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news.The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Insys Therapeutics' pharmaceutical cannabidiol (CBD) to treat glioblastoma multiforme (GBM).
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GBM is the most common and most aggressive malignant primary brain tumor in humans.
Insys Therapeutics president and chief executive officer Michael Babich said the company is happy to have received orphan drug status for this aggressive and often incurable form of brain cancer.
"We look forward to advancing development of this product and offering a potential efficacious treatment for patients," Babich said.
The company has also entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) to license CPMCRI’s patent rights related to the usage of cannabinoids to treat GBM.
Under the licensing deal, the company is collaborating with Dr Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment.
Dr. McAllister said: "Based on previous research conducted with CBD to treat brain tumors, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans."