Pubdate: Sat, 10 Apr 2010
Source: Gazette, The (Colorado Springs, CO)
Copyright: 2010 The Gazette
Author: Bill Radford


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?"

Bumpy Beginning

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 

"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."

Decriminalization Favored

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." 
- ---
MAP posted-by: Richard Lake