Robert Melamede first used marijuana at age 16 — just as “a goof,” he said.
“It was fun,” he said. “You’d laugh, you’d do silly things.”
These days, though, he’s quite serious about marijuana and what he sees as its myriad benefits.
Melamede, a biology professor at the University of Colorado at Colorado Springs, is president and CEO of Cannabis Science, “an emerging pharmaceutical cannabis company.” The startup, which is looking to establish its offices in the Springs, has about 10 employees, including a lab director. The company’s goal: to tap into the growing use of medical marijuana in Colorado and elsewhere by developing cannabis-based medicines. (Cannabis is the botanical name for the plant that marijuana comes from.)
Cannabis-based medicines would have the same health benefits as marijuana, Melamede said, but with one key advantage: They could be covered by health insurance. Right now, “anybody who’s a medical marijuana user, they don’t have marijuana covered by health care.”
There’s precedent for such medicines. Sativex is a natural marijuana extract developed by a British company, GW Pharmaceuticals. Bayer Healthcare markets Sativex, which comes in the form of an oral spray, in Canada to relieve pain related to multiple scleroris and advanced cancer; in the United States, it’s been approved for use in clinical trials.
Cannabis Science, partnering with an international regulatory-compliance firm, is working toward approval from the Food and Drug Administration for a clinical trial using a cannabis-based medicine to treat post-traumatic stress disorder, or PTSD. After that, it’s targeting the chronic-pain market.
When all that might happen is one of the big unknowns.
“I couldn’t give you a time frame for getting this done because there are simply so many variables,” said Richard Cowan, chief financial officer for Cannabis Science.
Ideally, Melamede said, the company could submit an application to the Food and Drug Administration within a few months. After that, “it would very much depend on whether the FDA feels it is important enough to fast-track us.”
Early on, the company looked to follow in GW’s footsteps and eyed the Canadian market. But, Melamede said, “the Canadian bureaucracy is no better. And the market is much smaller. So why not just go for the gold?”
Cannabis Science has its roots in Cannex Therapeutics, a San Francisco-based company founded by Steve Kubby, an entrepreneur, medical marijuana user and former Libertarian Party candidate for California governor. Cannex became a public company last year through a reverse merger with an oil company, Gulf Onshore; a reverse merger is a fast-track way for a private company to go public without a conventional initial public offering.
Shortly after, the company was renamed Cannabis Science. In a rocky start, though, the board of directors ousted Kubby as president and CEO last July and replaced him with Melamede, who had been science officer. The public falling out involved accusations hurled against both sides; a filing by Cannabis Science with the Securities and Exchange Commission accused Kubby of “inappropriate and unauthorized” behavior on several fronts.
With the change in leadership, Cowan said, the focus of the company also changed: to Melamede and medical marijuana patients in Colorado.
“We refocused everything around him and around Colorado,” Cowan said.
GW’s approach to developing a cannabis-based medicine was a conventional one for a pharmaceutical startup, Cowan said, with millions of dollars raised upfront and everything “hush hush.” Cannabis Sciences’ leaner approach is to farm out as much as it can and to take advantage of starting in Colorado, “where the public is clearly and strongly behind medical marijuana. We have both patients and providers to collaborate with and study.”
Melamede’s reputation in the medical marijuana arena, meanwhile, is the company’s “secret weapon,” Cowan said.
Melamede is a medical marijuana patient himself, using it to relieve chronic back pain and other issues. At UCCS, he teaches a course on medical marijuana — “one of the only ones in the world,” he notes. He calls marijuana “an anti-aging drug with incredible health benefits.”
And one of the groups he sees reaping those benefits is soldiers struggling with PTSD.
A self-professed “old hippie” from the Vietnam War days, “I’ve learned over the years to really respect much of the military and separate the military from the government,” Melamede said. It tears at him, he said, to see soldiers suffering after their return from Iraq and Afghanistan — and the high rate of suicide among them.
Mitch Earleywine, an associate professor of psychology at the State University of New York in Albany and a member of Cannabis Science’s Scientific Advisory Board, conducted a survey of more than 1,300 veterans and others with PTSD. “Veterans reported that cannabis helped nearly all symptoms of PTSD, with special emphasis on three important components: sleep disturbance, irritability and disturbing memories,” he said in a release announcing the study.
A state lawmaker from Pueblo recently introduced an amendment to medical marijuana regulations that would have added PTSD to the conditions covered under Colorado’s medical marijuana program, but the amendment was rejected in committee.
Sensible Colorado, a medical marijuana advocacy group, had backed the amendment.
“We hear from dozens and dozens of veterans every year that say that this helps them get off pain pills or just helps them get through what’s going on in terms of their PTSD,” said Brian Vicente, executive director of Sensible Colorado. PTSD, he pointed out, is among the conditions covered by New Mexico’s medical marijuana program.
If Cannabis Science won approval for a PTSD treatment, it could have implications for a much wider group of patients, Cowan said.
“Twenty percent of prescriptions that are written are off-label use,” he said. “The point is — if, for example, in our study of PTSD that we determine cannabis helps them sleep, which we know it does, then a cannabis-based insomnia medicine could be prescribed to people with insomnia, whether they had PTSD or not.”
Cannabis Science, in its SEC filings, cites two big challenges as it seeks to move forward.
One is funding, but Cowan said undercapitalization is characteristic of most startups.
“Like everybody else, we’d like a little more money,” Cowan said. “But really, up to this point, that has not been a significant factor simply because we weren’t ready to proceed with anything that would take money.”
Given the current drought in venture capital, Cowan said the most likely sources of funding are “sophisticated investors who buy restricted shares in the company or from other possibilities, maybe licensing deals with larger companies.” Licensing is how GW got most of its financing, Cowan said.
The other issue for the company, the filings say, is “a significant prejudice against development of smoked cannabis medical products in the medical and law enforcement communities.”
Marijuana, the company notes, is still classified as a controlled substance by the federal government. But Cowan, who is the former executive director of the National Organization for the Reform of Marijuana Laws, and Melamede would like to see that change.
“We’re fully supportive of total decriminalization because it’s a God-given plant,” Melamede said.
If that happened, Cowan still sees a role for Cannabis Science, perhaps with over-the-counter, cannabis-based medicines at an affordable price. Sativex, he noted, is “terribly expensive,” and not everyone has the time or ability to grow his own pot.
“I live in an apartment,” he said. “I suppose I could grow somehow, but I don’t have a green thumb.”
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