QUEBEC CITY, Quebec, Aug 31, 2004 (BUSINESS WIRE) -- Advitech Inc. (TSX VENTURE:AVI) published today promising results of its recently completed open clinical study for its product XP-828L, a new oral treatment for psoriasis. The results relate to patients who have completed the initial eight-week (56-day) phase of the open clinical study as well as an additional eight weeks of treatment in an extension phase (total of 112 days). Results of the initial phase were first presented in May 2004.
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.
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. There is no effective long-term therapy for this chronic disease. All existing therapies 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 because of their ineffectiveness and their potential side effects. The market for psoriasis treatment is currently estimated at US $1 billion by various sources.
"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," said Renaud Beauchesne, President and CEO of Advitech. "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 (56-day) 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 patients were not allowed to use any other treatment during the study nor for the period preceding it (2 weeks for topical agents and 4 weeks for systemic drugs).
Final Clinical Study to be Completed in 2005
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 U.S. 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," Mr. Beauchesne concluded.
Efficacy of XP-828L
The main criteria for measuring the efficacy of XP-828L was the PASI score (Psoriasis Area and Severity Index). PASI score is a scientifically recognized measure of the severity and symptoms of psoriasis.
Eleven (11) patients were recruited and completed the initial 8-week phase of the open-label study. The following results were reported on May 25, 2004:
-- PASI scores started to improve after one month of treatment;
-- At day 28, 64% of the patients (6 of 11) showed a reduction in their PASI score relative to their baseline PASI score at day 1;
-- At the end of the 8-week period, 7 of the 11 patients showed improvements in their PASI scores ranging from 9.5% to 81.3%.
Eight (8) out of 11 patients agreed to participate in the 8-week extension phase. The remaining 3 patients refused for personal reasons unrelated to the study itself. One patient included in the extension study did not complete this phase due to a planned surgical procedure (exclusion criteria). A total of 7 patients completed the extension phase.
-- At day 84, 5 patients out of 7 showed improvements in their PASI score ranging from 6.7% to 71.6% relative to their baseline score;
-- At the end of the extension phase, (i.e. after 112 days of treatment), PASI score improvement for the same patients ranged from 6.7% to 78.4%;
-- Therefore, in the extension study, PASI scores further improved for 4 out of 7 patients.
Two patients reached PASI-75; one after 56 days of treatment and the other after 112 days of treatment.
Safety of XP-828L
Safety controls included blood tests for haematology and biochemistry. No clinically significant adverse reactions or laboratory abnormalities were observed during the XP-828L treatment. The product was considered to be safe.
Advitech specializes in the development of bioactive products derived from milk 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. Psoriasis affects between 2-3% of the global population and more than 6 million adults in North America alone. Advitech has 15 employees, with more than half of them engaged in research and development activities at its facility at Universite Laval in Quebec City.
Advitech's common shares are listed on the TSX Venture exchange under the symbol AVI. The number of common shares outstanding is 54,723,627.
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 Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.