Clinical Trials Arena Regulatory roundup: CytoDyn
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Posted On: 08/19/2024 9:33:54 AM
Clinical Trials Arena
Regulatory roundup: CytoDyn’s cancer asset leronlimab likely to advance after basket trial completion
Reynald Castañeda
Mon, Aug 19, 2024, 6:13 AM CDT2 min read
In this article:
GLDAF
0.00%
Impact on CytoDyn's Clinical Development Strategy
Need to know:
GlobalData’s Investigative News team reviews data generated by an in-house model that combines machine learning and its proprietary algorithm. Likelihood of Approval (LoA) provides the probability of a drug in securing market authorization; Phase Transition Success Rate (PTSR) indicates the probability of a drug advancing to the next stage of development. The model uses data points from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
Click here for last week's edition
Leronlimab solid tumour trial completed
CytoDyn’s leronlimab for CCR5+ locally advanced or metastatic solid tumours saw its PTSR increase in multiple cancer indications after its Phase II basket trial completed. The trial looked at 22 cancer types, and the largest PTSR changes occurred in glioblastoma multiforme (GBM), throat cancer, and bladder cancer. The PTSR leapt nine points to 32% in GBM, and four points to 37% in both throat and bladder cancer.
The 30-patient basket trial (NCT04504942) was announced as completed in a 24 November company press release, and the PTSR change occurred 26 November. As primary endpoints, the study looked at adverse events, abnormal laboratory test results, and changes in Eastern Cooperative Oncology Group (ECOG) performance status. Secondary endpoints include progression-free survival (PFS) and overall response rate (ORR). Leronlimab is a CCR5 antagonist with antitumour effects.
The completed trial also resulted in some modest increases to the drug’s LoA. In GBM, the LoA rose one point to 9%, and in throat cancer, the LoA rose one point to 15%. There was no score change in bladder cancer, which remains at 5%.
I saw this posted on stocktwits.....an article posted today on Yahoo finance
Regulatory roundup: CytoDyn’s cancer asset leronlimab likely to advance after basket trial completion
Reynald Castañeda
Mon, Aug 19, 2024, 6:13 AM CDT2 min read
In this article:
GLDAF
0.00%
Impact on CytoDyn's Clinical Development Strategy
Need to know:
GlobalData’s Investigative News team reviews data generated by an in-house model that combines machine learning and its proprietary algorithm. Likelihood of Approval (LoA) provides the probability of a drug in securing market authorization; Phase Transition Success Rate (PTSR) indicates the probability of a drug advancing to the next stage of development. The model uses data points from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
Click here for last week's edition
Leronlimab solid tumour trial completed
CytoDyn’s leronlimab for CCR5+ locally advanced or metastatic solid tumours saw its PTSR increase in multiple cancer indications after its Phase II basket trial completed. The trial looked at 22 cancer types, and the largest PTSR changes occurred in glioblastoma multiforme (GBM), throat cancer, and bladder cancer. The PTSR leapt nine points to 32% in GBM, and four points to 37% in both throat and bladder cancer.
The 30-patient basket trial (NCT04504942) was announced as completed in a 24 November company press release, and the PTSR change occurred 26 November. As primary endpoints, the study looked at adverse events, abnormal laboratory test results, and changes in Eastern Cooperative Oncology Group (ECOG) performance status. Secondary endpoints include progression-free survival (PFS) and overall response rate (ORR). Leronlimab is a CCR5 antagonist with antitumour effects.
The completed trial also resulted in some modest increases to the drug’s LoA. In GBM, the LoA rose one point to 9%, and in throat cancer, the LoA rose one point to 15%. There was no score change in bladder cancer, which remains at 5%.
I saw this posted on stocktwits.....an article posted today on Yahoo finance
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