Today, Insys Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational glioblastoma multiforme (GBM) drug.
The agency granted this designation to Insys’ pharmaceutical cannabidiol (CBD) for the treatment of GBM, the most common and most aggressive malignant primary brain tumor in humans. The designation provides Insys with some financial incentives to support development and seven years of US marketing exclusivity if the drug is approved. The drug has also received ODD for its potential to treat Lennox-Gastaut Syndrome and Dravet Syndrome, rare forms of epilepsy.
“We are pleased to have received orphan drug designation 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,” said Michael L. Babich, President and Chief Executive Officer.
The company also announced that it has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI’s patent rights related to the usage of cannabinoids for the treatment of GBM. Insys 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.
“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,” said Dr. McAllister.
In addition to GBM, Lennox-Gastaut Syndrome and Dravet Syndrome, Insys is evaluating the potential use of pharmaceutical CBD in several additional indications including adult epilepsy, chemotherapy-induced peripheral neuropathy, and addiction in cocaine, amphetamines and opioids.
Source: Insys Therapeutics, Inc.
Last updated: 8/25/14; 3:40pm EST