Advitech Solutions Reports Positive Interim Results on Novel Compound For Psoriasis
QUEBEC, QUEBEC – MAY 26, 2004 - Advitech Solutions has published today interim results for its on-going open label clinical study for a psoriasis treatment based on its XP-828L product.
The open label clinical study is being conducted by Dr. Yves Poulin, a leading dermatologist who has participated as principal investigator in more than 50 clinical studies on psoriasis. The main objectives of the study are to determine the safety and efficacy of the XP-828L, an oral treatment for psoriasis.
11 patients were recruited for an initial 8-week study, and 8 out of the 11 have accepted to continue for an 8-week extension period. The main inclusion criteria for the selection of patients were the following: subjects had to be a minimum of 18 years of age with chronic stable psoriasis covering at least 2% of their body surface. A 2-week wash-out period for topical agents and a 4-week wash-out period for systemic drugs were part of the inclusion criteria. Patients were not allowed to use any other treatments during the study. Pictures were also taken.
Four criteria are being used to measure the efficacy of the XP-828L on the treatment of psoriasis: the PASI score (Psoriasis Area and Severity Index), the Physician global assessment, the Patient’s global assessment and patient’s assessment of pruritus. Safety measures include blood tests for haematology, kidney and liver functions.
All 11 patients have completed the initial 8-week study. The investigator has communicated to Advitech the following results:
- 7 patients on 11 (or 64%) have shown a reduction in their PASI score compared with their baseline PASI score at day 1; 3 have remained stable and the PASI score has increased for 1 patient.
- The reduction in PASI score expressed in percentage terms varies from 9.5% to 81.3%.
- Safety data collected for all patients have shown no adverse reactions related to the use of the XP-828L product.
“While these results are still preliminary, I am very pleased that they are consistent with our earlier findings about the safety and effectiveness of the XP-828L product,” stated Renaud Beauchesne, President and CEO of Advitech. “We believe the treatment of psoriasis represents a significant market opportunity for any company able to provide an effective, but also a safe solution. The results of this study will help us in positioning the XP-828L as both a safe and effective solution for treating psoriasis”.
The full results of this study will be presented at the 10th International Psoriasis Symposium to be held in Toronto, Canada, on June 10-13, 2004, and information about the results will be posted on the website of the Symposium at www.sdefderm.com.
Psoriasis is a common immune-mediated chronic skin disease that comes in different forms and varying levels of severity. Most researchers now conclude that it is an auto immune disorder. This disease affects between 5 to 6 million adults in the United States, and its prevalence in other countries can reach between 2-3% of the total population. The market for psoriasis treatments in the United States alone is estimated at $US1.0 billion in 2005 according to a research report published in March 2003 by Script Report (“Skin Disorders, New Horizons for Psoriasis Management”, Script Report, March 2003).
About Advitech Solutions Inc.
Advitech is involved in the research, development and marketing of nutraceutical technologies and products. Advitech is a recognized leader in the area of bioactive peptides derived from milk proteins. Its key focus areas are in the fields of immunology and inflammatory processes. The company has 15 employees, with more than half of its staff engaged in research and development activities at its facility at Université Laval in Quebec City.
In May 2003, Advitech entered into a license agreement with Pierre Jouan Biotechnology SA, a French biotech company. Under this agreement, Advitech has the right to use Jouan’s patent-pending compound and process for the development of therapeutic applications for psoriasis and other similar auto-immune health conditions like inflammatory bowel diseases (IBD) and Crohn’s disease. This agreement also gives Advitech exclusive commercial rights to these applications for many worldwide markets, including North America.