LONDON, Aug. 17, 2005 (PRIMEZONE) -- Cancer drug developer Antisoma (LSE:ASM) has received notification from the U.S. Food and Drug Administration (FDA) that its aptamer drug AS1411 has been granted Orphan Drug Designation in the U.S. for the treatment of renal cancer. This provides Antisoma with a seven-year period of market exclusivity if AS1411 gains marketing approval for the treatment of renal cancer in the U.S. AS1411 already has Orphan Drug Designation in the U.S. for the treatment of pancreatic cancer.
Promising signs of activity against renal cancer were reported in a phase I trial of AS1411 presented at this year's meeting of the American Society of Clinical Oncology (ASCO). Antisoma expects to reopen this trial shortly.
Antisoma's CEO Glyn Edwards said: "The grant of orphan drug status for AS1411 in renal cancer is a further boost to our development programme, strengthening our commercial position in an indication where the drug has shown very promising first results in clinical trials."
Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company's clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management's current expectations, but actual results may differ materially.
Notes to Editors
Orphan Drug Designation
The U.S. Orphan Drug Act was introduced to stimulate the development of drugs that treat conditions affecting fewer than a defined number of patients by providing additional incentives to developers of such drugs. One of the most valuable of these incentives is a seven-year period of market exclusivity once the drug is approved for marketing in the U.S.
AS1411
AS1411 is an aptamer, an oligonucleotide that can fold into a stable, three-dimensional structure capable of interacting with a particular target protein. AS1411 binds to the protein nucleolin, which is found on the surface of cancer cells. It is then internalised and has been shown to kill cancer cells in a range of models. Promising signs of anticancer activity were reported at ASCO 2005 from a phase I clinical trial in patients with various cancers conducted at the Brown Cancer Center, Louisville, Kentucky.
Background on Antisoma
Based in London, U.K., Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. Antisoma fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. In 2002, Antisoma formed a broad strategic alliance with Roche to develop and commercialise products from Antisoma's pipeline. Please visit www.antisoma.com for further information about Antisoma.