Kitov Pharma Issues CEO Shareholder Letter Providing Business Update - Seite 3

NT219:

On May 22, 2020, we announced that the U.S. Food and Drug Administration had accepted our Investigational New Drug application to conduct a Phase 1/2 clinical trial of NT219. The study is designed to evaluate NT219 as a monotherapy treatment for advanced solid tumors and in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

Based on the encouraging pre-clinical data generated in various studies with NT219, as both monotherapy and in combination with cetuximab, we believe this promising drug candidate has the potential to be a safe and effective therapy for multiple hard-to-treat cancers. In addition to U.S. clinical sites, and in order to mitigate a potential COVID-19 pandemic-related slowdown in patient recruitment into the study, we are also including additional clinical sites in Canada.

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered in patients with refractory advanced solid tumors. A second cohort of patients, with either recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be dosed with NT219, dose escalated, in combination with cetuximab. Upon completion of the Phase 1 monotherapy and combination dose escalation portion of the trial, we plan to commence the expansion Phase 2 components of the study at the recommended Phase 2 dose of NT219 in combination with cetuximab. In addition, based on the data obtained in the Phase 1 monotherapy portion, we intend to pursue an expansion Phase 2 study in a yet to be defined indication for NT219 as monotherapy.

The principal investigator of the Phase 1/2 study is Dr. Ezra Cohen, Chief, Division of Hematology-Oncology at the University of California San Diego, and a distinguished key opinion leader. We expect to activate up to eight sites in the U.S. and Canada over the next few months and that our first clinical site will be initiated shortly.

CONSENSI:

On May 20, 2020, we announced the U.S. commercial launch of CONSENSI, a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain. CONSENSI is being sold in the U.S. by Burke Therapeutics, the marketing partner of Kitov’s U.S. distributor, Coeptis Pharmaceuticals.