Bresagen sues IMVS for $7million

Following aborted preclinical trials in the UK, Bresagen is to institute proceedings against pathology agency IMVS (Institute of Medical and Veterinary Science) and others involved in initial trials on potential anti-cancer compound E21R.

According to Bresagen medical director Chris Juttner, Bresagen’s partner British Biotech was unable to duplicate preclinical trial results published by IMVS, its IP development subsidiary Medvet, and professor Angel Lopez of the Hanson Centre for Cancer Research.

As a result of the UK trial results, which Bresagen claims raised concerns about E21R-induced cell killing or apoptosis in acute myeloid leukaemia (AML), BresaGen terminated its collaborative E21R development agreement with British Biotech.

“We have issued proceedings and the matter is now before the courts,” said Juttner, who refused to comment further on the case.

However, IMVS director professor Barrie Vernon-Roberts said the IMVS and Prof Lopez had always been “open and honest” about E21R.

“Studies of the effects of E21R on leukaemic cells were conducted at the Institute, beginning in 1994 in Lopez’ laboratory, and at that time we found that E21R induced apoptosis – programmed cell death – in some acute myeloid leukemia (AML) cells,” he asserted.

Prof Vernon-Roberts claimed that while apoptosis occurred to some extent in all 21 samples, not all cells in each sample had shown that response.

“I have absolute faith in the integrity of the scientists involved in this research and I want to put this dispute behind us,” said Vernon-Roberts. Professor Lopez declined to comment on the case other than to deny the allegations he said were made by Bresagen.

IMVS claims Bresagen was informed of a small repeat study which showed that apoptosis did not occur in all patients’ cells, and that it was: “was amazed when BresaGen later claimed that they had assumed E21R would be likely to induce significant apoptosis in a large majority, if not all, AML patients but not with others”.

Bresagen, which was offered a $2.9 million R&D Start grant to assist development of the drug, is claiming direct costs of around $7 million but will also seek additional costs which have not yet been fully quantified, noted Juttner.

He said the future of the drug itself was not yet certain, but indicated there was the possibility of further development.

“We are still looking at (E21R),” he said. “If you ask us if it is dead, then the answer is no,” he added, although he was reluctant to offer any new data on the compound.

Bresagen’s pre-prepared release claimed the company had tried to find a way of settling the dispute with IMVS without litigation, but now felt it had no choice but to pursue the matter through the courts. “We are seeking financial recompense and want to resolve this matter as soon as possible, but we know the civil courts tend to be slow,” warned Juttner.