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Why has GBM AGILE added this drug?, page-3

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rikki

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15/09/20

19:59

Post #: 47364793
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Originally posted by RBx: ↑

Global Coalition for Adaptive Research (GCAR) Selects DelMar Pharmaceuticals' VAL-083 to Participate in the GBM AGILE Pivotal Study, an Adaptive Clinical Trial Platform in Glioblastoma Multiforme
June 4, 2020
https://finance.yahoo.com/news/global-coalition-adaptive-research-gcar-120000245.html

DelMar Pharmaceuticals Presents Positive Interim Data on VAL-083 Demonstrating Favorable Outcomes in Both Newly- Diagnosed and Recurrent GBM at the AACR Virtual Annual Meeting II
June 22, 2020
https://finance.yahoo.com/news/delmar-pharmaceuticals-presents-positive-interim-123000934.html

Poster #CT273 - "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
Results:
For the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal study (30 mg/m²/day on days 1, 2 and 3 of a 21-day cycle) median progression-free survival (PFS) was reported to be 8.7 months (confidence interval, or CI 6.0-12.0 months) as of the May 15, 2020 cut-off date.
Overall PFS (n=29) with VAL-083 was 8.7 months (CI 6.4-11.2 months).
While not a head-to-head trial, historically temozolomide (TMZ), the standard of care, has been demonstrated to have 6.9 months PFS in newly_diagnosed unmethylated GBM patients.
The open-label Phase 2 study in newly-diagnosed unmethylated GBM is being conducted at Sun Yat-sen University Cancer Center in China. The Company announced full enrollment of the study on February 19, 2020.

Poster #CT272 - "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated bevacizumab-naïve glioblastoma in the recurrent of adjuvant setting"
Results:
In recurrent GBM, for the 37 patients initially receiving the intended treatment dose that will be carried forward in the GBM AGILE pivotal study (30 mg/m²/day on days 1, 2 and 3 of a 21-day cycle), median overall survival (mOS) is currently 8.5 months (CI 5.7-14.3 months) as of the May 28, 2020 cut-off date.
Overall mOS for the 72 patients who have completed at least one cycle of treatment was 7.1 months (CI 5.8-9.9 months).
While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated a mOS of 7.2 months in recurrent unmethylated GBM patients.
In the adjuvant setting, patients receive VAL-083 as adjuvant therapy following treatment with radiation and TMZ. As of the data cut-off date of May 28, 2020, 19 evaluable subjects have completed at least one 21-day cycle of treatment, with a total of 25 subjects enrolled. Enrollment for this arm was initiated in July 2019, and all 25 subjects enrolled to-date were alive at the data cut-off date.
Based on encouraging outcomes, the Company plans to increase the adjuvant arm from the originally planned 24 patients to include up to 12 additional patients.
The open-label Phase 2 study in recurrent and adjuvant unmethylated GBM is being conducted at M.D. Anderson Cancer Center in Houston.

And why were they able to get a $500,000 ‘loan’ to prepare for the AGILE trial; while KAZIA (as far as I know) has to use its own cash?
https://finance.yahoo.com/news/delmar-pharmaceuticals-receives-500-000-123000913.html

VAL-083 interim results seem to be inferior to 0084, yet the drug has been added to the AGILE program. What is going on?

Expand

Hey RBx,

you are too smart a guy so I’m assuming you are here looking to tease out your playmate!

hahaha

You are right we have better results to-date but we all know it’s good to have choices - GBM Agile is a multi-arm study sharing the same control group and funded from a number of foundations as well as contributions from the drug owners and has the FDA onside there will be a number of drugs go through.

it’s quicker and cheaper than conventional studies - they are already recruiting (probably for the control group).

you can take a deep dive here on GBM Agile:
https://www.gcaresearch.org/gbm-agile/

here is the latest KZA preso released today and it’s worth a look mate:
https://hotcopper.com.au/threads/ann-kazia-presents-to-h-c-wainwright-conference.5625869/
Last edited by rikki: 15/09/20

KZA Price at posting: 99.0¢ Sentiment: Buy Disclosure: Held
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