Invest-in-America
3 weeks ago
LGVN: And DON'T forget, Bro!!! At the BOTTOM of every one of MASTER MONK's ubiquitous "52-WEEK-LOW" posts --- covering every stock on Wall Street since the Bill Clinton Administration --- Mr. MONKSTER also displays a pump-&-dump LINK to his best-selling scholarly tome about the, "American Cars of 1958"!!! (LOVE-IT!!!) Hey, Klinsmann Dude, click below the handy link to my OWN motor-vehicles-related activities!!!
_____________________________________________________________________
I'm producing a movie entitled, "American Cars of 1918" --- click link below often, for the latest LIVE-STREAMING addition!!!
https://media.giphy.com/media/v1.Y2lkPTc5MGI3NjExNGpzYnRkMG5zeHM2ZmVyNmp5Z252N3Y4NHd0N3E4NTZzb202NzVxZCZlcD12MV9pbnRlcm5hbF9naWZfYnlfaWQmY3Q9Zw/f1NTdkdbG4XzW/giphy-downsized-large.gif
Invest-in-America
3 weeks ago
LGVN: How come iHub's legendary Mr. MONK never posts any stock's 53-WEEK-LOW, or maybe its 51-WEEK-LOW, or its 62-WEEK-LOW, or its 71-WEEK-LOW, or --- as if anyone might believe such is apropos and/or significant of anything known to Mankind --- perhaps Mr. MONK'S 67-WEEK-LOW???!!! Why not???
"But nevertheless, iHub's prophetic Mr. MONK accurately announced today the 52-YEAR-LOW in my SEX LIFE!!! And, Mr. MONK graciously prescribed for me a 2-week vacation at the disruptive new, VIAGRA-FALLS-ERECTILE-INJUNCTION-CLINIC-&-RESORT, in world famous Upstate New York --- no pun intended!!!"
Invest-in-America
3 weeks ago
LGVN: How come iHub's legendary Mr. MONK never posts any stock's 53-WEEK-LOW, or maybe its 51-WEEK-LOW, or its 62-WEEK-LOW, or its 71-WEEK-LOW, or --- as if anyone might believe such is apropos and/or significant of anything known to Mankind --- perhaps Mr. MONK'S 67-WEEK-LOW???!!! Why not???
"But nevertheless, iHub's prophetic Mr. MONK accurately announced today the 52-YEAR-LOW in my SEX LIFE!!! And, Mr. MONK graciously prescribed for me a 2-week vacation at the disruptive new, VIAGRA-FALLS-ERECTILE-INJUNCTION-CLINIC-&-RESORT, in world famous Upstate New York!!!"
Invest-in-America
3 weeks ago
LGVN: How come iHub's legendary Mr. MONK never posts any stock's 53-WEEK-LOW, or maybe its 51-WEEK-LOW, or its 62-WEEK-LOW, or its 71-WEEK-LOW, or --- as if anyone might believe such is apropos and/or significant of anything known to Mankind --- perhaps Mr. MONK'S 67-WEEK-LOW???!!! Why not???
"But nevertheless, iHub's prophetic Mr. MONK accurately announced today the 52-YEAR-LOW in my SEX LIFE!!! And, Mr. MONK graciously prescribed for me a 2-week vacation at the disruptive new, VIAGRA-FALLS-ERECTILE-INJUNCTION-CLINIC-&-RESORT, in world famous Upstate New York!!!"
Skydive21
3 months ago
Longeveron Inc. (NASDAQ: LGVN) Granted US Patent Allowance for Key Technology Behind Lead Investigation Product
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, has received notice from the United States Patent and Trademark Office (“USPTO”) of patent allowance for Medicinal Signaling Cells (“MSCs”). The patent covers the technology behind LGVN’s lead investigational product Lomecel-B(TM) and will impact patients with Aging-related Frailty receiving vaccines for conditions such as COVID-19 and the flu. Lomecel-B is a living-cell product made from MSCs that are essential to the body’s endogenous biological repair mechanism and that have been shown to perform complex functions in the body, including the formation of new tissue. The patent covers the impact of Lomecel-B on favorable modulation of the immune system, which is a foundational mechanism of action of the product. Longeveron is currently conducting trials in Aging-Related Frailty and Alzheimer’s disease as well a phase 2 trial for Hypoplastic Left Heart Syndrome (“HLHS”), a rare and often fatal cardiac condition in newborn infants. “These newly allowed claims extend our patent estate to include the use of Lomecel-B in conjunction with or after patients receive vaccines to enhance vaccine immune response,” said Longeveron cofounder, chief scientific officer and chair Joshua M. Hare, MD, FACC, FAHA, in the press release. “We believe this use for Lomecel-B and the broader potential it holds for patients in our current Aging-Related Frailty and Alzheimer’s disease trials reflects the broader potential of Lomecel-B.”
To view the full press release, visit https://ibn.fm/pIscy
subslover
7 months ago
Longeveron Announces Positive Top-Line Results for Lomecel-B™ in its CLEAR MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease
Company to Hold Conference Call & Webcast Today, October 5 at 8:00am ET
Primary Endpoint of Safety Met Across all Study Groups
Statistical Significance Met for Secondary Endpoint Composite Alzheimer’s Disease Score (CADS) for Lomecel-B™ Low-Dose and for the Pooled Lomecel-B™ Treatment Group Relative to Placebo
Other Doses Demonstrated Numerical Slowing/Prevention of Disease Worsening Relative to Placebo
Additional Biomarker Data Expected to be Announced in the Coming Weeks
MIAMI, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer’s disease. The Company is hosting a conference call and webcast today at 8:00 AM ET to discuss the results.
“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to announcing additional biomarker data from this trial, anticipated to be later this month, which may further characterize the clinical effects of Lomecel-B™ in this study population. With our Phase 2 ELPIS II trial in HLHS moving toward anticipated completion in 2024, and our Phase 2 program in Aging-related Frailty progressing in Japan as well, we look forward to meaningful milestones in the near term and to fully realizing the therapeutic potential of Lomecel-B™.”
“These study results with Lomecel-B™ are encouraging,” added Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health. “The study met its primary safety endpoint and is supported by lack of deterioration in cognitive or atrophy signals. The efficacy observations are encouraging, and these results should be used as a foundation for further studies.”
“We are encouraged by these results, which appear to be further supported by their consistency with the findings from Longeveron’s earlier Phase I study on Alzheimer’s disease,” concluded Dr. Nataliya Agafonova, Chief Medical Officer of Longeveron.”
An estimated 6.7 million Americans are living with Alzheimer’s disease. Of the total U.S. population, about 1 in 9 people aged 65 and older has Alzheimer’s disease. The percentage of people with Alzheimer’s disease increases with age. Despite progress for new anti-amyloid treatment, there remains a high unmet medical need.
Conference Call and Webcast Details
Investors Dial-In 1-877-407-0789
International Investors Dial-In 1-201-689-8562
Conference ID# 13741797
Call me™ Feature Click Here
Webcast Click Here
Results:
The primary endpoint of safety was met based on statistical and medical assessment. There was one Serious Adverse Event (SAE) reported on each Lomecel-B™ treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised.
The study safety data were consistent with an established safety profile with no incidence of hypersensitivity, no cases of Alzheimer Related Imagine Abnormalities (ARIA), no clinically asymptomatic microhemorrhages as revealed by Magnetic Resonance Imaging (MRI), and no notable changes in laboratory evaluations and electrocardiogram (EKG).
The secondary endpoint of change from baseline to week 39 in CADS, demonstrated positive results, at the prespecified statistical level of p
subslover
2 years ago
U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants
August 31 2022 - 08:30AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lomecel-B™ for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year. Lomecel-B™, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
Fast Track Designation is intended to facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need so a product can potentially be approved and reach patients more quickly. Fast Track Designation enables the company to have more frequent interactions with the FDA throughout the drug development process and allows for eligibility for priority review and accelerated approval if certain criteria are met, as well as a rolling review. The Fast Track Designation must continue to be met or FDA can withdraw the designation. The FDA previously granted Longeveron’s Lomecel-B™ Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS.
“Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B™ as a treatment for infants with HLHS,” said Chris Min, M.D., Ph.D., Longeveron’s Interim Chief Executive Officer and Chief Medical Officer. “Fast Track Designation underscores the urgent need in HLHS, and we look forward to continuing to work closely with the FDA to bring this potential new therapy to infants as expeditiously as possible.”
HLHS is a rare congenital heart defect that affects approximately 1,000 babies per year in the U.S. Infants born with HLHS have an underdeveloped or absent left ventricle, which impairs the heart’s ability to pump adequate amounts of blood throughout the body. Patients require three reconstructive heart surgeries within the first five years of life, and many require a heart transplant. Without treatment, the condition is always fatal. Even with reconstructive surgical interventions, HLHS is still associated with high mortality. Overall survival from birth to adolescence is estimated to be 50% to 60%.
Longeveron is currently evaluating Lomecel-B™ in ELPIS II, an ongoing 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial (directly into the heart) injection of the Lomecel-B™ product in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. In ELPIS, a Phase 1 open-label trial in ten HLHS patients, Lomecel-B™ was found to be well tolerated with no major adverse cardiac events one-year post-surgery, and/or treatment-related infections.
One hundred percent of the infants enrolled in the ELPIS Phase 1 trial (n=10) were alive and had not required a transplant between 2-3.5 years post-surgery. Normally, approximately 20% of patients require heart transplants to survive within one year of Stage II reconstructive surgery. Longeveron recently announced the release of a manuscript entitled “Intramyocardial cell-based therapy during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial” on MedRxiv, a preprint server that posts papers before they are peer reviewed. The paper will now undergo peer review prior to publication of the final study report.
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, 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: Alzheimer’s disease, hypoplastic left heart syndrome (HLHS), Aging Frailty, and Acute Respiratory Distress Syndrome (ARDS). Additional information about the Company is available at www.longeveron.com.