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World-leading Inflammatory Bowel Disease Clinical Investigators Join ENGENE's Newly Established Clinical Advisory Board

January 25, 2012

Vancouver, British Columbia - enGene Inc. is please to announce the establishment of a Clinical Advisory Board comprised of several preeminent clinical investigators in the field of Inflammatory Bowel Disease (IBD). The Clinical Advisory Board will provide the Company with guidance on the regulatory pathway and clinical development of EG-10 for the treatment of ulcerative colitis.


The newly appointed Clinical Advisors are Drs. Brian Feagan, Geert D'Haens and Richard Fedorak. They join Dr. Scott Plevy, who has served as a Scientific Advisor to the Company since 2008, to form the Clinical Advisory Board. This group of clinical experts has held leadership positions in pivotal clinical trials of many approved and new developmental therapies for IBD.

"With support from this group of leading IBD experts, our Company is well positioned to successfully navigate the clinical development for our EG-10 product in the coming years," said Dr. Anthony Cheung, Interim CEO and co-founder of enGene. "Their extensive experience in clinical trial design and implementation, together with their outstanding track record in advancing the care of patients with IBD, is truly unmatched. We are very fortunate to have their support for our program."


Commenting on enGene's technology, Dr. Scott Plevy said, "enGene's technology holds significant potential for the treatment of several autoimmune diseases, including IBD. The possibility of localizing the delivery of immune-modulating biologics to the gut not only opens the door to exploring new treatment paradigms, but also enables clinicians to revisit the role of compounds like IL-10 whose therapeutic potential was limited by dose-related systemic adverse events."


The following summarizes the biographies for members of enGene's new Clinical Advisory Board:


Brian G. Feagan, MD - Dr. Feagan is Professor of Medicine in the Division of Gastroenterology and Director of Robarts Clinical Trials at the University of Western Ontario, London, Canada. Robarts Clinical Trials is a premier academic CRO focusing on IBD and was responsible for successfully executing numerous important trials that have transformed the management of IBD. Dr. Feagan's research efforts focus on the design and implementation of randomized, controlled clinical trials and he has been the lead investigator on numerous large-scale randomized clinical trials for new IBD treatments. His research is very well published in many peer-reviewed medical journals, including 10 original articles in the New England Journal of Medicine.


Geert D'Haens, MD, PhD - Dr. D'Haens is Professor of Inflammatory Bowel Diseases and Head of the Academic Medical Centre (AMC)-IBD Unit at the University of Amsterdam, Netherlands. The AMC-IBD Unit is well known for spearheading many important developments in the treatment of IBD. Notably, the use of anti-TNF antibodies in IBD was first developed at AMC. Dr. D'Haens also founded and led the Imelda GI Clinical Research Centre in Belgium, where clinical testing of many new medications for IBD and colorectal cancer have been conducted. In addition, he co-founded the European Crohn's and Colitis Organization. Currently, he serves as Scientific Secretary for the International Organization for Inflammatory Bowel Disease and Director of Robarts Europe, a new satellite CRO facility of Robarts Clinical Trials. Dr. D'Haens' main research interests are in the fields of IBD, mucosal immunology, gastrointestinal endoscopy and immunosuppression. His clinical and research work is widely published in many high caliber peer-reviewed medical journals.


Richard N. Fedorak, MD - Dr. Fedorak is the Associate Vice President for Research and a Professor of Medicine in the Division of Gastroenterology at the University of Alberta, Edmonton, Canada. He also serves as Director for the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR) and Director of the Northern Alberta Clinical Trials and Research Centre (NACTRC). Outside of the University, he serves as the President of Canadian Digestive Health Foundation (CDHF) and Chairman of World Gastroenterology Organization Research Committee. Dr. Fedorak has an active basic gastrointestinal research laboratory and he leads a large clinical research group that focuses on gastrointestinal diseases. He has been leading clinical development of many novel IBD treatments. Notably, he was the principal investigator in the clinical trial for Schering Plough's Tenovil (injectable recombinant IL-10) in patients with Crohn's disease. Dr. Fedorak has published over 400 peer-reviewed manuscripts and book chapters. He holds editorial positions with many gastrointestinal journals.


Scott E. Plevy, MD - Dr. Plevy is an Associate Professor of Medicine, Microbiology and Immunology at the University of North Carolina (UNC) School of Medicine. Prior to that, he was co-Director of the Inflammatory Bowel Disease Center at the University of Pittsburgh. Dr. Plevy also serves as Chair of the Education Committee for the Federation of Clinical Immunology Societies (FOCIS) and Director of the UNC FOCIS Center of Excellence. He is a current member of the National Scientific Advisory Committee and Chair of the Research Training Award Committee for the Crohn's and Colitis Foundation of America. Dr. Plevy is an elected member of the prestigious American Society for Clinical Investigation. He has been the principal investigator for numerous IBD clinical trials. His research interests include IBD, innate immunity, cytokine biology, and inflammation and his research work is widely published in peer-reviewed journals. Dr. Plevy has served as editor and reviewer for several top ranking scientific and clinical journals and has served on numerous NIH study sections.


About EG-10


EG-10 for treatment of ulcerative colitis localizes the delivery of human IL-10 to the diseased tissue in the intestine. IL-10 is a natural potent anti-inflammatory and tolerogenic cytokine that plays a dominant role in preventing inflammation and inducing immune tolerance in many autoimmune diseases. Recent research unequivocally identified IL-10 as a crucial suppressor of intestinal inflammation associated with IBD and celiac diseases. The effectiveness of injectable IL-10, while demonstrating some therapeutic efficacy in humans with Crohn's disease, is limited by systemic adverse drug effects at higher doses. EG-10 is designed to limit the systemic exposure and thus toxicity of IL-10, while maximizing its local concentration and therapeutic effects in the gut. Significant proof-of-efficacy for EG-10 has been demonstrated in several IBD animal models. The Company has also demonstrated that gut-localized delivery of IL-10 resulted in changes in overall gut immunity, which ultimately led to significant therapeutic benefits in several animal models of autoimmune diseases, including IBD and Type 1 diabetes. EG-10 is a mucosal immunotherapy platform that can be quickly modified to target other immune disorders (e.g. Crohn's disease, prevention of Type 1 diabetes, celiac disease).


About enGene


enGene is a Vancouver-based biotechnology company developing an innovative mucosal immunotherapy platform for treating several prevalent, chronic diseases including inflammatory bowel disease (IBD) and diabetes. enGene Inc. has developed a proprietary, highly flexible, non-integrating biopolymer-based nucleotide (DNA and siRNA) delivery technology that facilitates localized delivery of immune-modulating proteins to the intestinal mucosa for treating various immune disorders. For more information please visit www.engeneinc.com.




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