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Swedish-based biopharmaceutical company Immunicum has commenced enrolment in the Phase I/II clinical trial of INTUVAX for the treatment of patients with gastrointestinal stromal tumour (GIST).
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The move follows a study protocol amendment approved by the ethical committee and the Swedish Medical Products Agency.
Developed to treat solid tumours, INTUVAX is a cancer immune pimer consisting of activated dendritic white blood cells that are sourced from healthy blood donors.
According to the revised study design, the trial will see an enrolment of 12 patients.
Conducted in collaboration with the Karolinska Institute, the open-label Phase I/II trial will evaluate the safety and efficacy of various intratumorally administered doses of INTUVAX in patients with progressing GIST during ongoing treatment with a tyrosine kinase inhibitor.
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By GlobalDataImmunicum chief medical officer Peter Suenaert said: "GIST is a very rare and complex disease and we are very pleased that the optimisation of the protocol to broaden the recruitment basis has achieved the first new patient enrolled.
"Treatment options for GIST patients are limited and we believe that INTUVAX can have a significant impact in this patient population.
"We look forward to continuing our collaboration with the Karolinska Institute and establishing clinical proof of safety and activity in this indication."
It is expected that the intratumoral injection of the dendritic cells present in the drug will induce an inflammatory response resulting in tumour-specific activation of the cytotoxic T-lymphocytes.
INTUVAX is currently being studied for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumours.
Image: Histopathologic image of gastrointestinal stromal tumour. Photo: courtesy of KGH/Wikipedia.
