Steele Clarke Smith III is chairman and CEO of C3 International, a post-proof of concept, pre-revenue life sciences company specializing in cannabinoid therapeutics.
C3 achieved proof of concept in 2015.
"I have been in the financial markets ever since, raising the massive amount of capital necessary to build out a GMP manufacturing facility with an ISO-9001 laboratory to produce Idrasil," Smith told Green Entrepreneur during a recent chat.
"Idrasil is born out of necessity from the market's lack of a whole, natural and active, standardized and consistent, divisible and titratable cannabis tablet."
C3's pioneering patient, a 21-year-old San Diego man, came monthly from San Diego for raw cannabis and capsules prepared for him, Smith said. The patient was on an organ transplant list and marked the first reimbursement the company received for medical cannabis in 2007, he said.
Smith and his wife Theresa were indicted for the illegal cultivation of 20,000 marijuana plants on Nov. 1, 2007. As part of a wider DEA operation in Southern California, 46 other early dispensary owners were also indicted.
The other dispensary owners faced other charges in addition to cultivation and were ultimately convicted, Smith said.
"We only had two charges: cultivation and conspiracy to cultivate. Those charges were ultimately dropped because of our strict compliance with California state law and successful threat to invoke the Fourth Amendment of the U.S. Constitution at trial, which never happened. We ultimately [pleaded] guilty to a lesser charge."
After the case ended in 2012, Smith said he decided to develop C3 into a "sophisticated biopharmaceutical company."
C3 is focused on the production of Idrasil, which the company defines as "the first Rx cannabis tablet." The company said Idrasil can be reimbursed by insurance and urges patients to ask their doctors about the pill.
What does it mean that Idrasil is a standardized pill? What makes it a prescription pill?
"Standardized means doseable," Smith said. "Doseable means titratable. And, titratable means: milligrams over body weight over time."
The Rx component derives from Idrasil's positioning as a pharmaceutical product rather than an over-the-counter pill. C3 intends to pursue FDA approval by 2020, Smith said.
"I developed Idrasil because I am a patient. The best way for patients like me with Crohn's disease to benefit from cannabis is orally, via the hepatic process, which is the only method of ingestion that delivers metabolized cannabinoids to the bloodstream."
C3 has raised $33 million to date. Stay tuned for further updates.
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