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Toronto, ON-- Canada shone on the world stage when ground-breaking
research was announced at the European Investigative Dermatology
annual meeting early this year.
"We were proud of presenting these results at international
meetings," Neil H. Shear, MD, said in a telephone interview
with Dermatology Times of Canada. Phase I ("first in
man") and Phase II ("proof of concept") trials of
a vitamin A metabolite were led by Ed Sellers, MD, chief of Ventana
Clinical Research, University of Toronto, and Dr. Shear, respectively.
The metabolite, 4-oxo-isotretinoin was found to be pharmacologically
active, with half the activity of its parent, isotretinoin. Although
the project was originally designed to characterize the metabolites
of isotretinoin, the result could lead to a "gentler Accutane,"
with slower onset and lower doses, said Dr. Shear, dermatologist
and clinical pharmacologist at Ventana.
Also involved in Phase II were Drs. Kevin Smith (Niagara Falls),
Ron Vender (Hamilton), Jerry Tan (Windsor), Maha Haroun (Toronto),
Sheetal Sapra (Oakville), Charles Lynde (Toronto), and Rod Kunynetz
(Toronto). Gail Somer, Ventana's vice president of clinical trials,
did an "amazing" scheduling job under the pressure of
a three-month deadline, Dr. Shear said.
Early-stage research is rarely done in Canada, but he feels it could
be, and should be, for a variety of reasons. Canadians have the
expertise, and the economics are superior to European countries.
"Industry in Canada should be going to their head offices and
saying, 'We can do these in Canada,'" Dr. Shear said. Indeed,
this is what happened with the 4-oxo-isotretinoin project when Roche
Canada's associate medical director, Lynne Bulger, approached her
head office in Basel, Switzerland with the idea. Dr. Ulf-W. Wiegand,
international clinical leader for dermatology in Basel, was convinced,
and in the end he was very impressed with the way Canadian scientists,
Health Canada and Roche Canada pulled together to get the job done.
"Dr. Wiegand said these studies were among the best-run he's
ever done," Lynne Bulger said. "We've had a unique opportunity
to showcase our talent. Developing and demonstrating our competence
in this way should lead to more projects."
The research was good for Roche, and it was a great opportunity
for dermatologists. In this project the researchers were flown to
Leeds, England to receive training from Dr. Bill Cunliffe, developer
of the sebum excretion rate (SER) measurement technique. SER was
used in Phase II as a biomarker for the anti-acne effects of isotretinoin
and 4-oxo-isotretinoin.
The Canadian investigators reported that the metabolite was responsible
for half the activity of the parent compound. Further research is
needed to determine what contribution the metabolites make to the
clinical efficacy and side-effect profile of the parent drug.
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