May 2014. VCN Biosciences has announced that it has initiated its two first clinical studies examining the use of VCN-01in patients with cancer.
One of thesePhase I studies(P-VCNA-001) will enrol 25-35patients and examine single direct administration of VCN-01 into the blood, either administered alone or in combination with gemcitabine(a chemotherapeutic agent). Initial indications will include patients with any advanced solid tumor. This will be a dose escalation study whose primary endpoint is safety and secondary outcome will be to measure tumour response. Enrollment in the study began last April.
The second study (P-VCNA-002) examine three intratumoral (into the tumour) injections of VCN-01, also tested alone or in combination with gemcitabine. In this case, only patients with advanced pancreatic cancer will be enrolled. The primary and secondary endpoints are identical than for P-VCNA-001 trial, and this is also dose escalation study. Enrollment in the studyhas already begun recently.
Both trials are conducted simultaneously in Barcelona and Madrid (Spain)
"We are very excited to be initiating thesefirst clinical studiesof VCN-01in patients," said Dr. Manel Cascalló,CEO of VCN Biosciences, "The efficacy of VCN-01 against a number of different cancers in animal models has been clearly established. These clinical studieswill begin to determine if these results can be duplicated in humans. All of the work performed by the Company and our collaborators has been aimed at evaluatingVCN-01in peoplewith cancer”.