LONDON, UK / ACCESSWIRE / October 4, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for Kitov Pharmaceuticals Holdings Ltd (NASDAQ: KTOV), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=KTOV. The Company announced on October 02, 2017, hat the US Food and Drug Administration (FDA) filed its New Drug Application (NDA) for KIT-302, thereby accepting the NDA for a full review. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About KIT-302
Kitov Pharma's lead drug candidate KIT-302 is a patented combination of celecoxib and amlodipine, and is intended to treat osteoarthritis pain and hypertension simultaneously. On July 31, 2017, Kitov Pharma announced that it has submitted a NDA to the US FDA for KIT-302.
The data in KIT-302's pivotal Phase-III clinical trial were generated, collected, validated, and analyzed by leading independent clinical research organizations and service providers, and demonstrated that the Phase-III study of KIT-302 met its primary endpoint with the statistical significance of 0.001. In connection with its determination that Kitov Pharma's application is sufficiently complete to permit a substantive review, the FDA has set a target date of May 31, 2018, to complete its review.
Going Forward
The acceptance of filing of the NDA for KIT-302 represents a key achievement for Kitov Pharma towards commercialization of its lead drug candidate. The Company noted that it intends to work closely with FDA as it reviews the NDA. Kitov Pharma noted that it will look forward to FDA rendering a decision on approval for marketing of KIT-302 during Q2 2018.
J. Paul Waymack, M.D., Sc.D., Kitov Pharma's Chairman of the Board and Chief Medical Officer, commented:
"We are extremely proud of the high-quality NDA package that has now been filed by FDA. We appreciate the hard work of our internal regulatory team in the preparation of NDA package, the participation of various clinics and hospitals in the United Kingdom in the trial, and the European Contract Research Organizations that collected, stored, and performed statistical analysis of the data."
Other Developments
Kitov Pharma's newest drug, NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd, is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models.
On July 18, 2017, Kitov Pharma announced results of a pre-clinical study demonstrating that NT-219, in combination with Keytruda®, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model.
The study, conducted in collaboration with researchers at Bar Ilan University and Rabin Medical Center, assessed NT-219's ability to overcome cancer drug resistance in a patient-derived xenograft (PDX) model of immune-deficient mice, in which a tumor originated from an esophagus cancer biopsy was implanted. The mice were supplemented with immune cells from the same patient (double autologous). While no response was observed with Keytruda® alone or with NT-219 alone, and the tumors aggressively progressed, mice treated concomitantly with a combination of Keytruda® and NT-219 demonstrated complete blockage of tumor progression.
About Kitov Pharmaceuticals Holdings Ltd
Kitov Pharma is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov Pharma 's veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. By lowering development risk and cost through fast-track regulatory approval of novel therapeutics, Kitov Pharma plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives.
Last Close Stock Review
On Tuesday, October 03, 2017, the stock closed the trading session at $1.87, dropping 2.09% from its previous closing price of $1.91. A total volume of 277.99 thousand shares have exchanged hands. Kitov Pharma's stock price surged 2.75% in the last one month and 12.65% in the past three months. The stock currently has a market cap of $306.27 million.
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