Kancera reports that the phase I study of KAND145 has received regulatory approval
Kancera AB (publ) today reports that the Finnish regulatory agency (FIMEA) has approved Kancera’s application to conduct a phase I study of KAND145, the company’s second generation fractalkine blocking candidate drug.
“This is an important milestone for Kancera, as KAND145 is the primary candidate drug intended for treatment of cancer”, says Peter Selin, Chief Executive Officer at Kancera.
The application has been submitted through the new centralized EMA process for clinical studies that became mandatory on February 1, 2023. Kancera will now start enrollment of subjects and expect to present top line study results in the second quarter of 2024.
About the phase I study of KAND145
The study is a randomized, double-blind and placebo-controlled phase I study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND145 and interaction with other pharmaceutical products after multiple ascending dosing. The study will be conducted at two sites in Finland and approximately 50 study subjects in total are expected to be enrolled.
About Kancera AB (publ)
Kancera is developing a new class of drugs for treatment of cancer and severe inflammatory conditions, that today are lacking effective treatments. Kancera’s main focus is to develop small molecule drug candidates based on the fractalkine axis. The fractalkine axis regulates certain immune cells and cancer cells with precision. The stock is traded on the Nasdaq First North Premier Growth Market. FNCA Sweden AB is the company’s Certified Adviser.
For further information:
CEO, Kancera AB
Tel: +46 (0)8-5012 6080
Visit Kancera’s web page: https://www.kancera.com/en