QLT announces positive skin cancer results
VANCOUVER, Oct. 31 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSE: QLT) today
announced positive results for its phase II study using photodynamic therapy
with verteporfin to treat non-melanoma skin cancer, the most common form of
skin cancer in the United States.
The study involved 54 patients with a total of 421 tumors who were
randomized to one of three different light doses. The highest light dose was
found to be the most effective, with 98% of the assessed tumors showing a
complete clinical response 6 months after initial treatment. Ninety-two of the
94 tumors biopsied from this group were confirmed to be tumor-free
pathologically.
The open-label trial, which took place at two U.S. and two Canadian
centers, was conducted to determine preliminary safety and efficacy of QLT's
verteporfin at three different light doses on patients with non-melanoma skin
cancer with multiple lesions. Patients were treated with verteporfin and then
followed for six months, with the option of retreatment at three months if a
complete clinical response was not achieved after the initial treatment.
"Many of our resources at QLT have been focused on the ongoing expansion
of Visudyne(TM) therapy and our breakthrough ophthalmology program. This
promising skin cancer study clearly shows our company's ability to
concurrently and effectively advance our other core programs which focus on
cancer, cardiovascular disease and immune disorders," said Dr. Julia Levy,
President and Chief Executive Officer of QLT.
Clinical investigators and patients were asked to assess their level of
satisfaction with the treatment during the study. Both patients and physicians
report an equally high degree of acceptance.
"These results are extremely exciting," said Dr. Harvey Lui, Chairman and
Associate Professor, Division of Dermatology, University of British Columbia
and one of the investigators in the trial. "All of the standard treatments for
non-melanoma skin cancer result in some degree of scarring. Besides obtaining
a very high tumor response rate, the cosmetic outcome of the therapy appeared
to be better than what we have seen with other therapies."
As a treatment for skin cancer, verteporfin is injected into the patient
intravenously and, after one to two hours, selectively concentrates in the
tumor relative to normal tissue. Activation of verteporfin by a non-thermal
light emitting diode (LED) at a wavelength of 689nm at the tumor site produces
a cytotoxic form of oxygen that destroys the cancer cells.
Photodynamic therapy is easy, minimally-invasive and, by virtue of its
ability to better preserve surrounding skin tissue, may have the added benefit
of better cosmetic outcome. Only four percent of the treatment sites required
local anesthesia during treatment. There were no systemic safety issues. Local
pain and discomfort at the treatment sites were among the most common adverse
effects but they were usually well controlled with oral pain relief medicine.
"The advantage of this therapy is that for those patients with a large
number of tumors, the treatment is very efficient," said Dr. Robert
Bissonnette, Assistant Research Professor, University of Montreal Hospital
Centre who was also an investigator in this study. "Up to 20 tumors can easily
be treated in one session with photodynamic therapy versus only 3 or 4 per
session with standard therapies." Standard therapies include surgical excision
and cryotherapy, a procedure that involves destroying the cancerous tissue
through freezing with liquid nitrogen.
Approximately one million new patients are diagnosed with non-melanoma
tumors in North America annually. It is estimated that approximately 50,000
patients develop multiple non-melanoma skin cancers every year. At present, it
is the most common cancer in the U.S., accounting for nearly half of all
malignancies. Sun exposure and loss of the ozone layer play a large role in
cancer development among the growing population of individuals who are
diagnosed with this disease. Areas of the body which are most frequently
exposed to the sun - including the face, neck and hands - are among the most
likely areas to develop skin cancer tumors.
QLT Inc. is a world leader in the development and commercialization of
pharmaceutical products for use in photodynamic therapy, a field of medicine
utilizing light-activated drugs in the treatment of disease. QLT's innovative
science has advanced photodynamic therapy beyond applications in cancer
towards potential breakthrough treatments in ophthalmology and autoimmune
disease. QLT's portfolio of products includes Visudyne therapy a treatment for
age-related macular degeneration, the leading cause of blindness in men and
women over the age of 50. For more information visit the QLT web site at
www.qltinc.com.
Visudyne(TM) is a trademark of Novartis AG
QLT Inc. is listed on The Nasdaq Stock Market under the trading symbol
"QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
The foregoing information may contain forward-looking statements which
involve known and unknown risks, uncertainties and other factors which may
cause the actual results to be materially different from any future results,
performance, or achievements expressed or implied by such statements. Such
factors include: risks associated with the commercialization of Visudyne(TM)
therapy including patient and doctor demand for the treatment; dependence on
corporate relationships; manufacturing uncertainties; uncertainty of pricing
and reimbursement; uncertainties relating to clinical trials and product
development; QLT Inc.'s history of operating losses and uncertainty of future
profitability; competition; QLT Inc.'s rapid growth; uncertainty regarding
patents and proprietary rights; QLT Inc.'s product liability claims and
insurance; no assurance of regulatory approval; government regulation; QLT
Inc.'s uncertainty of access to capital; anti-takeover provisions; and
volatility of common share price; among others, all as described in the
Company's Annual Information Form on Form 10-K, recent and forthcoming
Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and
Exchange Commission.
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