Yes, I understand that there are no rigid guidelin
Post# of 72447
Posted On: 01/11/2013 2:11:47 PM
Yes, I understand that there are no rigid guidelines for compassionate use and that the company, doctor and patient can have input.
But in this case I'm interested in how this is applied at Dana-Farber in particular, not industry wide.
From the DF team member's email it is pretty clear to me that their application is to add the condition of 'stable disease or improvement if scans are performed'. He was talking in general as to their procedures.
"A participant can advance to the next cycle assuming they tolerate the drug and perceive a benefit (stable disease or improvement) if scans are performed" -DF team member
Short of scans they could continue if they tolerate the drug. But " and perceive a benefit(stable disease or improvement)' becomes a requirement "if scans are performed."
That is my interpretation.
We know from the company PR that the first cohort is moving to the third dosing cycle. We know they are past the time of the first scans required by the protocol. We also know that the doctor could perform additional scans related to that patients treatment planning. We also know that they are testing for biomarkers.
Thus according to how things are done at DF and the CTIX PR, we can infer that the scans showed stable disease or improvement. Otherwise cohort 1 would not be receiving a third round of kevetrin at Dana Farber. (While I accept that a different team or cancer center may use different standards)
In this case the team member has not declared kevetrin specific study results by any means. It is too small a sample size, too early, and not his job. This would be done by the company and/or hospital in coordination on whatever terms they have agreed. What he has done is clarify general procedures for these trials at DF, from which we can correlate with the kevetrin study.
At this time, first cohort patients are about to begin their third cycle of dosing and the second cohort – in which dosing levels were doubled – are in their first cycle of dosing. The information that we have received at this early stage of the trial so far has been very encouraging with no data being delivered outside of the parameters of the protocol. -CTIX CEO PR
So we see confirmation that the third dose is anticipated. We also see the information so far is "very encouraging", which could be just a reference to the expected lack of toxicity, but I believe goes beyond that.
I take that as fantastic news, a further indication of very encouraging preliminary results, while awaiting actual confirmation and a larger sample size to give statistical significance.
I would agree that Dana-Farber and Cellceutix would want solid data ahead of any major announcement, but they are keeping us informed of developments and initial results. It sounds like we will hear about the p21 as soon as that is available also, based upon email from the CEO.
As a speculator my way is to look for clues to things not yet priced into the share price and to interpret the PRs and company filings. I am not publishing in peer reviewed journals, I am posting in 'peer' read message boards. Though our peer review process can be quite passionate at times.
JMO
But in this case I'm interested in how this is applied at Dana-Farber in particular, not industry wide.
From the DF team member's email it is pretty clear to me that their application is to add the condition of 'stable disease or improvement if scans are performed'. He was talking in general as to their procedures.
"A participant can advance to the next cycle assuming they tolerate the drug and perceive a benefit (stable disease or improvement) if scans are performed" -DF team member
Short of scans they could continue if they tolerate the drug. But " and perceive a benefit(stable disease or improvement)' becomes a requirement "if scans are performed."
That is my interpretation.
We know from the company PR that the first cohort is moving to the third dosing cycle. We know they are past the time of the first scans required by the protocol. We also know that the doctor could perform additional scans related to that patients treatment planning. We also know that they are testing for biomarkers.
Thus according to how things are done at DF and the CTIX PR, we can infer that the scans showed stable disease or improvement. Otherwise cohort 1 would not be receiving a third round of kevetrin at Dana Farber. (While I accept that a different team or cancer center may use different standards)
In this case the team member has not declared kevetrin specific study results by any means. It is too small a sample size, too early, and not his job. This would be done by the company and/or hospital in coordination on whatever terms they have agreed. What he has done is clarify general procedures for these trials at DF, from which we can correlate with the kevetrin study.
At this time, first cohort patients are about to begin their third cycle of dosing and the second cohort – in which dosing levels were doubled – are in their first cycle of dosing. The information that we have received at this early stage of the trial so far has been very encouraging with no data being delivered outside of the parameters of the protocol. -CTIX CEO PR
So we see confirmation that the third dose is anticipated. We also see the information so far is "very encouraging", which could be just a reference to the expected lack of toxicity, but I believe goes beyond that.
I take that as fantastic news, a further indication of very encouraging preliminary results, while awaiting actual confirmation and a larger sample size to give statistical significance.
I would agree that Dana-Farber and Cellceutix would want solid data ahead of any major announcement, but they are keeping us informed of developments and initial results. It sounds like we will hear about the p21 as soon as that is available also, based upon email from the CEO.
As a speculator my way is to look for clues to things not yet priced into the share price and to interpret the PRs and company filings. I am not publishing in peer reviewed journals, I am posting in 'peer' read message boards. Though our peer review process can be quite passionate at times.
JMO
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