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Amazon Biotech Announces Preparation of a Protocol to Test AMZ0026 as an HIV Drug to Delay Onset of Full-Blown AIDS
NEW YORK, March 28, 2006 (PRIMEZONE) -- Amazon Biotech, Inc. (OTCBB:AMZB) today announced that it is designing a protocol to test AMZ0026 as an HIV drug to delay onset of full-blown AIDS. The study is designed to include 60 non-symptomatic HIV-infected subjects who have not been recently treated with any AIDS medications. AMZ0026 versus placebo will be administered for a 6 month treatment period, during which primary endpoint parameters will be monitored, including "T" Cell increases and the amount of HIV virus in the bloodstream.
The drug formulation is based upon the Amazon Biotech, Inc. philosophy of several active ingredients working in combination, utilizing cutting edge whole plant pharmaceutical drug technology to create a natural, healthier pharmaceutical drug.
The current guidelines of the DHHS recommend deferring initiation of conventional anti-retroviral therapy at least until the patient's CD4 (helper T cell) count reaches 350 cells/mm3 or less, in order to "avoid treatment-related negative effects on quality of life and drug-related toxicities, to preserve future treatment options and to delay the development of drug resistance if there is incomplete viral suppression."
A number of AIDS vaccines are in developmental stages, but none have been approved to date, with the stark fact remaining that approximately 40,000 people are infected with HIV each year in the United States alone. The need to prevent transition of HIV to Clinical AIDS is equally apparent when considering that over 3,000,000 people died of AIDS in 2005 (www.cdc.gov/hiv/PUBS/Facts/At-A-Glance.htm and UNAIDS).
Amazon Biotech strives to fill the obvious need for an AIDS prophylactic agent to treat HIV-infected individuals before they develop clinical (symptomatic) AIDS. The new AMZ0026 HIV protocol is designed to evaluate this breakthrough investigational drug's ability to prevent the progression to AIDS in HIV-infected individuals through assessment of AMZ0026's effect on benchmark clinical markers for AIDS in this six month study.
The protocol is expected to be submitted shortly to the FDA as part of an existing IND (Investigational New Drug Application). More details will follow.
A parallel study in the symptomatic AIDS population is also in preparation and will be announced in a separate press release
