Integrium helps clients beat patient enrollment timelines, reduce costs
INTEGRIUM HELPS CLIENTS BEAT PATIENT ENROLLMENT TIMELINES, REDUCE COSTS
Leading Specialized CRO Facilitates Patient Enrollment to Drive Efficiencies,
Ensure Biopharmaceutical Clients are Well-Positioned for Improved Trial Effectiveness
Tustin, Calif. – September 14, 2010 – Integrium LLC, a Contract Research Organization (CRO) specializing in cardiovascular and metabolic disease clinical research, today announced recent success with two of its leading biopharmaceutical customers, Graceway® Pharmaceuticals, LLC and Resverlogix Corp. (TSX: RVX). Integrium helped both companies tighten patient enrollment timelines to dramatically reduce study spend.
Headquartered in Calgary, Resverlogix is focused on developing novel therapies for unmet medical markets, primarily cardiovascular disease (CVD), vascular and inflammatory diseases. Graceway Pharmaceuticals is headquartered in Bristol, Tenn., and focused on acquiring, in-licensing and developing branded prescription pharmaceutical products.
Working in an increasingly competitive landscape thanks to sector consolidation, patent expirations and an outdated blockbuster drug model, specialty CROs like Integrium are well-positioned to meet the demands and requirements of leading sponsors due to its expertise in driving efficiencies during the patient enrollment phase. Integrium has differentiated itself by demonstrating a deep understanding of the complexities and nuances of clinical research in three core therapeutic areas – cardiovascular disease, metabolic disease and dermatology – and by delivering successful clinical study solutions to biopharmaceutical companies.
“Patient recruitment, enrollment and retention continue to represent a critical bottleneck in clinical research and drug development,” said David Smith, M.D., Founding Partner and Chief Medical Officer, Integrium. “We’re pleased to be working with Graceway and Resverlogix to ensure that they have the patient subjects they need to get the highest-quality data to run better, safer trials.”
“Integrium’s keen understanding of our specific therapy areas allows us to stay focused on our primary trial objectives,” said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals. “For a multi-center Phase 2 trial they helped us enroll and randomize many more patients than we thought possible – and did so with a very small drop-out rate and 19 weeks ahead of schedule.”
“Integrium understands that trial efficiencies come from the ground up,” said Dr Allan Gordon, Senior Vice President, Clinical Development for Resverlogix. “The services team understood that we required a ‘true’ partnership and that success would come from understanding our needs and the complexities inherent in running a 40-site study – and their results exceeded our expectations. That they reduced our cycle so dramatically – by nearly six months – allowed us to come in under budget and see the site results we hoped for.”
About Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC (“Graceway”), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Graceway has acquired or licensed products from 3M (NYSE: MMM), Pfizer (NYSE: PFE) and Gilead (NASDQ: GILD). Current prescription products marketed by Graceway include Zyclara™ (imiquimod) Cream, 3.75%, Aldara® (imiquimod) Cream, 5%, Maxair®Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). Zyclara™, Aldara®, Maxair®, Autohaler®, Atopiclair®, and Estrasorb® are trademarks owned by or licensed to Graceway. For more information on Graceway’s products, including important safety information, please visit www.gracewaypharma.com.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs. The NexVas™ Plaque Regression program is the Company’s primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Diabetes, Alzheimer’s disease, Peripheral Artery Disease and other vascular disorders. Resverlogix Corp.’s common shares trade on the Toronto Stock Exchange (TSX: RVX). For further information please visit www.resverlogix.com.
About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients. Combining the Integrium Clinical Excellence (ICE) study start-up and management methodology, and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. For more information please visit www.integrium.com.