Twelve Months Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to Be Presented at ENDO 2015 Conference
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), today announced the presentation of two posters at the 97th Annual Meeting of the Endocrine Society (ENDO) on March 5th, 2015 in San Diego, California, that will include twelve months data from OPKO’s advanced phase 2 trial for its long acting human growth hormone hGH-CTP in growth hormone deficient pediatric subjects.
The data to be presented include results for 45 patients completing twelve months of treatments. This phase 2 study is a dose finding study administering three different doses of once weekly hGH-CTP comparing to a fixed dose of daily Genotropin® to growth hormone deficient children. The twelve months data confirm comparable response of hGH-CTP to daily Genotropin®, as reflected by the similar twelve months IGF-1SDS profile, annual height velocity (HV), HV SDS and safety profile. The data affirm the selection of an optimal dose that will potentially demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study in pediatric GHD patients.
OPKO poster presentations include the following:
THR-148: “Top Line Results of 12 Months of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency (GHD)”
Session details: Thursday, March 5; Time: 1:00 – 3:00 PM
THR-151: "Twelve Months Pharmacokinetics and Pharmacodynamics Profile of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Study in Children with Growth Hormone Deficiency"
Session details: Thursday, March 5; Time: 1:00 – 3:00 PM
Visit: https://www.endocrine.org/news-room/endo-annual-meeting
About ENDO Conference
This is a unique opportunity to learn about the latest research in fields as diverse as obesity, endocrine-disrupting chemicals, diabetes, testosterone, infertility, menopause, thyroid conditions and much more. Plenary sessions, symposia, free communications and poster sessions in an interactive environment with international experts will enable exchange of high quality clinical information and basic science and promote international collaboration in research and clinical practice.
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 study results will demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study in pediatric patients, 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, litigation, and the success of our collaboration on hGH-CTP with Pfizer, Inc. 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 March 3, 2015