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Posted On: 12/27/2024 11:17:57 AM
Post# of 155808
Slow day at work today and as if you all don't already know this but regarding upcoming "milestones":
1. Phase II Oncology Trial in Colorectal Cancer:
* FDA Clearance: In November 2024, the FDA approved CytoDyn's Phase II trial to assess leronlimab's efficacy in patients with relapsed or refractory microsatellite-stable colorectal cancer.
*Trial Initiation: A kickoff meeting occurred in late November 2024, with patient enrollment slated to begin in early 2025.
2. Preclinical Studies in Metabolic-Associated Steatohepatitis (MASH):
**Ongoing Research: As of June 2024, CytoDyn initiated preclinical studies to evaluate leronlimab's potential in reversing liver fibrosis associated with MASH.
**Upcoming Results: Findings from these studies are anticipated in January 2025.
3. Pilot Study in Alzheimer's Disease:
***Protocol Finalization: CytoDyn has completed the protocol for a pilot study to assess leronlimab in patients with mild to moderate Alzheimer's disease.
***Regulatory Submissions: The protocol will soon be submitted to both the FDA and the Institutional Review Board (IRB) at Cornell Medical Center in New York.
4. Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS):
****NIH Application: In September 2024, CytoDyn applied to the NIH's RECOVER-TLC group to include leronlimab in upcoming Long COVID treatment studies.
****Pending Decision: A decision from the NIH is expected in the coming months.
5. HIV Program:
*****Clinical Hold Status: As of February 2024, CytoDyn submitted a revised HIV clinical trial protocol to the FDA, aiming to address the clinical hold on its HIV program.
*****Awaiting FDA Response: The company is awaiting feedback from the FDA regarding the potential lifting of the clinical hold.
1. Phase II Oncology Trial in Colorectal Cancer:
* FDA Clearance: In November 2024, the FDA approved CytoDyn's Phase II trial to assess leronlimab's efficacy in patients with relapsed or refractory microsatellite-stable colorectal cancer.
*Trial Initiation: A kickoff meeting occurred in late November 2024, with patient enrollment slated to begin in early 2025.
2. Preclinical Studies in Metabolic-Associated Steatohepatitis (MASH):
**Ongoing Research: As of June 2024, CytoDyn initiated preclinical studies to evaluate leronlimab's potential in reversing liver fibrosis associated with MASH.
**Upcoming Results: Findings from these studies are anticipated in January 2025.
3. Pilot Study in Alzheimer's Disease:
***Protocol Finalization: CytoDyn has completed the protocol for a pilot study to assess leronlimab in patients with mild to moderate Alzheimer's disease.
***Regulatory Submissions: The protocol will soon be submitted to both the FDA and the Institutional Review Board (IRB) at Cornell Medical Center in New York.
4. Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS):
****NIH Application: In September 2024, CytoDyn applied to the NIH's RECOVER-TLC group to include leronlimab in upcoming Long COVID treatment studies.
****Pending Decision: A decision from the NIH is expected in the coming months.
5. HIV Program:
*****Clinical Hold Status: As of February 2024, CytoDyn submitted a revised HIV clinical trial protocol to the FDA, aiming to address the clinical hold on its HIV program.
*****Awaiting FDA Response: The company is awaiting feedback from the FDA regarding the potential lifting of the clinical hold.
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LETS GO!!!
