NEW YORK, April 4, 2006 (PRIMEZONE) -- Amazon Biotech, Inc. (OTCBB:AMZB) today announced that it is redesigning its protocol for phase I/II 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 (highly active anti-retroviral therapy) therapy regimens, commonly known as cocktail therapies, 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.
In consultation with the U.S. Food & Drug Administration, Amazon Biotech revised the Phase II AIDS protocol to allow for, along other things, a smaller patient population, clarification of inclusion and exclusion criteria and more specific safety monitoring procedures.
The drug formulation of AMZ0026 is based upon the Amazon Biotech philosophy of potentiation of therapeutic drug effect by combining several active ingredients which work in synergy, utilizing cutting edge whole plant pharmaceutical drug technology to create a natural, healthier pharmaceutical drug.
Approximately 40,000 people are infected with HIV each year in the United States alone, and more than 3,000,000 people died of AIDS in 2005 (http://www.cdc.gov/hiv/PUBS/Facts/At-A-Glance.htm and UNAIDS).
Amazon Biotech, Inc. is investing its time and resources into filling the need for an AIDS therapy capable of effectively eradicating HIV virus, improving immunological markers of the disease, and providing improved quality of life with minimal adverse effects to individuals with HIV / AIDS when used independently from or in unison with conventional HAART therapy.
The revised AMZ0026 HIV protocol is designed to evaluate this breakthrough investigational drug's ability to attain the above-mentioned effects through assessment of AMZ0026's effect on benchmark clinical markers for HIV infection and on quality of life when used in unison with HAART therapy, in this six-month study.
The revised protocol is expected to be submitted shortly to the FDA as part of an existing IND (Investigational New Drug Application). More details will follow.
Commitment to do a study does not represent that the Company has FDA approval on the protocol to start the study, nor that the study design announced will be the final protocol design.
A parallel placebo-controlled study in the non-treated HIV population is also in preparation and has been announced in an earlier press release.
About Amazon Biotech, Inc.
Amazon Biotech, Inc. is a natural plant pharmaceutical company, primarily developing immune modulator drugs. AMZ0026 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 AMZ0026 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.