FLORENCE, Ky., Feb. 22 /PRNewswire/ -- PediaMed -- The Pediatrics Company(TM), a company specializing in the health and well-being of children, announced today that it has completed enrollment requirements for an important new Phase II research study that is evaluating an investigational medication for the treatment of persistent gastrointestinal (GI) dysfunction in children with autism.
“Meeting our goal of patient enrollment in the trial by mid-February conveys the priority that PediaMed places on continued autism research to patients, parents and physicians,” said Jon B. Bruss, MD, MSPH, MBA, chief medical officer, PediaMed Pharmaceuticals. “We believe this trial represents an important achievement in pediatric drug development and will provide clinicians and researchers with critical data that may enable a better understanding of how GI symptoms impact the quality-of-life for children living with autism.”
In April 2005, PediaMed began accepting candidates for the clinical trial. The 22-site, Phase II clinical study is designed to evaluate the efficacy of a specific treatment on improving GI symptoms. The study is also assessing whether the treatment has an impact on the unique emotional and behavioral manifestations of autism. Reaching the target number of enrolled patients is a significant milestone in this challenging medical condition and is essential to evaluating the drugs clinical efficacy.
“Parents of children with autism are highly motivated to find new ways to help their children live more connected and happier lives,” said Raun Melmed, MD, medical director, Southwest Autism Research and Resource Center (SARRC). “The PediaMed trial is among the handful of current studies available, and reaching this enrollment milestone demonstrates the partnership between families and physicians to achieve a common goal.”
“The autism project is one of several pipeline projects, which include products, devices, and platform technologies that PediaMed has in development,” said Thomas Jennings, president, PediaMed Pharmaceuticals. “PediaMed has strategically moved to focus its efforts on these high-value projects and is anticipating several significant milestones in 2006,” he added.
In January 2006, PediaMed successfully concluded the sale and transfer of its sales operations to California based Connectics Corporation. PediaMed is now focused on its proprietary drug- and technology-product pipeline, and on clinical development of pediatric innovation and will build properly targeted sales forces as these projects mature.
About PediaMed - The Pediatrics Company(TM)
PediaMed Pharmaceuticals, Inc. - The Pediatrics Company(TM) is a privately held, specialty pharmaceutical company focused on providing safe and effective medicine to pediatric patients, parents and the healthcare professionals that serve them. In keeping with its mission, the company is identifying underserved pediatric market opportunities in the areas of respiratory/allergy, anti-infectives, gastroenterology, and central nervous system (CNS).
Founded in 1999 and with commercial operations commencing in March 2001, PediaMed is a member of the Union Springs, L.L.C. portfolio of companies, who alongside Essex-Woodlands Health Ventures and Blue Chip Venture Company are key investors. For more information, visit the PediaMed web site at www.pediamedpharma.com.
PediaMed Pharmaceuticals, Inc.
CONTACT: David Patti, Makovsky + Company, +1-212-508-9623,dpatti@makovsky.com, for PediaMed
Web site: http://www.pediamedpharma.com//
