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FDA Allows Phase 2 Trials of Aplidin To Begin

MADRID, Spain--(BUSINESS WIRE)--June 22, 2004--PharmaMar announces today that an Investigational New Drug application (IND)(1) has been accepted by the U.S. Food and Drug Administration (FDA) for the clinical testing of Aplidin(R). This IND allows the start of Phase II clinical studies in the U.S. 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 U.S.), another in prostate cancer patients (U.S.).

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 U.S."

About Aplidin(R)
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(R) is a PharmaMar registered trademark.

Source: PharmaMar

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