|Drug delivery of Photofrin laser-activated dye at the site of a tumor.|
Canada's Concordia Healthcare is initiating a Phase II study to expand the use of its Photofrin combination therapy to include adults with high-grade gliomas, a class of brain and spinal cord tumors, as it continues to aggressively expand the indication of the product to include more forms of cancer.
The combination therapy consists of an intravenously administered photosensitive dye and laser device. Forty to 50 hours after injection, the laser is inserted at the site of the tumor. When the device's red light is emitted, the dye is activated and a cytotoxic reaction occurs, resulting in tumor cell death, according to a Concordia video. The company says the dye also damages blood vessels in the tumor and may stimulate the immune system into attacking other tumor cells.
The Phase II trial at the Medical College of Wisconsin will study the effect of Photofrin on 30 glioma brain tumor patients. There is no control arm. Concordia will measure progression-free survival (the amount of time before patients experience tumor regrowth) and overall survival time following therapy to see if the outcomes are improved compared to typical results, according to ClinicalTrials.gov.
Photofrin is already approved to treat esophageal cancer, non-small-cell lung cancer and high-grade dysplasia in Barrett's esophagus.
Concordia says that the drug delivery method, known as photodynamic therapy, targets tumor-specific cells, not healthy tissue, because the light only activates the dye in the localized area.
The survival rate of patients with brain tumors is 20%, and even lower if the tumors are gliomas. "Photodynamic therapy with Photofrin has the potential to add to the multi-modal approach of surgery and chemotherapy by providing another treatment option for patients with rare cancers for which there is no clear standard of care," said lead investigator Dr. Harry Whelan in a statement.
Dr. Whelan is also leading a Phase I study of Photofrin in patients younger than 18 who have progressive brain tumors. In addition, a Phase III trial of the therapy on unresectable cholangiocarcinoma patients and a Phase II trial on epithelioid malignant pleural mesothelioma (caused by exposure to asbestos) patients are enrolling subjects.
The trials helped push the company's R&D expenditure from $1.9 million in 2013 to $9.3 million in 2014. Revenue from the orphan drug division, consisting of Photofrin and the cancer drug Ethyol, was $10.6 million in 2014, or about 8% of the company's total.
Concordia is seeking to gain approval to sell Photofrin in China with the help of partner Union Med.
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