It is interesting to see that the FDA is willing to give drug...

It is interesting to see that the FDA is willing to give drug approvals, at an early stage of testing, for treatments of conditions where patients have no other choice. This is true even when adverse event rates from the treatment is high. Over the past two years, several Car T drugs have been approved after phase 1 and phase 2 testing.

GBM is one of these conditions. Survival rate is low. "Many factors can affect brain cancer survival rate. Average survival rate is one to two years. There is no cure for brain cancer but there are many treatment options." This statement is copied from a GBM website. Survival rates in younger people (up to 14yrs old 73%) is far better than older people (5% for elderly).

From the CHM prospectus p 22, they state:

"There have been no new glioblastoma drugs
for many years and current drugs only provide
a very short extension of life. Consequently, the
Directors believe that the US FDA would be willing
to consider any glioblastoma drugs showing
even a small survival improvement over existing
treatments."

and

"Due to the severity of
glioblastoma, the Directors
believe that this drug may
qualify for an expedited
approval pathway through
the FDA".

CHM has also developed a new way of administering the CarT (prospectus p25) :

"CLTX-CAR T is also unique in that it constitutes a novel delivery method for the CAR T product.
Approved CAR T therapies, Kymriah®, Tecartus and Yescarta®, are delivered by intravenous
infusion. CLTX-CAR T is being delivered via intracranial intratumoral or intracranial
intraventricular dosing methods.
Glioblastoma is one of the deadliest cancers with a median survival time of 12 to 15 months.
There have been no new glioblastoma drugs for many years and the Directors believe current
drugs only provide a very short extension of life. Consequently the Directors believe that the US
FDA may be willing to consider any glioblastoma drugs showing a small survival improvement
over existing treatments."

So, if CHM can show efficacy and a better than average CR, the approval pathway could be shorter than normal.

Phase 1 testing is primarily a test for safety, and with an increasing dose trial, a test for optimal dose amount. Of the CarT drugs approved so far, Adverse events have been high, due to the drug interaction including, cytokine storm and off target binding. From Prospectus p40:

"COH researchers screened the CLTX peptide on a panel of cells from 23 tumour samples resected from 15
glioblastoma patients. The toxin bound strongly to almost all patient tumours, with more than 80% of the
cells binding CLTX. Only samples from two of the 15 patients revealed binding in less than 40% of total
cells. Similarly, when examining CLTX binding in patient-derived glioblastoma cell lines, the team found
that 21 of 22 cultured cell lines showed greater than 70% binding. In contrast, three other targeting agents
currently being evaluated for CAR T cell therapy, viz. IL13Rα2, EGFRvIII and HER-2, bound less broadly
and less uniformly to cells from the tumour samples and cultured lines demonstrating CLTX’s ability to
address heterogeneity both within and between tumours.
CLTX binding was also demonstrated against the glioblastoma stem-like cells that are thought to seed
tumour recurrence.
One of the potential dangers of CAR T cell therapy is off-target binding, when the CARs cause adverse
effects by killing the wrong cells. To assess the novel CAR’s safety in pre-clinical models, the COH
researchers measured binding in a panel of non-tumour human cells, revealing little to undetectable off-target
recognition.
The findings were verified in mouse models with human tumours where the CAR T cells only targeted
glioblastoma cells, and there were no adverse reactions in the mice when the therapeutic cells were delivered.
The engineered T cells only bound to tumour cells, leaving the surrounding normal brain tissue intact. The
treatment was able to control tumour growth, prolonging the survival of the animals and did not cause
adverse reactions or organ damage in the animals"

A video from 2016 so not using CLTX.



And a video about CLTX