Good report with no fluff.
"The dosing of this 4th patient marks the completion of planned dosing in the first and lowest dose level. Patients in
this dose cohort were dosed via single site administration (intracranial intratumoral or intracavitary (ICT)
administration) at a dose of 44 X 106 CLTX CAR T cells.
As this is a first in human phase 1 cell therapy trial, the 4 patients dosed within this first cohort received staggered
treatment, in accordance with FDA guidance. Staggered treatment requires a follow up interval between the
administration of the product to one patient and administration of the product to the next patient, essentially only
allowing for sequential treatment of patients with an interval long enough to monitor for adverse events between
the dosing of each patient.
As the final patient of this first dose cohort successfully completes the DLT period, the study will begin to recruit
patients for the next dose level which will introduce dual administration (ICT administration and intracranial
intraventricular (ICV) administration) at a dose of 88 X 106 CAR T cells."
No reports that any of these patients have lost their battle with this disease, and no report of any adverse event. Remember that these patients are "in patients with recurrent or progressive glioblastoma (GBM)." The normal SOC has already failed them and options are limited.
"reported rates in historical control groups reported in the composite of clinical literature; namely, approximately 9.5 weeks, 15.3% and 29.3 weeks, respectively." Quote from a Touch Oncology trial. The 9.5 weeks is tumor free progression, 15.3% is the progression free survival rate at 6 months, and the 29.3 weeks is the overall survival rate. So extension of life of patient 1 from now on will show early signs of efficacy.
The trial progression from here, will happen at a faster rate, and be more representative of the normal proposed treatment method. Taken from todays announcement:
"As this is a first in human phase 1 cell therapy trial, the 4 patients dosed within this first cohort received staggered
treatment, in accordance with FDA guidance. Staggered treatment requires a follow up interval between the
administration of the product to one patient and administration of the product to the next patient, essentially only
allowing for sequential treatment of patients with an interval long enough to monitor for adverse events between
the dosing of each patient.
As the final patient of this first dose cohort successfully completes the DLT period, the study will begin to recruit
patients for the next dose level which will introduce dual administration (ICT administration and intracranial
intraventricular (ICV) administration) at a dose of 88 X 106 CAR T cells."
From the IPO documentation: "Total Securities of Top 20 Holdings : 225,450,009 Total Securities: 330,526,401". Half of the total share holdings are in escrow (these are all held within the top 20). So really only 30% of the shares are available for trade, and most of these seem tightly held. Its very hard to make a substantial holding without driving the price higher.
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- Ann: Successful Completion of Dosing in First Patient Cohort
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Good report with no fluff."The dosing of this 4th patient marks...
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