VANCOUVER, British Columbia, July 7 /PRNewswire/ -- QLT PhotoTherapeutics Inc. (Nasdaq: QLTIF: Toronto: QLT) announced today it has filed a Supplemental New Drug Submission (S/NDS) with the Canadian Health Protection Branch (HPB) seeking approval of the Company's light-activated drug, PHOTOFRIN(R) (porfimer sodium) for Injection, as a treatment for specific types of lung cancer.
Dr. Julia Levy, QLT President and CEO, says the lung cancer submission is supported by data from clinical trials involving 650 patients in Canada, the United States and Europe. "Our data shows PHOTOFRIN to be promising in treating certain early and late-stage lung cancers," says Dr. Levy. "Although the commercial significance of the Canadian market is much smaller than other markets where we have received or are seeking approval, it is important to us to be able to offer this potential treatment to Canadians."
Dr. Levy said QLT filed a similar application in February with the U.S. Food and Drug Administration.
According to the National Cancer Institute of Canada, lung cancer remains the leading cause of cancer death and the second most frequently diagnosed cancer in both Canadian men and women. In 1996 alone, 20,000 new cases were diagnosed while 17,000 deaths were attributed to this disease.
QLT's S/NDS filed today is for PHOTOFRIN to be used for reduction of obstruction and palliation of symptoms in patients with obstructing endobronchial nonsmall cell lung cancer (NSCLC), and also for the treatment of superficial endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. Three-quarters of all lung cancers are identified as NSCLC.
In two multicenter randomized controlled studies comparing photodynamic therapy using PHOTOFRIN with Nd:YAG laser therapy for the palliation of patients with advanced disease, PHOTOFRIN was reported to be equal to or better than Nd:YAG laser therapy for objective tumor response, palliation of symptoms, and time to local progression.
In those patients with early-stage, superficial lung cancer, results from three single-arm studies showed photodynamic therapy using PHOTOFRIN provided complete tumor responses while preserving normal lung tissue.
Unlike current therapies such as surgery and radiation, photodynamic therapy using PHOTOFRIN offers a low risk of damage to adjacent normal bronchial tissue thereby allowing for retreatment or the use of other modalities if required.
PHOTOFRIN is currently marketed in Canada for the treatment of certain types of bladder and esophageal cancers by Ligand Pharmaceuticals, of San Diego, CA.
PHOTOFRIN has also been approved as a treatment for lung and esophageal cancer in France and the Netherlands; for esophageal cancer in the U.S.; and for early-stage lung cancer, superficial esophageal cancer, superficial and early-stage gastric cancers, early-stage cervical cancer, and cervical dysplasia, a pre-cancerous condition, in Japan. Additional European approvals are expected in 1997.
PHOTOFRIN is activated by light in a process called photodynamic therapy. After PHOTOFRIN is administered intravenously to the patient, it accumulates in tumors. The drug is subsequently activated by non-thermal light from a medical laser producing an active form of oxygen that destroys cancer cells.
QLT PhotoTherapeutics Inc. is a world-leader in the development and commercialization of proprietary pharmaceutical products for photodynamic therapy, an emerging therapy that uses light-activated drugs in the treatment of cancers, diseases of the eye and other medical conditions.
The Company is listed on the Nasdaq National Market under the trading symbol "QLTIF" and on the Toronto Stock Exchange under the trading symbol "QLT."
The foregoing information contains 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, among others, those described in the Company's Annual Information Form, or Form 10-K. Such factors include, among others, the following: risks associated with the commercialization of PHOTOFRIN and BPD; uncertainties relating to product development; the Company's history of operating losses and uncertainty of future profitability; uncertainty of access to additional capital; rapid technological change and competition; uncertainty regarding patents and proprietary rights; product liability claims and insurance; manufacturing uncertainties; anti-takeover provisions; uncertainty of pricing and reimbursement; no assurance of regulatory approval; government regulation; volatility of Common Share price; and dependence on corporate relationships
SOURCE QLT PhotoTherapeutics Inc.
-0- 07/07/97 /CONTACT: Elayne Wandler, Director, Investor Relations & Corporate Communications, ewandler@qlt-pdt.com or Tamara Hicks, Manager, Corporate Communications, thicks@qlt-pdt.com, both of QLT PhotoTherapeutics, 604-872-7881, or 800-663-5486/
(QLTIF) CO: QLT PhotoTherapeutics Inc. ST: British Columbia IN: MTC SU:
(07 Jul 1997 06:03 EDT)