Rodolfo, Liver biopsy has been the gold standar
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Posted On: 10/23/2021 6:49:01 AM
Rodolfo,
Liver biopsy has been the gold standard for assessing NASH, but fibroscans (fat fraction and fibrosis by MRI) have become an accepted non-invasive tool for evaluation.
A quick look on clinical trials website shows 202 trials with fibroscan as the evaluative tool for disease progression
https://clinicaltrials.gov/ct2/results?cond=N...&dist=
Cancer BTD is often granted on small patient populations. Unmet need + significant improvement over existing therapy (400% improvement in OMS) = BTD
I’m struggling to determine how the breast cancer trials are deemed retrospective. Patients were enrolled based on clinical status, administered Leronlimab, and evaluated for clinical response.
Prospective.
This was not an evaluation of previously incidental findings among the large HIV population receiving Leronlimab. Clinical response was compared to historical controls, normal for an exploratory trial.
LH/PASC P2 already completed, phase 3 upcoming.
I’m a bit surprised that MD xenograft trial taking place, as 98% reduction in tumors seen without checkpoint inhibitors, supporting the conjecture (I believe) by Ohm that their use in combination with Leronlimab will be superfluous.
Leronlimab, a humanized monoclonal antibody to CCR5, blocks breast cancer cellular metastasis and enhances cell death induced by DNA damaging chemotherapy
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7825185/
“ Results: Herein, leronlimab was shown to bind CCR5 in multiple breast cancer cell lines. Binding of leronlimab to CCR5 reduced ligand-induced Ca+ 2 signaling, invasion of TNBC into Matrigel, and transwell migration. Leronlimab enhanced the BCa cell killing of the BCa chemotherapy reagent, doxorubicin. In xenografts conducted with Nu/Nu mice, leronlimab reduced lung metastasis of the TNBC cell line, MB-MDA-231, by > 98% at 6 weeks. Treatment with leronlimab reduced the metastatic tumor burden of established TNBC lung metastasis.”
I am frustrated by the HIV BLA issues and the failure to quickly recognize the short comings of Amarex.
As discussed previously, the arrival of Dr Recknor, after his rescue from Covid by Leronlimab, has been incredibly beneficial to Cytodyn.
As we discuss concerns for the clinical development of leronlimab, let’s make certain that we are factually correct.
Liver biopsy has been the gold standard for assessing NASH, but fibroscans (fat fraction and fibrosis by MRI) have become an accepted non-invasive tool for evaluation.
A quick look on clinical trials website shows 202 trials with fibroscan as the evaluative tool for disease progression
https://clinicaltrials.gov/ct2/results?cond=N...&dist=
Cancer BTD is often granted on small patient populations. Unmet need + significant improvement over existing therapy (400% improvement in OMS) = BTD
I’m struggling to determine how the breast cancer trials are deemed retrospective. Patients were enrolled based on clinical status, administered Leronlimab, and evaluated for clinical response.
Prospective.
This was not an evaluation of previously incidental findings among the large HIV population receiving Leronlimab. Clinical response was compared to historical controls, normal for an exploratory trial.
LH/PASC P2 already completed, phase 3 upcoming.
I’m a bit surprised that MD xenograft trial taking place, as 98% reduction in tumors seen without checkpoint inhibitors, supporting the conjecture (I believe) by Ohm that their use in combination with Leronlimab will be superfluous.
Leronlimab, a humanized monoclonal antibody to CCR5, blocks breast cancer cellular metastasis and enhances cell death induced by DNA damaging chemotherapy
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7825185/
“ Results: Herein, leronlimab was shown to bind CCR5 in multiple breast cancer cell lines. Binding of leronlimab to CCR5 reduced ligand-induced Ca+ 2 signaling, invasion of TNBC into Matrigel, and transwell migration. Leronlimab enhanced the BCa cell killing of the BCa chemotherapy reagent, doxorubicin. In xenografts conducted with Nu/Nu mice, leronlimab reduced lung metastasis of the TNBC cell line, MB-MDA-231, by > 98% at 6 weeks. Treatment with leronlimab reduced the metastatic tumor burden of established TNBC lung metastasis.”
I am frustrated by the HIV BLA issues and the failure to quickly recognize the short comings of Amarex.
As discussed previously, the arrival of Dr Recknor, after his rescue from Covid by Leronlimab, has been incredibly beneficial to Cytodyn.
As we discuss concerns for the clinical development of leronlimab, let’s make certain that we are factually correct.
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