First Photodynamic Therapy Drug Cleared by FDA ROCKVILLE, MD, Dec. 27 /CNW/ - QLT PhotoTherapeutics Inc. (QLT) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the proprietary drug, PHOTOFRIN(R) (porfimer sodium) as a treatment for advanced esophageal cancer. PHOTOFRIN(R) is approved for palliative treatment of patients with totally obstructing tumors and partially obstructing esophageal cancers that are unsuitable for treatment with thermal laser therapy.
"Esophageal cancer is a very aggressive disease with a high mortality rate. PHOTOFRIN(R) added to the quality-of-life for patients with advanced disease by improving their ability to swallow," said QLT co-founder and Acting President and C.E.O., Dr. Julia Levy. "We are especially pleased with today's announcement as FDA clearance is the goal every pharmaceutical company strives for."
According to the American Cancer Society, there are more than 12,000 new cases of esophageal cancer in the United States and about 11,000 deaths annually. The five-year survival rate is approximately 10 percent.
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.
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.
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".