8CornerPocket wrote: Claritas Anticipates Response from Australian Ethics Committee by February 18, 2022
Ethics Committee Approval is Final Step Prior to Enrollment of Claritas’ Phase 1 Clinical Study of R-107
SAN FRANCISCO, CA and TORONTO, ON, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that the Australian Human Research Ethics Committee (HREC) will meet on February 16th to review the submission made by the Company for the Phase 1 clinical study of R-107. The Company expects to receive comments or approval from the HREC by February 18th. HREC approval is the final regulatory step prior to initiation of the study. Claritas will begin enrollment in the study immediately following receipt of HREC approval.
Phase 1 Study Overview
The Phase 1 study will be a double-blind, single-center, single ascending dose escalation study that will evaluate the tolerability, safety, and pharmacokinetics of R-107 intramuscular injection. The study will enroll a total of 40 subjects, with 8 subjects in each of 5 cohorts. The study is being conducted at Scientia Clinical Research in Sydney, Australia.
Multiple Phase 2 Studies to be Conducted in 2H 2022
Following completion of the Phase 1 study, Claritas will initiate several Phase 2 clinical studies across multiple clinical indications, including pulmonary arterial hypertension (“PAH”); persistent pulmonary hypertension of the newborn (“PPHN”); and COVID-related sepsis and COVID-related ARDS.
As the Company previously announced, R-107 has been evaluated in validated animal model studies of PAH and sepsis. The costs of these studies were funded through grants provided by the U.S. Department of Health and Human Services. The data from these studies in both PAH and sepsis are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for each of these diseases. In the animal model study of PAH, R-107 was demonstrated to be the first and only drug to produce a durable reversal, or potential cure, of this lethal disease.
R-107 is a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia, and South Korea.