Zeltia’s hopes of getting a second cancer compound to market after Yondelis has been boosted by the news that US regulators have given the thumbs-up to the production process of Aplidin.
The US Food and Drug Administration has accepted the proposal made by the Spanish firm’s PharmaMar unit for the production process of Aplidin (plitidepsin), a novel anti-tumour agent which the company says leads to “a rapid and persistent induction of apoptosis, inhibits secretion of vascular endothelial growth factor 1 and blocks the cell cycle”.
Aplidin is being evaluated in preclinical studies and Phase II trials in solid tumours and haematological malignancies, including paediatric tumours in Europe and the USA. Data have shown antitumour activity in multiple myeloma, renal cancer and aggressive lymphomas and PharmaMar said the compound has been in studies in combination with other antitumour agents since late 2005 as the basis for possible Phase III trials.
Zeltia says it is in advanced talks to licence Aplidin in the USA and the rest of the world, with the exception of Europe, where it will hopefully market the drug itself. The Madrid-based group is expected to look for a deal that mirrors its agreement with Johnson & Johnson on Yondelis (trabectedin) which was approved a year ago by the European Commission for the treatment of soft tissue sarcoma.
PharmaMar recently announced plans to submit data on the use of Yondelis against ovarian cancer from a Phase III trial. US partner J&J’s Ortho-Biotech will make a regulatory filing in the USA for the drug in the new indication in the last quarter of the year, and Zeltia will do likewise in Europe at the same time.
The news on Aplidin comes days after Zeltia presented promising early-stage data on two new marine-based compounds, Zalypsis and Irvalec. The former is being investigated in solid tumours, while Irvalec is being studied against a broad spectrum of tumor types, including breast, colon, pancreas, lung and prostate cancer.
