On February 17, 2022 Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop and commercialize novel therapies targeting the fight against cancer reported that the first patient has received treatment with Orotecan (irinotecan HCI oral solution) in a Phase I/IIa clinical trial for patients with recurrent pediatric solid tumors (Press release, Edison Oncology, FEB 17, 2022, View Source [SID1234608250]).
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The clinical trial will enroll up to 20 patients with recurrent pediatric and solid tumors, including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma. The trial endpoints will characterize the pharmacokinetics of Orotecan vs. unformulated irinotecan in an already established oral treatment regimen, document safety and tolerability, and assess tumor response. The trial is currently enrolling patients at Duke University Children’s Hospital and Cincinnati Children’s Hospital Medical Center, with opening of additional sites anticipated in the near future.
"We are excited to have treated the first patient treated with Orotecan, our novel oral formulation of irinotecan, which we believe has the potential to improve the quality of life for pediatric and adult cancer patients, improve patient compliance and reduce costs" said Jeffrey Bacha, Edison Oncology’s chief executive officer.
Further details of the trial can be found on clinicaltrials.gov (NCT04337177).
About Orotecan
Orotecan is a patented, novel formulation of irinotecan that was developed to improve palatability and
clinical utility of an established oral delivery regimen for numerous pediatric cancers.