BioAlliance Pharma SA (Paris:BIO), a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, has presented results on its new biotherapy, plasmid AMEP™, for metastatic melanoma treatment at the at the American Association for Cancer Research (AACR) 100th Annual Meeting, in Denver, April 18 to 22, 2009.
Worldwide melanoma incidence is about 140 000 per year with a high frequency especially in Australia, North America and Europe. When treated at early stage, the prognosis of local melanoma is excellent and associated with a prolonged survival. Nevertheless, the five-year survival rate of advanced or metastatic cancers is low, between 5 and 25% according to the stage and localisation of the disease. No treatments or treatment strategies are demonstrated to be consistently effective in these advanced melanoma patients. Recommendations from all medical and scientific cancer and dermatology societies are thus to evaluate new treatments.
BioAlliance Pharma develops a new biotherapy, plasmid AMEP™, which displays anti-angiogenic and anti-metastatic properties. AMEP™ binds avß3 and a5ß1 integrins which are receptors overexpressed by tumoral melanocytes and also activated endothelial cells involved in new blood vessel formation.
Results presented during the AACR annual meeting describe these anti-angiogenic and anti-tumoral properties of the plasmid AMEP™ biotherapy in in vitro and in vivo models. In an in vivo experimental model of invasive melanoma, tumor treatment by plasmid AMEP™ biotherapy, applied through either intratumoral or intramuscular route, induced a strong tumor growth inhibition (>95% and >50% respectively). Moreover, preliminary acute toxicology studies show that plasmid AMEP™ biotherapy is safe and well-tolerated.
Preclinical toxicology and biodistribution regulatory studies are in progress and will allow the submission of the regulatory file for a phase I clinical trial planned in 2009 in metastatic melanoma patients.