THERATECHNOLOGIES GIVEN GO AHEAD BY HEALTH CANADA FOR CLINICAL
VALIDATION OF ITS PHOTODYNAMIC TREATMENT OF CHRONIC MYELOID LEUKEMIA
MONTREAL, July 13 /CNW-PRN/ - Theratechnologies (TH; ME) has announced
today that it has received authorization from Health Canada's Medical
Devices Bureau to begin clinical validation of its patented photodynamic
treatment with patients suffering from chronic myeloid leukemia (CML).
This trial will be conducted by Dr. Denis Claude Roy, a hematologist at
Maisonneuve-Rosemont Hospital in Montreal. The hospital's ethics
committee has already approved the clinical protocol.
This authorization by Health Canada enables Theratechnologies to
clinically validate this unique process, our second therapeutic product
to enter into clinical trials, and thus be in line with its 1998
strategic plan,'' said Dr. Andr de Villers, President and Chief
Executive Officer. Theratechnologies' ex vivo photodynamic purging
process (PDP) has been classified by Health Canada as a medical device,
and not as a drug or biological product, which could cut down the
clinical validation period considerably compared to standard drug
development and as a result accelerate commercialization.
The efficacy shown by our photosensitive molecule and our photodynamic
device in the course of preclinical trials, combined with the broad
expertise of the clinicians who will be conducting the trial, give us
reason to be confident as we begin clinical validation,'' said Dr.
Nestor Molfino, Vice President, Scientific Affairs.
Theratechnologies' process consists of withdrawing bone marrow or
peripheral blood from patients with cancer, saturating the cancerous
cells with its photosensitive TH 9402 molecule and destroying them using
an activated light source. Theratechnologies has recently received the
notice of allowance for the US patent on its photodynamic device, while
its photosensitive molecule was already patented. Preclinical trials
have shown that this purging process not only destroys cancerous cells
but also allows healthy cells to survive. The healthy cells can then be
reinfused into the patient, through an autologous graft, thus
eliminating the need to find a compatible donor.
Theratechnologies' photodynamic treatment is considered a technological
platform which will apply to other liquid cancers, that is affecting
bone marrow. Theratechnologies is currently conducting preclinical
trials in another indication : non-Hodgkin's lymphoma. Chronic myeloid
leukemia alone represents 11,000 new cases each year in Canada, the
U.S., Europe and Japan. The other indications which could be targeted by
Theratechnologies' technological platform represent approximately
258,000 new cases in these same countries, not including breast cancer.
Theratechnologies is a Canadian biotechnology company that develops
innovative therapeutic products showing strong commercial potential. In
addition to the photodynamic treatment of cancers, Theratechnologies has
two GRF (Growth Hormone-Releasing Factor) analogues used, among other
indications, for tissue regeneration. Theratechnologies plans to
continue developing strategic alliances for its other products included
in its scientific portfolio.
Theratechnologies' press releases as well as any other information
concerning the Company can be accessed on the Internet at the following
site: http :/www.theratech.com
Theratechnologies is listed on the Montreal Exchange (TH)
Theratechnologies' warrants are listed as TH.WT
CO: Theratechnologies Inc. ST: Quebec IN: MTC
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TAke care all and have a great day. HOpe this info benefits those trying
to find out means of therapies for this disease.
God Bless
marty auslander
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