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Celularity & Fountain Life Announce Partnership to Deliver Stem Cell Therapies Under New Florida Law
GlobeNewswire News Room· 2025-07-09 12:30
Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, 2025, authorizes licensed physicians to administer stem cell therapies to members with conditions in orthopedics, wound care, and pain management. FLORHAM PARK, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it entered into ...
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes
Globenewswire· 2025-05-15 08:10
Core Viewpoint - PolTREG S.A. has received a positive opinion from the European Medicines Agency's Paediatric Committee regarding its Pediatric Investigation Plan for PTG-007, a therapy aimed at preventing symptomatic type 1 diabetes in children, which could lead to potential marketing authorization in the EU and EEA [1][2][8] Group 1: Pediatric Investigation Plan and Clinical Trials - The PDCO's positive opinion is based on PolTREG's clinical trial protocol initiated in October 2024, which originally enrolled children aged 6–16 years, with a recommendation to broaden eligibility to ages 3–18 years [3][8] - Achieving the clinical endpoints defined in the PIP may serve as a basis for obtaining marketing authorization for PTG-007 [2][8] Group 2: Product Development and Safety Data - PolTREG combines over 12 years of clinical data confirming the safety and efficacy of polyclonal Treg therapies, making it the only company with such extensive patient-safety and efficacy data for autologous polyclonal Treg therapies [4][9] - In vivo murine studies have shown preliminary safety and efficacy for CAR-TREG lymphocytes, supporting upcoming Phase 1 clinical trials in multiple sclerosis and amyotrophic lateral sclerosis [2][5][8] Group 3: Manufacturing and Expansion Capabilities - PolTREG operates a GMP-certified manufacturing facility, one of Europe's largest, with over 2,100 sqm of laboratory space and 15 production lines, allowing for the production of Treg therapeutics [6][7] - The company has the option to expand its facility to accommodate next-generation engineered therapies and can ship its cellular therapy products across Europe within 24 hours [7]