Research and development of stem cell-based therapies, where a patients own cells, or those from a donor, are used to fight injury and disease, is one of the fastest growing areas in the biotech space. Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company in the thick of clinical development, continues to advance its investigational therapeutic, Lomecel-B, for chronic, aging-related and life-threatening conditions.

The company recently announced the results of its randomized, blinded and placebo-controlled Phase 2 trial to evaluate the safety and efficacy of its proprietary Lomecel-B infusion in frail, older patients between 70 and 85 years old. The trial, which was partially funded by the National Institute on Aging, evaluated a single intravenous infusion of 4 different doses of Lomecel-B cell therapy compared to placebo on the change in the distance a person could walk in 6 minutes (a test known as the 6-minute walk test). Results showed that a single infusion of Lomecel-B resulted in an increase in walk distance of approximately 50 meters (164 feet) at 6 and 9 months after infusion, while the placebo-treated subjects showed minimal improvement at 6 months and a deterioration by 9 months.

Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors, which are culture-expanded in Longeverons current good manufacturing practice cell-processing facility. According to trial results so far, Lomecel-B, and MSCs in general, may be injected or infused into an unrelated recipient without triggering a harmful reaction (rejection) due to the biochemical properties of these specialized cells. This is in part what makes this class of biologic so intriguing for use as a regenerative therapeutic.

A growing global trend is for biotech companies to direct their services to the cell and gene therapy industry and moving to expand into a new branch of the pharmaceutical contract development and manufacturing organization world.

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The U.S. Food and Drug Administration (FDA) has approved a small number of cell and gene therapy drugs. Still, a new product pipeline is fighting for the agencys attention with approximately 1,200 experimental therapies more than half in Phase 2 clinical trials. The annual sales growth estimates for cell therapies are projected to reach 15%.

Longeveron has also initiated a Phase 2 trial evaluating the safety and efficacy of Lomecel-B injection into the heart of children born with hypoplastic left heart syndrome (HLHS), a rare and often fatal congenital heart defect.

Longeveron believes that using the same cells that promote tissue repair, organ maintenance and immune system function can develop safe and effective therapies for some of the most challenging diseases and conditions associated with aging.

We continue to make steady progress advancing our Lomecel-B clinical research programs forward, Longeveron CEO Geoff Green said. We have encouraging top-line results from our Aging Frailty program, and anticipate initiating a Phase 2 trial in Alzheimers disease later this year.

Longeveron shared their review of the Aging Frailty trial data with independent frailty experts, with the objective of planning the next steps for the program. The company presented clinical data at the 2021 International Conference on Frailty & Sarcopenia Research on Sept. 29 during a round-table presentation.

Learn more about Longeveron at http://www.longeveron.com.

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