Cell Therapeutics' () Opaxio medicine has been granted orphan-drug designation by U.S. health regulators, the company said Tuesday.
Shares, in early Tuesday trade, gained 17.94 per cent to $2.63 each. Its stock touched as high as $2.74 earlier. ?
The drug, which snagged the orphan drug status to treat malignant brain cancer, is used to treat a range of cancers like ovarian, esophageal, head and neck.?
Orphan drug status is granted by the FDA to novel drugs that seek to treat a rare disease. The status provides the developer with benefits like seven years of market exclusivity, fee waivers as well as tax incentives.
The FDA's decision in this case was backed by preliminary phase 2 results, which revealed progression free and overall survival to be encouraging in patients with glioblastoma multiforme, an aggressive type of brain cancer.
Current standard therapy is less effective in patients with tumours that have unmethylated MGMT, an important DNA repair enzyme. ?
Cell Therapeutics noted a randomized trial is now underway for patients with these types of tumours that will compare standard chemotherapy drugs and radiation to Opaxio and radiation.?
According to the National Cancer Institute, glioblastoma is the most common and deadliest type of brain tumour in adults. It is estimated about 10,000 to 12,000 new cases of glioblastoma will be diagnosed in the U.S. this year. ?
Less than 25 per cent of patients survive two years with current therapies. Survival is shorter for people whose tumours are unmethylated.?
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