Advitech Announces Promising Results From Open Clinical Study On New Oral Psoriasis Treatment.QUEBEC CITY, Quebec -- Advitech Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension VENTURE:AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. ) 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 bi·o·ac·tive adj. Of or relating to a substance that has an effect on living tissue. bioactive having an effect on or eliciting a response from living tissue. 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 immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. 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 North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. alone. There is no effective long-term therapy for this chronic disease. All existing therapies have significant side effects Side effects Effects of a proposed project on other parts of the firm. which limit their long-term use. In a survey conducted in 2002 by the U.S. National Psoriasis Foundation The National Psoriasis Foundation is a patient-driven, non-profit US-based psoriasis education and advocacy group. The National Psoriasis Foundation's mission is to improve the quality of life of the millions of Americans with psoriasis and/or psoriatic arthritis by promoting , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. under the Dietary Supplement Noun 1. dietary supplement - something added to complete a diet or to make up for a dietary deficiency diet - a prescribed selection of foods vitamin pill - a pill containing one or more vitamins; taken as a dietary supplement and Health Education Act (DSHEA DSHEA Dietary Supplement Health and Education Act of 1994 (US legislation) ) 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. Clinical Results Efficacy of XP-828L The main criteria for measuring the efficacy of XP-828L was the PASI PASI Psoriasis Area and Severity Index PASI Public Authority for Social Insurance PASI Pan American Studies Institute PASI Professional Account Services Inc. PASI Production, Availability, Shipments, Inventory PASI Pioneer Air Systems, Inc. score (Psoriasis Area and Severity Index). PASI score is a scientifically recognized measure of the severity and symptoms of psoriasis. Initial phase 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%. Extension phase 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 exclusion criteria AIDS Donor exclusion criteria, see there ). 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 adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. or laboratory abnormalities were observed during the XP-828L treatment. The product was considered to be safe. About Advitech 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 TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. 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. |
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