NEW YORK – Biotechnology company PolTreg announced Monday that some type 1 diabetes patients treated with its autologous T-regulatory cell therapy have remained in clinical remission for up to 12 years.
Gdańsk, Poland-based PolTreg monitored 54 patients who took part in Phase I and Phase II trials of its lead product PTG-007 to treat early-onset T1D for between seven and 12 years. A subset of patients were still in clinical remission — meaning they had a limited need for external insulin to maintain glycemic control — for that time.
According to the company, some patients were insulin independent for a year and a half to two years after treatment. The best results were among patients who received PTG-007 in combination with Biogen and Genentech's anti-CD20 treatment Rituxan (rituximab), and the company noted no severe adverse effects of the treatment. It plans to publish these results in a peer-reviewed journal.
PolTreg is now seeking partnership funding to launch a pivotal Phase II/III study of PTG-007.
"We believe that PTG-007 has the potential to free many type 1 diabetics from the lifelong burden of having to take frequent insulin injections, and the serious long-term complications of the disease," PolTreg CEO Piotr Trzonkowski said in a statement.
PolTreg is also launching a Phase II clinical trial of PTG-007 in presymptomatic T1D this year, and Phase II trials examining the drug in relapsing-remitting and primary progressive multiple sclerosis.