Hemispherx BioPharma, Inc (NYSEMKT:HEB) 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.
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.
Shares of Hemispherx Biopharma closed yesterday at $0.39, down $0.01 or -2.50%. HEB has a 1-year high of $2.64 and a 1-year low of $0.38. The stock’s 50-day moving average is $0.47 and its 200-day moving average is $0.53.
Hemispherx Biopharma, Inc. is a biopharmaceutical company, which engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based disorders. Its products include Alferon N Injection and the experimental immunotherapeutic/antiviral Ampligen. Alferon N Injection is a purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high-purified alpha interferon. Ampligen includes application as a treatment for Chronic Fatigue Syndrome and as a vaccine enhancer for therapeutic and/or preventative development related to influenza and cancer treatments.