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Federal Government. Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. Learn more. Try the modernized ClinicalTrials. Investigators must include in their application proposed adverse event AE and serious adverse event SAE definitions and discuss their monitoring and reporting.
All clinical trials of drugs and biological products conducted under an Investigational New Drug Application IND must use definitions of adverse events and adverse reactions and follow the reporting requirements established by 21 Code of Federal Regulations CFR Part All other interventional studies must propose their definitions of adverse events and their reporting procedures.
The NIA Safety Training Course available below , an online training venue, provides an overview of human subject safety surveillance and reporting requirements in clinical research studies.
The intent of the course is to help clinical study investigators and staff understand and implement NIA and regulatory requirements for safe, high quality clinical research. The course requires about 40 minutes to complete. Screening Log MS Excel, 47K Provides documentation of all individuals who were evaluated for participation in a research study. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease GvHD and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.
CytoDyn was conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn expects to refile its BLA in the first half of calendar year
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