FDA grants IND for Aplidin® to enter Phase II trials in US
22 June 2004
PharmaMar announces today that an Investigational New Drug application (IND)
has been accepted by the US Food and Drug Administration (FDA) for the clinical
testing of Aplidin. This IND allows the start of Phase II clinical studies
in the US. Phase I clinical trials with Aplidin have been completed in Europe
and Canada.
The IND has been granted on the basis of satisfying FDA criteria regarding
preclinical data, chemistry, manufacturing and safety data from the completed
and ongoing clinical studies. Initially, two Phase II trials will run under
this IND, one in patients with multiple myeloma (EU and US), another in prostate
cancer patients (US).
Aplidin is already in clinical development in Europe and Canada for the treatment
of solid tumours, haematological malignancies and paediatric tumours. Phase
II trials are ongoing for melanoma, colorectal, renal, lung (NSCLC and SCLC),
medullary thyroid, head and neck and pancreatic carcinomas. Aplidin is also
in Phase I in paediatric trials for solid and haematological tumours.
Commenting on the IND, Isabel Lozano, PharmaMar CEO, said: “This IND is a
significant milestone for the company. It is very satisfying to have a second
compound in clinical development in the US.”
About Aplidin®
Aplidin* is a novel antitumour agent derived from the marine tunicate Aplidium
albicans. It induces rapid and persistent activation of apoptosis combined
with blocking of cell division in the G1/G2 phase of the cell cycle in tumour
cells. It also inhibits the secretion of vascular endothelial growth factor
(VEGF), a crucial protein involved in the vascularization and growth of a
number of tumours, and the expression of the VEGF receptor 1 (VEGFR1).
*Aplidin® is a PharmaMar registered trademark.
PharmaMar
PharmaMar is a biopharmaceutical company, advancing cancer care through the
discovery and development of innovative marine-derived medicines. PharmaMar’s
clinical portfolio currently includes YondelisTM in phase II clinical trials
(co-developed with Johnson & Johnson Pharmaceutical Research & Development),
designated Orphan Drug for STS by the EMEA in 2001 and Orphan Drug for ovarian
cancer in 2003; Aplidin®, in phase II, designated Orphan Drug for acute lymphoblastic
leukaemia in 2003; Kahalalide F in phase II and ES-285 in phase I clinical
trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish
stock exchange: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC). PharmaMar can
be found on the Web at http://www.pharmamar.com
For more information, please contact:
Lola Casals
PharmaMar
Tel: + 34 91 846 6000
Francetta Carr
Financial Dynamics
Tel: + 44 (0)20 7831 3113