SOURCE: Amazon Biotech, Inc.

May 02, 2006 01:00 ET

Amazon Biotech Announces Submission to FDA of HIV Test Protocol for AMZ0026 as Add-on to Conventional HAART Therapy in Non-Symptomatic HIV Subjects

NEW YORK, NY -- (MARKET WIRE) -- May 2, 2006 -- Amazon Biotech, Inc. (OTC BB: AMZB) today announced that it has submitted to the FDA its protocol to test AMZ0026 as an antiviral and immuno-modulating agent in HAART-treated HIV subjects. The current study design includes 32 non-symptomatic HIV subjects who are currently treated with Highly Active Anti-Retroviral Therapy (HAART), whereby 50% of the subjects will be continuing their current HAART regimen without change, and 50% will receive AMZ0026 along with their current HAART regimen. The study will entail six months treatment with monitoring of T Cell increases, HIV plasma viral load decreases and improvements in quality of life.

In discussions with the FDA, Amazon Biotech, Inc. was advised to revise the former Phase II HIV protocol to allow for a smaller patient population, clarification of inclusion and exclusion criteria and more specific safety monitoring procedures.

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. An added benefit to using all natural ingredients is the higher probability of an acceptable safety profile.

Amazon Biotech, Inc. is investing its time and capital into filling the obvious 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 side effects to individuals with AIDS when used independently or in concert 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 AIDS and on quality of life when used in unison with HAART therapy, in this six month study.

A parallel placebo-controlled study in the non-symptomatic non-treated HIV population has also been submitted and has been announced in an earlier press release. The placebo-controlled study also plans to enroll 32 subjects (not 60, as previously announced) in subjects infected with HIV-1, but not yet treated with antivirals. T cell levels and HIV viral counts will be monitored.

These protocols are part of an existing IND (Investigational New Drug Application). FDA feedback on these protocols is expected within a few weeks. The Company will provide more details on the FDA's input at a later date.

Approximately 40,000 people are infected with HIV each year in the United States alone and over 3,000,000 people died of AIDS in 2005 (http://www.cdc.gov/hiv/PUBS/Facts/At-A-Glance.htm and UNAIDS).

Submission of a protocol with the FDA does not guarantee that the FDA will approve the protocol, nor does it mean that there won't be changes made in the protocol. Amazon Biotech is working closely with the FDA, hoping to arrive at a protocol that will satisfy first and foremost, all safety concerns and also show efficacy.

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, nor that the study design announced will be the final protocol design.

Contact Information

  • CONTACT:

    LC group
    Rick Lutz
    404-261-1196