The question I have about the Phase 1 Trials for o
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Posted On: 10/07/2018 12:25:33 AM
The question I have about the Phase 1 Trials for other than psoriasis is, are they treating people with the diseases they believe they'll benefit, or only healthy volunteers. Most of the trial I'm familiar with are for oncology products and they are escalating dose trials in patients who have at least one of the diseases the drug is intended for.
Many of the drugs I follow are intended for several different cancers, but companies generally zero in on a single cancer to initiate trials for the drug. In many cases the cancer chosen isn't the one which may be most effective for the drug, but rather one that can produce results the quickest which reduces the cost and time. For instance, I colon cancer appears to be an excellent target, but the SOC already is extending life 5 years, a Pivotal trial for it might take 15 years. If the chance of success was substantially less with pancreatic cancer, it still might be the choice as the SOC is so much shorter. I believe that many drugs fail because of selecting a target that isn't the best, but few companies have either the resources to do trials that could take a decade or more, nor do they have the money to try a different target if they fail in a Phase 3, so the drug is simply abandoned.
I believe OWCP has good targets with MM, psoriasis, and fibromyalgia, but I suspect the MM trials will take longer and cost far more than the others for two reasons. One is that people with the disease often live for many years, I know two people in remission for years, one over a decade. Secondly, I don't believe this drug can be sold for the disease prior to full approval, whereas the other drug can be sold in cannabis stores once efficacy is shown, probably in Phase 2. I'm not completely uncertain that if a Phase 1/2 were done with patients with the disease the company wouldn't consider marketing it if efficacy was clear by the time the Phase 2 portion of the trial was begun.
There are currently products for sale that really have undergone almost no testing for efficacy, cannabis stores will sell them as long as they're proven to be made with materials deemed safe to sell but not tested for their intended use. People testify as to their working, but it's not done as an approved trial. It's like many other cosmetics and nutraceuticals on the market, but these products contain components found in cannabis, or hemp.
Gary
Many of the drugs I follow are intended for several different cancers, but companies generally zero in on a single cancer to initiate trials for the drug. In many cases the cancer chosen isn't the one which may be most effective for the drug, but rather one that can produce results the quickest which reduces the cost and time. For instance, I colon cancer appears to be an excellent target, but the SOC already is extending life 5 years, a Pivotal trial for it might take 15 years. If the chance of success was substantially less with pancreatic cancer, it still might be the choice as the SOC is so much shorter. I believe that many drugs fail because of selecting a target that isn't the best, but few companies have either the resources to do trials that could take a decade or more, nor do they have the money to try a different target if they fail in a Phase 3, so the drug is simply abandoned.
I believe OWCP has good targets with MM, psoriasis, and fibromyalgia, but I suspect the MM trials will take longer and cost far more than the others for two reasons. One is that people with the disease often live for many years, I know two people in remission for years, one over a decade. Secondly, I don't believe this drug can be sold for the disease prior to full approval, whereas the other drug can be sold in cannabis stores once efficacy is shown, probably in Phase 2. I'm not completely uncertain that if a Phase 1/2 were done with patients with the disease the company wouldn't consider marketing it if efficacy was clear by the time the Phase 2 portion of the trial was begun.
There are currently products for sale that really have undergone almost no testing for efficacy, cannabis stores will sell them as long as they're proven to be made with materials deemed safe to sell but not tested for their intended use. People testify as to their working, but it's not done as an approved trial. It's like many other cosmetics and nutraceuticals on the market, but these products contain components found in cannabis, or hemp.
Gary
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