>From the Friday, August 21,1998 edition of the Globe and Mail newspaper
Leonard Zehr
Biotechnology Reporter
Shulman seeks people for drug study
Parkinson's trust needs volunteers to determine whether Deprenyl can
increase life span
Seventy-three-year-old Morton Shulman thinks he's found the Fountain of
Youth.
Beginning Monday, the Parkinson's Charitable Trust will begin running ads
in Toronto newspapers looking for 1,500 volunteers to participate in a
long-term study to determine whether the drug Deprenyl can make you live
longer and better.
"Without Deprenyl, I would have been dead in 1989," said Dr. Shulman, who
was instrumental in setting up the trust after he contracted Parkinson's
disease 15 years ago.
Dr. Shulman's study is the latest attempt in a centuries-old search to
stave off the aging process, an obsession that dates back to the 16th
century when Spanish explorer Ponce de Leon, searching for the Fountain of
Youth, discovered Florida instead.
Today, pharmaceutical companies are developing more than 150 medicines for
the debilitating diseases of aging. Moreover, Canadian researchers recently
indentified a gene that plays a central role in aging. And biologists,
studying aging at the cellular and genetic levels, are finding that life
span is far easier to manipulate than they had expected.
"Dr. Shulman has always had a nagging interest that Deprenyl slows down
the breakdown of certain cells in the brain that cause the aging process,"
said Trevor Williams, the former head of the Parkinson Foundation of
Canada. Mr. Williams left the foundation in March and will manage the new
Deprenyl studies as the senior staffer at the Parkinson's trust.
Half of the 1,500 volunteers in the "double-blind" Deprenyl study will
take five milligrams of the drug twice a week beginning in September, while
the other half will take a like amount of a placebo. Dr. Shulman, who says
Deprenyl is harmless and doesn't interact with any other drug, wants
healthy individuals aged 40 to 65 for the 15-year study. Initial results
will be reviewed in five years.
But the real drama will begin in the next 12 months when the Parkinson's
trust will begin testing a newly developed derivative of Deprenyl on 1,500
new volunteers.
In an interview, Dr. Shulman said Jozsef Knoll, the Hungarian
pharmacologist who originally invented Deprenyl, has been working with
animals for the past three years to improve the drug. "By cutting off one
part of the molecular chemical structure, Dr. Knoll has produced a drug
that is 100 times more effective than Deprenyl."
The new drug, which is hush-hush because Dr. Knoll hasn't applied for a
patent yet and hasn't published his findings, will also be tested against
Deprenyl and a placebo next year.
Dr. Shulman said that like Deprenyl, the new drug has no side effects.
"The effect it has on dogs and cats and smaller animals is amazing. Dogs
are living 50 per cent longer and smaller animals, like birds, live twice
as long."
Dr. Shulman and Dr. Knoll have been friends and colleagues for several
decades. Dr. Shulman originally acquired Dr. Knoll's work in 1990 for his
company, Deprenyl Research Ltd., now Draxis Health Inc or Toronto.
Last December, when Draxis sold the rights to an animal version of
Deprenyl to Pfizer Inc., DR. Shulman forced Draxis to issue 200,000
warrents to Dr. Knoll to fulfill part of the original 1990 contract.
Largely at the urging and backing of Dr. Shulman, Dr. Knoll is now suing
Draxis for $100-million (U.S.) claiming breach of contract and infringement
of patent rights. Draxis has countered by suing Dr. Shulman for, among
other things, interfering with its $41-million deal with Pfizer.
According to Dr. Shulman, the only longevity study with Deprenyl on humans
was conducted in 1985 by Walter Birkmayer at the University of Vienna. His
patients - all suffering from Parkinson's - lived on average an additional
15 to 28 months. "It wasn't an ideal study because it wasn't a
double-blind," Dr. Shulman said.
In a double-blind study, neither patients nor researchers know who is
getting the real drug and who is taking the placebo.
Earlier this week, Dr. Shulman offered New York-based Pfizer a chance to
participate in Dr. Knoll's new studies and possibly acquire 50 per cent "of
all our end holdings." Pfizer hasn't responded. But Dr. Shulman believes a
more potent form of Deprenyl will have "important competitive implications"
for Pfizer.
"Dr. Knoll has never been wrong before," Dr. Shulman said. "Can you
imagine the significance if we can prove in humans what we know works in
animals."