PHILADELPHIA—While currently available drug-based AIDS therapies can inhibit the HIV virus for many years, a natural compound may actually cure the disease, according to a recent clinical study—a study that could lead to a new paradigm in the treatment of AIDS, according to Dr. William Carter, CEO of Hemispherx Biopharma Inc., an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders.

 

Hemispherx has launched an agreement to seek South African government approval to investigate the use of Alferon N, the only U.S. Food and Drug Administration (FDA)-approved natural interferon, in the suppression of HIV Type 1 replication and the reduction/elimination of functional cell-associated HIV DNA integration (latent HIV). The study is contemplated as part of a broad strategic alliance with Bioclones (Pty) Ltd., a leading South African biotechnology company dedicated to the manufacture of products for human pharmaceutical use.

 

At the Wistar Institute in Philadelphia, a recent clinical study was conducted to test the effect of Interferon Alfa-2a in the suppression and/or eradication of HIV. This pilot study concluded that alpha interferon resulted in control of HIV replication in 45 percent of patients following cessation of antiretroviral therapy. Decreased levels of latent HIV (chromosomal integrated HIV provirus responsible for chronic infection non-responsive to current approved anti-retroviral drugs) occurred in patients in which HIV replication was suppressed by antiretroviral drugs, supporting a role for immune-mediated approaches in HIV suppression and potential eradication of latent virus required for cure. Hemispherx’ flagship products, Alferon N and Ampligen (experimental) are both potentially key players in successful long-term immune-mediated therapy.

 

Hemispherx’ product, Alferon N, is a natural interferon that has certain apparent advantages over recombinant (synthetic) interferons. Unlike synthetic alpha interferons which typically are single species, Alferon N is a multispecies alpha interferon. In a side-by-side clinical comparison, it has a superior safety profile relative to a commercially available synthetic interferon and can be successfully used in the treatment of certain refractory patients. In some studies, Alferon N produces more antiviral control and less neutralizing antibody formation compared to synthetic interferons. It is the only natural source alpha interferon product currently approved by the FDA in the United States. Alferon N is also approved for sale in Argentina for an unrestricted indication of patients that fail or become intolerant to treatment with recombinant interferons.

 

“Alferon N is a unique compound made solely from human blood cells collected from the American Red Cross, so these are blood cells made by the body under normal conditions,” Carter says. “It allows us to attack AIDS from a different perspective with an immunologically based biological therapy that boosts the body’s immune system to find the AIDS virus that hides in sanctuaries and actually destroy it. The addition of the natural interferon may be the magic bullet.”

 

Hemispherx and Bioclones will co-sponsor the clinical study of the safety and biological effects, including clinical, immunologic and virologic assessments, of adding Alferon N to a strategic therapeutic intervention protocol in 30 South African patients with HIV. Bioclones, a global partner to Hemispherx, will serve as the company’s South African representative and will organize the trials to take place in South Africa.

 

In the Wistar study, Interferon Alfa-2a immunotherapy resulted in control of HIV replication and decreased levels of HIV-1 integrated provirus, supporting a role for immune-mediated approaches in HIV suppression and/or eradication. The objective of the Bioclones/Hemispherx program is to build on the Wistar results by increasing the complete response rate. People will be enrolled in the clinical trial in one to two quarters, and results could be available in a year.
“The potential is enormous,” says Carter. “All other antiretrovirals are directed toward setting up individuals for additional treatment regimens. Most vaccines have resulted in progress and have even given people with AIDS two or more decades of normal life, but eventually, the AIDS virus resists the therapy.”

 

He concludes: “More than $1 trillion has been spent on AIDS, and hundreds of millions of people have it. Alferon is 50 to 100 times more active than recombinant interferons and offers a great chance for a real cure.”