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Helping drug companies pick winners
Clinicians form national network to identify
promising new therapies for allergy and asthma
The AllerGen Network of Centres of Excellence has launched
a new initiative that will fast-track the development of new
asthma and allergy therapies, making Canada an attractive
location for early-stage research and development (R&D).
Industry demand is growing for a unique Canadian service
that could save drug companies hundreds of millions of dollars
in R&D costs by identifying which medicines show promise
for treating asthma and allergies – and which ones are
duds.
Launched in 2005 with funding from AllerGen, the Clinical
Investigator Collaborative (CIC) provides a "one-stop
shop" for pharmaceutical and biotechnology companies
to test early-stage molecules and compounds. The CIC has already
completed three early-stage clinical trials with another three
in line for 2007. Clients include Topigen Pharmaceuticals
(Montreal), Boehringer Ingelheim Ltd. (Mississauga), IVAX
Research (Miami), MedImmune (Frederick, MD) and Alexion Pharmaceuticals
(Cheshire, CT).
"We're getting overwhelmed with the response from
industry. There are even two studies we couldn't take
on because we're too busy," says Dr. Paul
O'Byrne, principal investigator for the CIC and Chair
of Medicine at McMaster University.
| CIC trial moves asthma
therapy to next stage
A potential new therapy for asthma has moved
one step closer to market as a result of studies
conducted by AllerGen's Clinical Investigator
Collaborative (CIC).
Topigen Pharmaceuticals, Inc., an emerging biopharmaceutical
company based in Montreal, has reported positive
results for a new inhalant for people with mild-to-moderate
asthma. It could eventually provide an alternative
to inhaled corticosteroids, which can cause weight
gain, high blood pressure, cataracts and other
side effects.
"This is a significant milestone towards
building Topigen into a leading biopharmaceutical
company focused on developing innovative treatments
for respiratory diseases," said Dr. Paul
Wotton, President and CEO of Topigen.
The Phase II trial of 17 patients was led by
Dr. Paul O'Byrne, Chair of Medicine at McMaster
University and a principal investigator with the
CIC. |
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Canada has broken new ground internationally with the AllerGen
CIC – a unique consortium that pools the nation's collective
expertise in allergy research to conduct early-stage clinical
trials at McMaster, the University of Saskatchewan, University
of Alberta, University of British Columbia and Université
Laval. The CIC provides a cost-effective way to evaluate how
well new molecular compounds treat inflammation in people's
breathing passages.
But the CIC is about much more than clinical trials, stresses
Dr. Judah Denburg, AllerGen's Scientific Director and
CEO. With a broader focus on clinical investigation, Dr. Denburg
says researchers will study the mechanisms of allergic disease,
including what causes it, how it develops and how it persists.
The CIC also assists with the development of research protocols,
regulatory submissions, budget management, and the training
of research assistants, graduate students and postdoctoral
fellows.
"Our goal is not to turn Canada into a clinical trials
machine. We're looking for something more comprehensive,"
says Dr. Denburg, whose Network brings together some
158 investigators and 83 trainees from across Canada. "The
main purpose of CIC is to take the earliest frontier-breaking
medicines for allergy and asthma, test them quickly, understand
how they work and predict whether they will be right for big-scale
market development."
For a fee, pharmaceutical companies work with the CIC to
test therapies and molecules at multiple research centres,
using "gold standard" scientific methods pioneered
by Canadian researchers.
"If you have methods that aren't really well done or
standardized, you might need 50 or 100 patients in the study,"
explains Dr. O'Bryne. "Using our model and multiple
sites, we can produce reliable and reproducible results often
with as few as 20 or 30 patients. It means we can do these
studies with greater speed and efficiency, and that's what
industry is really attracted by."
| Allergy Facts
- Canada ranks near the top of the list of
countries facing a growing epidemic of allergies
- Nearly half of Canadians suffer from some
sort of allergic reaction and 15 to 20 per cent
of children have asthma
- $15 billion cost to the Canadian economy
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Another major benefit to companies is finding out early in
the research cycle if a molecule or drug has potential. It
can take 10 to 12 years to move a molecule from its early
stage to regulatory approval. The CIC can let companies know
within the first three to four years if the molecule works,
saving them millions of dollars in development costs.
"The worst thing that can happen for companies is to
push ahead with a big, very expensive development program
that doesn't produce very much at the end of the day, and
that often happens, unfortunately," says Dr. O'Byrne.
Researchers are in the process of analyzing data from the
first three studies, and the results so far look promising
(see sidebar article on TOPIGEN). The studies examined new
molecules that have never been tested and new combinations
of anti-inflammatories. One study has produced information
on new DNA sequences that could help to reverse a patient's
allergic response.
Dr. Denburg says the studies likely would not have happened
without the CIC: "What will this mean for people with
allergies and asthma? It will mean a better understanding
of the medications they're getting, better medications, better
treatments and possibly even cures."
www.allergen-nce.ca
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