That link and news item from Bill_T last weekend........ from...

That link and news item from Bill_T last weekend........ from UCLA suggesting new imagining likely showed GDC 0084 was working (during the week the company tweeted the same link) - is well and true surpassed by this actual medical publication.

See below (all underlining and bold is mine). Investors can't get any better than this, from the initial Phase 1 trial.

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But at very bottom its gets even better - at a FDA convened meeting way back in March 2019 (just check who was in attendance) - Dr Ellingston's imaging is to be adopted also in Brain Metastases studies. (in addition to GBM).

Now we have a strong link between UCLA Doctors M Ellingston, T. Cloughesy (GBM AGILE) and Harvard Medical/Dana Farber. Priscilla K Brastianos , Nancy U Lin , Patrick Y Wen


An outstanding share price opportunity......

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NIMG-34. MULTI-PARAMETRIC MR-PET IMAGING PREDICTS PHARMACOKINETICS AND CLINICAL RESPONSE TO GDC-0084 IN HUMAN RECURRENT HIGH-GRADE GLIOMA 11 November 2019.

Benjamin Ellingson, Jingwen Yao, Catalina Raymond, David Nathanson, Jeremy Simpson, James Garner, Alan Olivero, Lars Mueller, Jordi Rodon, Elizabeth Gerstner, Timothy Cloughesy, Patrick WenNeuro-Oncology, Volume 21, Issue Supplement_6, November 2019, Page vi168, https://doi.org/10.1093/neuonc/noz175.704 Published: 11 November 2019Cite Permissions Icon Permissions ShareAbstractAlterations in the PI3K pathway are found in the majority of malignant gliomas, but lack of efficacy has caused investigators to question the viability of this target, particularly due to lack of brain penetration. GDC-0084 was specifically optimized to penetrate the brain, targeting both PI3K and mTOR. Since these two targets alter tumor vascularity and metabolism, respectively, we hypothesized that multi-parametric MR-PET could be used to quantify the response, estimate pharmacokinetic (PK) parameters, and predict progression-free survival (PFS) in patients with recurrent malignant gliomas. In this first-in-man, multicenter, phase I, dose-escalation study (NCT01547546), we show in 47 patients that the measured maximum concentration (Cmax) of GDC0084 was associated with a decrease in enhancing tumor volume (P=0.0287) and an increase in fractional anisotropy (FA) (P=0.0418). Post-treatment tumor volume, 18F-FDG uptake, Ktrans, and relative cerebral blood volume (rCBV) were all correlated with Cmax. A linear combination of change in 18F-FDG PET uptake, apparent diffusion coefficient (ADC), FA, Ktrans, vp, and rCBV were able to estimate both Cmax (R2=0.4113, P< 0.0001) and drug exposure (AUC) (R2=0.3481, P< 0.0001). Using this composite multi-parametric MR-PET imaging response biomarker to predict PK, patients with an estimated Cmax >0.1 uM and AUC > 1.25 uM*hr demonstrated significantly longer PFS compared with patients with a lower estimated concentration and exposure (P=0.0039 and P=0.0296, respectively). Results from the current study suggest composite biomarkers created from multi-parametric MR-PET imaging targeting metabolic and/or physiologic processes specific to the drug mechanism of action may be useful for subsequent evaluation of treatment efficacy for larger phase II-III studies.


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Neuro Oncol. 2020 Feb 12;noaa030. doi: 10.1093/neuonc/noaa030. Online ahead of print.Consensus Recommendations for a Standardized Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases

(BTIP-BM)Timothy J Kaufmann 1, Marion Smits 2, Jerrold Boxerman 3, Raymond Huang 4, Daniel P Barboriak 5, Michael Weller 6, Caroline Chung 7, Christina Tsien 8, Paul D Brown 9, Lalitha Shankar 10, Evanthia Galanis 11, Elizabeth Gerstner 12, Martin J van den Bent 13, Terry C Burns 14, Ian F Parney 14, Gavin Dunn 15, Priscilla K Brastianos 16, Nancy U Lin 17, Patrick Y Wen 18, Benjamin M Ellingson 19 20Affiliations expandPMID: 32048719 DOI: 10.1093/neuonc/noaa030Abstract


https://pubmed.ncbi.nlm.nih.gov/32048719/


A recent meeting was held on March 22, 2019, among the U.S. Food and Drug Administration (FDA), clinical scientists, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocacy groups to discuss challenges and potential solutions for increasing development of therapeutics for central nervous system (CNS) metastases.....