Cel Sci Corporation (CVM)

[Spideyboy]

Thanks for posting about IRX.

Looking at the trial, design and product, indeed as you say it is strikingly similar to Cel-Sci.

The key difference in the Trial design is that IRX's Primary Endpoint is "Change in Event Free Survival" (Longer Event-Free survival) within 2 years.
https://clinicaltrials.gov/ct2/show/NCT02609386

But it doesn't specify what would constitute IRX's "Event". I don't think this will be death as, they have OS as a separate and Secondary Endpoint.

For their current phase II they are recruiting 200 Patients. So overall we should still be a couple of years ahead of them, which is good. Also like you say, the fact that they are essentially emulating Cel-Sci would hopefully mean that there is additional support for the chance of success.

IRX earlier open label study showed 65% OS at 5 years. Where we showed 63.2 at 3 years. So probably the same efficacy really. same study numbers of 27 vs 21.

Vis-a-vis product similarity, should there not be some kind of patent protection from Cel-Sci on the composition of the drug? I know the proportions of drug used and will not be the same, but given it's essentially a blatant copy, would Cel-Sci not be able to protect itself?

Interesting find and just hope our Clinical Trial design doesn't shoot us in the foot. And that we can enforce our IP somehow.