Genesis defends latest psoriasis results

By Phil Boeyen, ShareChat Business News Editor

Friday 16th February 2001

Auckland-based biotech company Genesis (NZSE: GEN) is standing behind the results of its latest psoriasis drug treatment results despite a market backlash against the company's US partner, Corixa.

Although the latest results have shown further encouraging signs that the PVAC treatment works, the US market has marked down Corixa's stock around 25% for not delivering better results, and because of an analyst's downgrade.

Genesis too has taken a hit this morning, its shares falling more than 10% to $6.60 in early trading.

In the latest Phase II FDA-approved trial, which took place in the United States, 241 patients with moderate to severe psoriasis were treated with either a control or one of three different dosages of PVAC.

The trial looked at three factors: safety, dosage and efficacy - or how well the treatment works.

The market has taken issue with the efficacy results of the tests, which did not achieve statistically significant effectiveness.

However Genesis CEO, Dr Jim Watson, says in the 21 patients who had not had previous drug therapy for the skin disease, 43% showed a 50% or greater reduction in PASI score at the end of the trial.

The PASI score is an index that measures the area and severity of the disease on a patient.

"That 43% figure is a significant result in anyone's books" says Dr Watson.

He says it also supports the company's aim to get company's PVAC product approved as a 'first-line treatment' against psoriasis. That is, patients suffering from the disease would use PVAC before they try any other from of drug therapy.

Dr Watson says the company is also keen for the next trial to last longer than 12 weeks and will be asking for FDA approval for an extension.

"The latest results suggested that patients tended to improve the longer they were being treated, and we believe that more patients may have been found to reach either a 50% or 75% improvement in disease severity if the trials had gone for longer."

One explanation for today's tough downgrading of both Corixa and Genesis is the fact that an earlier Phase I/II open-label trial, performed in the Philippines, had shown such an encouraging preliminary result.

In that investigational study of around 20 moderate to severe psoriatic patients more than half of them demonstrated a greater than a 75% decrease in disease severity in the 52-week trial.

At stake for Genesis is a bite at what is a huge and lucrative market. In the US alone psoriasis affects around 2.6% of the population, with 150,000 to 260,000 new cases diagnosed each year.

Annual outpatient costs for treating the skin disease are currently estimated at approximately US$1.6 to US$3.2 billion.

Any US Food and Drug Administration approval for a PVAC treatment is some time away because a Phase III trial still needs to be done, which Dr Watson says will treat many more patients and be followed for a greater period of time.

"We have always targeted 2004 as a potential approval time-frame," he says.

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