SYDNEY, AUSTRALIA--(Marketwired - Jul 12, 2016) - Prima BioMed Ltd (
The new clinical trial is called "INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities."
The Lead Investigator of this up-to-40-patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.
Dr Al-Batran commented: "The promising results from previous studies and favourable safety profile of IMP321 have led us to conduct a phase I trial investigating a potential enhancement of the immune-activating effects of IMP321 by new routes of administration. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumour entities."
Marc Voigt, Chief Executive of Prima, said: "This is potentially an exciting new therapeutic application for IMP321 and is the result of the extensive research carried out by Dr Frédéric Triebel and the Prima team in our Paris laboratory. It is the first ever investigation into whether direct injection of IMP321 into a solid tumour can activate the antigen presenting cells located inside the tumour to boost the body's immune response. As this trial is investigator initiated, it will also not require any significant near-term resource commitment from Prima."
| Clinical Trial Synopsis | ||
| Title of Study | INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities | |
| Objectives | Feasibility, safety and toxicity Immune response in whole blood and tumour tissue Identification of biomarkers that correlate with clinical response / clinical outcome | |
| Study design | Monocentre, open-label, phase I study | |
| Planned Sample size | Up to 40 patients | |
| Clinical trial identifier: | To be determined | |
About Prima BioMed
Prima BioMed is listed on the Australian Securities Exchange, and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au .
For further information please contact: Prima BioMed Ltd: Australia Investor/Media: Mr. Matthew Gregorowski Citadel-MAGNUS +61 (2) 8234 0100 mgregorowski@citadelmagnus.com U.S. Investors: Matthew Beck The Trout Group LLC +1 (646) 378-2933 mbeck@troutgroup.com
