MIAMI, April 13, 2022 (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, announced today a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) for the addition of a Miami VA clinical site to its ongoing Phase 2 Alzheimer’s Disease (AD) trial.
As recently reported in a peer reviewed article in Alzheimer’s & Dementia®, The Journal of the Alzheimer’s Association, Longeveron’s Phase 1 trial met its primary endpoint, demonstrating that its drug Lomecel-B was well tolerated in Alzheimer’s patient. In addition, the data provided indications supporting further exploration of Lomecel-B, particularly the therapeutic potential to slow cognitive decline and improve quality of life in patients with AD.
“After meeting the rigorous requirements of the VA, we are pleased to announce the addition of this particular Miami VA site to our ongoing trial,” said Geoff Green, Chief Executive Officer at Longeveron. “This continued collaboration between Longeveron and the Miami VA reflects our ongoing efforts to develop a safe and effective cell-based therapy for this devastating disease in the vital setting of the VA health system.”
This marks the third separate CRADA agreement between the VA and Longeveron, including an Aging Frailty study and an ongoing study on Covid-19, further cementing the strong partnership and focus on the Veteran population. The VA Miami Healthcare System provides primary and specialty health care services to approximately 63,000 Veterans in three south Florida counties – Miami-Dade, Broward and Monroe. The lead trial investigator at the Miami VA is Dr. Jorge G. Ruiz, the Associate Director of the VA’s Department of Geriatric Research Education and Clinical Center (GRECC).
“The Miami VA Healthcare System GRECC is, once again, pleased to be partnering with Longeveron on another important study,” Dr. Ruiz stated. “We share the goal of caring for our Veteran’s with Alzheimer’s disease, which is affecting many older Veterans and the overall older population,” he added.
The CLEAR MIND Trial, a Phase 2a study, is a blinded, randomized, placebo-controlled design investigating safety and tolerability, as well as secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of Lomecel-B compared to placebo, in individuals with mild AD. The study consists of four treatment arms of 12 patients each, for a total target enrollment of 48 patients.
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 medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: 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.
Contact:
Brendan Payne
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com
Source: Longeveron
