Up $1.60 (so far) this morning on news:
QLT PHOTOTHERAPEUTICS INC. ANNOUNCES RESULTS OF PHOTOFRIN(R) LUNG CANCER TRIALS
PRESENTED AT ASCO CONFERENCE IN LOS ANGELES
LOS ANGELES, May 20 /CNW/ - At the American Society of Clinical Oncology (ASCO) conference held yesterday, investigators presented results from clinical trials studying photodynamic therapy with PHOTOFRIN(R) (porfimer sodium) for Injection, as a treatment for certain types of early- and late-stage non-small cell lung cancers (NSCLC).
e results included as yet unpublished data that led the U.S. Food and
Drug Administration (FDA) to approve PHOTOFRIN in January as a treatment for microinvasive endobronchial NSCLC in patients who are not candidates for surgery and radiotherapy. The FDA decision marked the first North American approval of photodynamic therapy as a potentially curative treatment.
Dr. Stephen Lam, head of the bronchoscopy program at the British Columbia Cancer Agency in Vancouver, and one of the key investigators in the clinical trials that led to the FDA approval, presented the study results at ASCO. The trials, which included a total of 102 patients, were conducted in Canada and Europe.
''It can be concluded from the results that photodynamic therapy with PHOTOFRIN is an effective method for treating early-stage lung cancer which minimizes damage to surrounding normal tissue,'' he said. ''In our clinical trials, approximately three-quarters of the patients had a biopsy proven complete tumor response following treatment and about half of these patients maintained this response in long-term follow-up.''
Following the procedure, approximately 20% of patients experienced a mild to moderate photosensitivity reaction similar to that of a sunburn. As well, some patients experienced inflammation at the treatment site which resulted in varying degrees of shortness of breath and coughing.
''Most adverse events were mild to moderate and self-limiting, however,'' said Dr. Lam.
Separate results presented at ASCO from two additional phase III clinical trials conducted in Europe and North America involving 211 patients compared the effects of photodynamic therapy with PHOTOFRIN versus thermal Nd:YAG laser ablation in the palliation of patients with endobronchial obstruction due to late-stage lung cancer.
''One month after treatment, over half of the PHOTOFRIN treated patients experienced an objective tumor response compared to just less than one-third of those patients treated with thermal YAG ablation,'' said Dr. T.J. Wieman, of the Norton Cancer Center, in Louisville, Kentucky, who participated in the trials. ''Responses were also measured based on symptomatic improvement. The greatest symptom improvements were observed in those patients treated with PHOTOFRIN with moderate to severe symptoms at baseline.''
''The overall safety profile was comparable between photodynamic therapy and thermal YAG. Those adverse events that were reported more frequently with PHOTOFRIN compared to YAG included photosensitivity reaction, dyspnea, hemoptysis, and bronchitis. Apart from photosensitivity, these adverse events often occurred more than 30 days following treatment and were thus more likely related to disease progression than treatment modality,'' said Dr. Wieman.
As a treatment for lung cancer, PHOTOFRIN 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 by 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. PHOTOFRIN, developed by QLT PhotoTherapeutics Inc. of Vancouver, is marketed exclusively in the U.S. by New York-based Sanofi Pharmaceuticals Inc., the U.S. pharmaceutical unit of Sanofi, a Paris-based global health care
company.
QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy. 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 include PHOTOFRIN (porfimer sodium), the world's only approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe; and verteporfin (BPD-MA), a therapy in final stages of testing to treat age-related macular degeneration, the leading cause of blindness among the elderly.
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