FDA grants IND for PharmaMar's Zalypsis in US
The US Food and Drug Administration (FDA) has accepted PharmaMar's Investigational New Drug application (IND) for the clinical testing of Zalypsis (PM00104/50), a novel marine anti-tumour agent.
The US Food and Drug Administration (FDA) has accepted PharmaMar's Investigational New Drug application (IND) for the clinical testing of Zalypsis (PM00104/50), a novel marine anti-tumour agent.
Headquartered in Madrid, Spain, PharmaMar has already started Phase I clinical development in Europe for Zalypsis, where three multicenter studies in solid tumours or lymphoma are being carried out.
Zalypsis is related to the marine natural compounds Jorumycin ( from molluscs) and the family of Renieramycins (from sponges), and it binds to DNA and is cytotoxic.
The US 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 in the second quarter of 2006.
'This IND is another significant milestone for the company, being the third compound in clinical development in the US', said Isabel Lozano, ceo of PharmaMar.