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 (http://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.
About Amazon Biotech, Inc.
Amazon Biotech, Inc. is a natural plant pharmaceutical company, primarily developing immune modulator drugs. AMZ 0026 is the Company's first such drug, to be used for the treatment of HIV/AIDS. The Company plans on initiating Phase I/II clinical studies of AMZ 0026 in the near future, with an eventual goal of attracting a joint venture partner with a major pharmaceutical company in Phase III trials, or follow the FDA Fast Track program to market. Amazon Biotech specializes in natural plant pharmaceutical drugs and is focused on bringing healthier pharmaceutical drugs to market.
Additional information on Amazon Biotech may be found at: http://www.amazonbiotech.com.
Forward-Looking Statements
"Safe-Harbor'' Statement Under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, including statements regarding any potential sales of products as well as statements that include the words "believes,'' "expects,'' "anticipates,'' or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Amazon Biotech, to differ materially from those implied or expressed by such forward-looking statements. Such factors include, among others, the risk factors included in Amazon Biotech's subsequent reports filed with the Securities and Exchange Commission under the Exchange Act. This press release speaks as of the date first set forth above and Amazon Biotech assumes no responsibility to update the information included herein for events occurring after the date hereof.
Commitment to do a study does not represent that the Company has FDA approval on the Protocol to start the study.