US FDA grants IND to PharmaMar's Zalypsis

Spanish drugmaker PharmaMar says that its Investigational New Drug application has been accepted by the US Food and Drug Administration, thus enalblng it to start clinical testing of Zalypsis (PM00104/50), its novel marine anti-tumor drug candidate.

The agent is already in Phase I development in Europe, where three multicenter studies in solid tumors or lymphoma are underway. The IND has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the European studies and PharmaMar intends to begin US testing of the compound in the same indications in the second quarter.