NEW YORK, NY--(Marketwired - November 26, 2013) - Plandaí Biotechnology (OTCQB: PLPL) timed its move into medical marijuana research perfectly. This month the U.S. Food and Drug Administration (FDA) approved clinical trials of the cannabis-based drug, Epidolex, and its effects on epilepsy. This approval is a landmark decision by the FDA that puts the drug front and center and may show that the FDA is ready to embrace the drug as a treatment.
The FDA says this epilepsy treatment is 98 percent purified cannabidiol (CBD) made by GW Pharmaceuticals based out of the U.K. Plandaí, a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, announced at the end of October that it had entered the pharmaceutical marijuana industry with its new subsidiary, Cannabis Biosciences, Inc., for the purpose of developing and testing a new Phytofare™ botanical extract derived from cannabinoids.
Plandaí expects to exploit the benefits of phyto-cannabinoids in its extract, Phytofare™ Phyto-cannabinoid Complex, which is an area the FDA clearly wants to learn more about in its approval of clinical trials using the cannabis compound. In the FDA’s statement when it approved the clinical trials using the CBD compound, it said there are around 60 known chemicals contained in cannabis called cannabinoids. Tetrahydrocannabinol (THC), is the component responsible for the drug’s psychoactive nature. CBD, however, is the second most abundant cannabinoid in the cannabis and provides medicinal benefits without the “high.”
Plandaí has stated it could remove the compound THC in its extraction process leaving them with a botanical drug that offers many of the medicinal benefits of cannabis without the “high” the FDA writes about. The new extract will share a similar extraction process to that used by the company for its other Phytofare™ products, and management expects the extract will demonstrate the same high levels of bioavailability and purity.
These FDA approved clinical trials could open the industry up to more treatments being approved sooner rather than later. Plandaí says it expects to begin preliminary bioavailability testing in early 2014, and then later in the year start animal trials to pursue various pharmaceutical and nutraceutical applications.
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