KTOV SEC filing just out:
On February 7, 2017, the Kitov Pharmaceuticals Holdings Ltd. (the “Company” or the “Registrant”) announced that it is currently being investigated by the Israeli Securities Authority (the “ISA” and the “Investigation,” or “ISA Investigation” respectively). The Company has not yet been advised by the ISA of the full scope and focus of the Investigation. However, the Company has had discussions with the ISA regarding the Investigation, and is now able to provide additional information to the Company’s investors and other stakeholders, with regard to the nature of the ISA’s concerns with respect to the Company.
Based on these discussions with the ISA, the Company now understands that the Investigation with respect to the Company relates to the Data Monitoring Committee (“DMC”) that was appointed in connection with the Company’s Phase III clinical trial of KIT-302. In connection with the clinical trial, the Company appointed an independent statistician and an orthopedist to serve as the Company’s DMC in order to review the preliminary results of the initial patient group, with respect to determining if it would be necessary to increase the number of patients to be enrolled in the clinical trial in order to demonstrate statistical validity required to meet the primary endpoint of the clinical trial.
This DMC’s responsibilities and reporting procedures were detailed in a document that was distributed to all the team members involved in the clinical trial, including the members of the DMC (the “Procedure”). According to this Procedure, a group of external independent statisticians was to receive the preliminary clinical trial results and analyze the standard deviations. The Procedure provided that the independent statisticians would send the analyzed standard deviations to both of the DMC members, who would then review the analysis, and determine whether or not the primary efficacy endpoint was met (i.e. they were to look at the statistician's printout and see if the lower limit of the 95% confidence interval for the KIT-302 drug exceed 50% of the value for amlodipine). The Company understands that the ISA is investigating the circumstances surrounding the actual dissemination of the statistical analysis to the members of the DMC, and whether or not this led to any misleading disclosures in any of the Company’s public filings.
The Company believes that the ISA’s concerns with respect to the DMC are misguided and not consistent with industry accepted U.S. Food and Drug Administration (“FDA”) regulatory requirements, nor with the procedures for the conduct of clinical trials for the purposes of New Drug Application submissions to the FDA. In addition, the Company strongly disputes the legal ramifications of any possible concerns of the ISA with respect to the Company’s disclosures in these matters.
The Company firmly believes that, (i) information relating to the circumstances surrounding the actual dissemination of the statistical analysis to the members of this DMC is not material; and, (ii) that such information was not material at the time of the Company’s announcement of the final clinical trial results. This matter had no impact whatsoever on the validity of the statistical analysis of the KIT-302 Phase III clinical trial data, which met its primary efficacy endpoint with statistical significance. Furthermore, the Company believes that the ISA is not the regulatory body authorized to evaluate the materiality of events and the completeness of public disclosures made by the Company in compliance with United States federal securities laws.
The process actually undertaken by the Company in connection with such clinical trial results, fully complied with the requirements of the FDA, and the Medicines and Healthcare products Regulatory Agency (“MHRA”) and the human ethics committee agreed-to protocol for the Phase III clinical trial of KIT-302 (“Clinical Trial Protocol”). Some clinical studies, mostly in certain types of Phase III clinical trial studies where it is required under the applicable clinical trial protocol, are overseen by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group recommends whether or not a trial may move forward at designated check points based on access to certain data from the study. The clinical study sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate. According to the KIT-302 Phase III Clinical Trial Protocol approved by the above-mentioned regulatory authorities, no data monitoring committee or data safety monitoring board or committee was required at all, and the committee named “DMC” by the Company, had no authority or power to modify or otherwise alter the conduct of the clinical trial, and was not tasked with usual data safety monitoring board or committee responsibilities related to a clinical trial. In accordance with the Clinical Trial Protocol, which had been approved by the FDA, the decision as to whether or not to add additional patients, or to stop patient enrollment, was based solely upon the statistical analysis of the preliminary data performed by an independent statistician (who was also a member of our “DMC”). The statistical analysis of the preliminary data collected in the Phase III clinical trial definitively showed that the study met the pre-specified criteria the FDA required for stopping patient enrollment and completing the final statistical analyses. The statistical analyses of the efficacy data collected in the Phase III clinical trial of KIT-302 resulted in a p-value of less than 0.001, clearly demonstrating that the Phase III clinical trial met its primary efficacy endpoint with statistical significance (any p-value less than 0.05 would have been adequate by statistical standards for proving efficacy).
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The Investigation is still ongoing, and the Company’s officers are fully cooperating with the ISA in its Investigation. The Company’s Board of Directors has expressed its full support of Company management. The Company, its officers and Board of Directors look forward to the conclusion of this Investigation in the most expeditious manner possible.
The Company is continuing with the process of completing a New Drug Application for KIT-302, which is expected to be submitted to the FDA during the second quarter of 2017. In addition, the Company is continuing with all of its other ongoing activities, including its 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 products and activities.
The additional information disclosed herein may not necessarily reflect the full scope or focus of the Investigation or the entirety of any allegations being investigated and/or which may ultimately be raised by the ISA against the Company and/or any of its officers or affiliates. At this preliminary stage, the Company is still unable, with any degree of certainty, to make any other evaluations or any other assessments with respect to the ISA Investigation or the scope of potential exposure, if any.
