Aphios Corp Developing New Manufacturing Process

NIHInformation found in a search of the public NIH database for Therapeutic Cannabinoid Research has turned up an interesting project that is underway.

A new way to make Cannabinoid Medications, including THC, that use the Cannabis Plant as it’s source.

Funded with $1 Million from NIDA, this is kind of surprising.  First the company has had a license to make these substances since 2002 from the DEA and second that NIDA is sponsoring this research.

It is clear that with this research project and the ones being done in secrete by Sigma-Aldrich Pharmaceutical companies see money in Cannabis based medications.

NIDA“The primary goal of this Research program is to develop a process for manufacturing pharmaceutical grade CBD following current Good Manufacturing Practices (cGMP) of the US FDA for use in clinical trials for childhood epilepsy and other CNS indications by the NIH and other Researchers.”

Going even further to say that they can make this from the Cannabis Plant.

We hypothesize that CBD and CW can be cost-effectively manufactured from high CBD content wss_skunk_cured_budCannabis sativa (hemp) utilizing supercritical fluid technology, and that such a process could also produce other bioactive Cannabinoid mixtures for future Research and Therapeutic use. We propose to manufacture pharmaceutical-grade CBD (>98.5% and < 0.3% Δ9-THC) and a standardized CW fraction (30% CBD and < 0.3% Δ9-THC) both following cGMP guidelines by utilizing supercritical fluids and near- critical fluids with or without polar co-solvents such as alcohols (SuperFluids¿). These fluids are gases such as carbon dioxide which when compressed, exhibit enhanced thermodynamic properties that can be “fine-tuned” for rapid and selective extraction of bioactive molecules. We will obtain sufficient quantities of high CBD content Cannabis sativa from growers in Colorado, Maine or Massachusetts and/or NIDA to conduct the proposed Research.

hempThey add  “Under the newly passed Farm bill, recently signed by President Obama, the farming and intra-state transportation of hemp (< 0.3% Δ9-THC) are now exempt from the Schedule 1 requirements of the Drug Enforcement Agency. Since 2002, Aphios has been an approved Schedule 1 Research facility with DEA license No. RC0288058 to Research and develop DEA Schedule 1 products.

Going further they state “The legitimate use of marijuana for several medical indications has far outpaced the medical and Clinical Evaluation of marijuana and specific Cannabinoids for different medical uses. In 1997, the National Institutes of Health convened an Ad Hoc Expert Panel to discuss current knowledge of the medical uses of Cannabis. The report discussed the importance of other Cannabinoids and their potential interaction effects upon THC, stating: “Varying proportions of other Cannabinoids, mainly cannabidiol (CBD) and cannabinol (CBN), are also present in Cannabis, sometimes in quantities that might modify the pharmacology of THC or cause effects of their own. CBD is not psychoactive but has significant anticonvulsant, sedative, and other pharmacological activity likely to interact with THC.” The Institute of Medicine (IOM, 1999) concluded that scientific data indicate the potential Therapeutic value of Cannabinoid drugs, primarily Δ9-THC, for pain relief, control of nausea and vomiting, and appetite stimulation and clinical trials of Cannabinoid drugs for symptom management should be conducted.”

adding “We propose to manufacture pharmaceutical-grade CBD for Clinical Evaluation by the NIH and other pharmaceutical companies for Multiple Sclerosis and other CNS diseases, and a standardized Charlotte’s Web (CW) product for use by medical marijuana dispensaries in Massachusetts and other states for childhood epilepsy.

“PUBLIC HEALTH RELEVANCE: The legitimate use of marijuana for several medical indications has far outpaced the medical and Clinical Evaluation of marijuana and specific Cannabinoids for different medical uses. In 1997, the National Institutes of Health convened an Ad Hoc Expert Panel to discuss current knowledge of the medical uses of Cannabis. The report discussed the importance of other Cannabinoids and their potential interaction effects upon THC, stating: “Varying proportions of other Cannabinoids, mainly cannabidiol (CBD) and cannabinol (CBN), are also present in Cannabis, sometimes in quantities that might modify the pharmacology of THC or cause effects of their own. CBD is not psychoactive but has significant anticonvulsant, sedative, and other pharmacological activity likely to interact with THC.” The Institute of Medicine (IOM, 1999) concluded that scientific data indicate the potential Therapeutic value of Cannabinoid drugs, primarily Δ9-THC, for pain relief, control of nausea and vomiting, and appetite stimulation and clinical trials of Cannabinoid drugs for symptom management should be conducted. We propose to manufacture pharmaceutical-grade CBD for Clinical Evaluation by the NIH and other pharmaceutical companies for Multiple Sclerosis and other CNS diseases, and a standardized Charlotte’s Web (CW) product for use by medical marijuana dispensaries in Massachusetts and other states for childhood epilepsy. “

Link to current information on NIH RePORTS system – LINK

Current information as of July 2016 – 4R44DA038932-02