ALDA Pharmaceuticals Corp. has received the final results from BioScience Laboratories, Inc. for the T36 formulation tested against 10 different types of viruses.
Of these, 5 types were killed within the minimum 30-second time required by the FDA, including Herpes types I and II and Influenza B. The remaining 5 types, including Polio and Hepatitis A, the hardiest viruses, were killed within 1 to 3 minutes.
Successful completion of these tests allows ALDA to approach Health Canada with a Clinical Trial Application ("CTA") for testing of T36 as a skin antiseptic for surgical use and for personal sanitation. Once the CTA has been approved by Health Canada, human trials can begin. ALDA can also request a "pre-IND" (pre-Investigational New Drug) meeting with the FDA for the same indications. This meeting will determine if any additional tests are required by the FDA before human trials can begin in the US.
Dr Terrance Owen, president and CEO, states, "This is an important milestone for ALDA. Now that ALDA has successfully passed all of the initial microbial tests, we can advance to the next stage and request human trials for registration of T36 as a skin antiseptic for institutional and consumer use. From our extensive toxicology studies, we know that T36 is very safe, as well as being very effective. On this basis, we are hoping for a positive outcome from these meetings".
ALDA is focused on the development of infection-control therapeutics derived from its patented T36 technology. The company trades on the TSX Venture Exchange under the symbol APH.