Revive Therapeutics Ltd (RVVTF)

[Triple9]

On 2/7/17, Revive Therapeutics Announces Initiation of a Phase 2 Study of REV-004 (Bucillamine) in Cystinuria

TORONTO, ONTARIO--(Marketwired - Feb 7, 2017) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV)(OTCQB:RVVTF), a company focused on the research, development and commercialization of novel treatments for serious and unmet medical needs, today announced the initiation of a Phase II clinical study in patients with cystinuria in the U.S. The initiation of the Phase II clinical study for cystinuria follows Revive's recent announcement that the U.S. Food and Drug Administration ("US FDA") has accepted the Company's Investigational New Drug Application ("IND") to commence a clinical trial for REV-004 (Bucillamine) for the treatment of cystinuria. The Company received US FDA orphan designation status for the use of Bucillamine for the treatment of cystinuria.

The Phase II study is the first clinical investigation of REV-004 in patients with cystinuria. Designed as a multicenter, open-label, sequential dose escalation trial, eligible patients will be treated over 7-days with follow-up for safety of an additional 7-days. The study will be performed in up to thirty patients. The primary outcome measures will be the incidence of treatment-emergent adverse events (Safety and Tolerability). The secondary outcome measures are 24-hour urine cystine excretion and 24-hour urine cystine capacity. It is believed that REV-004 will require a lower effective dose, which in turn may result in less adverse events and better patient compliance than other thiol drugs currently approved for cystinuria.

"The initiation of the Phase II study marks another important clinical milestone for Revive," says Fabio Chianelli, President of Revive. "I am very excited to advance our cystinuria treatment into human clinical trials in the U.S., and we look forward to updating the investment and medical communities on our developments as they arise."

https://www.otcmarkets.com/stock/RVVTF/news/Revive-Therapeutics-Announces-Initiation-of-a-Phase-2-Study-of-REV-004--Bucillamine--in-Cystinuria?id=150584&b=y

This FDA Phase 2 Clinical Trial is taking place at Mass General Hospital and NYU School of Medicine.