Longeveron Selects Clinical Research Organization for Phase 2 Alzheimer’s Disease Trial
Longeveron Inc. (NASDAQ: LGVN) has selected Biorasi LLC as its clinical research organization to conduct a Phase 2 clinical trial evaluating its Lomecel-B infusion for Alzheimer’s Disease. This partnership aims to enhance the development of Lomecel-B, a cell-based therapy derived from medicinal signaling cells, targeting chronic aging-related conditions. The trial is expected to commence by the end of this year or early 2022, as per Kevin N. Ramdas, MD, MPH from Longeveron. Biorasi’s extensive experience in neurology studies positions them as a strong collaborator for this project.
- Selection of Biorasi as CRO enhances the Phase 2 trial execution for Lomecel-B.
- Lomecel-B targets Alzheimer’s, a significant market opportunity in aging-related therapies.
- Initiation of the trial expected by year-end 2021 or Q1 2022.
- Reliance on successful execution of trials for future market approval.
- Forward-looking statements may involve uncertainties affecting future performance.
MIAMI, Nov. 05, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the selection of Biorasi LLC (“Biorasi”) 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 I through IV 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,” commented 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.”
About Longeveron Inc.
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. Additional information about the Company is available at www.longeveron.com.
About Biorasi:
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, Florida, and has regional offices around the globe.
Forward-Looking and Other Statements
Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
Brendan Payne
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com
Source: Longeveron Inc
Source: LGVN
Source: Longeveron
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