{"id":773742,"date":"2023-07-31T10:14:02","date_gmt":"2023-07-31T14:14:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/"},"modified":"2023-07-31T10:14:02","modified_gmt":"2023-07-31T14:14:02","slug":"enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/","title":{"rendered":"Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis"},"content":{"rendered":"
\n

Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company\u2019s Phase II trial evaluating Allocetra\u2122 in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity.\u00a0 Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the \u00a0prior protocol\u2019s four-cohort structure.<\/p>\n

\u00a0\u201cWe are pleased that the approval of the amended protocol in France, Belgium and Netherlands aligns with the Company\u2019s planned timeline for the initiation of recruitment as per the amended protocol,\u201d stated Oren Hershkovitz, CEO of Enlivex. \u00a0\u201cTherefore, we believe that the top-line data readout from the Phase II trial will be in Q1 2024, which is consistent with our previously announced timeline.\u201d<\/p>\n

\n ABOUT ALLOCETRA\u2122<\/strong>\n <\/p>\n

Allocetra\u2122 is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra\u2122 has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents.<\/p>\n

\n ABOUT ENLIVEX<\/strong>\n <\/p>\n

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra\u2122, 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\u00a0 http:\/\/www.enlivex.com.<\/u><\/a><\/p>\n

\n Safe Harbor Statement:\u00a0 This press release contains forward-looking statements, which may be identified by words such as \u201cexpects,\u201d \u201cplans,\u201d \u201cprojects,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201cshould,\u201d \u201cwould\u201d, \u201ccould,\u201d \u201cintends,\u201d \u201cestimates,\u201d \u201csuggests,\u201d \u201chas the potential to\u201d and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM<\/sup>\u00a0programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.\u00a0 Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect\u00a0Enlivex\u2019s\u00a0business and prospects, including the risks that\u00a0Enlivex\u00a0may 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<\/sup>\u00a0product line could also be affected by\u00a0a number of\u00a0other 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.\u00a0 In addition to the risk factors described above, investors should consider the economic, competitive, governmental,\u00a0technological\u00a0and other factors discussed in\u00a0Enlivex\u2019s\u00a0filings with the Securities and Exchange Commission, including in the Company\u2019s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.\u00a0 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.<\/em>\n <\/p>\n

\n ENLIVEX CONTACT<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Shachar Shlosberger, CFO\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Enlivex Therapeutics, Ltd.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
shachar@enlivexpharm.com<\/u><\/a><\/p>\n

\n INVESTOR RELATIONS CONTACT<\/strong>
\n
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com<\/u><\/a><\/p>\n

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company\u2019s Phase II trial evaluating Allocetra\u2122 in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity.\u00a0 Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the \u00a0prior protocol\u2019s four-cohort structure. \u00a0\u201cWe are pleased that the approval of the amended protocol in France, Belgium and Netherlands aligns with the Company\u2019s planned timeline for the initiation of recruitment as per the amended protocol,\u201d … <\/p>\n

Continue reading “Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-773742","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nEnlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. 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(Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company\u2019s Phase II trial evaluating Allocetra\u2122 in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity.\u00a0 Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the \u00a0prior protocol\u2019s four-cohort structure. \u00a0\u201cWe are pleased that the approval of the amended protocol in France, Belgium and Netherlands aligns with the Company\u2019s planned timeline for the initiation of recruitment as per the amended protocol,\u201d … Continue reading \"Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/","og_site_name":"Market Newsdesk","article_published_time":"2023-07-31T14:14:02+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg4MzczNiM1NzI3NTUyIzUwMDA2NTE3NA==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis","datePublished":"2023-07-31T14:14:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/"},"wordCount":713,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg4MzczNiM1NzI3NTUyIzUwMDA2NTE3NA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-announces-dosing-of-first-patient-under-the-amended-protocol-of-its-phase-ii-trial-evaluating-allocetra-in-patients-with-sepsis\/","name":"Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra\u2122 In Patients With Sepsis - 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