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Oxilio and Quotient Sciences Announce Regulatory Approval for Oxilio’s OXL001 Development Program
Oxilio, a pioneering drug development company repurposing existing drugs to address unmet needs in cancer treatment, and Quotient Sciences, a drug development and manufacturing accelerator, today announced an update on the development of Oxilio’s OXL001 product.
Oxilio is pleased to announce that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its first Clinical Trial Application (CTA) with OXL001.
Following initial formulation development by Oxilio in collaboration with its partner company, TRx Biosciences, Quotient Sciences’ integrated Translational Pharmaceutics® platform has been used to carry out the technical transfer and scale-up activities associated with this program and will continue to be used to support clinical trial material manufacturing and the investigation of the pharmacokinetics and safety of OXL001 in healthy volunteers.
Mark Egerton, PhD, CEO of Quotient Sciences, said: “We are delighted to be able to continue to assist Oxilio with their OXL001 program. By leveraging our unique, integrated Translational Pharmaceutics platform, Oxilio will have the flexibility to adjust doses based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time, and ultimately get new medicines to patients faster.”
Dr Simon Yaxley, Director of Oxilio, added: “Utilizing Quotient Sciences’ Translational Pharmaceutics platform has enabled us to successfully achieve this important milestone of receiving regulatory approval to undertake our first Phase 1 clinical trial with OXL001. We look forward to commencing this study within the next few weeks.”