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news.Amazon Biotech has gained approval from the FDA for the protocol of its phase I/II trial of its proprietary AMZ0026 therapy in HIV positive patients.
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The approved protocol is designed to test the safety, immunological and antiviral effects of AMZ0026, Amazon Biotech’s anti-HIV parent formula. The double-blind, placebo-controlled clinical trial design involves 32 non-symptomatic HIV subjects who have yet to be treated with highly active anti-retroviral therapy (HAART). The six-month study will include the monitoring of T cell increases and HIV plasma viral load decreases.
“I am excited that we have completed the protocol design and can move forward with the phase I/II and complete negotiations of agreements with AIDS study sites,” said Avraham Harris, director of clinical development and regulatory compliance at Amazon.