Replies to post #12993 on CytoSorbents Corporation (CTSO)

[berthabluefish1]

Dr. June said you do not want to jeopardize a $475,000 treatment cost with Cytokine Release Syndrome.Novartis will be glad to get this taken care of.The sooner the better.

[techxen]

Novartis Kymriah Product Information sheet.

Here is a link to Novartis product sheet on Kymriah. If you haven't seen it already you should download it and read it. Sprinkled all throughout it are very prominent warnings and precautions about CRS including treatment which points to tocilizumab as pretty much the only option.

https://www.hcp.novartis.com/globalassets/products37/kymriah---day-10/kym-1168047-kymriah-now-approved-referring-physician-guide-817_digital.pdf

Cytokine Release Syndrome:
Cytokine release syndrome (CRS), including fatal or life-threatening
reactions, occurred following treatment with KYMRIAH. In Study 1, CRS occurred in 79% (54/68) of patients receiving KYMRIAH, including Grade 3 or 4 (Penn grading system) CRS in 49% (33/68) patients. The median time to onset of CRS was 3 days (range: 1-22 days). Of the 54 patients with CRS, 27 (50%) received tocilizumab; 7 (13%) patients received two doses of tocilizumab, 3 (6%) patients received three doses of tocilizumab and 14 (26%) patients received addition of corticosteroids (e.g. methylprednisolone). The median time to
resolution of CRS was 8 days (range: 1-36 days).

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients
receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory
disorders. Treat severe or life-threatening CRS with tocilizumab
[see Dosage and Administration
(2.2, 2.3), Warnings and Precautions (5.1)].
• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with
KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with
KYMRIAH. Provide supportive care as needed
[see Warnings and Precautions (5.2)].
• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the KYMRIAH REMS
[see Warnings and Precautions (5.3)]

It is a very high probability the company has been in discussions with Novartis about using Cytosorb as a treatment option. This is supported by Dr. Chan's comments on the last quarterly call when asked about the pending Novartis EU approval: "Yes, I think that we're watching that very closely they've already been recommended for approval, and then we're just waiting for the final approval. And I think what we've been doing is positioning ourselves such that we are in a position to be used as a therapy to treat cytokine release syndrome in the CAR T cell immunotherapy space. So I think that's an active program that we have ongoing internally. In terms of any kind of business development efforts, we'll leave that for a future discussion."

It will be interesting to hear Dr. Chan's comments on the panel next week. Hopefully they will provide some insight as to the potential future usage of CytoSorb to treat cytokine release syndrome. There has been a hive of activity in the CAR-T space, with a half dozen companies including Novartis working out deals to become the leader in this space. I would think having Cytosorb as a part of their toxicity-mitigation strategy would be a differentiator for them.