Opko Health Inc. (NYSE:OPK) has announced the appointment of Dr. Ronald Trust as the Vice President of Regulatory Affairs of the company. Before the new position Trust held a senior regulatory position at Allergan plc. He has spent over 16 years at Pfizer Inc. (NYSE:PFE), working at various regulatory affairs positions. Most recently, he worked as an independent consultant providing strategic regulatory consulting service to the pharmaceutical industry. He has a Ph.D. in organic chemistry from the California Institute of Technology and a Master in Business Administration from Fairleigh Dickinson University.
Dr. Trust has over 40 years of experience in the pharmaceutical industry including 30 years in the regulatory affairs, quality assurance, and safety/risk management. Phillip Frost, M.D the Chairman and Chief Executive Officer of OPKO, noted that all these experience will be of tremendous value as the company continues to bring their product candidates to market
In other, News OPKO recently announced that it would present clinical data from its ongoing extension HGH-CTP study in an oral presentation at the Endocrine Society at the 8th Annual Meeting that will be held on April 1-4, 2016 in Boston MA. The open-label extension study is a continuation of their phase 2 of the one-year dose finding a study that had 53 naïve growth hormone deficient children who received one of the three doses of HGH-CTP on a weekly basis or daily Genotropin as a comparator arm.
The published twelve-month data confirms proportionate response of Hgh-CTP to regular Genotropin as reflected by the twelve-month efficacy, safety, and pharmacodynamics profile. Concerned patients were rolled into open label extension portion of the study while the regular patients were randomized to one of the HGH-CTP dose.
Based on the promising phase 2 trial, OPKO noted that it plans to initiate a global pivotal Phase 3 study later this year. The study will focus on pre-puberty growth hormone-deficient children, evaluating a single weekly dose of HGH-CTP versus daily injection of the growth hormone. The company currently has a collaboration with Pfizer Inc. for the development and commercialization of HGH-CTP.
