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FDA authorizes a clinical study with Alferon LDO for HIV.
2004 APR 1 - (NewsRx.com & NewsRx.net) -- Hemispherx Biopharma, Inc., (HEB) announced the authorization by the U.S. Food and Drug Administration to conduct a clinical trial with Alferon LDO in HIV-infected patients.
The submission of the investigational new drug application for "Human Leukocyte Interferon (Alferon N), Oral," ref. BB-IND 3534, allows the company to initiate a phase II study of Alferon LDO, low dose oral natural alpha interferon, in HIV-positive subjects in early stage of disease. The company expects to initiate the clinical trial in the coming weeks. The trial may be expanded into other life threatening viral diseases.
The objective of the randomized, dose-ranging study is to evaluate the safety and activity of orally administered low dose interferon alpha-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of the natural immune response using cutting edge gene chip technology. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.
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Source: HighBeam Research, FDA authorizes a clinical study with Alferon LDO for HIV.