Longeveron Selects Clinical Research Organization for Phase 2 Alzheimer’s Disease Trial
Longeveron Inc. recently announced the selection of Biorasi LLC as its clinical research organization (CRO) to help conduct its Phase 2 clinical trial evaluating Lomecel-B infusion in Alzheimer’s Disease (AD) subjects.
Biorasi has extensive experience in the management and execution of neurology clinical studies, with deep experience in Phase 1 through 4 trials, both in the US and globally.
“Partnering with Biorasi for Longeveron’s next Phase 2 AD trial will help continue to advance the development of Lomecel-B for the treatment of Alzheimer’s disease,” said Kevin N. Ramdas, MD, MPH, Director, Medical Affairs at Longeveron. “We look forward to initiating the trial by year-end, or in the first quarter of 2022.”
Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The company’s lead investigational product is the LOMECEL-B cell-based therapy product (Lomecel-B), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other life-threatening conditions. Longeveron is conducting clinical research in the following indications/conditions: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. For more information, visit www.longeveron.com.
Biorasi is an award-winning contract research organization accelerating drug and device clinical development for life sciences companies around the world. Since 2002, Biorasi has achieved success in bringing innovative therapies to market by forming true partnerships with sponsors, and focusing on processes, methodologies, and technologies that move the industry forward. Biorasi is headquartered in Miami, FL, and has regional offices around the globe.
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