Live In Play

Live In Play®

Updated: 06-Jul-21 07:18 ET

ORGS: Orgenesis announces it has achieved multiple Ranpirnase development milestones and provides an update on its resultant plans (5.00)

Orgenesis has completed its pre-Investigational New Drug ("IND") consultation with the U.S. Food and Drug Administration ("FDA") regarding the development of RanTop® (Ranpirnase topical gel) for the treatment of anogenital warts (AGW). The Company is on track to start phase 2 trials in this indication after completing the FDA pre-IND requests.
Two phase 1/2a trials were previously completed for the treatment of AGW caused by human papillomavirus. In both these trials, Ranpirnase 0.1% gel was applied twice daily to the affected areas for up to 8 weeks. The results demonstrated the product's tolerability and signs of preliminary clinical efficacy.