Phoenix Biosciences, Inc. updates status in Tanzania

Phoenix Biosciences, Inc. updates status in Tanzania

Since reporting on the Company’s trip to Africa in June 2007, communications with Dr. Julius Massaga and Dr. Janneth Mghamba (the team assigned by the National Institute for Medical Research (NIMR) on behalf of the Tanzanian government to collaborate with the Company on the clinical trial utilizing PBS119 in Tanzania) have been frequent. Despite our best efforts the original timetable we reported on has not been met, but for good reasons. We believe the trials will commence in the first quarter of 2008.

NIMR Ethical Approval Certificate

We were informed last month that we have gained ethical approval but have not received the approval certificate. Two weeks ago we were informed that NIMR had formed a sub-committee specifically to re-review all approved Clinical Trials. Our proposal was recently discussed by the sub committee and we have received their comments and are in the process of responding to them. Although this new procedure has caused us to delay the commencement of the clinical trial, we welcome this approach as it will help us to identify areas which we might have overlooked during the proposal development and preliminary review process.

Clearance timeframe at Tanzania Food and Drug Authority (TFDA)

The clearance with the TFDA is dependant upon the completeness of the application which cannot be submitted until we obtain the ethical approval certificate. The application is complete and is awaiting any changes that may result from the ethical review committee.

Visiting to Tanzania

Once we receive the Ethical Clearance Approval Certificate we will travel to Tanzania. This trip will include finalizing the actual contract with Tanzania which will address such issues as gaining approval to distribute PBS119 assuming positive clinical trial results, beginning training for the performance of the trial, reviewing study monitor procedures to comply with United States FDA guidelines to allow for inclusion of the study results in our IND filing amongst other matters.
Phoenix Biosciences, Inc. is an emerging biotech company focused on developing affordable, non-toxic treatments for HIV/AIDS and other viral infections. The company’s current lead research compound, PBS119, is indicated to possess broad-spectrum, HIV-specific, antiviral qualities. Phoenix Biosciences, Inc. is privately-held and headquartered in Hollywood, Florida.