TORONTO, Dec. 19 /PRNewswire/ - 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
"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."
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 Inc.