Date: 2016-07-12
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Oncodesign (France)
Product: ODS2004436
Action
mechanism: radiotracer/radiopharmaceutical. ODS2004436 is a mutated EGFR-receptor marker in patients using PET
(Positron Emission Tomography) imaging. This radiotracer was generated using Oncodesign's Nanocyclix technology, a chemical platform of next generation kinase inhibitors. This product is developed as part of the IMAkinib project. This Oncodesign research program has been launched in 2009 to develop biomarkers used in nuclear medicine to provide diagnostic solutions in oncology and help select the treatment best suited to individual patients, then monitor its efficacy and any potential resistance. The radiotracers developed are small molecules generated by Oncodesign’s labelled with radioactive 18F-fluorine [18F]. This program is conducted jointly with Cyclopharma and Ariana Pharmaceuticals. It has received a grant from Bpifrance of €10.3m as part of the Industrial Strategic Innovation Programme, with an overall funding of €25m.
Disease: lung cancer
Therapeutic area: Cancer - Oncology
Country: France
Trial details:
Latest
news: * On July 12, 2016, Oncodesign, a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, announced the launch of a clinical study focusing on the evaluation of its first radiotracer in humans, as part of the IMAkinib project conducted jointly with Cyclopharma and the study sponsor, the Cancer Centre Georges-François Leclerc (CGFL) in Dijon. The objective of this radiotracer (ODS2004436) is to measure increased EGFR1 kinase activity during the development of a tumour, to select the treatment best suited to individual patients and to detect the emergence of any resistance early on. The radiotracer will be visualised by PET (Positron Emission Tomography), a standard nuclear imaging technique used for clinical diagnosis.
The clinical study, authorised by the French National Agency for Medicines and Health Products ANSM, is now ready
to begin at the CGFL Cancer Centre, which has been granted the CLIP designation to conduct early-stage clinical
trials. The first patient with lung cancer will be recruited within the next few weeks in the medical oncology department of the CGFL Cancer Centre in Dijon (Dr. Isambert, Head of the early-stage unit). The objective of this phase 0/1 is to demonstrate the sensitivity and specificity of the radiotracer in human lung tumours. The clinical study will include 3 successive stages, designed to verify the specific labelling of tumours expressing the mutated EGFR receptor, verify the absence of significant marking on non-mutated tumours, and finally confirm the findings in a larger number of patients.
