Cannasat lighting up THC drug

Twenty-year cancer survivor Sara Lee Irwin is a passionate advocate for the pain relieving benefits of medicinal cannabis drugs and health risks of chronic use of opioid medicines.

“Nothing beats opioids for blunt-hammer pain and trauma, but for chronic, life-long pain management, cannabinoids are the better choice,” she says in an exclusive interview with biotuesdays.com.

“What you feel is a gentle moving away from pain in the front of your face.  The pain is dulled, but you’re not dulled.”

Ms. Irwin was diagnosed with cancer in her pelvis and hip in 1989, resulting in the removal of her left hip and half of her pelvis.  That was followed by a pelvic transplant and implant of an artificial hip.  She walks with a cane and experiences constant pain, opting to use federally-licensed cannabis and several synthetics as her primary source of medicine.  That lets her function in the real world, enjoy a better quality of life and avoid long-term damage to her organs from opioid use.

All of which paved the way for her to become one of the earliest employees of Cannasat Therapeutics (TSX-V: CTH) of Toronto.  Once the investment darling of well-heeled pot smokers, Cannasat has now distanced itself from the medicinal marijuana label.

“Bay Street didn’t want to hear about it because doctors aren’t going to prescribe inhaled cannabis and smoking a medicine is the antithesis of good health,” explains Cannasat CEO David Hill.

Instead, the company has reformulated Solvay Pharma’s synthetic-THC drug Marinol into a new drug candidate Relivar. THC is the active ingredient in cannabis.

Marinol, with annual sales of around $150-million (U.S.), is approved for cancer chemotherapy nausea and vomiting, and loss of appetite in AIDS’ patients.  But many chronic pain patients, including Ms. Irwin, take it as well.

Cannasat, on the other hand, is targeting Relivar in a “much larger market opportunity” of neuropathic pain – $4-billion a year and growing, Mr. Hill points out.

“We’ve developed a platform technology for THC that changes the thick, oily, unstable substance into a powder that is stable and, therefore easy to manufacture, and doesn’t have to be refrigerated,” he says.

And Relivar is delivered into the bloodstream by melting the pill against the gum in the mouth, so that it avoids being swallowed where THC is metabolized and becomes highly intoxicating.

Cannasat has completed early phase testing with Relivar, showing the drug is safe, without any adverse side-effects, Mr. Hill says.

“We’ve been able to get twice as much THC into the bloodstream over a longer period of time, with only about half of the metabolite levels (compared with Marinol),” he explains.  And besides reduced side-effects, Relivar has to be taken only once- or-twice-a-day, instead of three-to-four times.

By improving Marinol’s performance, he is confident Relivar has the potential to be a “mainstream medicine” for pain.  Phase 2 efficacy testing is set to begin in 2010.  The company is also developing a skin cream for neuropathic pain, using its platform technology.

Mr. Hill says Cannasat is “actively talking” with pharma partners about its technology and the potential to create different delivery systems and target different markets.  “Ideally, we’d like to option the drug out to move the work forward, which would make our task in the capital markets easier.”

An option agreement, in exchange for an upfront payment, would give a partner the first right to negotiate a licensing and marketing agreement, he says, and possibly result in moving the Phase 2 trials to the U.S. from Canada.  Cannasat also is in talks with “one group for the European market,” he adds.

The company’s other early-stage drug candidate Modulyn as a potential treatment for schizophrenia has been put on the back burner for now, Mr. Hill points out, as the company is totally focused on advancing its THC platform and Relivar.

“Schizophrenia is such a big field that any clinical trials would have to be done with a Big Pharma partner.”  But he suggests that work on Modulyn will resume after Relivar is partnered and a big financing achieved.

If all goes well, he figures Relivar could reach the market in four years, citing shorter clinical and regulatory time lines because Marinol is already on the market and approved for a couple indications.  But Marinol and other synthetic-THC drugs “do not represent elegant pharmaceutical solutions,” he says.

That’s also what drives Ms. Irwin.  “I’m not here because I want to be a business woman per se,” she contends.  “I’m here because this is an important message and (Cannasat) has the opportunity to do well by doing good.”