QLT Photo Therapeutics Inc. (formerly Quadra Logic Technologies
Inc.) is a world-leader in the development of new pharmaceutical
products and applications for Photodynamic Therapy, an emerging
medical technology that utilizes drugs that are activated by light in
the treatment of cancer, ophthalmology and other diseases. The
Company has several drugs under development, including clinical
trials for Benzoporphyrin derivative, a second-generation
photosensitizer. QLT is the first and only company, in any
jurisdiction, to gain regulatory approval to market a light-activated
drug for use of Photodynamic Therapy.
PHOTOFRIN(R) is the first light-activated drug for use in
Photodynamic Therapy to be approved in the United States. It marks
the introduction of a new modality for the treatment of cancer that
has the potential to benefit a great number of people in the U.S.,''
added Dr. Levy.
PHOTOFRIN(R) was discovered by Dr. Thomas Dougherty and fellow
researchers Roswell Park Cancer Institute in Buffalo, New York, and
developed by QLT PhotoTherapeutics Inc., a Canadian biopharmaceutical
company.
In Photodynamic Therapy, the light-activity drug is administered
intravenously to the patient. This is followed by an interval during
which the drug circulates, accumulates and is retained in tumors,
while largely clearing from other tissues. The drug has no apparent
effect on tumors until it is activated by non-thermal light from a
medical laser and produces an active form of oxygen that destroys the
cancers.
The FDA approval also includes marketing clearance for laser
systems and a fiber optic used to activate PHOTOFRIN(R). The device
approvals include: the Coherent Lambda Plus PDL1 and PDL2
Photodynamic lasers, the Laserscope Series 600 Dye modules and the
Series 700 and 800 Laserscope Surgical Lasers, and the OPTIGUIDE(TM)
fibre optic diffuser.
QLT submitted a New Drug Application for PHOTOFRIN(R) and three
device Pre-Market Approval Applications (PMAs) for the therapy in
April 1994. These applications were the first drug-device
combination submissions ever filed in the U.S. for Photodynamic
Therapy.
Clinical data submitted for review by the FDA included results
from the largest multi-center, randomized trial ever conducted for
palliation of advanced esophageal cancer. Results from the study
were published in the December 1995 issue of Gastrointestinal
Endoscopy, a U.S. peer reviewed medical journal. A total of 236
patients with partially obstructing esophageal cancer were enrolled
in the study.
The submission also included very encouraging data from a second
study of PHOTOFRIN(R) in 17 patients with completely obstructing
esophageal cancer who were considered to have no other acceptable
treatment options. All patients who receive PHOTOFRIN(R) will be
photosensitive until the drug has cleared from the body and are
advised to protect themselves from exposure to direct sunlight or
bright lights.
Photodynamic Therapy with PHOTOFRIN(R) has also been approved by
health authorities in Japan, Holland, and Canada for the treatment of
several types of cancer. PHOTFRIN(R) is also under review for
marketing approval in five other European countries. The FDA has
been presented with data from esophageal trials only and plans are
underway to submit data for review from clinical trials involving
other forms of cancer.
QLT has entered into specific alliances for the marketing and
development of Photodynamic Therapy devices in the United States.
These include Laserscope and Coherent Inc., the two major suppliers
of medical lasers cleared by the FDA for use with PHOTOFRIN(R).
QLT is currently in advanced negotiations to finalize a
marketing and distribution agreement for PHOTOFRIN(R) in the United
States.
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