Anyone in pain like me (clearly demonstrated by my last post),...should read the articles below,...Concurrent Phase 2 trials of Tetrodin for pain management and drug withdrawal look to be scheduled for this fall, and fast tracking could be on the way with the potential for government funding on the drug side. Newspapers are picking up the story and starting to run with it.
If phase 2 results confirm the drugs efficacy and safety, a decent deal could come from a big drug producer looking to secure Wex's patent protection.
Calgary facility fishes for pain drug study
Calgary Herald
Saturday, August 18, 2001
City
Page: B7
Robin Summerfield and Shelley Knapp
An unidentified Calgary facility is a front-runner for the second phase of a clinical trial involving a new pain-killing drug derived from the toxic pufferfish.
Sites in Ontario and Quebec are also being considered for the Tetrodin trial involving cancer patients, with a decision anticipated by mid-September. Officials have not revealed the Calgary facility being considered for the trial.
A phase one study was completed in Toronto on June 14 to test safe dosage levels. The subsequent study will test the drug's efficacy.
Tetrodin is considered 3,000 times more powerful than morphine, with one injection providing pain relief within five to 20 minutes which lasts up to eight hours. In 16 pre-clinical trials at Beijing Medical University in China it was proven to be non-addictive.
A major benefit is it doesn't send patients into a morphine or other opiate-based haze, said Donna Shum, chief operating officer at Wex Technologies, the Vancouver-based pharmaceutical company that formulated the new drug.
"It gives them great relief and a better quality of life. Lots of cancer patients that we've seen, when they get to the terminal stages, the pain, they suffer so much. Even when they get to the highest level of morphine, you still suffer the pain and you become unconscious," said Shum.
"They just don't want to wait, they just want to finish their lives."
The drug, in development for 16 years, has also already been hailed for its non-addictive qualities in dealing with heroin withdrawal.
In Asia, the allure of the pufferfish lies in the Russian roulette game that noshers play when chowing down. When not prepared properly, the tetro-dotoxin-laced delicacy can be fatal, starting with cardiac arrhythmia, seizures and an oxygen deficiency in the blood that causes the skin to take a bluish tinge, and then laboured breathing. In worst-case scenarios, within four to six hours, the diner can be dead from paralysis of the respiratory nerves and muscles.
TTX is considered to be 10 to 100 times more potent than black widow spider venom and 10,000 times more potent than cyanide.
In the Tetrodin form, patients are given 30 micrograms or less, compared to an average 200-milligram dose of other pain-management drugs, making the drug non-toxic in micro-doses.
"Anything that looks too good to be true, you have to be skeptical, keep an open mind, but still, it makes you wonder," said Dr. Howard Cohen, a Dallas-based geriatric and addictions psychiatrist and pain medicine specialist.
"The crux will be this phase two study. I mean the proof will be in the pudding right here," added Cohen, who has extensively studied the pufferfish toxin.
While researchers have not yet pinned down how the drug works, theoretically it may block the pain message to the brain on a cellular level, perhaps targeting the skeleton and muscle nerve cells, or working on a gene level, again blocking or inhibiting a specific gene's effects on the body.
Shum said the drug would cost on "the high end" but said treatment would perhaps be shorter in duration, thereby cutting long-term prescription costs.
According to the drug's profile on the Internet, the cost of the one-time injection ranges from $30 to $50 US and $300 for the whole treatment program. Methadone treatment for heroin addiction, on the other hand, is more costly at about $2,000 to $2,500 US per year.
Trials here, if approved, would begin as soon as possible after the mid-September approval, with the aim of finding the perfect dosage for varying cancer patients.
The more compelling the results, the more likely Tetrodin will be fast-tracked to the shelves. The earliest time for it to hit the market would be by the end of 2002 or the beginning of 2003, said Shum.
Starting at the end of October, the company also hopes to begin Canadian clinical trials on heroin addicts suffering with painful and debilitating withdrawal symptoms.
"Toxin-based drugs are one of the newest things in medicine right now," said Cohen, pointing to the current research in snails, frogs, spiders, scorpions and sponges, which takes its cue from native folk cultures and shamanism.
"We can't be too quick to dismiss them as unsophisticated. We need to take a look at it, and by following their leads, sometimes we're able to modify the drugs, maybe in a more powerful or careful way," said Cohen.
Shum said there is almost a limitless supply of the drug, as one pufferfish can yield 600 doses of the drug.
Colour Photo: Calgary Herald Archive / Researchers have turned to the toxic pufferfish for a new pain management drug called Tetrodin.
MEDICINE; MEDICAL RESEARCH; MEDICAL DRUGS; CALGARY; FISH
WEX TECHNOLOGIES
Calgary Herald
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http://www.canoe.ca/LondonNews/lf.lf-08-22-0016.html
Wednesday, August 22, 2001
London to test new cancer drug
Doctors hope blow fish-based Tetrodin could offer more pain relief than morphine
By MARY-JANE EGAN, Free Press Health Reporter
A drug derived from toxic blow fish venom and developed to ease the pain of heroin withdrawal could offer new hope for treating cancer pain.
London is one of five Canadian centres poised to begin testing the drug Tetrodin, developed by Vancouver-based International Wex Technologies. It's derived from tetrodotoxin -- the venom that blow fish, also known as puffer fish, inject into predators to leave them paralysed.
The company has applied to Health Canada's Health Protection branch for fast-track status in bringing the drug to market.
Doctors involved in pain management are excited about Tetrodin because it's purported to be as effective as morphine, but without such side effects as nausea, drowsiness, delirium, constipation and addictiveness.
Dr. Dwight Moulin, principal investigator for the London study, said he's excited, but cautious, about heralding Tetrodin as the new pain relief "wonder drug."
To date, the drug has only been tested in open trials in China where, after only two injections, cancer patients were reported to be pain-free for up to three weeks in some cases.
"It sounds very promising and exciting, but right now all we have are the China results and you can get profound placebo results from any new medicine called a new wonderful drug," said Moulin, chief of pain and symptom management at the London Regional Cancer Centre. "We're interested in seeing if there's anything there to get excited about."
Local trials -- expected to begin by October or November -- will be a collaboration of the cancer centre and London Health Sciences Centre. Only about 40 patients will be recruited nationwide, about eight in London.
Moulin said he's reluctant to call recruits "terminal" cancer patients, since many will live months or years. But he said it's encouraging a drug may be available that doesn't render patients so sedated they have no quality of life.
Still, Moulin noted Tetrodin is not without side effects. It's been known to cause tingling, numbness and muscle weakness.
In fact, in China, a blow fish dish called fugu is considered a delicacy served as soup and causes numbness and tingling of the lips.
Dr. Howard Cohen of Dallas, Tex., a consultant for International Wex Technologies and founder of the Texas Pain Medicine Clinic, said patrons will pay up to $100 a plate for the dish.
"It's said to be extremely tasty and it's kind of a macho thing to cheat death," he said. The drug itself is derived from parts of the blow fish discarded in cooking -- the gonads, testes and liver.
Cohen said the blow fish toxin -- tetrodotoxin -- is also used in Haiti in voodoo rituals as a "zombie potion" where its paralysing effects make a person appear dead.
"Obviously, you've got to be very careful getting the correct dose," Cohen said of the drug. "But where morphine can leave a patient delirious and sedated, this drug leaves patients lucid and pain-free to the point they've been able to travel or leave hospital to be with family and friends."
The drug has also proven effective in relieving neuropathic pain involving nerve endings, common with gunshot wounds or invasion of nerves by cancer -- pain that often doesn't respond to morphine.
And because Tetrodin is believed to help opium addicts with quick, inexpensive and efficient withdrawal, Cohen said the drug could help stem the spread of AIDS by reducing use of infected needles.
"There are a lot of social and political reasons to bring this drug to market quickly." |
