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Drug Substance and Drug Products: AS101's Active Pharmaceutical Ingredients (“API”), the Bulk powder, and AS101 drug products, ointment for topical use and aseptic solution for intravenous (IV) infusion, are synthesized in Israel and in the USA by three reputed GMP manufacturers, according to a validated protocol.

Toxicity: Acute sub-chronic and chronic toxicity studies (up to six months) were conducted in rats and dogs. All studies were in compliance with GLP regulations.

Pharmacokinetics: Pharmacokinetic studies were carried out in mice with three different routes of acute administration (intravenous-IV, intragastric-IG and subcutaneous –SC) and in dogs following IV chronic infusion (for a period of 3 and 6 months, 3 times a week).

Safety: Safety of the AS101 have been established up to a dose of 12mg/m² with minor adverse events (garlic odor (up to 77%), mild or low grade fever (up to 45%), and other low-incidence side effects in 5% to 10% of patients). Grade III fever and nausea and vomiting were observed in concentrations above 12mg/m².

In most clinical trials, the efficacious dose range is 1-5 mg/m2.

Up-to-date, more than 450 patients have been treated with AS101 IV administration in different clinical trials, and more than 300 additional patients have been treated with AS101 in various topical formulations.

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