Paris, October 12th, 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs announces today that it will organize a symposium at the Société Internationale d’Oncologie Pédiatrique (SIOP) congress 2020. The session will focus on the pediatric use of temozolomide in the treatment of relapsed or refractory pediatric tumors and will showcase the development of Kimozo a ready-to-use and taste-masked oral suspension of temozolomide adapted to children. “ORPHELIA Pharma is committed to improving the care of patients with pediatric and rare diseases, including developing innovative formulations to address children needs,” comments Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma. “Our commitment to develop child-friendly medicines is a historical pillar of our company and this session at the SIOP meeting highlights our long-term close collaboration with the pediatric oncology community”. This industry symposium entitled “Improving children care with temozolomide oral suspension” will be held virtually on Friday, October 16th from 9:15 AM to 9:35 AM local time (Ottawa), from 3:15 PM. to 3:35 PM. Central European Time (CET) and accessible by connecting on the SIOP meeting website (SIOP-congress.eu) in the “Product theatre” section. Dr Lucas Moreno (Val d’Hebron Hospital, Spain) and Dr Dominique Valteau-Couanet (Gustave Roussy Hospital, France), two internationally renowned clinicians, will talk about the critical role of temozolomide in the management of relapsed or refractory pediatric tumors, including high-risk neuroblastomas. The third presenter, Dr Caroline Lemarchand, Chief Pharmaceutical Development Officer of ORPHELIA Pharma, will discuss the development of Kimozo, the first pediatric formulation of temozolomide under clinical development. We look forward to welcoming you during this unique event. About Kimozo Kimozo (also known as Ped-TMZ or ORP-005) is a ready-to-use and taste-masked oral suspension of temozolomide that is currently under clinical development to address children needs. Kimozo is an investigational medicinal product not yet approved for use or marketing anywhere in the world. About SIOP 2020 virtual congress The SIOP Annual Meetings bring together more than 2,500 leading clinicians and scientists from over 100 countries to share recent momentous scientific advances in the field of paediatric oncology. This congress represents an unique opportunity to stay up to date in this rapidly moving field and to bring the latest science to bedside. In light of the impact of the COVID-19 pandemic on travel restrictions and physical distancing requirements, the SIOP 2020 Annual Meeting will be held virtually on October 14-17, 2020.
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ORPHELIA announces the inclusion of the first patient in a clinical study evaluating Kimozo, its pediatric formulation of temozolomide Paris and Lyon, October 5th, 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs is pleased to announce the inclusion of the first-in patient in a clinical study aimed at demonstrating the bioequivalence between Kimozo, the first pediatric formulation of temozolomide under clinical development, and Temodal® capsule. Although not approved in this indication, temozolomide is an essential anticancer medicine recommended for use in treatment protocols of relapsed or refractory neuroblastoma, a condition that affects young children. However, the only oral formulations that are commercially available are in the form of capsules that are poorly adapted to children. Caretakers are thus compelled to open capsules and disperse the content into a soft food prior to administration to the child, which harbors several risks such as the uncertainty with regards to the delivered dose, the exposure of the caregiver to the cytotoxic drug and the instability of the drug in aqueous milieu. To overcome the risks this situation implies, Kimozo, a ready to use oral formulation has been specifically designed to address the needs of the pediatric population. Kimozo has been developed in collaboration with Gustave Roussy, one of the leading cancer centers in Europe. The current clinical trial conducted by ORPHELIA Pharma aims at demonstrating, first for regulatory purposes, the bioequivalence between Kimozo and the Temodal® capsules in adult patients having brain cancers, with additional clinical investigation to come in the pediatric population of interest. “We have reached an important milestone for Kimozo with the clinical trial approval from competent authorities and the recruitment of a first patient“, said Caroline Lemarchand, Chief Pharmaceutical Development Officer of ORPHELIA Pharma “We plan to enroll 30 patients by mid-2021 thanks to the support of the three neuro-oncology teams involved in the study: Professor Ducray of the Hospices Civils de Lyon (coordinating investigator), Professor Chinot of the Timone Hospital in Marseille and Dr Bronnimann of Saint-André Hospital in Bordeaux. ” “We are pleased to contribute to the development of this new pediatric formulation of temozolomide. A liquid form is unambiguously of interest for treating children.“, underlines Pr. François Ducray. Hugues Bienaymé, General Manager of ORPHELIA Pharma further comments: “This first administration is a major milestone in the development of Kimozo. We are now preparing the opening of our […]
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Meet us at BIO-Europe 2020, October 26-29 Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma, will participate in the upcoming BIO-Europe conference to be held virtuallly on october 26-29, 2020. BIO-Europe is Europe’s largest partnering conference serving the global biotech industry. Jeremy will actively take part in this business event, registered under the name of the holding company, initiative OCTALFA.
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ORPHELIA Pharma will support and attend the upcoming SIOP Congress from October 14th to 17th (52nd Congress of the International Society of Paediatric Oncology), which will be virtual this year. This event aims to bring together the oncology community and share the latest advances in pediatric oncology. Join the ORPHELIA Pharma virtual symposium to share on innovation in the use of temozolomide in children, which will take place on Friday October 16th between 9:15 AM and 9:35 AM (Ottawa time) by logging on to the SIOP website (SIOP-Congress.org). Please contact us if you have any questions (pierre-julien.cotte@orphelia-pharma.eu).
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