Palm Beach, FL –August 13, 2021 – FinancialNewsMedia.com News Commentary – The normal aging process is characterized by a progression of physiologic events that occur throughout the life cycle. Changes associated with aging occur throughout the body and are most prominent in the later years. Changes in the musculoskeletal system begin to occur after the third decade and continue into the eighth and ninth decades. The frailty syndrome can be described as a culmination of the effects of these changes on the human body. An article in Today’s Geriatric Medicine says that, although it lacks a standardized clinical definition, older adults’ frailty warrants special considerations in terms of treatment and nutritional needs. “As normal aging progresses, the musculoskeletal system shows declines in several different areas. The term “sarcopenia” describes the biochemical changes that occur within the muscle fibers as they relate to declining muscle mass and muscle function. Visible atrophy of muscle fibers results in decreased strength. These changes result from fat deposition replacing lean muscle mass, a process that begins after the third decade of life and can result in up to a 40% decrease in muscle mass by the eighth decade of life. Marked losses in muscle strength and decreased endurance become more prominent over time and correlate with an increased risk of falls.” Active Companies in the markets today include Longeveron Inc. (NASDAQ: LGVN), Celularity Inc. (NASDAQ: CELU), CohBar, Inc. (NASDAQ: CWBR), Geron Corporation (NASDAQ: GERN), Athersys, Inc. (NASDAQ: ATHX).
Today’s Geriatric Medicine added: “The structural integrity of the skeleton plays a major role in maintaining optimal posture and gait. The body’s peak bone density occurs during an individual’s late 20s. An ongoing process of bone formation and resorption occurs throughout life in healthy bones. After the age of 40, however, the rate of bone resorption increases, resulting in decreased bone mass and bone density. This process is exacerbated in women following menopause and can lead to osteopenia and osteoporosis. These normal processes of aging affect both the muscular and skeletal systems and, as a result, play a significant role in the decreased mobility that often is observed in later life. Nevertheless, the frailty syndrome is not defined by mobility alone; malnourishment, as evidenced by involuntary weight loss, also is an important component. Although it’s difficult to define precisely, most clinicians will concur that frailty can be easily recognized as “you know it when you see it.”
Longeveron Inc. (NASDAQ: LGVN) BREAKING NEWS: Longeveron Announces Topline Results of Phase 2b Study of Lomecel-B for Aging Frailty – Longeveron Inc. (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced results from the Company’s Phase 2b trial of its lead product Lomecel-B for Aging Frailty subjects. Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors and culture-expanded in Longeveron’s cGMP cell processing facility. The trial, which was partially funded by a Small Business Innovation Research (SBIR) grant from the National Institute on Aging, evaluated the safety and efficacy of a single peripheral intravenous infusion of 4 different doses of Lomecel-B cell therapy (25 million (n=37), 50 million (n=31), 100 million (n=34) and 200 million (n=16) cells; sample size reflects any subject that was randomized and received an infusion) compared to placebo (n=30), on signs and symptoms of Aging Frailty, including mobility and exercise tolerance.
The pre-specified statistical analysis plan for the primary efficacy endpoint, change in six-minute walk test distance at 180 days post-infusion, involved a primary analysis and a secondary analysis:
Primary analysis of the primary efficacy endpoint: The primary analysis compared the change from baseline in 6MWT distance for the four Lomecel-B cohorts to the placebo cohort at Day 180. All cohorts showed a mean increase from baseline (25 million=7.8 meters, p=0.5040; 50 million=35.8 meters, p=0.0053; 100 million=24.9 meters p=0.0443; 200 million=49.3 meters, p=0.0065; placebo=8.0 meters, p=0.5371). After adjusting for multiple comparisons using the Hochberg method (1988), the four Lomecel-B cohorts did not show a statistically significant placebo-adjusted difference (Δ) when compared to the placebo cohort (25 million Δ=0.2, p=0.9902; 50 million Δ=27.7, p=0.1279; 100 million Δ=16.8, p =0.3472; 200 million Δ=41.3, p=0.0635).
Secondary analysis of the primary efficacy endpoint: The secondary analysis was to determine whether a dose-response relationship exists using the multiple comparisons and modeling approach by Bretz et. al (2003). The results showed a clear, statistically significant dose-response curve at day 180. Among the various dose-response curves evaluated (Emax, Linear, Exponential, Quadratic, and Sigmoid Emax), all had p-values of less than 0.05, with the Sigmoid Emax model having the most significant dose-response relationship (p=0.0170).
Despite not achieving the statistical significance for the pairwise comparison to placebo at Day 180, significant differences from placebo were observed at Day 270, which was a pre-specified exploratory endpoint (25 million Δ=27.5, p=0.1530; 50 million Δ=49.2, p=0.0122; 100 million Δ=31.0, p=0.1071; 200 million Δ=63.4, p=0.0077).
“Improving physical function in older adults with frailty is one of the primary goals in geriatric medicine,” said Dr. Jorge G. Ruiz, MD, geriatrician at the Miami Veterans Affairs Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), the study’s highest enrolling site. “The fact that patients enrolled in this study, with an average age of 75 and with clear mobility limitations, showed 6-month and 9-month placebo-adjusted increases in walking distance of 40 meters and 63 meters, respectively (200 million cell dose), is significant for a number of reasons. Frailty is associated with poor clinical outcomes and high healthcare utilization and being able to improve and extend walking distance suggests preservation of function and potentially independence,” Dr. Ruiz continued. “I would consider these results clinically significant and relevant for the older veteran population since one third of American Veterans 65 years and older have frailty.”
“We are very pleased to report a statistically significant dose response curve with our cell therapy product,” commented Geoff Green, CEO of Longeveron Inc. “One of the main objectives of this trial was to determine whether a dose response relationship could be demonstrated in the primary efficacy endpoint, so this finding is important for the research program,” Mr. Green continued. “Furthermore, the safety profile of Lomecel-B continues to look very good, with no Lomecel-B related Serious Adverse Events reported in this study, which is consistent with previous clinical trial data.” CONTINUED… For more information about Longeveron, please visit https://investors.longeveron.com/news/default.aspx
Other recent developments in markets include:
Imugene Ltd (“Imugene”) (IMU), a clinical stage immuno-oncology company and Celularity Inc. (NASDAQ: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, recently announced they have entered into a research collaboration in 2021. As part of the partnership, Imugene and Celularity will initially collaborate to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CyCART-19, for the treatment of solid tumors. CyCART-19 is a placental-derived T-cell investigational therapy engineered with a CAR that is cryopreserved and will be available off-the-shelf.
CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, recently reported its financial results for the second quarter ended June 30, 2021.
“Our positive CB4211 topline data announcement today marks an important milestone in our path towards demonstrating the full potential of our novel therapeutic platform sourced from the mitochondrial genome,” stated Dr. Joseph Sarret, Chief Executive Officer. “In parallel with our ongoing analysis of the promising data from the CB4211 study, we are diligently working to enable CB5138-3 to enter the clinic next year for the treatment of idiopathic pulmonary fibrosis. This is an exciting time for the company as we look forward to continued progress in the development of product candidates designed to address serious unmet medical needs.”
Geron Corporation (NASDAQ: GERN) recently announced that it will release its second quarter and year to date 2021 financial results after the market closes on Monday, August 16, 2021 via press release, which will be available on the Company’s website. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.
A live, listen-only webcast will be available on the Company’s website. An archive of the webcast will be available on the Company’s website for 30 days.
Participants may access the conference call live via telephone by pre-registering online using the following link, http://www.directeventreg.com/registration/event/5548255. Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.
Athersys, Inc. (NASDAQ: ATHX) recently announced that its partner, HEALIOS K.K. (“Healios”), has completed enrollment in its TREASURE study in Japan, evaluating MultiStem® (invimestrocel) cell therapy treatment in patients who have suffered an ischemic stroke.
The TREASURE study is a placebo-controlled, double-blind, phase 2/3 trial designed to confirm the efficacy and safety of MultiStem (HLCM051) in treating patients with ischemic stroke. Patients were randomized 1:1 to receive either a single intravenous infusion of HLCM051 or placebo within 18–36 hours of the onset of stroke. The primary efficacy outcome is the proportion of subjects achieving an Excellent Outcome at day 90.
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