Date: 2012-10-01
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the annual congress of ESMO (European Society for Medical Oncology) in Vienna, Austria (September 28th – October 1st).
Company: BioAlliance Pharma (France)
Product: AMEP® (targeted biotherapy)
Action
mechanism: AMEP® targets specific receptors (integrins) particularly expressed by melanoma cells and vascular endothelial cells, both involved in tumor growth and tumor angiogenesis (formation of neovascularization inducing tumour growth).
Disease: metastatic melanoma
Therapeutic area: Cancer - Oncology
Country: France, Denmark, Slovenia
Trial details:
Latest
news: BioAlliance Pharma has presented safety and tolerance results of the phase I clinical study with the AMEP® biotherapy in the metastatic melanoma at the annual congress of ESMO (European Society for Medical Oncology) in Vienna, Austria (September 28th – October 1st). These results were presented by Dr Julie Gehl (Clinical Associate Research Professor at University of Copenhagen Department of Oncology, Herlev Hospital of Copenhagen, Denmark), Principal Investigator of the study, in the form of an abstract and of a poster: “Proof of concept of gene therapy using plasmid AMEP in disseminated melanoma: Safety and efficacy results of a phase I first-in-man study”. Two other specialized European cancer centers were also involved in the study: the Gustave Roussy Institute in Villejuif (France) and the Institute of Oncology in Ljubljana (Slovenia).
This first phase I clinical trial, conducted in advanced or metastatic melanoma, has shown a very good safety profile of the biotherapy administered by local electrotransfer (intratumoral) as well as satisfactory signals of efficacy.
Based on these positive results, BioAlliance Pharma is pursuing the development of its biotherapy and obtained last June the approval of the phase I/II clinical trial application from the regulatory authorities. This trial, to be conducted on a European level, aims now at evaluating the safety and efficacy profile of the AMEP® biotherapy administered via systemic route (intramuscular) in the same indication.
“This first-in-man study showed that gene electrotransfer of plasmid AMEP® could be safely administered, and transfection was obtained in tumors. This represents the successful conclusion of a European collaboration to perform gene therapy using this novel agent. Already follow-up studies are approved, and we look forward to the results of this continued effort to explore novel treatment paradigms”, declares Dr Julie Gehl.
