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.
Subscribe to our email newsletter
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.