Drug company Verastem, focused on drugs that specifically target cancer stem cells, has announced that it is about to commence a late-stage trial for its potential mesothelioma drug in hopes that they’ll be able to offer meso patients a better and more successful treatment alternative in the near future.
According to a press release by the company, the trial is really a Stage 2 study but the scope and design are indicative of a Stage 3 pivotal trial. The result, they hope, will form the basis of a new drug application as early as about three years from now.
Currently, the only other drug approved by the FDA specifically for the treatment of mesothelioma cancer is Alimta®, manufactured by pharmaceutical giant Eli Lilly and Co. The approval for Alimta came nearly 12 years ago, a true indication that it’s time for a new and better drug that can increase the life expectancy of those with this hard-to-treat cancer.
The trial, nicknamed COMMAND, will involve 350-400 patients who have already exhibited a positive response to Alimta. Half will be given Verastem’s compound, called defactinib, while the other half will be given a placebo.
According to Verastem president and CEO, Robert Forrester, the test will be further split into groups based on levels of the biomarker, merlin, which is a tumor regulator controlled by the NF2 gene. FAK inhibitors such as defactinib have been shown to be most effective in mesothelioma patients with low merlin levels, Forrester explains.
The clinical trial will be conducted at 35 sites in the U.S., UK, Australia, Canada, South Africa, New Zealand and Europe. An interim evaluation is expected in about 18 months. Forrester notes that this will give the first indication of not only whether the trial version of defactinib appears to be effective enough to support an application for approval, but also whether it is effective in patients with low levels of merlin, or in all patients.
Both the U.S. and Europe have already granted orphan drug status to defactnib, which allows for faster review by the FDA (or the British drug administration) and allows it additional time on the market before less expensive generics are permitted.
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