Replies to post #35884 on Cel Sci Corporation (CVM)

[lightrock]

@james

More on that note

For example purposes only, say that 50% of the test group responds to injection and 50% does not.

That means that three fourths of the test+control are equivalent to control group expectation.

This could skew the "signal" in terms of "top line data". We might look for "10% improvement to over all survival at 3 years measured on a kaplan meier chart", and it might get nitty gritty.

HOWEVER, of those 50% who DID respond to injection, what if the over all survival is dramatic.

The over all study might not notice so much, but this "sub-group" did notice. Big time.

That is a very distinct possibility.

The IDMC did not halt the trial early due to dramatic success "Ok do it".

So, to some degree, for some reason, I think we are squeaking by; but somehow there is some pretty good differential going on.

This "factor", call it that, really put the hurt on my ability to agree all the way with Fosco on how effective this can be so far, over all.

[jamesnhansen]

A possible reason for higher test arm dropout

Lightrock:

Here is a possible reason for some dropouts in the test arm. This taken from the NIH Clinical Trials Website.

Biological: LI
LI 400IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 weeks administered in combination with cyclophosphamide indomethacin and zinc (CIZ) as adjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100mg/m^2 intravenously) to determine if LI plus CIZ affects the overall survival of subjects at median 3 years.
Other Names:
Multikine
Leukocyte interleukin, injection

This is pretty invasive. Imagine this can be pretty painful. Fifteen doses in 21 days. I assume multiple shot around and in the tumor. Ouch.

Cheers from Oregon on a winter evening.

Jim

[jamesnhansen]

An interesting communication with CELSCI concerning response rate

Lightrock:

Concerning response rate: One thing we have all observed in the past few years is the relation between certain genes or protiens and the effectiveness of cancer drugs. Could this account for a positive response rate by a subset of the test arm?

I asked this question to Gavin on February 9, 2021:

Many cancer treatments are specific to whether the cancer expresses a certain gene or mutation.

Are the enrollees going to be tested to see if there is a correlation between the survivability and any genetic markers or mutations?

The response:

Yes, we will be looking into this as well.

So, I read this to mean that if you hypothetically have a 100% response rate with only some individuals the study results could contain data concerning the efficacy of MK compared with certain DNA markers. This might be another reason why the P3 trial results are delayed, no?

Perhaps the calculator should calculate the p value for any scenario. A new feature?

Cheers again from an even-later evening in Oregon.

Jim