Longeveron recently announced the results of a Phase 2b Aging Frailty study, which showed that frail subjects (average age for study was 75.2 years) with impaired mobility could walk nearly 50 meters further 180 days after a single intravenous infusion of Lomecel-B (200 million Lomecel-B group; p=0.0065). This increase was durable, persisting through 270 days (200 million Lomecel-B group change from baseline 47.9 meters; p=0.0115, and p<0.0077 compared to placebo). By comparison, the placebo-treated subjects change from baseline at 180 days and 270 days was 8.0 meters (p=0.5371) and -15.5 meters (p=0.2728), respectively.
Kinesiometrics will provide Longeveron with a patented Software as a Solution (SaaS), mobile-phone based platform that can collect not only years of historical data regarding a subject's activity levels via steps, distance walked, flights climbed and energy expenditure, but also real-time response information for comparison of activity level changes pre- and post-Lomecel-B infusion. This vital data may be used to understand and gauge outcomes of treatment regimens, and information is presented in an easy to understand and compelling graphical format. With the Kinesiometrics technology, activity levels can be provided continuously, rather than relying solely on single time points throughout the follow-up period. This could provide rapid understanding of the effect of Lomecel-B and has the potential to reduce the number of protocol-specific visits a research subject needs to make to the clinic.
"Both walking speed and walking distance are highly accurate clinical indicators of overall health in older people, as well as powerful predictors of survival," said Dr. Kevin Ramdas, Director of Clinical Affairs at Longeveron. "With this new tool, we will get a richer and more comprehensive understanding of a subject's functional performance before and after infusion with Lomecel-B."
"We are extremely excited about the collaboration with Kinesiometrics as it fits perfectly with our strategic vision to develop biological solutions for aging," said Geoff Green, CEO of Longeveron. "The Kinesiometrics platform has the potential to help us advance our clinical development program and gain greater insights into how Lomecel-B impacts patient's quality of life and functional capacity. The new data generated may help with FDA regulatory filings and is highly consistent with the introduction of digital wearable technology into advancement of novel therapeutic strategies."
Dr. Michael Wang, a co-founder of Kinesiometrics and Chief of Neurosurgery at the University of Miami Hospital commented, "We have been looking for a partner that understands the need to use novel and modern digital methods to accelerate how patient outcomes are measured. Longeveron understands the core value of using data visualization that allows clinicians to identify critical inflection points and setbacks during a patient's recovery phase, and we look forward to working with Longeveron to achieve the goal of helping patients increase in their functional capacity and quality of life."
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.
About Kinesiometrics Inc.
Kinesiometrics has created a smartphone-based application to enhance our understanding of the post-surgical and post-treatment for patients. Based on thousands of data points, artificial intelligence will guide the intervention decision-making and recovery process. By partnering with academic medical centers, medical device, pharmaceutical, and insurance companies, we are conducting multiple trials to delineate the relationship between objective physical activity data, and patient outcome as well as its effect on the overall health economics. The raw accelerometer data gleaned from the patients' smartphones is fully encrypted and Health Insurance Portability and Accountability Act (HIPAA) compliant and uses machine learning algorithms for output.
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Source: Longeveron Inc
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