Ark To File For Exceptional Approval Of Cerepro Gene Therapy

LONDON (Agence de Presse Medicale for Reuters Health) - Ark Therapeutics is to ask European regulators in the first half of this year to consider granting exceptional approval of its gene therapy product Cerepro for malignant glioma, the UK biotech company said on Monday.

Chief executive officer Dr Nigel Parker said that although the company had not yet started phase III trials, two phase II studies showed that the treatment doubled survival time to around 15 months.

Marketing approvals under exceptional circumstances can be granted in the EU pending phase III trial results if a product shows great promise and there are no other effective therapies, he told APM following a company trading statement.

Cerepro, which has orphan drug status in the EU and the United States, uses a viral vector to introduce the gene that causes cells to express thymidine kinase.

Following standard surgery to remove the solid tumour mass, it is injected through the wall of the cavity left behind by the surgical removal of the solid tumour into the surrounding healthy brain tissue.

In the following days, the healthy cells in the wall of the cavity express thymidine kinase. Five days after surgery, ganciclovir is given and the two agents react together to produce a substance which destroys rapidly dividing cells.

In its trading statement, Ark said its balance sheet remains strong, with approximately 47 million pounds cash at the end of the year.

(one pound = 1.43 euros)

MeSH Headings: Biological Therapy : Genetic Engineering : Genetic Techniques : Investigative Techniques : Therapeutics : Gene Therapy : Analytical, Diagnostic and Therapeutic Techniques and Equipment