BioWorld International Correspondent

SYDNEY, Australia - BresaGen Ltd. is suing a government research organization for an amount greater than A$7 million (US$4.8 million), alleging it was misled over test results for an anticancer drug.

BresaGen, of Adelaide, has started an action in the Supreme Court of the state of South Australia against the Institute of Medical and Veterinary Science and its commercialization arm, Medvet Science Pty Ltd., both based in Adelaide, along with IMVS employee Angel Lopez. All were involved in the original research for the cancer drug E21R.

The company said it decided to sue after British Biotech, of Oxford, UK, was unable to repeat certain published preclinical data concerning the ability of the drug to kill acute myeloid leukemia (AML) cells, supplied by IMVS, Medvet and Lopez. Those parties licensed E21R to BresaGen.

BresaGen and British Biotech ended a collaborative development agreement involving E21R in July of last year after unfavorable results from clinical trials held in England.

In a statement, the IMVS has dismissed the claims against itself and Lopez, saying that it was always "open and honest" about the tests conducted in Lopez's laboratory in 1994 by a visiting fellow from the Norwegian Cancer Society, Per Iverson.

IMVS Director Barrie Vernon-Roberts said that 50 samples were screened for suitability and 21 eventually were used in the test. At the time Iverson emphasized the fact that although apoptosis occurred to some extent in 21 samples, not all cells in each sample had shown that response.

"BresaGen now claims to be unaware that the 21 samples had been selected for testing after screening about 50 for suitability," Vernon-Roberts said.

He said IMVS scientists were surprised when BresaGen later claimed that it had assumed that E21R would be likely to induce significant apoptosis in a large majority, if not all, AML patients.

BresaGen Medical Director Christopher Juttner said that the company "has tried to find a way to settle this dispute without litigation but now feels that it has no choice but to pursue the matter through the courts."

He said direct costs alone for this project are in the order of $7 million, but the company will be seeking additional costs that have not yet been quantified.

A complex civil matter such as this may take many months, if not years, to reach a court hearing.