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ORPHELIA reports positive results of the bioequivalence study of KIMOZO® (oral suspension of temozolomide)

31 May 2022

Paris and Lyon, May 31st, 2022 – ORPHELIA Pharma, the French biopharmaceutical company focused on developing and commercializing orphan medicines in oncology and neurology, announces today 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.

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 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®.

About ORPHELIA Pharma

ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of pediatric and orphan diseases. ORPHELIA Pharma’s mission is to provide patients with essential products in the fields of neurology and oncology, with formulations adapted to the pediatric population. With two medicines approved in the European Union and one investigational medicine in an advanced clinical development phase, ORPHELIA Pharma has recently signed regional agreements in the European Union, the USA and China with several partners and is carrying out research projects through academic and industrial partnerships.