Kitov Pharmaceutical Holdings Ltd. (TASE: KTOV) today notified the Tel Aviv Stock Exchange (TASE) that, due to the holiday season in the US, the US Food and Drug Administration's (FDA) handling of the company's application for the final statistical plan for the protocols of the Phase III clinical of its drug KIT-302 will likely take an additional 45 days. The company added it has been asked to formally notify the FDA that the clinical trial has not yet begun, and that it will submit the notice in a few days.
Kitov's share price rose 13.4% by early afternoon to NIS 1.25, giving a market cap of NIS 31 million, following the announcement.
Kitov said that it does not expect a delay in the start of the clinical trial, scheduled for the first half of 2014.
FDA approval of the statistical plan is the final stage in the approval process of the study protocols. The FDA has already approved the rest of the protocols under a Special Protocol Assessment with Kitov.
The primary endpoint of the Phase III clinical trial of KIT-302 for the treatment of hypertension is a reduction of at least 50% in observable blood pressure in the treatment group, without the need for pain relievers. The study includes 200 patients in four groups of 30-60 patients each (KIT-302, Anti-HTN, Celecoxib, and a placebo) over a two-week period. The estimated cost of the study is $2 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 5, 2014
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