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Sunday, February 14, 2016 8:25:14 AM
And to echo what you have said John, patients like Allan (he says so himself in his Nat Geo video) exhausted all other treatment options. They are not being deceived or discouraged from seeking other treatments, and to AVII's mistaken assertion, there are no other viable treatment options for these patients. One of the patients, who was also a pancreatic patient, who wanted to get into the trial but was thwarted by the sequential rule went from being relatively treatable (but Stage 4 and out of options) to dead in a matter of days because a tumor was blocking an important duct. The patients that were lucky enough to find out about the trial that I knew were out of options. And remember, patients who opted not to go into the trial and who tried other targeted immune therapies with the exact same kind of cancer at the same stage as Allan passed very quickly. So the idea that there is some other magic option out there that patients are trying and living longer on is not supported by any evidence at all. I know three stage four patients who had types of cancers that Direct treated, but who chose the targeted immune therapies.
One never made it to the first dose
One blew up like a balloon and developed metastases were none had ever been seen with that type of cancer before, and passed in weeks
One went into a coma the day after starting treatment and died 8 days later.
The other targeted immune therapies work only on select patients when they do work, and have the potential for extreme toxicity. Direct works on all markers and has little or no toxicity, and works on many cancer types.
It appears as if the maturing data is helping create a new blueprint for the Phase II trial. Although it would have been nice to have been started already, making sure that there are no unforseen study design problems or that they are able to take advantage of what they are learning in Phase I is good reason to take time and get Phase II right, because the potential for early approval with a well designed trial is very significant.
One never made it to the first dose
One blew up like a balloon and developed metastases were none had ever been seen with that type of cancer before, and passed in weeks
One went into a coma the day after starting treatment and died 8 days later.
The other targeted immune therapies work only on select patients when they do work, and have the potential for extreme toxicity. Direct works on all markers and has little or no toxicity, and works on many cancer types.
It appears as if the maturing data is helping create a new blueprint for the Phase II trial. Although it would have been nice to have been started already, making sure that there are no unforseen study design problems or that they are able to take advantage of what they are learning in Phase I is good reason to take time and get Phase II right, because the potential for early approval with a well designed trial is very significant.
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