Latest news with #OrenHershkovitz
Yahoo
2 days ago
- Business
- Yahoo
Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis
- In the overall modified intention-to-treat (mITT) population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% improvement in knee function, were observed in the AllocetraTM treatment arm vs placebo; moreover, 72% reduction in knee pain and 95% improvement in knee function were observed for age-related primary osteoarthritis patients compared with placebo – a substantial, clinically meaningful and statistically significant effect in commonly used Phase III primary endpoints for knee osteoarthritis clinical trials. - Favorable safety profile – No severe adverse events; limited, typically mild to moderate, transient, and treatable side effects occurred in most patients treated with Allocetra™ - Webinar today at 8:00 a.m. Eastern Time Nes-Ziona, Israel, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the 'Company'), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis. Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, 'We are excited to share the topline three-month data from ENX-CL-05-001. We believe these results provide clear indication that Allocetra™ has the potential to become a novel, safe and effective treatment for knee osteoarthritis, a growing market with significant unmet medical need.' The Company will host a webinar today at 8:00 am Eastern Time to provide in-depth analysis of the results. To join the webinar, please click To join the webinar, please register at: It is suggested participants join the webinar at least 15 minutes prior to the scheduled start time to avoid any delays in attendance. About ENX-CL-05-001ENX-CL-05-001 is a multi-center Phase I/II clinical trial consisting of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee, in order to identify the dose and injection regimen for the subsequent Phase IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol was designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial's key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment. ABOUT KNEE OSTEOARTHRITIS Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. For more information, visit Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as 'expects,' 'plans,' 'projects,' 'will,' 'may,' 'anticipates,' 'believes,' 'should,' 'would,' 'could,' 'intends,' 'estimates,' 'suggests,' 'target,' 'has the potential to' and other words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex's business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACT Shachar Shlosberger, CFOEnlivex Therapeutics, INVESTOR RELATIONS CONTACT Dave Gentry, CEORedChip Companies Inc.1-407-644-4256ENLV@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Indianapolis Star
13-06-2025
- Business
- Indianapolis Star
Enlivex Therapeutics and Foremost Clean Energy Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
ORLANDO, FL / ACCESS Newswire RedChip Companies will air interviews with Enlivex Therapeutics (NASDAQ:ENLV) and Foremost Clean Energy (Nasdaq:FMST) on the RedChip Small Stocks, Big Money™ show, a sponsored program on Bloomberg TV this Saturday, June 14, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S. Access the interviews in their entirety at: In an exclusive interview, Oren Hershkovitz, CEO of Enlivex Therapeutics, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to provide a corporate update. Enlivex is pioneering macrophage reprogramming immunotherapy with its Allocetra™ platform, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. This innovative approach aims to address critical medical challenges, including debilitating diseases like osteoarthritis. In 2024, the company achieved a significant milestone with the initiation of a multi-country, randomize, double -blind, placebo-controlled Phase I/II trial evaluating Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis. With promising data from the open-label Phase 1 stage of the trial the company had completed the enrollment of 134 patients for the Phase 2 stage and expecting knee osteoarthritis key data by August 2025, potentially paving the way for future therapeutic breakthroughs. Jason Barnard, President and CEO of Foremost Clean Energy, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to share the company's strategic vision for advancing uranium exploration in the world-renowned Athabasca Basin. Barnard details Foremost's expansive portfolio of 10 uranium properties spanning over 330,000 acres, including high-priority drill targets at Hatchet Lake and Murphy Lake South, where recent assays confirm strong mineralization and discovery potential. He also discusses the company's transformational partnership with Denison Mines, which brings technical, financial, and strategic backing from a C$2.9 billion uranium leader with a 19.13% equity stake in Foremost. With nuclear energy gaining momentum as a critical clean power source – and global pledges to triple capacity by 2050 – Foremost is uniquely positioned to benefit from structural supply deficits and surging demand. Barnard highlights the company's fully funded 2025 exploration program, robust institutional backing, and dual exposure to uranium and lithium as key drivers of long-term shareholder value. ENLV and FMST are clients of RedChip Companies. Please read our full disclosure at About Enlivex Therapeutics Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit About Foremost Clean Energy Foremost Clean Energy Ltd. (NASDAQ:FMST)(CSE:FAT)(WKN:A3DCC8) is a rapidly growing North American uranium and lithium exploration company. The Company holds an option to earn up to a 70% interest in 10 prospective uranium properties (with the exception of the Hatchet Lake, where Foremost is able to earn up to 51%), spanning over 330,000 acres in the prolific, uranium-rich Athabasca Basin region of northern Saskatchewan. As the demand for carbon-free energy continues to accelerate, domestically mined uranium and lithium are poised for dynamic growth, playing an important role in the future of clean energy. Foremost's uranium projects are at different stages of exploration, from grassroots to those with significant historical exploration and drill-ready targets. The Company's mission is to make significant discoveries alongside and in collaboration with Denison through systematic and disciplined exploration programs. Foremost also has a portfolio of lithium projects at varying stages of development, which are located across 55,000+ acres in Manitoba and Quebec. For further information, please visit the Company's website at About RedChip Companies RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on microcap and small-cap companies. For 33 years, RedChip has delivered concrete, measurable results for its clients. Our newsletter, Small Stocks, Big Money™, is delivered online weekly to 60,000 investors. RedChip has developed the most comprehensive service platform in the industry for microcap and small-cap companies. These services include the following: a worldwide distribution network for its stock research; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated millions of unique investor views; investor webinars and group calls; a television show, Small Stocks, Big Money™, which airs weekly on Bloomberg US; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more. RedChip also offers RedChat™, a proprietary AI-powered chatbot that analyzes SEC filings and corporate disclosures for all Nasdaq and NYSE-listed companies, giving investors instant, on-demand insights. To learn more about RedChip's products and services, please visit: 'Discovering Tomorrow's Blue Chips Today'™ Follow RedChip on LinkedIn: Follow RedChip on Facebook: Follow RedChip on Instagram: Follow RedChip on Twitter: Follow RedChip on YouTube: Follow RedChip on Rumble: Subscribe to our Mailing List: Contact: Dave Gentry RedChip Companies Inc. 1-407-644-4256 info@ SOURCE: RedChip Companies, Inc. View the original press release on ACCESS Newswire
Yahoo
22-04-2025
- Health
- Yahoo
PhaseV to Host New Webinar Episode on Patient-Centric Clinical Development
BOSTON, April 22, 2025 /PRNewswire/ -- PhaseV, a leader in AI/ML-driven clinical development, today announced that the second episode in its webinar series will focus on improving patient-centricity and efficiency in clinical trial design. The session Putting Patients First: Novelty, Adaptivity, and Collaboration in Clinical Development, will air on Thursday, May 1, 2025, at 1:00 PM EST. Click here to register for the webinar, which will feature industry leaders exploring how patient-centric approaches are shaping adaptive trial design and driving more efficient clinical development: Angela Dobes, Senior Vice President, IBD Plexus, Crohn's & Colitis Foundation Oren Hershkovitz, PhD, CEO, Enlivex Therapeutics Aaron Galluzzi, Consulting Statistician, Alimentiv Moderated by Keren Peri-Hanania, MD, Medical Director at PhaseV, the panel will discuss: How patient-centricity in trial design increases efficiency in clinical development The integration of real-world data with causal and adaptive methods to improve patient stratification and enhance trial results The role of patient advocacy organizations in connecting sponsors, patients, and technology developers to increase the inclusivity and impact of new research The importance of collaboration, providing examples of biotech sponsors, CROs, foundations, and technology providers working together to accelerate drug development while prioritizing patient needs "Our webinar series is more than a discussion, it's an opportunity to share the practical insights we've gained in clinical development to help drive meaningful change in the field," said Raviv Pryluk, PhD, CEO and Co-founder of PhaseV. "Participants will gain actionable strategies to incorporate new AI-driven approaches, real-time data and patient-centered design into their trials for more efficient and effective clinical development." About PhaseV PhaseV is developing advanced AI/ML solutions to optimize clinical development. Biopharma sponsors and CROs are leveraging PhaseV's platform to rapidly design and execute adaptive, Bayesian and fixed clinical trials, analyze data to uncover heterogeneous treatment effects, stratify patients, and inform future R&D and portfolio decisions. PhaseV's platform has reduced trial costs by up to 25%, decreased enrollment size and trial duration by up to 40%, and increased the probability of trial success by over 30%. To date, the company has delivered results for more than 30 leading pharma/biotech sponsors and CROs spanning multiple therapeutic areas, including neurology, oncology, immunology, GI, rare diseases, and others. Learn more at and follow us on LinkedIn. Infographic: Media Contact: Ellie HansonFINN Partners for 929-588-2008 View original content to download multimedia: SOURCE PhaseV Sign in to access your portfolio
