Hemispherx Biopharma Inc’s (NYSEAMERICAN:HEB) flagship drug ampligen is approved only in Argentina to battle myalgic ncephalomyelitis, commonly called Chronic Fatigue Syndrome, or ME/CFS. And the company has been seeking ways to expand the drug’s commercialization to treat the disease.
On Monday, the Orlando, Florida-based biotech said it is hopeful about the drug's potential expanded use given a recent Stanford University real-time diagnostic test of patients suffering from ME/CFS. Stanford researchers conducted blood-based test on 20 patients, the company said.
The news pushed Hemispherx’s stock up more than 8% to $0.18 in midday trade.
READ: Hemispherx Biopharma's stock soars on 'significant progress' in ovarian cancer study of Ampligen
People with the disease experience symptoms such as fatigue, sleep abnormalities and pain. But ME/CFS is notoriously hard to diagnose. The disease is diagnosis of exclusion, which means that all other conditions and illnesses that cause the system are ruled out.
The Stanford study essentially demonstrated “an ability to identify moderate to severe ME/CFS patients from normal controls,” the company said.
CEO Thomas Equels called the Stanford study a potential landmark in that “ME/CFS has been thought of by many as a psychological disorder without a physical basis, leaving ME/CFS sufferers with the pain of the disease and a sense of hopelessness. This diagnostic creates a new paradigm of hope for therapy for those with the disease.”
Hemispherx called getting ampligen approved for ME/CFS in the US a "corporate goal.”
Equels said in the statement that the company looks “ forward to the day when we can incorporate such a diagnostic platform into our own clinical testing for ME/CFS. We have the only late-stage drug candidate in the FDA pipeline and have been asked to do a confirmatory clinical trial.”
In the US, Hemispherx sponsors an Expanded Access Program (EAP), known as AMP-511, in which the US Food and Drug Administration has authorized use of ampligen in ME/CFS patients in an effort to expand compassionate care in the absence of commercially approved therapy, the company said.
Hemispherx is studying ampligen to treat ovarian cancer and whether the drug is effective in treating breast cancer in combination with Merck’s (NYSE:MRK) cancer drug Keytruda.
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