ALERT- FDA Approval---LSCP Devices activate this drug!! POSITIVE
This is approval for one indication, with great potential for many other types of cancer--some approved. Also, expect LSCP to release statement explaining why their laser system is superior to their two competitiors. One positive step forward!
QLT PhotoTherapeutics Announces FDA Approves PHOTOFRIN(R) As A Treatment For Certain Early-Stage Lung Cancers
VANCOUVER, Jan. 9 /CNW-PRN/ - QLT PhotoTherapeutics Inc., a
Canadian biotechnology company, announced today that the Food and
Drug Administration (FDA) has given marketing clearance for its
light-activated drug, PHOTOFRIN(R) (porfimer sodium) for Injection, as a potentially curative treatment for certain types of early-stage, microinvasive lung cancer.
Specifically, the FDA approved PHOTOFRIN(R) for the treatment of
microinvasive endobronchial non-small cell lung cancer in patients who are not indicated for surgery and radiotherapy. This means a new option is now available for people whose lung cancer is diagnosed at an early-stage, but for a variety of reasons, are not eligible for surgery and radiotherapy.
Dr, Julia Levy, QLT President and CEO, said, ''This is a landmark decision for PHOTOFRIN(R), photodynamic therapy, and for QLT. It marks the first North American approval of the technology as a potentially curative treatment, which is where photodynamic therapy can provide the greatest benefit to patients.''
Dr. Stephen Lam, one of the investigators in the clinical trials which led to this approval, explains ''Photodynamic therapy offers an effective method to treat lung cancer without removing adjacent, normal lung tissue. In the clinical trials, approximately three quarters of the patients had a complete response following treatment and about half of them are cancer-free in long-term follow-up.'' Dr. Stephen Lam is head of the bronchoscopy program at the British Columbia Cancer Agency in Vancouver, Canada.
Peggy McCarthy, Executive Director of ALCASE (Alliance for Lung
Cancer Advocacy, Support, Education) in Vancouver, Washington said,
''Cure can be achieved when lung cancer is diagnosed at an early stage. The major problem is that currently so few patients are diagnosed early.''
According to the American Cancer Society, the 5-year survival rate for the 178,000 Americans diagnosed with lung cancer every year is only 14%. The poor survival rate is attributable to the fact that only 15% of lung cancer is detected at an early-stage.
Dr. Levy said, ''It is imperative that patients at high risk for getting lung cancer ask their doctor to be tested for the disease on a regular basis. People at high risk include smokers, former smokers, and those with obstructive lung disease or a family history of lung cancer. Improved techniques for early detection makes the outlook for the disease much more promising.''
The FDA approval includes marketing clearance for laser systems and a
fiber optic used to activate PHOTOFRIN(R). The device approvals include: the Coherent Lambda Plus(TM) PDL1 and PDL2 photodynamic lasers, the Laserscope Series 600 and 630 Dye Modules and the Series 800 Laserscope Surgical Laser Systems, and the OPTIGUIDE(TM) Cylindrical Fiber Optic Diffusers.
As a treatment for lung cancer, PHOTOFRIN(R) is injected into a patient intravenously and after a short period of time, selectively concentrates in tumor cells while largely clearing from normal tissue. Activation of PHOTOFRIN(R) by a non-thermal laser light at the tumor site produces a toxic form of oxygen that destroys the cancer cells. Necrotic tissue and exudate are subsequently removed two days later through a bronchoscope.
Principal side effects include a skin sensitivity to light for four to six weeks, and, following the procedure, some patients experience inflammation at the treatment site causing varying degrees of shortness of breath and coughing. Photodynamic therapy is typically done on an out-patient basis.
PHOTOFRIN(R) is marketed exclusively in the U.S. by New York-based
Sanofi Pharmaceuticals Inc., the U.S. pharmaceutical unit of Sanofi, the global health care company with headquarters in Paris. Previously,
PHOTOFRIN(R) was approved in the United States for the palliative
treatment of certain advanced esophageal cancers.
QLT PhotoTherapeutics is a world leader in the development and
commercialization of proprietary pharmaceutical products for photodynamic therapy, a field of medicine that utilizes light-activated drugs in the treatment of cancer, diseases of the eye and other medical conditions. QLT's lead product, PHOTOFRIN(R) has also been approved for the treatment of various cancers by regulatory authorities in Canada, Japan and parts of Europe. QLT's second product, verteporfin (BPD-MA), is in final phases of testing for the treatment of age-related macular degeneration.
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, 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(R) and BPD; uncertainties relating to product development, rapid technological change and competition; uncertainty regarding patents and proprietary rights; product liability claims and insurance; manufacturing uncertainties; uncertainty of pricing and reimbursement; government regulation: and
dependence on corporate relationships. SOURCE: QLT PhotoTherapeutics
Inc.
/CONTACT: QLT Investor Relations Contact: Elayne Wandler Director,
Investor Relations & Corporate Communications, ewandler(at)qlt-pdt.com
or phone (604) 872-7881, ext. 302 or 1-800-663-5486/
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