VDA-1102 ointment is being developed under an IND from the FDA as a topical treatment for a variety of skin cancers. It has completed a randomized, double-blinded, placebo-controlled, dose-escalation Phase 1 study in healthy older-adult volunteers which revealed no safety concerns.
A Phase 2 B was was successfully completed in 2019 (NCT 03538951) demonstrating a 40% Complete Clearance and 80% lesions reduction in 50% of the population with a good skin permeability to the present formulation. A Phase 2C with a slightly enhanced skin permeability is programmed as soon as Corona Pandemics will allow.
In view of the exceptional safety found in the Phase 2B for AK, the Company was allowed to enter directly into a Phase 2 for CTCL. The Phase 2 was initiated in December 2020 under Ministry of Health of Israel at Beilinson Hospital and is to continue through 2022.