On October 4, 2023 Orphelia Pharma, a pharmaceutical company dedicated to the development and marketing of pediatric and orphan medicines reported that results from the pediatric TEMOkids clinical trial will be presented at the 55th Société Internationale d’Oncologie Pédiatrique (SIOP) annual congress to be held in Ottawa, Canada, October 11-14, 2023 (Press release, ORPHELIA Pharma, OCT 4, 2023, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-to-present-results-of-the-temokids-study-pharmacokinetic [SID1234635645]). The results will be presented on October 14 during the oral session entitled "novel therapeutic approaches" by Dr. Lucy METAYER, co-investigator of the TEMOkids study and pediatric oncologist at Gustave Roussy, ranked 3rd cancer center worldwide (Villejuif, France).
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TEMOkids (NCT04610736) is a European, multicenter, population pharmacokinetic, acceptability and safety clinical study evaluating KIZFIZO (temozolomide oral suspension, 40 mg/ml) in children from the age of one year and in need of temozolomide. KIZFIZO, formerly known as KIMOZO or Ped-TMZ, has been designed specifically for use in the treatment of children with relapsed or refractory neuroblastoma, an oncology indication of dismal prognosis.
"Forty-three young patients were recruited in TEMOkids across 12 European clinical cancer centers", comments Caroline LEMARCHAND, Chief Pharmaceutical Development Officer at Orphelia Pharma. "TEMOkids is an integral part of the clinical development plan of KIZFIZO and results will be presented at the SIOP conference for the first time".
"Results from TEMOkids are very compelling" adds Dr. Samuel ABBOU, principal investigator of theTEMOkids study and pediatric oncologist at Gustave Roussy. "Not only the population pharmacokinetics show that there is no need for temozolomide dose adjustment in the pediatric population, but KIZFIZO was well accepted by children and its safety profile was similar to that of temozolomide capsules (Temodal), with no specific signal of local intolerance".
About the TEMOkids study (NCT04610736)
TEMOkids is an international, open-label, non-randomized, study evaluating Ped-TMZ oral suspension (KIZFIZO) in 40 pediatric patients aged 1 year and over. The main objective of this study was to determine the pharmacokinetic parameters of KIZFIZO in this population. The secondary objectives were to evaluate its tolerance and acceptability by children, and their response to treatment.
Twelve clinical centers were involved in the TEMOkids study: Gustave Roussy, Villejuif, France (coordinating center); Institut Curie, Paris, France; La Timone Children’s Hospital, Marseille, France; Institute of Pediatric Hematology and Oncology, Lyon, France; Oscar Lambret Center, Lille, France; Charité University Medical Hospital, Berlin, Germany; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Hospital Universitari Vall d’Hebron, Barcelona, Spain; Hospital La Fe, Valencia, Spain; University Pediatric Hospital Niño Jesús, Madrid, Spain; Southampton General Hospital, the United Kingdom and Great Ormond Street Hospital for Children NHS Trust, London, the United Kingdom.
About KIZFIZO 40 mg/ml
KIZFIZO (temozolomide oral suspension, 40 mg/ml) is a ready-to-use oral liquid pediatric formulation of temozolomide developed for use in the treatment of relapsed or refractory neuroblastoma, the most common extracranial solid tumor of childhood carrying a dismal prognosis. This age-adapted and taste-masked formulation delivers an accurate drug load in a small volume, while avoiding drug handling and caregiver exposure to temozolomide. It is the result of a fruitful collaboration between the pharmacists and clinicians of Gustave Roussy Cancer Center and the development team of Orphelia Pharma.
KIZFIZO, under the product name KIMOZO, has been granted Early Access Authorization (Autorisation d’Accès Précoce) by the French authorities in March 2022 for the treatment of refractory and relapsed neuroblastoma.
KIZFIZO received orphan drug designation from the EMA and FDA and its formulation is covered by granted patents and pending applications in Europe and in the US.