Kitov CEO questioned over Ph III data concerns

By Melissa Fassbender contact

- Last updated on GMT

Kitov CEO questioned over Ph III data concerns
Kitov Pharmaceuticals Holdings Ltd. is standing by the validity of its Phase III clinical trial data results as investigations begin.

The company’s CEO Mr. Isaac Israel, was detained for questioning earlier this week before being released later in the day “under certain limited restrictive terms established by a court​,” Kitov said in a statement.

Per an SEC filing, the Israeli Securities Authority has begun a formal investigation into Kitov’s “public disclosures around its lead drug candidate, KIT-302​.”

Following a request made by the NASDAQ Stock Market, the company provided an update on the investigation today, as trading resumes after being halted on Tuesday, February 7, 2017.

To the best of the company's knowledge, the focus of the investigation is on matters in connection with the Data Monitoring Committee (DMC) appointed in connection with the company’s Phase III trial of KIT-302​,” and what was publically disclosed by Kitov, according to the statement.

The investigation is in its initial stages and Kitov is cooperating fully, according to the SEC filing.

The Phase III study

J. Paul Waymack, M.D., Sc.D., Chairman of the Board and Chief Medical Officer, explained investigators located in England, Scotland, and Northern Ireland generated the trial’s data.

The contract research organization (CRO) DABL Ltd. collected and validated blood pressure data; non-blood pressure data was collected and validated by the CRO Java Clinical Research Ltd.; Statistica Medica Ltd. analyzed the clinical study data.

According to the company, the Phase III study was conducted in accordance with the FDA’s requested and approved method, as part of the Special Protocol Assessment (SPA).

Statistical analysis of the preliminary data collected in the Phase III study showed that the study met the pre-specified criteria the FDA required for stopping patient enrollment and completing the final statistical analysis​,” it said. “The final statistical analysis of the data demonstrated that the Phase III study of KIT-302 met its primary endpoint with statistical significance based upon the efficacy endpoint of less than 0.001​.”

KIT-302 was developed to treat pain caused by osteoarthritis and hypertension. Last week, the company announced expanding patent coverage for KIT-302 to include oral dosage compositions containing both amlodipine and celecoxib.

According to the company, Kitov is continuing with its New Drug Application (NDA) for KIT-302 and expects to file at the end of the first quarter 2017. The company also said it will continue ongoing research and development activities in connection with KIT-302 and TyrNovo’s NT 219.

Waymack said, “Kitov stands fully behind the validity of all of its clinical trial results. The Company continues to move forward toward the filing of our New Drug Application for KIT-302 with the FDA.​”

(Feature image: iStock/BernardaSv)

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