LONDON ¿ Ark Therapeutics Ltd. raised #14.5 million (US$21 million) in its third financing round, increasing cash reserves to #25 million, sufficient to fund the company into 2003 and enable it to carry out pivotal trials of its three lead products.

Chief Financial Officer Martyn Williams told BioWorld International, ¿This gives us two years [of] money and within that time we have a number of critical milestones we can now devote our energies to meeting.¿

The money raised is at the top end of the range. ¿We agreed with the existing investors that they would follow on,¿ he said. ¿As a result we only went out to a targeted group of new investors who responded positively.¿ The fund raising was led by BankInvest, of Denmark. The existing investors are Merlin Biosciences, Nomura International, Biofund and TVM.

Ark, based in London, raised #3 million when it was founded in 1997 and #15 million in April 2000. In January 2001 the company took over OY Quattrogene Ltd., of Kuopio, Finland, in an all-share deal and at the same time changed its name from Eurogene Ltd. to Ark.

The company also announced it was awarded a EUR1.2 million grant by the European Commission for further research on its Scavidin family of drug-targeting genes.

Ark is developing a range of gene therapeutics. Its lead product, EG009 for the treatment of malignant glioma, is in a Phase IIb trial in 60 patients in Finland, with results expected around the end of the year.

¿Internally we are extremely happy with our progress, though we are not in a position to release any data at present,¿ Williams said. Given that there are few other treatments for glioma, the company may decide to apply for approval on the basis of this trial.

EG009 consists of a herpes simplex vector carrying a gene for the enzyme thymidine kinase that is injected into the brain following removal of the glioma. The enzyme converts intravenously administered ganciclovir into a toxic nucleotide analogue, which blocks DNA replication and kills the cells if they try to divide. Healthy neurons rarely divide, and thus are not affected. Survival time was doubled in the Phase I/II trial in 21 patients.

Ark also is planning a Phase II/III trial in the U.S. of Trinam (EG004) for the prevention of intimal hyperplasia (the overgrowth of smooth muscle cells) after vascular surgery. Trinam, a biodegradable collar device fitted at the time of surgery, locally delivers a gene for vascular endothelial growth factor. This increases the production of nitric oxide in the endothelium, inhibiting smooth muscle proliferation. The product has FDA orphan drug status.

A third product, EG006, for the treatment of cancer cachexia, is expected to start a Phase II/III trial in the U.S. next month. It uses an existing, registered agent in a new indication.

Ark said the money raised would also enable it to build a targeted sales infrastructure for the commercialization of its products.