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Trillium to Commence Clinical Testing of TTI-1612 in Patients with Interstitial Cystitis/Bladder Pain Syndrome

December 15, 2011

TORONTO, Dec. 15, 2011 /PRNewswire/ -Trillium Therapeutics Inc., a
privately-held biopharmaceutical company developing proprietary and
innovative biologic therapies, today announced that it will begin a
phase I clinical trial of its experimental drug, TTI-1612, in patients
with interstitial cystitis/bladder pain syndrome (IC/BPS). The company
has recently received a No Objection Letter to its Clinical Trial
Application from Health Canada’s Biologics and Genetic Therapies
Directorate. The single ascending dose trial, which will be conducted
at multiple sites across southern Ontario, will evaluate the safety and
tolerability of TTI-1612 in IC/BPS patients.

“This clinical trial represents an important first step to what we
believe will lead to a paradigm shift in the treatment of this
devastating disease”, added Trillium’s Director, Drug Development, Dr.
Penka Petrova. “The opportunity to begin testing TTI-1612 directly in
IC/BPS patients is a major advancement of the program, which will
accelerate our progression towards pivotal trials.”

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, a locally-delivered recombinant growth factor, 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″, commented Trillium’s CEO, Dr. Niclas Stiernholm.

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 approached 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 and the prevention of
necrotizing enterocolitis. Trillium also has a broad portfolio of
preclinical immunology programs, including two programs that target the
CD200 immunoregulatory axis: a CD200-specific monoclonal antibody for
the treatment of cancer, and a CD200Fc fusion protein for the treatment
of autoimmune and inflammatory diseases. In addition, the company has
two programs targeting the CD47-SIRPa axis: a SIRPaFc fusion protein
that blocks CD47 and activates macrophages to destroy leukemic stem
cells, and a CD47Fc fusion protein that is being developed to improve
human hematopoietic stem cell engraftment. 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.


Source: PR Newswire