Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to Be Presented at the 2014 ICE/ENDO Meeting
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), announced that it will present new clinical data on its long-acting human growth hormone product (hGH-CTP) at the ICE/Endo 2014, the joint meeting of The Endocrine Society and The International Congress of Endocrinology in Chicago on June 21st-24th.
OPKO Biologics (formerly PROLOR Biotech) scientists will present pharmacokinetic and pharmacodynamic data from the company's advanced phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects. The data to be presented include results from the company’s phase 2 trial, which is a one year dose finding study administering hGH-CTP to growth hormone deficient children once a week using daily hGH as a comparator arm. These data affirmed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed hGH, further validating the dosing regimen for the upcoming phase 3 trial. In addition, hGH-CTP demonstrated a very good safety and tolerability profile in this ongoing study, with no unexpected adverse events.
In addition, OPKO will hold a clinical workshop and present to endocrinologists participating in the hGH-CTP clinical studies, top line six month efficacy data from the phase 2 trial.
About Endocrine Society
The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. The Society works to foster a greater understanding of endocrinology amongst the general public and practitioners of complementary medical disciplines and to promote the interests of all endocrinologists at the national scientific research and health policy levels of government. For more information, visit https://www.endocrine.org/endo-2014.
In June 2013, OPKO initiated a pivotal phase 3 clinical trial in adults of its proprietary long-acting version of hGH-CTP. hGH-CTP has been awarded orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.
ABOUT OPKO HEALTH
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of hGH-CTP, whether OPKO's clinical trials for adult and pediatric growth hormone deficiency will generate data to support marketing approval, whether hGH-CTP will be successfully developed or commercialized, expectations regarding the product and its market potential, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released May 20, 2014