QLT PhotoTherapeutics Inc. (QLTIF) hopes to win support for its Photofrin drug as a treatment for brain, head and neck, skin and bladder cancers under the FDA's ''fast-track'' program, QLT chief financial officer Kenneth Galbraith says.
To this end, Vancouver-based QLT hopes to meet with the U.S. agency later this month to discuss the possibility of filing formal applications, Galbraith says.
They are confident of receiving FDA support at the meetings, based on preliminary studies showing that their treatments meet the FDA's basic criteria under the new policy: proof of safety and the ability to extend a patient's life.
Success under the fast-track process would allow the companies to start marketing their proposed treatments significantly sooner than possible under the original rules.
Under the Food and Drug Administration's original rules, a cancer drug is considered for approval after successfully undergoing three levels of clinical tests. The third phase alone, which is meant to statistically prove a drug's effectiveness, can take several years and cost millions of dollars.
QLT Phototherapeutics Inc.'s (QLTIF) Kenneth Galbraith also believes that the safety of Photofrin and its effectiveness will encourage the FDA to ''fast-track'' the drug for several cancer applications.
It's safe, Galbraith says, and it already has FDA approval under the original guidelines to treat esophageal cancer.
In addition, studies carried out independently of QLT indicate that Photofrin achieved successful results, for example, to treat head and neck cancer, Galbraith says.
Dr. Merrill Biel of the Minneapolis Ear, Nose and Throat Clinic in the U.S. reported in March eliminating early-stage head and neck cancer in 85 patients using QLT PhotoTherapeutics Inc.'s (QLTIF) Photofrin treatment. In a paper presented at the Royal Australasian College of Surgeons, Dr. Biel also said the cancer didn't reappear in the treated area during 70 months of follow-up.
Though the Toronto Stock Exchange share prices QLT doubled so far this year, some analysts predict the stock will surge further if the companies are allowed to file applications under the Food and Drug Administration's accelerated approval process.
QLT's recent surge results mainly from the potential of the company's Benzoporphyran derivatives (BPD), which are proving effective in treating the blindness that comes from age-related macular degeneration, she says.
However, Photofrin's potential for various cancer applications will come to the forefront of investors' minds in about five months, as a result of the FDA's new approval policy, the analyst predicts. |
