The partnership aims to provide an earlier and more precise method for evaluating cardiac safety
ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that its clinical research unit in San Antonio is a certified and preferred site in iCardiac’s Early Precision QT Program.
The certification enables ICON to offer iCardiac’s Early Precision QT® services for evaluating the cardiac safety of new compounds in Phase I clinical trials. This solution provides clients with an earlier and more precise assessment of the safety risk of their drug and potentially eliminates the need for a separate Thorough QT (TQT) study in later stages of development.
Commenting on the announcement, Steve Unwin, ICON’s Executive Vice President, Early Phase Services, said: “We are looking to streamline the time and cost of early clinical development through our industry-leading technologies, agile and adaptive processes and by collaborating with industry partners who can bring new approaches to drug development. As an iCardiac Certified Site Partner, we can help our clients to assess the cardiac safety of their compounds earlier and more precisely which will enable them to prioritise clinical programs with strong safety profiles. In addition, more accurate early QT studies may eliminate the need for later stage TQT studies, saving our clients significant costs.”
Since 2005, the FDA has required all new compounds in development to be tested for cardiac safety. A dedicated TQT study determines the compound’s impact on the QT interval - the time between the start of the Q wave and the end of the T wave during the heart’s electrical cycle. A prolonged QT interval indicates a potential safety risk for a new drug.
TQT studies typically occur concurrently with Phase II or III trials. However, the results of a prospective validation study, which was carried out in in December 2014 through a collaboration between the FDA and Cardiac Safety Research Consortium, demonstrated that actionable cardiac safety assessments can be conducted in Phase I trials using ECGs collected during routine SAD or MAD studies. iCardiac Technologies’ Early Precision QT methodology was used in the validation study, which ICON is now certified to offer in clients’ SAD/MAD trials.
“ICON and iCardiac have frequently worked together on QT assessment studies, and that working experience has repeatedly confirmed the strong expertise that ICON possesses in ensuring that cardiac safety data of the highest quality is acquired during their Phase I studies,” said Alex Zapesochny, President & CEO of iCardiac Technologies. “We look forward to continuing to work closely with ICON to bring the many benefits of Early Precision QT to their clients.”
About ICON plc
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 77 locations in 38 countries and has approximately 11,700 employees.
ICON Media Contact
+44 (0) 207 067 0190
Email: [email protected]
This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.