Contact: Claire R. Wynters, Public Relations
SARATOGA SPRINGS, NY (May 18, 2007) Criterium, Inc. today announced that it has been selected by Cardium Therapeutics of San Diego, CA over competing vendors to provide it’s Interactive Voice Response System (IVRS) services for conducting a Phase 3 clinical trial to evaluate the effectiveness of Generx™ (alferminogene tadenovec, Ad5FGF-4) in women for the potential treatment of myocardial ischemia (insufficient blood flow within the heart muscle) which gives rise to the clinical symptom of angina associated with coronary heart disease.
For this study, entitled AWARE (which stands for Angiogenesis in Women with Angina pectoris who are not optimal candidates for Revascularization), Criterium will design, validate, and monitor a customized IVRS patient diary that will be utilized in 50 study sites throughout the United States. Criterium will have responsibility for tracking the study patients’ responses and reporting compliance beginning with initial enrollment through the month 6 visit, including querying sites when needed, and providing regular data transfers to Cardium via its EDC vendor for analysis.
“Cardium is pleased to be partnering with Criterium, utilizing their <a href="connect.php">IVR</a> system for our AWARE program,” said Sherri B. Pratt, Senior Manager of Clinical Operations for Cardium. “Their <a href="connect.php">IVR</a> system is efficient and easy to follow for both patients and sites. Their ability to fit into our electronic system is an appreciated feature. The people of Criterium are also quite easy to work with.”
“This clinical trial is a perfect application for our <a href="connect.php">IVR</a> technology,” notes Mary T. Stefanzick, Associate Director of Operations for Criterium, Inc., “we have a system that is extremely flexible and user-friendly. Previous studies for other sponsors have proven our ability to integrate seamlessly with a variety of EDC providers. Because of Cardium’s need for realtime data and population of electronic Case Report Forms (CRF’s), this history is one that will increase the confidence of everyone who participates in this study that the data they receive from us will be reliable and on-time.
Criterium’s Interactive Voice Response System utilizes the telephone as the primary method of patient reporting. Patients record responses via a touch-tone keypad into that computer via PIN secured 800 numbers. Criterium personnel custom design the questionnaire according to sponsor specifications, and program all applications into its secure computer system. This <a href="connect.php">IVR</a> system is capable of randomizing and enrolling quality subjects efficiently, and tracking their responses effectively. It is a system that is FDA 21 CFR Part 11compliant, and achieves a greater measure of flexibility and control than paper diaries and is more cost-effective than hand-held diaries.
Generx™ is considered the first and only DNA-based cardiovascular therapeutic to be advanced to Phase 3 and is believed to be the only current Phase 3 product candidate for the potential treatment of patients with stable angina, a chronic medical condition affecting millions of patients in the U.S. and worldwide.
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies
and the Tissue Repair Company, are medical technology companies primarily
focused on the development, manufacture and sale of innovative therapeutic
products and devices for cardiovascular, ischemic and related indications.
For more information about Cardium and its businesses, products and
therapeutic candidates, please visit cardiumthx.com
or view its filings with the Securities and Exchange Commission.
With headquarters in Saratoga Springs, N.Y., and offices worldwide, Criterium is a small global technology-based contract research organization that offers a unique mix of high quality, innovative clinical-research solutions and communications tools to manage the entire clinical-research process from initial planning to approval. The biopharmaceutical, pharmaceutical, medical-device, and CRO industries benefit from Criterium’s expertise, high-value services and products, and high-end results. Founded in 1991, Criterium’s services are customized to fit each client’s specific needs, providing a seamless flow of data and information from the investigative site through Criterium back to the sponsor.