BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan oncology products, today announced preliminary phase I clinical results with its AMEP® biotherapy developed in advanced or metastatic melanoma, an invasive skin cancer of bad prognosis.
The objectives of this first phase I trial were to evaluate the safety of intratumoral electrotransfer of AMEP® biotherapy and to detect a first signal of efficacy. The evolution of the AMEP electrotransferred melanoma lesions was compared with that of a distant lesion in the same patient, with the same initial size. Ten intratumoral electrotransfers have been performed in 3 specialized centers in Europe: in Denmark at the Copenhagen University Herlev Hospital, in France at the Gustave Roussy Institute of Villejuif and in Slovenia at the Institute of Oncology of Ljubljana.
Safety has been shown to be satisfactory at doses assessed, 0.5mg and 1mg. A stabilization of tumor growth has been obtained in 60% of lesions treated with AMEP® biotherapy whereas all control tumors, not treated, were progressing. Moreover, objective tumor regression has been observed in 20% of cases.
AMEP® targets specific receptors (integrins), particularly expressed by melanoma cells, both involved in tumor growth and tumor angiogenesis. These preliminary phase I results validate the clinical concept of AMEP® and enable to prepare the next step: AMEP® will be administered via intramuscular route to confirm its safety and to obtain a systemic effect in patients with metastatic melanoma.
“These preliminary clinical results confirm the interest of the AMEP® biotherapy. It is a breakthrough treatment combining a new target, integrins, to an original transfer of therapeutic nucleic acid. This program, co-financed by OSEO’s Strategic Industrial Innovation Program to the “Cancer Anti-invasive Program” (CAP), is developed in a consortium associating the academic research, industrials and melanoma clinicians, with notably a research extended to specific “companion” markers, necessary to the follow up of these patients suffering from a severe disease”, explains Pierre Attali, COO of BioAlliance Pharma, in charge of Strategy and Medical Affairs.
“It was important to AMEP® to have efficacy together with in situ safety data to prepare the next step of its development. AMEP® is one of the 3 “Orphan oncology products” portfolio in clinical phase supporting BioAlliance’s ambition to become a major player in this area”, comments Judith Greciet, CEO of BioAlliance Pharma.
About the electrotransfer technology
The electrotransfer technology enables chemical or biological substances to be transferred to target cells thanks to an effective, safe, simple, and repeatable delivery of electric pulses. Used for several years in chemotherapy for cutaneous and subcutaneous metastatic lesions, notably in skin, breast and head & neck cancers, this technology is specifically used for the transfer of biological active substances, such as AMEP® plasmid.