PharmaTher’s Sairiyo receives approval to initiate Phase 1 trial of PD-001

PharmaTherannounced Sairiyo Therapeutics, a company that is forty-nine percent owned by PharmaTher and fifty-one percent owned by PharmaDrug, has received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study investigating a patented reformulated enteric coated version of oral cepharanthine as a potential treatment for Medical Countermeasures and cancer. PD-001 was previously awarded a $3.4 million contract from the Defense Threat Reduction Agency for the Ebola virus. Once completed, the Study entitled “Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess the Bioavailability and Pharmacokinetics Of 15 mg and 30 mg Capsules Containing Oral Enteric Coated Cepharanthine Dihydrochloride in Comparison to 15 mg Oral Cepharanthine Tablets in Healthy Volunteers”, will support Sairiyo’s submission of an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration to commence Phase 2 and Phase 3 clinical trials in the United States. Sairiyo’s wholly-owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty Ltd., is the sponsor of the Study.