Kitov Provides Further Update on Formal Investigation by Israeli Securities Authority
TEL AVIV, Israel, Feb. 09, 2017 (GLOBE NEWSWIRE) -- Kitov Pharmaceuticals Holdings Ltd. (KTOV) (KTOV), an innovative biopharmaceutical company, in response to requests made by the NASDAQ Stock Market, today provided a further update on the recently disclosed formal investigation by the Israeli Securities Authority (ISA) into the Company’s public disclosures around certain aspects of the studies related to its lead drug candidate, KIT-302.
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, the results of which were announced in December 2015, and what information was disclosed publicly by Kitov. A DMC is generally an external independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing, and in the case of the KIT-302 Phase III clinical trial was established in order to analyze the preliminary results of the initial patient group enrolled in the clinical trial and determine the number of additional patients, if any, that Kitov might have needed to recruit in order to demonstrate statistical validity, and to meet the primary end point of the clinical trial.
J. Paul Waymack, M.D., Sc.D., Chairman of the Board and Chief Medical Officer, explained, “The data in Kitov’s pivotal Phase 3 clinical trial were generated by investigators located in England, Scotland and Northern Ireland. The blood pressure data were collected and validated by the clinical research organization (CRO) DABL Ltd., a leader in the provision of centralized ambulatory blood pressure monitoring services for clinical trials. The non-blood pressure data were collected and validated by the CRO Java Clinical Research Ltd., a leading authority on clinical research in Ireland and the United Kingdom. The clinical study data were analyzed by Statistica Medica Ltd, a leading European provider of specialist services for the design and implementation of clinical trials and studies in the pharmaceutical, medical device, diagnostics, food and healthcare industries, including the provision of services in connection with statistical analysis and statistical tests. As background, in the Phase III study of KIT-302, the decision as to whether or not to add additional patients was based upon the statistical analysis of the data performed by an independent statistician in accordance with the FDA’s requested and approved method as part of the Special Protocol Assessment (SPA), as agreed upon between the FDA and the Company. 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. 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.”
Kitov is continuing with the process of completing the preparations for submitting a New Drug Application for KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and hypertension, and which is still expected to be submitted to the U.S. Food and Drug Administration at the end of the first quarter 2017.
In addition, the Company is continuing with all of its other ongoing activities, including its ongoing research and development activities in connection with KIT-302 and TyrNovo’s NT 219, further expanding its intellectual property portfolio and seeking commercialization opportunities for its therapeutic activities.
As is standard practice in Israel during ISA investigations and enforcement proceedings, Mr. Isaac Israel, Kitov’s CEO, was detained for questioning and subsequently released on the same day, under certain limited restrictive terms established by a court, as per standard practice in such ISA investigations.
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