Amazon Biotech redesigns HIV protocol to test AMZ0026 in conventional therapy

By Elaine Rigoli

Tampa, Fla., April 4 - Amazon Biotech, Inc. said it is redesigning its protocol for phase 1/2 trials to test AMZ0026 as an antiviral and immunomodulatory agent in HIV-positive subjects receiving highly active anti-retroviral therapy (HAART).

The current study design includes 32 non-symptomatic HIV positive subjects who are currently treated with HAART therapy regimens, whereby 50% of the subjects will be continuing their current HAART regimen without change, and 50% will receive AMZ0026 along with their existing HAART regimen.

The new study will entail six months' treatment with monitoring of T cell increases, HIV plasma viral load decreases and improvements in quality of life, according to a news release.

In consultation with the Food and Drug Administration, Amazon Biotech revised the test to allow for a smaller patient population, clarification of inclusion and exclusion criteria and more specific safety monitoring procedures, the release said.

The revised protocol is expected to be submitted shortly to the FDA as part of an existing Investigational New Drug application.

New York-based Amazon Biotech is a natural plant pharmaceutical company, primarily developing immune modulator drugs.

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