RE:Where things are at In non-cancer drug trial Ph1a is usually something like 6 healthy volunteers getting dose escalation to check for major reactions. I guess we are through the equivalent of that. It depends what you mean by safe though. If you mean patients haven't dropped dead or had a serious immediate reaction to the drug then probably yes we are over that hurdle. But it seems ever cancer drug has toxicity, after all the goal here is to kill cells directly or indirectly with the drug, the trick being to kill tumour cells and not healthy cells. So expect some toxicity, I read the way MTD is defined leads to a drug profile with 40-70% of patients having serious events, this is the price you pay for injecting cell killing drugs into a person. As an example, at the working dose of docetaxel around 30-40% get febrile neutropenia, infection and fever caused by a damaged immune system. So you can't really take about completely safe cancer drugs, expect some toxicity, the question is how much, when, is it manageable by the doctor and bearable by the patient.
Having got over that first hurdle then the real goal in this trial is to start to define the therapeutic window, the relationship between efficacy and toxicity. This is the meat of Part1 and we are right in the middle of that period and it will go on until they reach their top dose. The viability of the drug going forward really depends on that.
SPCEO1 wrote: As simply put as I can do it, we are at a place now where we can reasonably assume that TH-1902 is safe to use in humans and, if it shown to be efficacious, it is going to be a pretty big deal. Those who visit this website are among the relatively small number of investors who have any knowledge at all of this drug or its potential. With TH's management now confident enough in TH-1902 to give the presentation they gave a week ago, and with LSA's involvement, it stands to reason that the number of people gaining an understanding of this potential will be growing. So, while we will not have proof of concept efficacy data until most likely September/October, there should be a growing number of investors willing to take a chance on TH between now and then. If it is shown to be efficacious as well as safe, then our little group here on Stcokhouse will quickly be overwhelmed with new investors/speculators and the stock will take on an entirely new character. While the overall market trend is always a dominant factor in a share price's evolution, we should be seeing increasing buying interest in the weeks approaching the expected announcement of the efficacy data.
If that data is really good, then it is off to the races for the stock obviously. If the data is just good, and not really good, then it will take longer (waiting for more data) for the stock to become a hot commodity. If the efficacy data is bad, then those who were betting on really good data will be sellers and the stock will give up some ground. The amount of ground given up will depend on how far the speculation about the efficacy data had driven the stock higher before it was announced. But we should expect that the number of people who are aware of the potential with TH-1902 will be growing in the weeks ahead.