Healthcare Industry News:  reperfusion injury 

Biopharmaceuticals Gastroenterology Regulatory

 News Release - December 19, 2006

Trillium's TTI-1612 product receives orphan drug designation in Europe and the United States

TORONTO, Dec. 19 (HSMN NewsFeed) - Trillium Therapeutics Inc. (Trillium) today announced that its gastrointestinal product, TTI-1612, has been designated an Orphan Drug by the European Medicines Agency (EMEA), and the U.S. Food and Drug Administration (FDA), for the prevention of necrotizing enterocolitis (NEC).

"Orphan drug status provides TTI-1612 with up to seven and ten years of market exclusivity in the US and Europe respectively, which significantly enhances its commercial potential", said CEO Dr. Niclas Stiernholm. "This may also generate opportunities for additional funding, as well as expert advice and assistance with regulatory issues and trial design."

TTI-1612 is a small, orally-available recombinant protein that has powerful cytoprotective and anti-inflammatory effects. It has shown remarkable efficacy in preclinical animal models of NEC and intestinal ischemia/reperfusion injury, and may have additional utility in the treatment of other intestinal disorders, such as short bowel syndrome, inflammatory bowel disease and chemotherapy-induced mucositis.

"NEC is now the most common surgical emergency procedure in the neonatal intensive care unit. Despite significant advances in neonatal care, the morbidity and mortality rates of this disease have not improved over the past 30 years. Approximately 30% of afflicted neonates die of NEC-related complications", added Dr. Craig Binnie, Trillium's Director, Drug Development. "Trillium's TTI-1612 drug candidate represents a promising new tool in the quest to prevent this devastating condition."

About Trillium:

Trillium Therapeutics Inc. is a private biopharmaceutical company specializing in innovative therapies that restore balance to the immune system in conditions associated with aberrant and harmful immune responses. These include autoimmune and inflammatory disorders, graft rejection, cancer and chronic viral diseases. In addition to its gastrointestinal inflammatory disease program, TTI currently has two scientific platforms encompassing five proprietary product opportunities at various stages of preclinical development. The first platform involves the recently identified CD200 immunoregulatory protein and its receptor. These represent novel targets for the treatment of a variety of autoimmune diseases and cancer. The second platform is focused on the activating receptor, FcRIIa, implicated in several autoimmune diseases, including rheumatoid arthritis and lupus. The company has a broad network of external academic and industry relationships, including some with major US and European biotechnology and pharmaceutical companies.

Source: Trillium Therapeutics

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