Psoriasis drug past key trials

By MONIQUE DEVEREUX health writer

Genesis Research and Development is one step closer to releasing on the world market a new treatment for a disfiguring skin disease.

The Auckland company yesterday announced successful trial results in phase two of the three-stage US Food and Drug Administration process for approving new drugs. The company expects FDA approval to begin phase three trials this year.

Genesis, which this month posted a small December-year profit of $723,000, has been researching a new psoriasis treatment for five years.

It is the first New Zealand company researching a drug from scratch to proceed this far through the FDA process.

Psoriasis affects around 3 per cent of the world's population, including about 100,000 New Zealanders.

Yesterday, chief executive Jim Watson said the progress of the drug, PVAC, was "absolutely fantastic."

The phase two clinical trials involved 241 US patients divided into four groups: a control group, who were not given the treatment; another group, given a very low dose of 2mg, another given a medium dose (15mg) and the fourth, given a very high dose (50mg).

In the phase one trials, Genesis had established that 15mg was an effective dosage, and the US trials confirmed that, Dr Watson said.

The latest results also highlighted the safety levels of the drug.

None of the patients suffered moderate or severe reactions, although some had a small reaction to the initial injection.

The trials also established that people who had not had any previous treatments responded best to PVAC.

Current treatments were prone to suppressing the immune system and Dr Watson likened their effects to "using Roundup on your lawn."

He said this meant Genesis would eventually market the PVAC vaccine as a "first line therapeutic," and he hoped it would become the world's drug of choice for psoriasis treatment.

The US patients treated had suffered psoriasis on average for 18 years. Dr Watson said the vaccine was effective in people despite their age, sex or race, and because of this - and the relatively low dosage needed - it might later be developed further for use as a treatment for children suffering the disfiguring skin disease.

Genesis was originally looking into tuberculosis treatments using patients in the Philippines before it switched tack to concentrate on psoriasis.

During the TB studies, it became apparent that compounds of the drug were helping to clear psoriasis in other patients.

The third phase of the FDA approval process will mean further tests on a larger number of people.

If the drug is approved after that stage, a new drug application will be submitted to the FDA to allow Genesis to market it.

Dr Watson said it might be up to four years before the drug was on the market, but that was ahead of most of its competitors.

He believed that the Genesis vaccine had financial advantages over its rivals - it was cheaper to produce, the market was large and US distribution channels were already set up.

Genesis shares closed 20c up at $7.35 yesterday.