Defence Therapeutics Inc. announced that it reached the final stages of its AccuTOX^TM Chemistry, Manufacturing and Controls (CMC) in preparation to IND filling for its Phase I clinical trial to treat melanoma patients at City of Hope, CA, USA. Every experimental drug must undergo rigorous manufacturing and quality control testing prior to IND submission. Biopeptek Pharmaceuticals, LLC using cutting-edge science and technology, was mandated by Defence Therapeutics to complete these final crucial steps.

With its state-of-the-art facilities and experienced scientific team, Biopeptek has optimized formulation and is currently manufacturing and packaging the AccuTOX^TM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements. Biopeptek has already successfully completed a 12-month stability study testing AccuTOX^TM active pharmaceutical ingredient (API).

Testing included temperature fluctuations, humidity as well as strong light treatments. The conclusion is that AccuTOX^TM is stable at temperatures ranging from 5 to -20C which is standard for a peptide API approved by Regulatory Agency. AccuTOX^TM API meets all manufacturing/stability criteria as a standard peptide API used for clinical trial.