr. Hyams is a consultant at the Complex Chronic Diseases Program at BC Woman's Hospital in Vancouver and is a clinical instructor in the Department of Family Medicine at the University of British Columbia with responsibilities in the training of medical students and residents.
Dr. Hyams, who has treated ME patients with Ampligen® in England and United States said that, both in his practice and in the Phase 3 clinical trial data, he has "seen significant improvement in ME patients receiving Ampligen®." Treatment with Ampligen® is by twice weekly intravenous infusions.
"We are pleased to work with Millions Missing Canada on this very important issue," said Thomas K. Equels, CEO and President of Hemispherx. "By working together we hope to be better able to achieve the goal of providing an effective therapy for the hundreds of thousands of people who suffer from ME. This unmet medical need must be addressed. Hemispherx and Millions Missing Canada will follow the model that Hemispherx used to obtain approval in Argentina by seeking a Canadian Pharmaceutical Partner who will file for regulatory approval in Canada."
The plan is to use the existing Ampligen® new drug application database, to gain approval of Ampligen® in severely debilitated ME/CFS patients in Canada.
"Canada has the highest ME rates in the world with 1.9% of the Canadian population suffering from this disease," said Scott Simpson, a ME patient and advocate and representative of Millions Missing Canada. Mr. Simpson further stated "For Millions Missing Canada to collaborate with Hemispherx to bring Ampligen® to Canada brings real data-driven hope to more than half a million Canadians with ME where little existed before."
"The time has come for physicians in Canada to realize that Myalgic Encephalomyelitis (ME) is a severely disabling disease for many, causing an increase in patients going on disability. I have personally witnessed as a physician treating these disorders for the last 25 years the potential for severely afflicted patients to rebuild quality of life, often resulting in patients being able to go back to work. It is an honor for me to be involved in the process of potentially introducing this drug to Canada, which will hopefully lead to many patients in need receiving this treatment," said Dr. Hyams.
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. For more information about Hemispherx visit www.hemispherx.net.
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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given that Millions Missing Canada's efforts will be successful, that the Company will be able to find a partner to assist with the filing of a new drug application for Ampligen® with the Canadian Food and Drug Administration, or that, if submitted, such application will be approved for use in Canada. It also should be noted that the clinical study referenced herein was previously reviewed by the U.S. FDA and is not, in and of itself, a sufficient basis for approval in the United States. The U.S. FDA has advised that potential approval for commercial sale in the U.S. will depend on the conduct and review of a follow up confirmatory clinical trial. Any failure to satisfy the U.S. FDA regulatory requirements or the requirements of other countries, including Health Canada, could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and similar applications in other countries. Additionally, the press release from Millions Missing Canada referred to in this press release mentions testimonials about the effectiveness of Ampligen®. The testimonials therein should not be construed as representative of the data obtained in the Ampligen® clinical study program or as evidence of the safety or effectiveness of Ampligen® in the general population or subpopulations of ME/CFS patients. 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.
CJones & Associates Public Relations