Positive result for Genesis treatment

By Phil Boeyen, ShareChat Business News Editor

Thursday 15th February 2001

Genesis Research and Development (NZSE: GEN) appears well on track to success with its PVAC psoriasis treatment following the latest trial results.

The results of a United States study have backed up earlier findings in the Philippines of the product's ability to treat the chronic skin disease, which affects more than 7 million people in the US alone.

The chairman and CEO of Genesis' US partner Corixa, Steven Gillis, says the latest results are encouraging.

"Based on the preliminary data disclosed today, we are quite encouraged that PVAC treatment continues to demonstrate clinical benefit in a controlled setting.

"Given the speed with which the current study was accrued and completed, we are hoping to construct a statistical plan very shortly for the next study that the FDA may consider supportive for product registration.

"In the interim, we will gather additional data from an on-going 180 patient, randomized study in Brazil," he says.

Genesis chief executive, Jim Watson, says the company is heartened by the consistent safety profile displayed by the treatment, and the strong parallels in the dose regimen and efficacy that have come from the Philippines and US Phase II studies.

"If our ongoing and further studies continue to show strong efficacy results, we believe PVAC has every prospect of being an excellent first-line therapeutic for psoriasis."

The Phase II PVAC treatment study in the USA covered 241 patients and was completed in August last year.

One of the interesting factors in the US trial is that a number of the moderate and severe psoriasis patients had been suffering from the disease for 18 or more years, while in the Philippines trial most patients had only had the disease for three years.

Jonah Shacknai, chairman and chief executive officer of Medicis, which has the US license for the treatment, says the latest trials have helped to improve the understanding of the right amount of dosing of PVAC.

"We believe PVAC demonstrated an impressive effect on some of the toughest psoriasis cases, with a clear reinforcement of the agent's attractive safety profile.

"If further trials continue to show strong efficacy and safety results, we believe that we that will have an excellent commercial platform for PVAC."

Genesis last month announced a profit for the year to the end of December of $723,00, well above the $9.97 million loss forecast in its prospectus.

The profit result came from a jump in operating income, which grew four-fold from the previous year to $28 million thanks to upfront licensing revenue for the psoriasis treatment.

The treatment has been licensed in the US and Japan and further licensees in Europe and elsewhere are being sought.

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