Prima BioMed Announces Approval for the Initiation of the ‘INSIGHT’ Clinical Trial
July 9th 2017
SYDNEY, Australia, July 09, 2017 (GLOBE NEWSWIRE) -- Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima” the “Company”) today announced that its collaboration partner, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany (“IKF”), has received the regulatory and ethical approvals for the clinical trial investigating IMP321 in new settings, called ”INSIGHT”.
Approval has been received from the Paul-Ehrlich-Institut (“PEI”), the Federal Institute for Vaccines and Biomedicines for the German Federal Ministry of Health, which is the competent regulatory authority in the field of medicinal products that assesses and monitors antibodies for the treatment of cancer and autoimmune diseases for human use. Approval has also been received from the Institute of Clinical Cancer Research ethics committee. The clinical trial will commence in due course.
The investigator sponsored INSIGHT clinical trial will explore different routes of administration of IMP321 in solid tumours.
The lead investigator of the study, Dr Salah-Eddin Al-Batran, commented, “We are thrilled by the prospect of injecting an active immunotherapy directly at the tumour site to see whether the locally induced antigen presenting cell activation leads to a regression of distant tumour masses, a characteristic of anti-tumour CD8 T cell responses. In addition, analysis of local tumour biopsies before and after IMP321 injection will inform us about the immune infiltrates induced by this APC activator.”
Marc Voigt, Chief Executive of Prima, commented, “We are pleased to see the initiation of this new therapeutic application for IMP321. It is the first ever investigation of 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.”
INSIGHT is an explorative, single centre, open-label, Phase I clinical trial 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 patient clinical trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF.
About Prima BioMed
Prima BioMed is listed on the Australian Stock Exchange, and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au