This Fast Track designation will help to push through the development of CLBS03, developed by Caladrius Biosciences, which is designed to support the immune system in protecting the insulin-producing beta cells of the pancreas.
The drug is currently being studied in a phase II clinical trial called the T-Rex study, which is expected to finalise enrolment of the first cohort of 18 patients within the next few weeks.
Patients will then be randomised to receive either a high dose of CLBS03, a low dose, or placebo.
The trial is being conducted in collaboration with healthcare company Sanford Health, with researchers set to evaluate pancreatic beta cell function, insulin use, HbA1c and severe hypoglycemic episodes, as well as several other health markers.
Treatment with CLBS03 is derived from the use of T regulatory cells (Tregs) to restore immune balance in patients with autoimmune diseases such as type 1 diabetes.
In type 1 diabetes, deficient Treg cells enable T effector cells to attack the body’s insulin-producing cells in the pancreas. CLBS03 consists of each patient’s own Tregs, which have been expanded in number and functionality to help protect the immune system.
Two previous phase I trials have demonstrated CLBS03 to safely infuse Treg cells into patients, which reduced the need for exogenous insulin in the majority of patients treated.
In one particular trial, CLBS03 treatment also preserved the function of pancreatic beta cells in pediatric patients aged 8-16 years with new onset type 1 diabetes.
David J. Mazzo, PhD, Chief Executive Officer of Caladrius, said: “Obtaining Fast Track designation is a key milestone in our regulatory and development strategy for CLBS03.
“It underscores the great need for innovative treatments, such as CLBS03, in the treatment of T1D and allows for the acceleration of its development.”