Date: 2012-04-26
Type of information: Initiation of the trial
phase: 1-2
Announcement: validation by the French drug agency (Afssaps) of BioAlliance Pharma's application for a phase I/II clinical trial with Amep® in the metastatic melanoma
Company: BioAlliance Pharma (France)
Product: AMEP® (targeted biotherapy)
Action
mechanism: AMEP®s biotherapy targets specific receptors (integrins) involved in tumor growth and in tumor angiogenesis.
Disease: metastatic melanoma
Therapeutic area: Cancer - Oncology
Country: France and other european countries
Trial
details: In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of plasmid AMEP into muscle. Treatment will be repeated every 28 days until progression or limiting toxicity. Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of plasmid AMEP at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will be no intra-patient dose escalation.
Latest
news: * On April 26, 2012, BioAlliance Pharma has announced the validation by the French drug agency (Afssaps) of its application for a phase I/II clinical trial with Amep® in the metastatic melanoma. The phase I/II clinical trial application has been submitted three months ago. This submission follows the positive preliminary results of a first phase I trial via local administration (intratumoral) in patients with metastatic melanoma. This phase I/II trial, to be conducted on a European level, aims at evaluating the safety and efficacy profile of the Amep® biotherapy via systemic route (intramuscular) in the same indication. The growing incidence of metastatic melanoma and the short survival duration of patients make this cancer a disease with a very strong therapeutic need.
* On January 23, 2012, BioAlliance Pharma has announced that it has submitted to the French drug agency (ANSM) of a phase I/II clinical trial in the metastatic melanoma. Based on the results of a first phase I clinical trial showing a satisfactory safety and a signal of efficacy via local administration in man, BioAlliance Pharma pursues the development of AMEP™ with a European phase I/II trial via intramuscular route in patients with metastatic melanoma.
