Longeveron Expands Enrollment Criteria for its Phase 1 RECOVER Trial Evaluating Lomecel-B Infusion to Treat Acute Respiratory Distress Syndrome due to COVID-19 or Influenza Infection
Longeveron Inc. (NASDAQ: LGVN) announced an expansion of enrollment criteria for its Phase 1 RECOVER trial targeting Acute Respiratory Distress Syndrome (ARDS). The trial now includes mild ARDS patients, in addition to those with moderate and severe cases. This double-blind, placebo-controlled study will assess the safety and efficacy of Lomecel-B, a bone marrow-derived therapy, in COVID-19 or Influenza-infected ARDS patients. The study aims to mitigate severe inflammation and improve clinical outcomes. The RECOVER trial is partially funded by a TEDCO award and is set to grow its participating clinical sites.
- Expansion of enrollment criteria to include mild ARDS patients, potentially increasing patient access.
- Lomecel-B has the potential to reduce severe inflammation in ARDS, possibly improving clinical outcomes.
- Received a TEDCO grant to support the Phase 1 study, reflecting confidence in the trial's importance.
- None.
Trial funded in part by a Maryland Stem Cell Research Fund TEDCO Grant
MIAMI, March 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, announced today that enrollment criteria for its Phase 1 Acute Respiratory Distress Syndrome (ARDS) RECOVER trial has been expanded to include mild ARDS, in addition to moderate and severe ARDS. Previously, only ARDS patients intubated with an endotracheal tube for positive pressure ventilation were eligible. The protocol amendment allows for the inclusion of milder cases of ARDS patients who present with the need for supplemental oxygen via high flow nasal cannula, partial or nonrebreathing mask, or non-invasive positive pressure mask.
The RECOVER Trial is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of up to 3 intravenous administrations of either Lomecel-B (allogeneic bone marrow-derived medicinal signaling cells) or placebo in COVID-19 or Influenza-infected ARDS patients. The primary measures of efficacy are functional lung recovery, recovery from infection, inflammatory status, immune status, and lung imaging.
“The goal here is to reduce the inflammatory response and to either prevent the need for mechanical support, or to allow these individuals to come off of the ventilator and leave the ICU,” stated Joe G. N. "Skip" Garcia, MD, a world-renowned pulmonologist and professor of medicine at the University of Arizona College of Medicine. ARDS resulting from COVID-19 or Influenza is driven by severe inflammation, called a cytokine storm. This can lead to accumulation of fluid in the lungs and severe tissue damage, and ultimately decreased ability to oxygenate the blood. The most severe cases lead to respiratory failure and the high mortality rate from COVID-19. Longeveron’s Lomecel-B has the potential to reduce the cytokine storm involved in ARDS and thus the possibility to improve clinical outcomes in COVID-19 patients.
The RECOVER Trial received a prestigious TEDCO award from the Maryland Stem Cell Research Fund (MSCRF) to help support the Phase 1 study. This is Longeveron’s third TEDCO Award since 2017.
Participating clinical centers currently include the Miami VA Health System, University of Maryland Medical Center, and Wake Forest University Hospital. The Company is in the process of expanding the number of participating clinical sites. Any clinical sites or investigators interested in learning more about participating in the phase 1 trial should contact: Kevin Ramdas, MD, MPH, Associate Director, Medical Affairs; kramdas@longeveron.com.
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 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.
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FAQ
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