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First Patient Treated in Trillium Therapeutics Inc.'s Interstitial Cystitis/Bladder Pain Syndrome Clinical Trial


3/28/2012 10:50:43 AM

TORONTO, March 28, 2012 /PRNewswire/ - Trillium Therapeutics Inc., a privately-held biopharmaceutical company developing proprietary and innovative biologic therapies, today announced that it has dosed the first patient in a phase I clinical trial evaluating TTI-1612, an investigational agent in development for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The study is designed to evaluate the safety and pharmacokinetics of single ascending doses of TTI-1612 in IC/BPS patients. It is being conducted at multiple sites across Southern Ontario and is currently recruiting subjects.

"The start of patient dosing represents a major first step towards a new and innovative treatment option for millions of people who suffer with IC/BPS", commented Trillium's Director, Drug Development, Dr. Penka Petrova. "We look forward to expanding this program into the United States and beyond with the start of our next trial in 2013".

IC/BPS, also known as painful bladder syndrome, is a chronic, debilitating and poorly treated bladder disease affecting millions of people. The disease is believed to develop as a result of dysfunction in the protective epithelial layer lining the bladder. Working with a premier advisory group of leading urologists, Trillium has assembled a robust development program aimed at addressing the underlying cause of IC/BPS. TTI-1612, recombinant growth factor that is administered directly into the bladder, is being developed to correct the dysfunction and restore the bladder epithelium to a normal, healthy state.

"The start of clinical development is a key milestone for Trillium, which will better position us to initiate partnership discussions with leading drug developers, as well as to attract interest from prospective investors. The company intends to secure additional financing in 2012 prior to the start of randomized efficacy studies in 2013", added Trillium's CEO, Dr. Niclas Stiernholm.

More information regarding this trial is available on the U.S. National Institutes of Health clinical trials database at www.clinicaltrials.gov (identifier NCT01559961).

About Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic bladder disease that primarily affects women. It is characterized by increased urinary urgency and/or frequency, nocturia (waking from sleep to urinate) and pelvic pain. These symptoms are often severe, and can impact both the physical and emotional health of patients. For many IC/BPS sufferers, the disease adversely affects all major aspects of their lives, including social relationships, travel, leisure activities and employment. Once considered a rare disease, IC/BPS is now recognized as an increasingly common medical problem. Recently, a large epidemiological study found that 3.3 to 7.9 million women in the US alone suffer from IC symptoms. Current therapies often provide inadequate relief, and many IC/BPS patients report dissatisfaction with available treatment options. Since the current pipeline of new IC/BPS drugs is largely focused on analgesics and is unlikely to significantly alter the IC treatment landscape, novel and innovative approaches to treatment are needed.

About Trillium:

Trillium Therapeutics Inc. is a private biopharmaceutical company specializing in innovative therapies in two main areas: cytoprotection and immune regulation. The company's most advanced program, TTI-1612, is a cytoprotective recombinant growth factor that is being developed for the treatment of interstitial cystitis. The company also has a long-standing interest in the field of immune regulation, in particular the negative pathways that malignant cells exploit to suppress anti-tumour responses. Trillium currently has two preclinical programs, CD200 mAb and SIRPaFc, that target two key immunoregulatory pathways that tumour cells exploit to evade the host immune system. The CD200 mAb is fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumours. SIRPaFc is fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and other tumours. Trillium has a broad network of external academic and industry R&D collaborations, and is supported by three premier Canadian venture capital investors: Covington Capital, Growthworks and BDC Capital.

SOURCE Trillium Therapeutics Inc.



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