Tel Aviv, Israel -- February 9, 2017 -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: 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.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare and research professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. KIT-302’s New Drug Application with the U.S. Food and Drug Administration is currently being prepared for submission. Kitov's newest drug NT219, a potential immuno-oncology combination product, is being developed by Kitov's recently acquired subsidiary, TyrNovo Ltd. NT219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT219 demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. By lowering development risk and cost, including via fast-track regulatory approval of novel late-stage and other therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully acquire, develop or commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; the exposure to litigation, including patent litigation, and/or regulatory actions; the final ruling of the Tel Aviv District Court in connection with a motion in connection with our acquisition of holdings in TyrNovo Ltd.; the uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to commercialize our products, and other factors that are discussed in our Registration Statements on Form F-3 filed with the U.S. Securities and Exchange Commission (the "SEC") (file numbers 333-211477, 333-207117, and 333-215037), in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the SEC, including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.
Bob Yedid Managing