The safety committee reviewing all safety-related aspects of the clinical trial was satisfied with the profile of AZX100. On this basis, OrthoLogic plans to initiate its next Phase I human clinical trial of AZX100 in dermal or hypertrophic scarring during the third quarter of 2008.
The next Phase I human clinical trial of AZX100 will be a placebo-controlled, single-center dose ranging study to evaluate the safety and preliminary pharmacokinetics of AZX100 in healthy adult subjects undergoing elective skin punch biopsy. Approximately 40 adult subjects will be enrolled at an experienced Phase I clinic. Preliminary results are anticipated for internal analysis by year-end 2008.
Randolph Steer, president of OrthoLogic, said: “The goal of this AZX100 program is to develop a safe and effective medication for a significant unmet market need, and we are on track with announced timelines. Our next step is to move forward with our second planned Phase I clinical trial.”