Oxford, UK, 11 June 2018 – Celleron Therapeutics, the UK-based company developing personalised medicine for cancer patients, has today announced that the expansion cohort of its Phase I clinical trial is open to patient enrolment.
Celleron Therapeutics has been conducting the following phase 1 study at the Oxford Experimental Cancer Medicine Centre (OECMC) at the Churchill Hospital in Oxford to evaluate CXD101, the medicinal product containing N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin)benzamide. CXD101 is a next generation epigenetic immune-regulator representing a class of drug that kills cancer cells by blocking certain vital functions involved in gene expression and reactivating the patient’s immune system so that cancer cells can no longer evade immune recognition. The trial is a unique partnership between Celleron Therapeutics, Oxford University Hospitals NHS Foundation Trust and the OECMC:
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CXD101 Given Orally (twice daily dosing for 5 consecutive days in a 21-day period) in Patients with Advanced Malignancies Expressing the Biomarker HR23B
The trial is a phase 1 open-label, non-randomised study in patients with advanced tumours. Patients have been treated with CXD101 administered orally starting at 1mg twice a day (i.e., 2mg/day). Dose escalation proceeded according to a standard 3+3 phase 1 scheme. Adverse experiences were evaluated according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. Dose escalation continued until dose limiting toxicity was encountered in >1/3rd of patients and the dose level below this was determined to be the maximum tolerated dose.
As the maximum tolerated dose for this agent has now been established, a further 20 patients, defined by tumour HR23B expression, will be enrolled into the Expansion Cohort.
Dr. Graham Collin, Principal Investigator of the study commented:
“Enrolling more than a dozen additional patients into this study at the MTD should enable us to confirm the single agent utility of CXD101 in a range of patients with selected tumour types. This has potential to be very exciting indeed“.
Dr John Whittaker, Celleron’s Chief Operating Officer commented
“Commencement of the expansion cohort is an important milestone for Celleron in working towards understanding the utility of CXD101 as a single agent. This is an important step in pursuing Celleron’s strategy to progress its proprietary targeted therapeutic, CXD101, and in driving the phase I clinical trial forward using our personalised treatment approach”.
Clinical trials with Celleron’s CXD101 drug are investigating not only the efficacy of the new drug but also studying a novel biomarker test, known as a companion diagnostic, to predict which patients will respond best to treatment with the drug. This approach avoids the problem of treating patients who have little chance of benefiting from the treatment so that alternative options may be considered in a timely manner.
Professor Nick La Thangue, Founder and Chief Executive of Celleron Therapeutics and Professor of Cancer Biology in the Department of Oncology at Oxford University, commented: “CXD101 is an early stage drug with exciting clinical potential. We have deep scientific insights into its cancer biology and have observed significant clinical effects in cancer patients. We are excited to evaluate its potential as a precision medicine in the current study”.