GW Cannabinoid Drug Fails Cancer Pain Trial

[420]

GW Pharmaceuticals PLC (NASDAQ: GWPH) and Otsuka Pharmaceutical Development & Commercialization reported top-line results from the first of three Phase 3 trials for Sativex. The drug candidate is an investigational product for the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. With so much attention around drugs tied to medical marijuana and its derivatives, this could be a big deal for investors in this field.

There was little difference in the adverse event pattern between Sativex and a placebo. There were 38, or 19%, withdrawals due to adverse events on Sativex, compared to 29, or 15%, on the placebo. Unfortunately, the results were such that Sativex did not meet the primary endpoint in the first trial by not demonstrating a statistically significant difference from the placebo.

The main adverse events reported for the Sativex trial were:

Neoplasm progression at 16% on Sativex, compared to 18% on the placebo
Somnolence at 12% on Sativex, versus 4% on the placebo
Dizziness at 8% on Sativex, against 5% on the placebo
Justin Gover, GW's CEO, explained the current situation and then the outlook for later this year:

Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population. We have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.

GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. GW has a deep pipeline of additional cannabinoid product candidates, which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes and schizophrenia.

Shares of GW closed Wednesday up 2% at $71.06. In premarket trading on Thursday, shares were down 8% at $65.39. The stock has, or had, a consensus analyst price target of $119.25, as well as a 52-week trading range of $40.00 to $111.46.

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Full Article: GW Pharmaceuticals Cannabinoid Drug Sativex Fails Cancer Pain Trial (NASDAQ: GWPH) - 24/7 Wall St.
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[mlang52]

I would think that the need, for this in the treatment of cancer pain, is almost nil. The only reason would be adverse reactions to opiates. Most of the time, with proper titration, opiates will be effective. Tolerance has to be addressed. It has been found that tolerance can be treated with gradually increasing he dose. And, tolerance seems to have a level where it stabilizes, resulting in a constant effective dose. It might mean a cancer patient might be taking a dose of the opiate that would kill us that are not on a regular dose of the medicine. But, it would provide the patient with desired pain control. Since the full 180 on the use of opiates in treating chronic pain, even cancer patients have a problem getting adequate pain relief. This is because of politics and ignorance, and seems to have little to do with the real harm of chronic pain patients using opiates. But, alas, we are treating medical problems with emotional reactions, and not relying on scientific medical findings. Politics has no, useful, part of treating medical patients. But, after watching my mother receive a dose of Fentanyl after we removed the respirator, in the ICU, I wonder if there might be some truth to the "death panels". She was in no distress at all, yet, she was given a medication that can suppress respiration, at the time when she should have been allowed to try to wake up!! I, as a "retired" general surgeon, have a lot of questions about how these actions were assisting in giving patients a better quality of life! Politics? Maybe we, all, should be paying, better, attention.

 

[Radogast]

Their clinical trials weren't even against a minor pain reliever like aspirin.
It's almost as if they knew their product was worthless when they set up the trial.

 

[J9BLACK]

Cannabis is all about the entourage effect...which means whole plant medicine, which means the whole plant.

If the plant's medical and recreational benefits were ever scientifically quantified and qualified on a per strain basis, that would be very interesting...

 

[zepherlight]

In the end it will come down to the trading of one type of cartel for another. We should look ahead to what the pharmaceutical companies want in the long run which is profits. It won't take long before they will be doling out medical marijuana in the form of pills that won't work as well as the real thing. The government will back this because it gives them control and of course more taxes. They can't tax your personal grows and after seeing the taxes Colorado is starting get. It won't be long before the government wants in. In control that is. Let's be honest. What do you think is more important to them. The people that they serve or good old money. The genie is out of the bottle. Let's see how long it takes till he's in handcuffs.

 

[dingusmcgee]

Sativex is and always has been a stupid idea. i remember when these dipsticks were in early development, and one of the primary complaints from test subjects was that Sativex didnt have a comparable efficacy of relief when compared to bud. it was pointed out by many mj experts at the time that this is due to the beneficial components of mj being stripped out of Sativex. i guess the science behind Sativex didnt take into account the science behind mj.

 

[xtrchessreal]

Science has nothing to do with this. Money is being exchanged on the stock market and soon the largest stock holder will sellout and run to the Cayman Islands or Switzerland. It is an easy target for a so called New Money Investor to get caught in a trap like this. But now that the whole country is about to make marijuana use legal its time for the big shareholders to run. Not the first time fraud hiding in plain sight has bitten the greedy hand. That CEO sounds so typical it makes me sick. Get out now!