BioMendics is currently recruiting for a clinical study: A Phase I/IIa, Closed Label, Randomized, Pilot Study for the Safety and Efficacy of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex (TAMES), at Stanford University School of Medicine’s Department of Dermatology under the direction of Dr. Albert Chiou, Dr. Jean Tang, and Dr. Joyce Teng.
Learn more at clinicaltrials.gov and contact the Stanford study site directly for information about the trial:
Stanford University School of Medicine
Department of Dermatology
Contact: Surabhi Jain
Manufacturing: BM-3103 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 and serious adverse events in healthy volunteers. No patients discontinued use of BM-3103 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.