More than 6 million adults in North America suffer from psoriasis, an immune system disorder, but until now those with mild to medium forms of the condition have had to resort to topical therapies or aggressive drug treatments with significant side effects.
The 112-day study conducted by dermatologists Dr Robert Bissonnette and Dr Yves Poulin involved 84 patients, none of whom reported serious adverse effects associated with the product.
In the first 56-day phase, one group of patients received 5g of XP828L a day and the other group received a placebo. The effects were measured using the Physician's Global Assessment (PGA), which rates the severity of a disease.
Analysis of the results showed that the condition in 21.4 percent of the patients in the XP-828L group improved by at least one level on the PGA scale.
The second 56-day phase looked at the effects of 10g of XP-828L per day for 56 days and the effects of continuing the original, 5g per day dose for an additional 56 days.
The dermatologists found that the higher dose did not yield superior results, and that patients continuing with the 5g per day dose maintained the improvement seen in the first 56 days, but did not improve beyond that.
The new study confirms the results of a 2004 open study on 11 patients.
"I am extremely pleased with the results of this randomized study because they confirm that XP-828L, a natural product with an outstanding safety profile, reduces cutaneous psoriasis effectively," said Patrice Poubelle, chairman of Advitech's scientific advisory committee.
President and CEO Renaud Beauchesne said: "We believe that XP-828L is now uniquely positioned to meet a major demand for a safe, convenient and effective treatment for patients affected by mild-to-moderate psoriasis."
In May Beauchesne told NutraIngredients-USA.com that XP-828L is expected to make its debut as a dietary supplement ingredient in 2006. Now that its safety and efficacy have been ascertained, it remains for Advitech to find a suitable marketing partner.
The company acquired the exclusive rights to the technology behind XP-828L in 2003, when it entered into an agreement with French firm Pierre Jouan Biotechnologie. Originally it hoped to roll out the product by the end of 2004, but decided to delay whilst it carried out the clinical trial program in order to give it weight with dermatologists as well as natural products suppliers.
It stands to gain a lot from marketing the product, given that the market for psoriasis treatment has been estimated to be worth around US$1 billion. A 2002 survey by the US National Psoriasis Foundation found that 78 percent of sufferers steered clear of the more aggressive therapies because of the potential side effects.
Advitech recently announced that the Canadian government is contributing C$610,000 - half the total budget - towards a three-year research project at Université Laval to identify new applications for XP-828L and potential alternative sources besides sweet whey, such as bovine colostrum.
It is believed that the product may prove useful in the management of other chronic inflammatory diseases such as Crohn's disease, ulcerative colitis and arthritis.