On May 31, 2022 ORPHELIA Pharma, the French biopharmaceutical company focused on developing and commercializing orphan medicines in oncology and neurology, reported the successful completion of the phase 1 study of KIMOZO, novel ready-to-use oral suspension of temozolomide, aimed at determining bioequivalence between KIMOZO suspension and temozolomide capsules (Press release, ORPHELIA Pharma, MAY 31, 2022, View Source;utm_medium=rss&utm_campaign=orphelia-reports-positive-results-of-the-bioequivalence-study-of-kimozo-oral-suspension-of-temozolomide [SID1234615249]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The abstract #368704 entitled "bioequivalence study of a novel liquid and ready-to-use temozolomide oral suspension and temozolomide capsules in patients with primary central nervous system malignancies" by Ducray et al., was selected by the Scientific Program Committee of the 2022 ASCO (Free ASCO Whitepaper) annual meeting. The data released online demonstrate the equivalence between KIMOZO oral suspension and temozolomide capsules.
"The positive results of the bioequivalence study are an important milestone in the development of KIMOZO", comments Caroline Lemarchand, Chief Pharmaceutical Development Officer at ORPHELIA Pharma. "KIMOZO is the first drinkable form of temozolomide that has been specifically developed to address the needs of young children with cancer", she adds.
"Temozolomide is part of the standard of care for the treatment of relapsed or refractory neuroblastoma, a devastating cancer that affects young children. KIMOZO is currently undergoing further clinical evaluation (TEMOkids trial, NCT04610736) and our goal is to make this pediatric formulation of temozolomide available to children in the shortest timeframe possible"; concludes Jeremy Bastid, Chief Development Officer at ORPHELIA Pharma.
About the bioequivalence study (NCT04467346)
The NCT04467346 bioequivalence study was an open label, randomized, crossover, 2-period study in 30 adult patients with primary CNS malignancies. The study objective was to evaluate primarily the bioequivalence between KIMOZO oral suspension and TEMODAL capsules, to define KIMOZO pharmacokinetic parameters and to assess the safety and tolerability including buccal tolerance of KIMOZO.