Hemispherx Biopharma Inc announced that its partner Esteve Laboratorios, Spain, has received import authorization of the Ministry of Health for Ampligen, to conduct a clinical trial in HIV/Hep-C co-infected patients. The Company has shipped the total amount of vials of Ampligen, required for the trial, to Esteve.
In March 2002, Hemispherx S.A, a subsidiary of Hemispherx Biopharma, entered into a Sales and Distribution Agreement with Esteve. Pursuant to the terms of the Agreement, Esteve was granted the exclusive right to market Ampligen in Spain, Portugal and Andorra for the treatment of Chronic Fatigue Syndrome (CFS). In addition to other terms and other projected payments, Esteve agreed to conduct, at its expense, certain clinical trials using Ampligen in the patient population co-infected with Hepatitis C and HIV viruses.
At present, no single drug or biological product has been deemed by internationally recognized regulatory agencies as effective against both viruses, when coexisting in the same patients.
About 40 per cent of people living with HIV are co-infected with HCV, with disproportional high co-infection rates among intravenous drug users. Both HIV and HCV are chronic viral illnesses, and there are similarities in the mechanisms of viral reproduction (also known as replication) and acute infection. Both HIV and HCV replicate in the body at an incredibly fast rate.
Data gathered from 4,000 HIV-infected individuals indicates that liver failure due to HCV is the leading non-AIDS cause of death in people with HIV. Additionally, studies have shown that HIV worsens HCV infection. Individuals co-infected with HIV and HCV are about twenty times as likely to experience liver failure as individuals infected with HCV alone. Just as HIV mutates, resulting in drug-resistant strains, HCV can also mutate. If HCV is under pressure from medications that block replication, it will mutate at increased rates.