Cancer Programme IPP-204106 progresses into further clinical trials First cancer patients in new trial begin dosing8th October 2012 - 9:25 am
ImmuPharma plc (LSE:IMM) (“Immupharma” or the “Company” or the “Group”), the specialist drug discovery and development company, is pleased to announce that its cancer programme IPP-204106 has begun further clinical trials with the next generation of “polyplexed Nucant”.
The first patients have started dosing in this new Phase I/ II clinical trial. This “polyplexed Nucant” formulation has shown an impressive efficacy of about 10 times over the previous Nucant version in pre-clinical cancer models and represents a new discovery in that it combines the previous IPP-204106 Nucant version with a specific excipient that forms micro/nano stuctures. IPP-204106 has a novel mechanism of action aimed at preventing proliferation, inducing apoptosis and also controlling angiogenesis.
ImmuPharma has made promising progress with its anti-cancer nucleolin antagonist (“Nucant”) peptide programme. Having received approval from the French regulatory authorities, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) it initiated an initial Phase I dose ranging tolerability and safety study in three hospitals in France which is now completed. Patients were suffering from different types of cancer including breast, lung and bladder cancers which had all metastasised. No serious drug related adverse events were reported. 6 out of the 14 patients had a proven stabilization and for 2 out of the 6 the stabilization lasted for more than 6 months.
For this next Phase I/II study based on the next generation “polyplexed Nucant”, it is planned to re-evaluate the safety in a preliminary Phase I dose ranging tolerability study with the new formulation (first dose level about to be completed shortly) followed by a Phase II efficacy study designed to treat various cancers in approximately 30 patients to identify appropriate biomarkers. This trial will be conducted in three hospitals in Europe including the prestigious Institute Jules Bordet, an Integrated Multidisciplinary Centre which is the only autonomous hospital in Belgium totally dedicated to cancer. Our further intention is to conduct follow-up studies on patients showing the appropriate biomarkers with glioblastoma (brain tumour), metastatic melanoma, and pancreatic cancer where nucleolin plays a key role.