Palm Beach, FL – January 5, 2022 – FinancialNewsMedia.com News Commentary – Alzheimer’s disease (AD) is the most common reason of progressive dementia in the elderly population. There has been an exponential rise in the number of cases of Alzheimer’s disease worldwide emphasizing the necessity for developing an effective treatment. According to Alzheimer’s Association, in 2016, an estimated 5.4 million Americans of all ages have Alzheimer’s disease. One in nine people aged 65 and above has Alzheimer’s disease. By 2050, the number of people aged 65 and above affected with Alzheimer’s disease is expected to nearly triple, from 5.2 million to an expected 13.8 million, excluding the development of medical advances to avert or cure the disease. The mortality rates due to Alzheimer’s disease are quite high. Between 2000 and 2013, deaths due to heart disease, stroke and prostate cancer decreased 14%, 23% and 11%, respectively, while deaths from AD increased 71% in the U.S.  Similarly, according to Alzheimer’s disease International in 2015, there are an estimated 46.8 million people worldwide living with dementia and is further expected to grow in future. Thus, there is an increasing in the demand for Alzheimer’s therapeutics and diagnostics worldwide.   A report from 360 Research Reports said that the global Alzheimer’s Disease Therapeutics and Diagnostics market size is projected to reach US$ 6270.3 million by 2026, from US$ 4948.2 million in 2020, at a CAGR of 4.0% during 2021-2026.   Active Companies in the markets today include Longeveron Inc. (NASDAQ: LGVN), Athersys, Inc. (NASDAQ: ATHX), BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), Mesoblast Limited (NASDAQ: MESO), BioCardia, Inc. (NASDAQ: BCDA).

The report said: “Population aging across the globe is a major factor driving the market for Alzheimer’s therapeutics and diagnostics. Rising life expectancy is contributing to quick increases in number of aged population and is associated with increased prevalence of chronic diseases like dementia. Therapies for AD offer temporary and uncertain improvements in the well-being of individuals, and none of the approved drugs can modify the course of the disease advancement. Thus, the magnitude of the affected population and lack of suitable and effective treatment offers an incredible opportunity for drug manufacturers. Drug manufacturers have been unable to validate significant clinical benefits of treatment for a numerous of new compounds due to strict regulations. One of the significant trend observed in this market is collaboration of the existing players. Precisely, diagnostic technology companies are carefully trying to bring about effective biomarker technologies to support and improve the drug development process for potential drug candidates which is further expected to propel the demand.”

Longeveron Inc. (NASDAQ: LGVN) BREAKING NEWS:  Longeveron Announces Initiation of Phase 2a Clinical Trial of Lomecel-B for the Treatment of Alzheimer’s Disease – Longeveron Inc. (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today the initiation of its Phase 2a clinical trial evaluating Lomecel-B as a treatment for Alzheimer’s Disease (AD).  The first patient has consented to participate in the trial and patient screening has begun. The Company looks forward to generating data in a larger patient population.

The current Phase 2a study builds on encouraging safety, and preliminary efficacy and biomarker findings obtained in Longeveron’s phase I trial, announced last year. Additionally, the trial will measure brain anatomy using MRI and will perform detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of AD. The study, which will be conducted at a minimum of 6 centers, is led by Mark L. Brody, MD, of Brain Matters Research, Delray Beach, Florida.

“This is an important next step in the progress of our Alzheimer’s disease clinical program,” said Geoff Green, CEO of Longeveron.  “We are pleased to have activated this Phase 2a trial, as this study builds upon the Phase 1 results and marks an important milestone in our efforts to explore the therapeutic potential of Lomecel-B in AD,” Green added.

“Lomecel-B for the treatment of Alzheimer’s may be a game changer”, said Dr. Brody. “The ability to markedly reduce inflammation in the brain could lead to a major breakthrough in the treatment of this devastating disease.”

Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In the Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns – including no evidence of Alzheimer’s related imaging abnormality, known as ARIA – and showed potential to improve clinical assessments. In addition, the levels of pro-vascular and anti-inflammatory biomarkers increased in the Lomecel-B treated subjects compared to placebo.

The Phase 2a trial is a double-blind, randomized, placebo-controlled design investigating safety and tolerability, as well as secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of Lomecel-B compared to placebo, in mild AD patients.  The study consists of 4 treatment arms of 12 patients each for a total target enrollment of 48 patients.    CONTINUED…  For more information about Longeveron, please visit https://investors.longeveron.com/news/default.aspx

Other recent developments in markets include:

Athersys, Inc. (NASDAQ: ATHX) recently announced that a manuscript reporting data from the Company’s MUST-ARDS clinical trial have been published in the peer-reviewed journal Intensive Care Medicine. MUST-ARDS was a randomized, double-blind placebo-controlled Phase 1/2 trial evaluating the safety and efficacy of MultiStem^®(invimestrocel) cell therapy in patients with acute respiratory distress syndrome (ARDS). Enrolling patients at 12 intensive care units in the United Kingdom and the U.S., the study confirmed that intravenous administration of MultiStem cell therapy was well-tolerated among critically ill patients early in the course of moderate to severe ARDS. The trial also assessed multiple efficacy endpoints, including mortality, liberation from mechanical ventilation, discharge from intensive care, and quality of life (QoL) among survivors over one full year of recovery. Mechanisms of action were further explored by comparing acute changes in plasma inflammatory and lung injury biomarkers in MultiStem-treated and placebo-treated study participants. The results of this study provided the basis for the Food and Drug Administration (FDA) to grant the Company’s ARDS program Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designation.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, recently announced plans for a dosing extension of NurOwn® for participants who completed the Expanded Access Protocol (EAP). The U.S. Food and Drug Administration (FDA) recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it.

“This dosing extension for the expanded access protocol is an appropriate next step following the new analysis and biomarkers results of the Phase 3 study. It is deeply appreciated by our ALS patients. Eligible patients now have the opportunity to receive as many as 9 doses of NurOwn in total, allowing additional data collection to better understand the potential benefits of longer-term treatment,” said Robert Brown, MD DPhil, Leo P. and Theresa M. LaChance Chair in Medical Research, and Chair, Department of Neurology, University of Massachusetts Medical School and UMass Memorial Medical Center, and one of the Principal Investigators in the NurOwn® Phase 3 study.

Mesoblast Limited (NASDAQ: MESO), global leader in allogeneic cellular medicines for inflammatory diseases, recently provided a regulatory update on remestemcel-L for steroid-refractory acute graft versus host disease in children following its recent meeting with the FDA’s OTAT. Mesoblast requested the meeting to address the appropriateness of a potency assay related to remestemcel-L’s proposed immunomodulatory mechanism of action as well as the approach to outstanding CMC items identified in the CRL.

OTAT indicated that Mesoblast’s approach to address outstanding CMC items is reasonable, that the in vitro immunomodulatory activity of remestemcel-L proposed by Mesoblast as a measure of its potency is a reasonable CQA for the product in the treatment of children with SR-aGVHD, and the relevance of this immunomodulatory activity to clinical outcomes should be established.

BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, recently announces that it has entered into a long-term lease for a new facility in Sunnyvale, California. This facility is being built out to support the manufacturing of BioCardia’s cell and device products and product candidates across the Company’s therapeutic pipeline.  The new facility is expected to provide manufacturing capabilities across BioCardia’s portfolio, including its CardiAMP Cell Therapy Systems, NK1R+ mesenchymal stem cells, and Biotherapeutic Delivery Devices, with the ultimate goal of supporting clinical trials in multiple programs and early commercial activities.

“We have always believed that manufacturing during development needs to be kept close to capture new insights and innovate rapidly. Controlling manufacturing at this stage helps accelerate the development of our cell-based medicines, which we also believe is a key differentiator of BioCardia from many other cellular therapeutics companies,” said Peter Altman, BioCardia’s President and CEO. “We expect to soon see all four of the programs we discuss publicly in the clinic helping patients, with our in-house facilities providing the material.”

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