Enlivex Announces Positive DSMB Recommendation to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics (Nasdaq: ENLV) announced positive results from the Phase I safety run-in stage of its Phase I/II clinical trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. The independent Data and Safety Monitoring Board (DSMB) recommended proceeding to the Phase II stage after reviewing the safety data. Key points include:
1. No serious adverse reactions reported during or after treatment
2. DSMB confirmed Allocetra™'s safety profile allows progression to Phase II
3. Phase II will use the highest dose tested in Phase I
4. The trial will involve up to 160 patients
5. Phase II is a double-blind, randomized, placebo-controlled study
6. Primary measurements will assess joint pain and function at 3, 6, and 12 months post-treatment
Enlivex Therapeutics (Nasdaq: ENLV) ha annunciato risultati positivi dalla fase di sicurezza del Trial di Fase I del suo studio clinico di Fase I/II per Allocetra™ in pazienti affetti da osteoartrite del ginocchio da moderata a grave. Il Comitato Indipendente per il Monitoraggio dei Dati e della Sicurezza (DSMB) ha raccomandato di procedere alla fase II dopo aver revisionato i dati di sicurezza. I punti chiave includono:
1. Nessuna reazione avversa grave riportata durante o dopo il trattamento
2. Il DSMB ha confermato che il profilo di sicurezza di Allocetra™ consente di passare alla fase II
3. La fase II utilizzerà la dose più alta testata nella fase I
4. Il trial coinvolgerà fino a 160 pazienti
5. La fase II sarà uno studio in doppio cieco, randomizzato e controllato con placebo
6. Le misurazioni principali valuteranno il dolore articolare e la funzionalità a 3, 6 e 12 mesi dopo il trattamento
Enlivex Therapeutics (Nasdaq: ENLV) anunció resultados positivos de la fase I de seguridad del ensayo clínico de Fase I/II para Allocetra™ en pacientes con osteoartritis de rodilla de moderada a severa. La Junta Independiente de Monitoreo de Datos y Seguridad (DSMB) recomendó avanzar a la fase II tras revisar los datos de seguridad. Los puntos clave incluyen:
1. No se reportaron reacciones adversas graves durante o después del tratamiento
2. El DSMB confirmó que el perfil de seguridad de Allocetra™ permite avanzar a la fase II
3. La fase II utilizará la dosis más alta probada en la fase I
4. El ensayo involucrará hasta 160 pacientes
5. La fase II será un estudio doble ciego, aleatorizado y controlado con placebo
6. Las mediciones principales evaluarán el dolor articular y la función a los 3, 6 y 12 meses después del tratamiento
Enlivex Therapeutics (Nasdaq: ENLV)는 중등도에서 중증의 무릎 골관절염 환자를 대상으로 한 Allocetra™의 1/2상 임상시험의 1상 안전성 런인 단계에서 긍정적인 결과를 발표했습니다. 독립 데이터 및 안전성 모니터링 위원회(DSMB)는 안전성 데이터를 검토한 후 2상 단계로 진행할 것을 권장했습니다. 주요 사항은 다음과 같습니다:
1. 치료 중 또는 이후에 심각한 부작용이 보고되지 않았습니다
2. DSMB는 Allocetra™의 안전성 프로필이 2상으로 진행할 수 있도록 한다고 확인했습니다
3. 2상에서는 1상에서 테스트된 최고 용량이 사용됩니다
4. 이 임상시험은 최대 160명의 환자를 포함합니다
5. 2상은 이중 맹검, 무작위 배정, 위약 대조 연구입니다
6. 주요 측정은 치료 후 3, 6 및 12개월에 관절 통증 및 기능을 평가합니다
Enlivex Therapeutics (Nasdaq: ENLV) a annoncé des résultats positifs de la phase de sécurité de son essai clinique de Phase I/II pour Allocetra™ chez des patients atteints d'arthrose du genou modérée à sévère. Le Comité indépendant de surveillance des données et de la sécurité (DSMB) a recommandé de passer à la phase II après avoir examiné les données de sécurité. Les points clés incluent :
1. Aucun effet indésirable grave signalé pendant ou après le traitement
2. Le DSMB a confirmé que le profil de sécurité d'Allocetra™ permet de progresser à la phase II
3. La phase II utilisera la dose la plus élevée testée en phase I
4. L'essai impliquera jusqu'à 160 patients
5. La phase II sera une étude en double aveugle, randomisée et contrôlée par placebo
6. Les mesures principales évalueront la douleur articulaire et la fonction à 3, 6 et 12 mois après le traitement
Enlivex Therapeutics (Nasdaq: ENLV) hat positive Ergebnisse aus der Sicherheitsphase der Phase I seiner Phase I/II-Studie zu Allocetra™ bei Patienten mit mittelschwerer bis schwerer Kniearthrose verkündet. Das unabhängige Daten- und Sicherheitsüberwachungskomitee (DSMB) hat empfohlen, nach Überprüfung der Sicherheitsdaten mit der Phase II fortzufahren. Die wichtigsten Punkte beinhalten:
1. Keine schwerwiegenden unerwünschten Ereignisse während oder nach der Behandlung berichtet
2. Das DSMB bestätigte, dass das Sicherheitsprofil von Allocetra™ eine Fortsetzung zu Phase II erlaubt
3. In Phase II wird die höchste in Phase I getestete Dosis verwendet
4. Die Studie wird bis zu 160 Patienten einbeziehen
5. Phase II ist eine doppelblinde, randomisierte, placebo-kontrollierte Studie
6. Die primären Messungen werden Gelenkschmerzen und Funktion nach 3, 6 und 12 Monaten nach der Behandlung bewerten
- Positive DSMB recommendation to proceed to Phase II stage
- No serious adverse reactions reported in Phase I safety run-in
- Approval to use highest dose of Allocetra™ in Phase II
- Trial progressing as planned, moving from Phase I to Phase II
- None.
Insights
The DSMB's positive recommendation for Enlivex's Allocetra™ to advance to Phase II in knee osteoarthritis is a significant milestone. This progress indicates a favorable safety profile for the highest tested dose, which is important for developing new treatments in this field. The transition to a double-blind, randomized, placebo-controlled study marks a critical step in evaluating both safety and efficacy.
Key points to consider:
- The study will involve up to 160 patients, providing a substantial sample size for meaningful data.
- Primary endpoints focusing on joint pain and function at 3, 6 and 12 months post-treatment will offer insights into both short and long-term efficacy.
- As a macrophage reprogramming immunotherapy, Allocetra™ represents an innovative approach to treating osteoarthritis, potentially addressing underlying inflammatory processes.
While promising, investors should note that Phase II results are still pending and success is not guaranteed. However, positive outcomes could position Enlivex as a significant player in the lucrative osteoarthritis market.
Nes-Ziona, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the independent Data and Safety Monitoring Board (DSMB) has completed an interim data review at the conclusion of the Phase I safety run-in stage of the Company’s ongoing Phase I/II clinical trial of Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis. Patients in the Phase I safety run-in were treated with three sequential injections of Allocetra™ at escalating doses, and no serious adverse reactions were reported during or following the treatment. Following review of the data, the DSMB confirmed that the safety profile of Allocetra™ allows the Company to move forward to the Phase II stage of the Phase I/II trial, which is a double-blind, randomized evaluation of the safety and efficacy of intra-articular knee injections of Allocetra™ compared to placebo. The DSMB has also indicated that in light of the observed safety profile, the Phase II stage may proceed with the highest dose of Allocetra™ injections tested in the Phase I safety run-in.
The Phase I/II multi-center trial is composed of two stages. The first stage is 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 II stage. The Phase II stage is double-blind, randomized, placebo-controlled stage, which the Company is now initiating following the completion of the safety run-in Phase I stage and the safety confirmation by the DSMB. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
ABOUT KNEE OSTEOARTHRITIS1
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
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 https://enlivex.com/.
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,” “has the potential to” 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 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, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com
INVESTOR RELATIONS CONTACT
Dave Gentry, CEO
RedChip Companies Inc.
1-407-644-4256
ENLV@redchip.com
1 Source: The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)
FAQ
What is the current status of Enlivex's Allocetra™ trial for knee osteoarthritis (ENLV)?
What were the results of the Phase I safety run-in for Allocetra™ (ENLV)?
How many patients are expected to participate in Enlivex's Allocetra™ Phase I/II trial (ENLV)?
What is the design of the Phase II stage of Enlivex's Allocetra™ trial (ENLV)?
When will Enlivex measure the primary outcomes for Allocetra™ in knee osteoarthritis (ENLV)?
