February 22, 2017
Woburn, Mass. – February 22, 2017 − Aphios® Corporation today announced that it is spinning-off Aphios® Pharma to develop FDA-approved, cannabis-based drugs for treating highly unmet Central Nervous System (CNS) disorders such as opioid addiction, epilepsy including childhood epilepsy and multiple sclerosis that are only partially and anecdotally addressed by medical marijuana.
Opioid addiction has grown to epidemic proportions. Current statistics indicate that heroin overdoses have more than tripled over the last four years. Between 26.4 million and 36 million people abuse opioids worldwide with an estimated 2.1 million people in the US reporting substance abuse disorders related to prescription opioid pain relievers with an estimated 467,000 addicted to heroin. Apart from the enormous burdens on the individuals, families and communities, the US economic burden is significant amounting to an estimated $78 billion annually. All current FDA approved opioid addiction drugs including methadone, buprenorphine and naltrexone are themselves opioids, and have formulation, delivery and treatment challenges. Dr. Trevor P. Castor, President and CEO, Aphios® Pharma points out that “Fortunately, medical marijuana and its non-psychotropic component, cannabidiol (CBD) also impact opioid receptors and have been shown, both scientifically and anecdotally, to be potential anti-addiction therapeutics for the growing opioid epidemic.”
However, there is insufficient rigorous clinical evidence of the efficacy of cannabinoids for opioid addiction and other significant CNS disorders, and a lack of availability of pharmaceutical-grade cannabinoids to conduct rigorous clinical trials. These studies must also be conducted in the strict regulatory environments of both the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA). According to Dr. Castor, “We will resolve these issues by manufacturing cannabinoids using proprietary and patented supercritical carbon dioxide and co-solvent extraction and chromatographic purification technologies following current Good Manufacturing Practices (cGMP) of the US FDA. We will accomplish these activities in a DEA Schedule I facility following cGMP guidelines of the US FDA to establish rigorous clinical evidence of drug safety and efficacy.”
From a drug development perspective, cannabinoids are very hydrophobic (poorly water soluble) making their formulation difficult and bioavailability poor. Cannabinoids are also very sensitive to oxygen and unstable, leading to inconsistencies in therapeutic performance. Dr. Castor explains that “Aphios® Pharma will resolve these issues by nanoencapsulating cannabinoids in biodegradable polymer nanospheres using proprietary and patented supercritical fluid technologies to significantly improve cannabinoids stability as well as bioavailability and therapeutic efficacy.”
About Aphios® Corporation
Aphios® Corporation is a clinical stage biotechnology company developing green enabling technology platforms to improve drug discovery, manufacturing, nanotechnology drug delivery and pathogenic safety and, enhanced therapeutic products to improve quality-of-life and treat chronic diseases.
Research related to this press release is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R44DA038932. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.