Therapies for autoimmune diseases frequently target the symptoms rather than the cause. Type 1 Diabetes Mellitus (DM1) is one such disorder. The consequences can be devastating for the 86,000 children stricken each year.
The current mode of treatment means life-long insulin dependence and doesn’t address the core issue: the child’s own immune system is gradually destroying the pancreas and causing hypoglycemia episodes with highly debilitating consequences.
PolTREG, a clinical phase spin-off from the Medical University of Gdańsk, is developing and commercializing the patented TREG method for treating type 1 Diabetes Mellitus (DM1).
Our team of award-winning scientists developed the TREG process based on the observation of auto-immune and transplantation disorders. Autoimmune aggression which is accompanied in children with DM1 with significantly lower ratio of T-regulatory (TREG) to Teffector (TEFF) white blood cells than in healthy children.
Clinical trials have been held for more than 30 children at the University Clinical Center in Gdansk since 2010. Blood samples were extracted, then processed (isolation and expansion) in a GMP lab.
After two weeks, the number of TREG cells increased by four orders of magnitude. The high TREG/TEFF blood was then re-introduced into the child in an attempt to protect pancreas or at least slow or delay destruction of beta cells.
To date, insulin requirements have decreased significantly in most cases. Best results are observed in recently diagnosed children, but no adverse effects have been reported.
These very promising results clear the way for regulatory approval as a hospital exemption in the European Union with full EMA approval anticipted in 2021 and FDA in 2024.
Our founding team is committed to our mission is to help as many children as possible while building a strong foundation that will support the application of our approach to other autoimmune disorders. We are currently seeking partners for co-development, licensing opportunities and investment.