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Longeveron Announces Phase 2 Clinical Trial in Japan to Test Safety and Efficacy of Lomecel-B on Aging Frailty Patients

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New trial is in collaboration with Japan’s National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital

MIAMI, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or the "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today that it has entered into a sponsored clinical research agreement with the National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital in Japan, to explore the safety and efficacy of Lomecel-B in older, frail Japanese subjects.

“We are excited to embark on this collaboration with the NCGG, one of the top advanced and specialized medical research centers in Japan, and Juntendo University Hospital,” said Geoff Green, Chief Executive Officer at Longeveron. “We believe our work could be especially impactful in Japan, which has one of the oldest and fastest aging populations in the world, and where early identification and intervention of frailty is a priority,” continued Mr. Green.

Japan is considered to be a “super-aged” society, with approximately 29.1% of the population aged 65 or older in 2021, representing some 36.4 million individuals. The overall prevalence of frailty amongst this demographic is estimated to be 7.9% [1]

Lomecel-B has been evaluated in Phase 1 & 2 aging frailty clinical studies in the U.S. In addition, the U.S. Food and Drug Administration recently granted rare pediatric disease designation for Lomecel-B to treat Hypoplastic Left Heart Syndrome (HLHS), a life-threatening heart condition in infants. A Phase 2 clinical trial is currently underway in babies with HLHS.

The President of the NCGG, Hidenori Arai, M.D., Ph.D., stated “We look forward to collaborating with Longeveron and Juntendo University Hospital to advance this very important clinical study. NCGG’s mission is to improve independence and longevity in older people through the promotion of physical and mental health. Based on the results of Longeveron’s previously announced U.S. Phase 2b trial for aging frailty, where subjects receiving a single infusion of Lomecel-B showed a statistically significant improvement in walking distance at day 270 post infusion compared to placebo, we are hopeful that we see improvements in physical function in Japanese subjects as well.”

The Japanese Phase 2 study is a randomized, double-blind, placebo-controlled design approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The study has a target enrollment of 45 subjects and three cohorts, 15 per cohort, randomized to receive a single intravenous infusion of Lomecel-B 50 million cells, Lomecel-B 100 million cells, or placebo. The primary objective is to evaluate safety, and explore the effect Lomecel-B on physical function, activities of daily living, inflammation-related biomarkers (e.g. cytokines) in the blood, and other endpoints.

In addition to enrolling subjects at NCGG, Juntendo University Hospital in Tokyo and Koto city are participating sites. Juntendo University Hospital was established in 1838 as the first medical school in Japan to adopt western medicine and is one of Japan’s largest private hospital chains. Juntendo University Hospital in Tokyo will serve as the clinical coordinating center along with its sister campus in Koto City, the Juntendo Koto Geriatric Medical Center.

References:

[1] Kojima, et al. Prevalence of frailty in Japan: A systematic review and meta-analysis. Journal of Epidemiology, 27 (2017) 347 -353.

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.

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, including achievement of primary endpoints; 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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