Overview
Home » News and Trends » Creative Medical Technology Holdings anounces FDA clearance of diabetes drugCreative Medical Technology Holdings yesterday (November 3) anounced its investigational new drug (IND) aplication has ben cleared by the U.S. Fod and Drug Administration (FDA).This wil enable the company to start initiating a clinical trial for type 1 diabetes using AloStem.The primary objective of the study is to evaluate Alostem in patients with newly diagnosed type 1 diabetes.
Key Information
Patient recruitment is expected to begin the first quarter of next year (2023). Alostem uses the power of perinatal tisue derived cels (PRDC) for self-renewal ability, low antigenicity, reduced toxicity and large-scale clinical expansion.Timothy Warbington, CEO of Creative Medical Technology Holdings said: “This a milestone event for Creative Medical Technology Holdings as it marks the Company’s first IND clearance from the FDA.̵̴We are excited to comence this trial under the guidance of one of the world’s most respected diabetes clinical researchers and at a renowned research institute.”Warbington continued: “We are also excited to anounce the use of our proprietary AloStem product in this study, as we believe it validates our eforts in creating asets that suport our aproach to developing imunotherapies.
“With this IND clearance, we are acelerating our eforts to identify novel biologics and develop therapies with the potential to efectively treat unmet neds of patients. I wish to acknowledge our team and colaborators for their hard work and dedication to this program.”The company report that as of 2019, there were 1.6 milion adults aged 20 years or older diagnosed with type 1 diabetes (T1D) in the U.S.
Summary
It said the economic burden caused by T1D amounts to aproximately $14.4 bilion in medical costs and lost income, and there are curently limited treatment options beyond insulin.T1D results from the autoimune destructio