MIAMI -- (BUSINESS WIRE) -- OPKO Health, Inc. (NYSE: OPK), a multinational biopharmaceutical and diagnostics company that is developing a novel long-acting human growth hormone product (hGH-CTP) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Tuesday, June 24, 2014 at 8:30 a.m. EDT (7:30 a.m. CDT).
During the call, OPKO Biologics management will discuss data from the company's advanced phase 2 trial of hGH-CTP in growth hormone deficient pediatric subjects. The pharmacokinetic and pharmacodynamics portion of the results will also be presented at a poster presentation on the prior Monday afternoon from 2:00 p.m. to 4:00 p.m. EDT (1:00 p.m. to 3:00 p.m. CDT) during the International Congress of Endocrinology and Endocrine Society's Annual Meeting and Expo at the McCormick Place West in Chicago, IL. The poster is titled “Pharmacokinetics and Pharmacodynamics Profile of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with GH Deficiency”. An additional poster titled “Production and Characterization of MOD-4023, a LONG Acting Growth Hormone and Supporting Clinical and Commercial Drug Product Supply” will be presented in parallel.
The data to be discussed during the call will include six month height velocity and safety data 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 optimal dose and dosing regimen for the upcoming phase 3 trial in pediatric patients. In addition, hGH-CTP demonstrated a very good safety and tolerability profile in this ongoing study, with no unexpected adverse events.
Conference Call and Webcast
OPKO will hold a conference call on Tuesday, June 24, 2014 at 8:30 a.m. EDT (7:30 a.m. CDT). The dial-in numbers are 1-877-407-0789 for domestic callers and 1-201-689-8562 for international callers. A webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.opko.com.
After the webcast, the call will remain available on the OPKO website, www.opko.com, for 30 days.
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.