QUEBEC CITY, November 9, 2004 – Advitech Inc. (TSX-V: AVI) a Canadian biotech company, has received final authorization from the Bureau of Product Review and Assessment (BPRA), part of the Natural Health Product Directorate (NHPD) at Health Canada, to begin its next clinical trial on XP-828L, the company’s new oral treatment for psoriasis. Last July, Advitech published positive results from an open clinical study on 11 patients who took XP-828L for a total of 112 days. The next clinical study will involve 84 patients in a multicentre, double-blind, placebo-controlled protocol, for a period of 112 days.
This next study will be led by Dr. Yves Poulin, MD, a leading dermatologist and psoriasis specialist who has participated as a principal investigator in more than 65 clinical studies. The objectives of this milestone study are to confirm the early results obtained during the open study conducted last summer and to determine whether the efficacy of XP-828L is dose-dependent. Dr. Robert Bissonnette, MD, a dermatologist, will also participate as co-lead investigator of this study.
“This is a significant milestone for Advitech,” stated M. Renaud Beauchesne, President and CEO of Advitech. “This next clinical study will allow us to confirm our previous results and move on to preparing for the commercial introduction of XP-828L to psoriasis patients. We are expecting the results of this study during Q2-2005 after which we will finalize the filing with the FDA and Health Canada in order to launch the product at the beginning of 2006. There is an unmet demand for an efficient and safe oral treatment for patients suffering from light to moderate psoriasis. XP-828L will fill an important gap, either used alone or in combination with other therapies.”
Advitech specializes in the development of bioactive products derived from whey proteins. Whey proteins are recognized as a significant source of growth factors and other active molecules which play a significant role in the management of immune system disorders.
Psoriasis is an immune system disorder which affects between 2-3% of the global population and more than 6 million adults in North America alone. All existing systemic therapies for psoriasis have significant side effects which limit their long-term use. In a survey conducted in 2002 by the U.S. National Psoriasis Foundation, 78% of respondents with moderate-to-severe psoriasis indicated that they were not using the more aggressive therapies available because of their ineffectiveness and their potential side effects. Various sources estimate the current market for psoriasis treatment at $1B US.
The study protocol will involve 2 groups: a placebo group and a second group, which will receive a single dose of XP-828L for a period of 56 days. During the second phase of the double-blind study, the placebo group will be administered a double dose of XP-828L while the second group will remain on the initial single dose of XP-828L.
Advitech specializes in the development of bioactive products derived from dairy proteins. Its key focus areas are in the fields of immunology and inflammatory processes. Its main platform, XP-828L, is a bioactive complex used in the development of an oral treatment for psoriasis and other immune system disorders. Advitech’s common shares are listed on the TSX Venture Exchange under the symbol AVI. The number of common shares outstanding is 54,799,818. -30- This press release contains forward-looking statements which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward- looking statements. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.