Prima BioMed Announces Approval for the Initiation of the ‘INSIGHT’ Clinical Trial
09 Julio 2017 - 10:46PM
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.”
About INSIGHTINSIGHT 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
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
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