Medical Professionals
BioMendics will be recruiting soon for the TAMES-02 clinical study: A Phase II, Closed Label, Placebo Controlled, Randomized, Double-Blinded Clinical Trial to Evaluate the Efficacy and Safety of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (TAMES-02), in collaboration with Stanford University School of Medicine’s Department of Dermatology and Northwestern Medicine Department of Dermatology.
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Learn more at clinicaltrials.gov and contact the Stanford or Northwestern study site directly for information about the trial.
Manufacturing: TolaSure® is manufactured as a gel, under current Good Manufacturing Practice standards, for topical use only and may be administered to wounded, healing, or intact skin. Gel excipients are on the U.S. Food and Drug Administration’s list of inactive ingredients and are generally regarded as safe. BM-3103 can be stored at room temperature or refrigerated temperature.
Toxicology Studies in Animals: Evidence from toxicology studies (rodents and swine) completed under Good Laboratory Practice standards supports that BM-3103 is distributed in sufficient concentrations throughout the skin to have a pharmacological effect with limited absorption. Additionally, these studies revealed no clinically significant findings of local or systemic toxic effects after repeated topical application of BM-3103.
Human Clinical Trials: Phase I and Phase II acute wound healing clinical research trials reported no deaths or serious adverse events in healthy volunteers. No patients discontinued use of TolaSure® during the studies, and any adverse events related to erythema or edema peripheral to the wound bed were attributed to the normal wound healing process and most likely a result of frequent bandage changes.