{"id":749084,"date":"2023-04-19T09:02:42","date_gmt":"2023-04-19T13:02:42","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/"},"modified":"2023-04-19T09:02:42","modified_gmt":"2023-04-19T13:02:42","slug":"longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/","title":{"rendered":"Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan"},"content":{"rendered":"
\n

\n — The study\u2019s primary objective is to evaluate the safety of Lomecel-B\u2122<\/em>
\n \u00a0in Japan\u2019s elderly population — <\/em>\n <\/p>\n

\n — First-in-human clinical trial of Lomecel-B\u2122<\/em>
\n \u00a0in Japan —<\/em>\n <\/p>\n

\n — Study will also assess efficacy endpoints expanding Longeveron\u2019s database of Lomecel-B\u2122<\/em>
\n \u2019s physiologic effects in individuals of older age —<\/em>\n <\/p>\n

MIAMI, April 19, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced that the first patient has been treated with Lomecel-B\u2122\u00a0in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety.<\/p>\n

\u201cWe are excited to announce the dosing of the first patient in our Japanese Aging-Related Frailty trial,\u201d said Wa\u2019el Hashad, Longeveron\u2019s Chief Executive Officer. \u201cIn 2022, Longeveron aligned with the Japan Pharmaceuticals and Medical Devices Agency (PMDA), on the Phase 2 trial design and we hope the data from this trial will provide support for a limited approval under Japan\u2019s Act on the Safety of Regenerative Medicine (ASRM), which allows regenerative medicine products to be administered to patients by approved hospitals or clinics under the practice of medicine. This is the first use of our U.S.-manufactured product in Japan, and we look forward to advancing Lomecel-B\u2122 as a treatment for Aging-Related Frailty in Japan.\u201d<\/p>\n

Hidenori Arai, M.D., Ph.D., President of the National Center for Geriatrics and Gerontology, and principal investigator of the Phase 2 trial, commented, \u201cI am pleased to see this clinical trial program advancing, especially given the large unmet need in Japan, where nearly 30% of the population is over the age of 65. I was encouraged by Longeveron\u2019s previously announced Phase 2b Aging-Related Frailty study in the United States, where subjects receiving a single infusion of Lomecel-B\u2122\u00a0showed a statistically significant and clinically meaningful improvement in walking distance at 9 months post-infusion compared to placebo. I look forward to building on that data in the Japanese population.\u201d<\/p>\n

The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single infusion study of two different dose levels of Lomecel-B\u2122. The trial is expected to enroll 45 patients and has a primary objective of evaluating safety of Lomecel-B\u2122\u00a0as a treatment for Aging-Related Frailty. The trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG;Nagoya) and Juntendo University Hospital (Tokyo).<\/p>\n

Japan is considered to be a \u201csuper-aged\u201d society with some 36.4 million individuals aged 65 or older in 2021, representing 29.1% of the population. The overall prevalence of aging-related frailty amongst this demographic is estimated to be 7.9%.<\/p>\n

\n About Aging-Related Frailty<\/strong>\n <\/p>\n

Aging-Related Frailty is an age-associated decline in reserve and function across multiple physiologic systems leading to the inability to cope with stressors. It is characterized by mobility impairment, weakness, fatigue, weight loss, slowness, and low activity and puts individuals at higher risk for poor clinical outcomes, such as infections, falls, fractures, hospitalization, or death.<\/p>\n

\n About Longeveron Inc.<\/strong>\n <\/p>\n

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company\u2019s lead investigational product is Lomecel-B\u2122, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B\u2122 has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B\u2122 through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer\u2019s Disease, and Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com<\/a>.<\/p>\n

\n About the Act on the Safety of Regenerative Medicine (ASRM)<\/strong>\n <\/p>\n

The ASRM was passed in 2014 in order to provide incentives and accelerated approval pathways for regenerative medicine products in Japan. The act provides pathways for both conditional approval and limited use of products under the practice of medicine.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, 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. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron\u2019s clinical trials to demonstrate safety and efficacy of the Company\u2019s product candidates, and other positive results; the timing and focus of the Company\u2019s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company\u2019s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company\u2019s product candidates; the Company\u2019s ability to obtain and maintain regulatory approval of its product candidates; the Company\u2019s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; the Company\u2019s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company\u2019s ability to attract and retain such personnel; the Company\u2019s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company\u2019s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company\u2019s financial performance, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures requirements. 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 Securities and Exchange Commission, including Longeveron\u2019s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022, and the Company\u2019s Quarterly Reports on Form 10-Q. 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.<\/p>\n

\n Investor Contact:<\/strong>\n <\/p>\n

Stern IR, Inc.
212-698-8700
longeveron@sternir.com<\/u><\/p>\n

Source: Longeveron Inc<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

— The study\u2019s primary objective is to evaluate the safety of Lomecel-B\u2122 \u00a0in Japan\u2019s elderly population — — First-in-human clinical trial of Lomecel-B\u2122 \u00a0in Japan — — Study will also assess efficacy endpoints expanding Longeveron\u2019s database of Lomecel-B\u2122 \u2019s physiologic effects in individuals of older age — MIAMI, April 19, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced that the first patient has been treated with Lomecel-B\u2122\u00a0in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety. \u201cWe are excited to announce the dosing of the … <\/p>\n

Continue reading “Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-749084","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nLongeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"— The study\u2019s primary objective is to evaluate the safety of Lomecel-B\u2122 \u00a0in Japan\u2019s elderly population — — First-in-human clinical trial of Lomecel-B\u2122 \u00a0in Japan — — Study will also assess efficacy endpoints expanding Longeveron\u2019s database of Lomecel-B\u2122 \u2019s physiologic effects in individuals of older age — MIAMI, April 19, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. 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(NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced that the first patient has been treated with Lomecel-B\u2122\u00a0in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety. \u201cWe are excited to announce the dosing of the … Continue reading \"Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/","og_site_name":"Market Newsdesk","article_published_time":"2023-04-19T13:02:42+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgxMTI0MyM1NTM1NTM2IzIyMDcwNjA=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan","datePublished":"2023-04-19T13:02:42+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/"},"wordCount":1196,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgxMTI0MyM1NTM1NTM2IzIyMDcwNjA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/longeveron-announces-first-patient-dosed-in-phase-2-clinical-trial-of-lomecel-b-for-aging-related-frailty-in-japan\/","name":"Longeveron Announces First Patient Dosed in Phase 2\u00a0Clinical Trial of Lomecel-B\u2122 for Aging-Related Frailty in Japan - 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