Advitech Inc published promising results of its recently completed open clinical study for its product XP-828L, a new oral treatment for psoriasis. The results related to patients who have completed the initial eight-week phase of the open clinical study as well as an additional eight weeks of treatment in an extension phase (total of 112 days).

In a survey conducted in 2002 by the US National Psoriasis Foundation, 78 per cent of respondents with moderate-to-severe psoriasis indicated that they were not using the more aggressive therapies because of their ineffectiveness and their potential side effects. The market for psoriasis treatment is currently estimated at US $1 billion by various sources, a company release says.

"We are very pleased with the results of the study for XP-828L. These results show the potential of XP-828L in improving the condition of patients suffering from psoriasis without undesirable side effects," stated Renaud Beauchesne, president and CEO of Advitech. He added, "The results of the extension phase also suggest that XP-828L has a positive impact over a longer period of time. If the next and final clinical study proves to be as promising, XP-828L will represent a breakthrough in the treatment of this disease with its ability to be effective, user-friendly and affordable."

The initial open-label study was conducted by Dr. Yves Poulin, a leading dermatologist and psoriasis specialist who has participated as a principal investigator in more than 75 clinical studies on psoriasis. The objectives of the initial phase of the study were to evaluate the safety and efficacy of XP-828L in 11 adults suffering from mild to moderate psoriasis over an 8-week period. An extension study of an additional 8 weeks of treatment was also included in the protocol to assess the improvement in efficacy of XP-828L after the initial 8-week treatment, the release added.

Advitech is now in the final stages of preparing for the next clinical study which will involve a double-blind, placebo-controlled protocol and a larger experimental group. Results from this study should be available in the second quarter of 2005.

"Based on the results of this future study, we should have sufficient data to file with the FDA under the Dietary Supplement and Health Education Act (DSHEA) in the US and with Health Canada under the Regulations on Natural Health Products. The regulatory process for the approval of these products is much shorter than for drugs and if all continues to go well, we will launch the product at the beginning of 2006," Beauchesne concluded.

Advitech specializes in the development of bioactive products derived from milk proteins. Milk proteins are recognized as a significant source of peptides, growth factors and other bioactive complexes used in the development of treatments for immune system disorders.