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Posted On: 06/30/2025 1:06:17 AM
Post# of 154693
Aug. 12, 2024 & 350mg.....
Cytodyn: "...announced today that it completed a meeting with the U.S. Food and Drug Administration (FDA) to... ** gain alignment on the rationale and proposed dosing **...for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC).:
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From Clinicals site:
The SUNLIGHT trial evaluated the combination of trifluridine/tipiracil (also known as Lonsurf) plus bevacizumab versus trifluridine/tipiracil alone in patients with metastatic colorectal cancer that had stopped responding to previous treatments. The trial demonstrated a statistically significant improvement in overall survival for the combination therapy compared to trifluridine/tipiracil alone. This combination is now considered a new standard of care for this patient population.
Improved Overall Survival:
The combination of trifluridine/tipiracil and bevacizumab resulted in a median overall survival of 10.8 months, compared to 7.5 months for trifluridine/tipiracil alone. This translates to a 39% reduction in the risk of death.
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Our CRC trial mimicks SUNLIGHT with & without comparisons. I would guess the FDA & Cytodyn have agreed compiling data from 350mg to 700mg is once & for all, properly recognizing Leronlimab is far more than an Hiv blocker & not an immunesuppressior
Keep in mind, technically Cytodyn has never completed any special FDA designations from 2018 frwd...
Now Cytodyn agreeing with the new FDA,
DSMB can be trusted "middle man" with full FDA backing on that.
1 way squashing the...."past".
2nd -- 5 patients @ super fast pathway to 700mg = FDA show of good faith.
If trial Interim DSMB look reccomends stoppage & full approval, Cytodyn will have never needed to apply for AA or BTD....
All comes full circle with Cytodyn having praised FDA
Cytodyn: "...announced today that it completed a meeting with the U.S. Food and Drug Administration (FDA) to... ** gain alignment on the rationale and proposed dosing **...for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC).:
__
From Clinicals site:
The SUNLIGHT trial evaluated the combination of trifluridine/tipiracil (also known as Lonsurf) plus bevacizumab versus trifluridine/tipiracil alone in patients with metastatic colorectal cancer that had stopped responding to previous treatments. The trial demonstrated a statistically significant improvement in overall survival for the combination therapy compared to trifluridine/tipiracil alone. This combination is now considered a new standard of care for this patient population.
Improved Overall Survival:
The combination of trifluridine/tipiracil and bevacizumab resulted in a median overall survival of 10.8 months, compared to 7.5 months for trifluridine/tipiracil alone. This translates to a 39% reduction in the risk of death.
___
Our CRC trial mimicks SUNLIGHT with & without comparisons. I would guess the FDA & Cytodyn have agreed compiling data from 350mg to 700mg is once & for all, properly recognizing Leronlimab is far more than an Hiv blocker & not an immunesuppressior
Keep in mind, technically Cytodyn has never completed any special FDA designations from 2018 frwd...
Now Cytodyn agreeing with the new FDA,
DSMB can be trusted "middle man" with full FDA backing on that.
1 way squashing the...."past".
2nd -- 5 patients @ super fast pathway to 700mg = FDA show of good faith.
If trial Interim DSMB look reccomends stoppage & full approval, Cytodyn will have never needed to apply for AA or BTD....
All comes full circle with Cytodyn having praised FDA
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