Download MONTRÉAL (Québec), Canada – August 5, 2013 – gIcare Pharma

gIcare Pharma initiates Phase 2a study of its lead product, GIC-1001,
in sedation-free analgesia for colorectal cancer screening
MONTRÉAL (Québec), Canada – August 7, 2013 – gIcare Pharma Inc today announced the
initiation of a phase 2a study of GIC-1001, a novel orally-administered opioid agonist drug
candidate to provide sedation-free, colonic analgesia in patients undergoing colonoscopy.
The double-blind, randomized, placebo-controlled, dose-ranging trial will enroll 240 patients in
the US and Canada, to assess the efficacy and safety of GIC-1001 for sedation-less colorectal
cancer (CRC) screening using video-colonoscopy.
“GIC-1001 was shown to be safe during Phase I trials and we are pleased to announce that the
first patient has been enrolled and completed treatment,” said Maxime Ranger, Ph.D., President
and Chief Executive Officer, gIcare Pharma Inc.
“The IND has been cleared, and both the FDA and Health Canada agreed with gIcare’s drug
development plan. gIcare pharma obtained the support of regulatory agencies in the use of an
innovative pain assessment methodology as primary endpoint,” said Sander van Deventer, MD,
gastroenterologist and General Partner at Forbion Capital.
“Over the last decade, there has been a significant increase in the use of therapeutics that induce
moderate and deep sedation during colonoscopy procedures. Annual sedation-related costs in
colonoscopy exceed 5 billion dollars in the US and have yet to show a true procedural outcome
benefit”, said Jamie Stiff, Partner at Genesys Capital.
“Contrary to the current standard, GIC-1001 has the potential to provide significant procedural
benefit while removing significant costs associated with moderate and deep sedation. It is clear
that GIC-1001 aligns with the current US shift from fee-for-service to value-driven healthcare in
the era of cost containment” said Dr. Ranger.
Phase 2a Study Design
The Phase 2a, double-blind, placebo-controlled, dose-ranging study is designed to assess the
safety and efficacy of GIC-1001 in 240 adult patients undergoing sedation-free, full colonoscopy.
In the study, patients will be randomly assigned to one of three different dose levels (250, 375 or
500 mg) of GIC-1001, or matching placebo, for a 3-day dose regimen (three times a day) and a
10th dose will be taken about 2 hours prior to the colonoscopy. The pharmacokinetics of GIC1001 will be assessed on a subset of patients (N: 24). gIcare Pharma expects to provide topline
results from the study in the second quarter of 2014.
About Colonoscopy
Video-colonoscopy remains the best tool to screen for colorectal cancer and more than 14 million
endoscopic procedures are performed annually in the US alone. This number includes 9 million
full colonoscopies, which may cause serious discomfort and in many cases, pain. In almost 50%
of cases, deep sedation (i.e. propofol) is used, while the other half of colonoscopies are managed
through the use of moderate sedation (e.g. midazolam/fentanyl).
About GIC-1001
GIC-1001 is an orally-administered, non-centrally-acting opioid agonist interacting with colonic
mu- and kappa-opioid receptors. In addition to colon-restricted analgesia, the drug has significant
antispasmodic effects, which are expected to reduce colonic spasms, facilitate the insertion and
passage of the colonoscope, and then shorten the time to reach the caecum, without interfering
with the patient’s normal gastrointestinal tract motility.
About gIcare Pharma Inc
gIcare Pharma is a specialty company, which develops innovative drugs in gastroenterology. In
2011, the Company acquired a patent portfolio, which included GIC-1001, and envisioned the use
of non-centrally-acting opioid agonist in colonoscopy. For more information, please visit
www.gicarepharma.com
About Forbion Capital Partners
Forbion Capital Partners is a dedicated Life Sciences venture capital firm with offices in Naarden,
The Netherlands, and Munich, Germany. Forbion invests in life sciences companies, particularly
in world-class drug discovery & development as well as med tech companies addressing
substantial unmet medical needs. For more information, please visit www.forbion.com.
About Genesys Capital
Genesys Capital is focused on building companies in the fast-growing sectors of healthcare and
biotechnology. Through its expertise and industry network, Genesys accelerates the development
of commercially viable emerging companies that represent promising biotechnology investment
opportunities. Genesys is one of the largest Canadian-based venture capital firms exclusively
focused on the life sciences industry. For more information, visit www.genesyscapital.com
Contact:
Maxime Ranger, Ph.D.
President and CEO, gIcare Pharma Inc
Tel: +1.514.825.9035
Email: [email protected]
College Hill Life Sciences (media enquiries)
Robert Mayer, Cora Kaiser
Tel : +49 (0)89 5238 8030
Email : [email protected]