Dr. Paul Waymack , who lives in Washington DC in the U.S., will be chairman of the board of directors, The company has two late stage (Phase 3) drugs ready for clinical trials.
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Dr. Paul Waymack
Kitov Pharmaceuticals (TLV:MNRM), a drug development company, announced today that it has completed its merger with Mainrom Ltd. (TLV:MNRM), a “shell” company traded on the TASE, (renamed Kitov Pharmaceuticals Holdings Ltd.). According to the agreement, Kitov will be acquired in its entirety by Mainrom. Kitov’s shares will trade on the main board starting July 15th 2013.
Kitov Pharmaceuticals develops combination drugs. Two are in late stage (Phase 3) drugs ready for clinical trials.
The company has already agreed with the FDA about the regulatory requirements for its first combination drug- KIT 302, a combination of Celecoxib (Celecox) and an anti-hypertension drug. Based on written correspondence and an approved SPA from the FDA, the company will conduct only one required Phase 3 clinical trial + 2 relatively minor trials (a drug-drug interaction and PK test, without a need for pre-clinical trials or additional efficacy or safety trials [505(b)2 track].
KIT 302 is intended to treat pain associated with osteoarthritis while eliminating the hypertension elevation characteristics associated with NSAID’s.
Dr. Waymack, who lives in Washington DC in the U.S., will be chairman of the board of directors of Kitov Pharmaceutical Holdings. Isaac Israel of Tel Aviv will be the CEO, and Simcha Rock of Jerusalem will be the CFO.
The company was founded by Paul Waymack, M.D., Sc.D., a former academic transplant surgeon and former FDA medical officer ; Morris Laster, M.D., a founding CEO of BioLineRx (TASE: BLRX); and Peter Hoyle, PhD., a former FDA Pharmacologist/Toxicologist .