FREMONT, Calif. and HOFSTADE, Belgium, Oct. 23 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc. (PDL) , a California-based biopharmaceutical company, and the European Crohn’s and Colitis Organization (ECCO) announced today that they are collaborating to increase awareness among European physicians about a clinical research program for visilizumab, an antibody treatment under investigation for intravenous steroid refractory ulcerative colitis (IVSR-UC). The collaboration furthers ECCO’s mission to optimize care for patients with inflammatory bowel disease, a serious condition that affects more than 1.5 million people in Europe.
“Ulcerative colitis may be a devastating disease that affects people who, in the most severe cases, are often faced with life-altering treatments such as colon removal surgery as their only hope of symptom relief,” said Miquel Gassull, M.D., Ph.D., President of ECCO. “ECCO is pleased to be part of advancing research into new treatment options that could represent a much needed treatment alternative for these patients. For ECCO, this is the first time we have collaborated with a sponsor such as PDL to take an active role in helping to support an important clinical research program.”
“We are very pleased to have a relationship with ECCO to ensure the optimal design and conduct of the studies in the RESTORE program, which are evaluating visilizumab, a monoclonal antibody also known as Nuvion(R), as a potential treatment for IVSR-UC. ECCO’s deep knowledge of inflammatory bowel disease and unique structure linking leaders in the field from a wide variety of countries will be a key success factor for the program,” said Steven Benner, M.D., Chief Medical Officer of PDL BioPharma.
The collaboration between PDL and ECCO will ensure accurate and timely communications about the RESTORE program and disease awareness of IVSR-UC through ECCO’s leading network of physicians in Europe. ECCO is committed to leading specific initiatives among members of its network to ensure the success of this relationship.
The RESTORE program includes clinical trials conducted worldwide to evaluate visilizumab as a potential treatment for IVSR-UC. Visilizumab is designed to target and block the action of T cells, the cells believed to cause UC, with the aim of significantly reducing the symptoms of UC and potentially delaying the need for colectomy, or surgical removal of the colon.
The RESTORE trials are currently enrolling patients with IVSR-UC who no longer respond to standard medical therapies in Europe, the U.S. and other countries worldwide. The aim of the trials is to determine if visilizumab can reduce patient symptoms and potentially delay the need for colon removal surgery. Additional studies in the RESTORE program that are assessing long- term safety and retreatment are ongoing.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease caused by an abnormality in the body’s immune system that leads to inflammation and ulceration of the innermost lining of the colon (or large intestine), which can cause diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea 10 to 20 times a day, which may lead to dehydration, fever, hospitalization and the need for blood transfusions. More than one million people worldwide suffer from UC, which primarily affects men and women in their 30s, but can occur at any age. An estimated 25 to 40 percent of these patients eventually fail to respond to standard medical therapy of oral and intravenous steroids.
About ECCO
The European Crohn’s and Colitis Organization (ECCO) is a non-profit scientific organization founded in 2001, currently with 24 member nations. The goals of ECCO are to promote, sponsor and steer European international research efforts in the field of inflammatory bowel disease (IBD) and to develop protocols for studies which can be performed in European centers; to organize education and exchange in the field of IBD; to develop cooperation with patient organizations and other organizations sharing interest in IBD; to establish consensus and challenge dogmas in the field of IBD; to have a political voice in Europe and interact with the pharmaceutical industry; to educate “nurse specialists” in IBD; to participate in the activities of the United European Gastroenterology Federation (UEGF); and to influence the future of IBD management in Europe and beyond. For more information, please visit the ECCO website at www.ecco-ibd.org.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life- threatening illnesses. The company currently markets and sells a portfolio of leading products in the acute-care hospital setting in the United States and Canada and generates royalties through licensing agreements with top-tier biotechnology and pharmaceutical companies based on its pioneering antibody humanization technology. Currently, PDL’s diverse product pipeline includes investigational compounds in Phase 2 or Phase 3 clinical development for inflammation and autoimmune diseases, cardiovascular disorders and cancer. The company’s research platform is focused on the discovery and development of antibodies for the treatment of cancer and autoimmune diseases. For more information, please see PDL’s website at www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.
PDL BioPharma, Inc.
CONTACT: Jean Suzuki, Corporate and Investor Relations of PDL BioPharma,Inc., +1-510-574-1550, or jean.suzuki@pdl.com; or Dr. Daan Hommes, Chairmanof the ECCO Scientific Committee, d.w.hommes@lumc.nl
Web site: http://www.pdl.com/
