Replies to post #36189 on Cel Sci Corporation (CVM)

[meirluc]

I am suggesting it is remotely plausible that the initial CRO enrolled patients with high survivability ( base of the tongue ) in error since those are to be excluded.

So why would such inappropriate patients not be excluded? It would be the job of the IDMC to suggest that such patients should not be retained in this trial and that replacements should be enrolled.

With a midpoint enrollment of 63 months for the 795 patients, a consequent fatality rate of about 60% and a completely ineffective multikine treatment, we would have had about 480 fatalities before data lock. I grant you that with about a 10% dropout (LTFU) at various times during the trial, the number of fatalities would have been somewhat lower than 480. It is However difficult to account for about (give and take) 182 patients (480-298=182) who beat the odds. They could not all had the less dangerous base of the tongue cancer.

If so many inappropriate patients were enrolled and with other potential irregularities, where was the IDMC during the last 5+ years? Also does CVM have a Scientific Advisory Board (SAB) or any scientific advisors?

[Biobonic]

There is something afoot.

The Original CRO was in the process of being bought in 2012. In Feb 2013 Geert lowered the boom on the CRO.

Businesswire news story

The arbitration ruling in favor of CEL-SCI was for breach of contract by inVentiv on CEL-SCI’s Phase 3 cancer trial for its investigational product Multikine* (Leukocyte Interleukin Injection). inVentiv, which had enrolled fewer than 100 patients during its time as CRO, was replaced on the Phase 3 study in March 2013 with two new CROs, Ergomed and ICON.

In April 2013, CEL-SCI replaced inVentiv because enrollment in the study was far behind what been agreed to in its contract. During the two year time period between January 2011 and April 2013 a total of only 117 patients were enrolled in the trial. This total of 117 patients also included the patients enrolled by CEL-SCI’s partners Teva and Orient Europharma, which for the purposes of activities associated with the Phase 3 clinical trial, were managed by inVentiv.

Inventiv was replaced in early 2013 for failure to meet contractual obligations of enrollment.

Link

These changes were necessary as most of the key personnel at the prior CRO who were involved in our study departed after the CRO was acquired. This had a very negative effect on study enrollment. As a result, the number of patients that have been enrolled and treated in the study fell below the level agreed to with the CRO.

Of the 135 enrollments from year 2011 thru 2013, many of us place a bulk of that 135 into year 2013.

It's not really possible. CVM 2016 10K (pg 5) has a chart for monthly enrollments, Mar - Dec 2013 = 19.

To have 60 to 80 of the 135 enrolled in 2013 would mean the ousted CRO would have enrolled 25 a month in Jan and Feb. Couldn't cancel them for non performance, if that were the case.

Therefore there are 60-80 people who have been enrolled a year longer than we are figuring.

So something is quite out of whack.

It's my surmise that Geert took the action to enroll more than original design, the additional 48 - to up the number of trial participants who are within design protocol.



Which leads to another issue - increase the participants by 48 but the end point of 298 deaths remained unchanged.

OS of around 55% at 3 years and ADD 48 more participants in the study!

298 would of necessity be achieved quicker with more participants.

Under original statistical design the trial could still be waiting for the 298th event to start the Data Gathering in order to achieve Data Lock.