PolTREG Launches Phase II Trial for Revolutionary Diabetes Treatment
PolTREG Takes Bold Steps in Diabetes Research
PolTREG has made a significant advancement in diabetes treatment by dosing the first patient in their Phase II clinical trial with the innovative therapy PTG-007. This endeavor aims to tackle pre-symptomatic type 1 diabetes in high-risk children and adolescents aged 3 to 18.
PTG-007: A Unique Autologous Cell Therapy
PTG-007 represents a pioneering approach in the realm of T1D therapy, particularly crafted for young patients at genetic risk. The study plans to enroll up to 150 participants, including a control group receiving a placebo. This dual approach will enable researchers to analyze and compare the outcomes effectively to gather robust data on the therapy's efficacy.
Exploring Parallel Studies and Regulatory Insights
An exciting aspect of this trial is the proposed parallel study submitted to the U.S. Food and Drug Administration (FDA), which holds promise for inclusion of Polish patients in the U.S. statistical analysis. This FDA engagement came after favorable discussions at a recent Pre-Investigational New Drug (IND) meeting.
Funding and Future Prospects
To support its ambitious clinical trials, PolTREG secured an impressive $11.3 million non-dilutive grant from the Polish Medical Research Agency. Such financial backing underscores the confidence in PTG-007 and its potential to change the therapeutic landscape for type 1 diabetes prevention.
The Importance of Early Intervention
Understanding T1D's progression is crucial for PolTREG's mission. The company focuses primarily on stages 1 and 2, which precede clinical symptoms. During these stages, a sufficient number of pancreatic islets remain functional, allowing for effective intervention. This approach aims to halt the autoimmune processes that lead to the destruction of insulin-producing cells.
Safety and Efficacy: A Prime Concern
Patient safety is a priority in this trial, particularly given the young age group involved. The extensive 12-year safety data from previous studies on PTG-007 positions it as a suitable candidate for this initial therapeutic phase.
PolTREG's Innovative Pipeline
PolTREG is not only dedicated to PTG-007 but is also advancing its broader pipeline. The company is developing a series of multi-edited, allogeneic CAR-T regulatory cell therapies, which could significantly impact patients at different T1D stages. This comprehensive strategy positions PolTREG as a leader in diabetes therapy and reflects its commitment to innovation.
Expansion into U.S. Markets
In alignment with its growth strategy, PolTREG has strengthened its presence in the U.S. by establishing Immuthera, its wholly owned subsidiary. This move allows the company to navigate U.S. regulatory landscapes more effectively and capitalize on emerging clinical opportunities.
Experts Join Scientific Advisory Board
Recently, eminent figures in diabetes research have joined PolTREG's Scientific Advisory Board. Their expertise will bolster the company's efforts to adapt and expand its clinical strategies in addressing autoimmune diseases through cutting-edge treatments.
Contact Information for Inquiries
Those interested in learning more about PolTREG can reach out to:
PolTREG S.A.
Prof. Piotr Trzonkowski
Chief Executive Officer
ir@poltreg.com
+48 512 532 401
Frequently Asked Questions
What is PTG-007?
PTG-007 is an innovative autologous cell therapy developed by PolTREG aimed at preventing type 1 diabetes in genetically predisposed children.
How many participants are involved in the Phase II trial?
Up to 150 high-risk children and adolescents will participate in this clinical trial.
What is the goal of the parallel study proposed to the FDA?
The parallel study aims to include Polish patients in the U.S. statistical analysis, potentially aiding future regulatory submissions.
What funding has PolTREG received for this trial?
PolTREG has secured an $11.3 million grant from the Polish Medical Research Agency to support the Phase II trial's execution.
How does PolTREG plan to expand its presence in the U.S.?
PolTREG established Immuthera, its U.S. subsidiary, to enhance regulatory interactions and clinical development efforts in the United States.
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