Creative Medical Technology Reports Positive One-Year Results for AlloStem™ Type 2 Diabetes Program
Creative Medical Technology Holdings (NASDAQ: CELZ) has announced promising one-year follow-up data from its AlloStem™ (CELZ-201) Type 2 Diabetes pilot study. The trial demonstrated an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported.
The study involved 20 patients, split equally between CELZ-201 treatment and optimized medical therapy. The treatment utilized the same infusion procedure approved for the company's FDA-cleared Type 1 Diabetes clinical trial. CELZ-201 is an off-the-shelf, universal allogenic cell line developed by the company.
Based on these results, Creative Medical Technology plans to advance AlloStem's development for late-stage Type 2 Diabetes treatment and explore additional therapeutic applications to expand their pipeline, which includes CELZ-201 for early-stage Type 1 Diabetes and CELZ-101 for brittle Type 1 Diabetes.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha annunciato dati promettenti di follow-up a un anno dal suo studio pilota sul diabete di tipo 2 con AlloStem™ (CELZ-201). Lo studio ha dimostrato un tasso di efficacia complessivo dell'80% nella riduzione della dipendenza da insulina e nella stabilizzazione dei livelli di emoglobina A1c, senza segnalazioni di effetti avversi gravi.
Lo studio ha coinvolto 20 pazienti, suddivisi equamente tra trattamento CELZ-201 e terapia medica ottimizzata. Il trattamento ha utilizzato la stessa procedura di infusione approvata per il trial clinico sul diabete di tipo 1 autorizzato dalla FDA. CELZ-201 è una linea cellulare allogenica universale disponibile, sviluppata dall'azienda.
In base a questi risultati, Creative Medical Technology prevede di avanzare nello sviluppo di AlloStem per il trattamento del diabete di tipo 2 in fase avanzata ed esplorare ulteriori applicazioni terapeutiche per espandere il loro portafoglio, che comprende CELZ-201 per il diabete di tipo 1 in fase iniziale e CELZ-101 per il diabete di tipo 1 fragile.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha anunciado datos prometedores de seguimiento a un año de su estudio piloto sobre la diabetes tipo 2 con AlloStem™ (CELZ-201). El ensayo demostró una tasa de eficacia general del 80% en la disminución de la dependencia de insulina y la estabilización de los niveles de hemoglobina A1c, sin efectos adversos graves reportados.
El estudio involucró a 20 pacientes, divididos equitativamente entre el tratamiento CELZ-201 y la terapia médica optimizada. El tratamiento utilizó el mismo procedimiento de infusión aprobado para el ensayo clínico de la compañía sobre la diabetes tipo 1 autorizado por la FDA. CELZ-201 es una línea celular alogénica universal disponible, desarrollada por la compañía.
Con base en estos resultados, Creative Medical Technology planea avanzar en el desarrollo de AlloStem para el tratamiento de la diabetes tipo 2 en etapas avanzadas y explorar aplicaciones terapéuticas adicionales para expandir su cartera, que incluye CELZ-201 para la diabetes tipo 1 en etapas iniciales y CELZ-101 para la diabetes tipo 1 frágil.
크리에이티브 메디컬 테크놀로지 홀딩스 (NASDAQ: CELZ)는 AlloStem™ (CELZ-201)의 제2형 당뇨병 파일럿 연구에서 1년 후속 데이터를 발표했습니다. 이 시험은 인슐린 의존도를 감소시키고 헤모글로빈 A1c 수치를 안정화하는 데 있어 80%의 전반적인 효능률을 보여주었으며, 심각한 부작용 보고는 없었습니다.
이번 연구에는 총 20명의 환자가 참여했으며, CELZ-201 치료 그룹과 최적화된 의료 치료 그룹으로 균등하게 나누어졌습니다. 이 치료는 FDA 승인된 제1형 당뇨병 임상시험에 승인된 동일한 주사 절차를 사용했습니다. CELZ-201은 회사에서 개발한 기성품의 범용 동종 세포 라인입니다.
이러한 결과를 바탕으로 크리에이티브 메디컬 테크놀로지는 제2형 당뇨병 치료를 위한 AlloStem의 개발을 진행하고, 초기 단계 제1형 당뇨병을 위한 CELZ-201 및 취약한 제1형 당뇨병을 위한 CELZ-101을 포함하여 추가적인 치료 응용 프로그램도 탐색할 계획입니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a annoncé des données prometteuses de suivi sur un an de son étude pilote sur le diabète de type 2 avec AlloStem™ (CELZ-201). L'essai a démontré un taux d'efficacité global de 80% dans la réduction de la dépendance à l'insuline et la stabilisation des niveaux d'hémoglobine A1c, sans effets indésirables graves signalés.
L'étude a impliqué 20 patients, répartis également entre le traitement CELZ-201 et la thérapie médicale optimisée. Le traitement a utilisé la même procédure d'infusion approuvée pour l'essai clinique de l'entreprise sur le diabète de type 1, agréé par la FDA. CELZ-201 est une lignée cellulaire allogène universelle développée par l'entreprise.
Sur la base de ces résultats, Creative Medical Technology prévoit de faire progresser le développement d'AlloStem pour le traitement du diabète de type 2 à un stade avancé et d'explorer d'autres applications thérapeutiques pour élargir son portefeuille, qui comprend CELZ-201 pour le diabète de type 1 au stade précoce et CELZ-101 pour le diabète de type 1 fragile.
Creative Medical Technology Holdings (NASDAQ: CELZ) hat vielversprechende Ein-Jahres-Follow-up-Daten aus seiner Pilotstudie zu Typ-2-Diabetes mit AlloStem™ (CELZ-201) bekannt gegeben. Die Studie zeigte eine gesamtwirksamkeitsquote von 80% bei der Reduktion der Insulinabhängigkeit und der Stabilisierung der Hämoglobin-A1c-Werte, ohne dass schwerwiegende Nebenwirkungen berichtet wurden.
Die Studie umfasste 20 Patienten, die gleichmäßig auf die Behandlung mit CELZ-201 und die optimierte medizinische Therapie verteilt wurden. Die Behandlung verwendete dasselbe Infusionsverfahren, das für die von der FDA genehmigte klinische Studie zu Typ-1-Diabetes genehmigt wurde. CELZ-201 ist eine universelle, allogene Zelllinie, die von dem Unternehmen entwickelt wurde.
Basierend auf diesen Ergebnissen plant Creative Medical Technology, die Entwicklung von AlloStem für die Therapie des fortgeschrittenen Typ-2-Diabetes voranzutreiben und zusätzliche therapeutische Anwendungen zu erkunden, um ihre Pipeline zu erweitern, die CELZ-201 für frühe Stadien von Typ-1-Diabetes und CELZ-101 für instabilen Typ-1-Diabetes umfasst.
- 80% efficacy rate in reducing insulin dependency
- No serious adverse effects reported in clinical trial
- Successful validation of treatment procedure
- Potential expansion of treatment applications
- Small sample size of only 20 patients in pilot study
Significant Efficacy and No Serious Adverse Effects Observed with CELZ-201
PHOENIX, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced promising one-year follow-up data from the AlloStem ™ (CELZ-201) Type 2 Diabetes pilot study for late-stage patients. CELZ-201 is an off the shelf, ready-to-use universal and proprietary allogenic (donor) cell line developed by the Company.
Results demonstrate that CELZ-201 achieved an
The study, which included 20 patients—10 receiving CELZ-201 and 10 undergoing optimized medical therapy—validated the safety and efficacy of CELZ-201 through the same infusion procedure used in the Company’s U.S. FDA-cleared Type 1 Diabetes clinical trial, which is currently underway. The absence of safety concerns further supports the potential of CELZ-201 as a breakthrough treatment for late-stage Type 2 Diabetes.
Given these compelling results, Creative Medical Technology plans to advance the development of AlloStem (CELZ-201) for the treatment of late-stage Type 2 Diabetes and explore other potential applications of this therapy to expand the Company’s pipeline.
"The positive one-year data from the study represents a significant milestone in our mission to revolutionize diabetes treatment and help a wide variety of patients who potentially may not benefit from autologous therapies," said Timothy Warbington, President and CEO of Creative Medical Technology. "With a diversified portfolio that includes CELZ-201 for early-stage Type 1 Diabetes, CELZ-101 for brittle Type 1 Diabetes, and CELZ-201 for late-stage Type 2 Diabetes, we are committed to delivering innovative solutions that transform patient care."
About Type 2 Diabetes*
Type 2 diabetes affects approximately 90
*https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company dedicated to developing groundbreaking regenerative cell therapies. The company’s pipeline targets a range of conditions, with a focus on endocrinology, immunotherapy, orthopedic and neurological diseases. For more information, visit www.creativemedicaltechnology.com.
Forward Looking Statements
This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.
Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com
FAQ
What were the one-year results of CELZ's AlloStem Type 2 Diabetes trial?
How many patients participated in CELZ's AlloStem Type 2 Diabetes study?
What is CELZ-201's current development status for Type 2 Diabetes?
What other diabetes treatments is CELZ developing besides AlloStem for Type 2 Diabetes?
