Pharmalink Reports Positive Phase III Results for Xepol, a Treatment for Post-Polio Syndrome
STOCKHOLM, SWEDEN, August 26, 2008 - Pharmalink AB today announces positive results from a follow-on Phase III study of Xepol®, its candidate for the treatment of post-polio syndrome (PPS). The data have shown the candidate to be effective and well tolerated with no serious adverse events attributed to the product being reported in the treated patients.
The Phase III study, involving 142 patients, is a placebo controlled, double blind trial designed to evaluate the efficacy and safety of Xepol® in PPS, a neurological pain and weakness syndrome in patients that have survived poliovirus infection. The original placebo controlled, double blind Phase III trial was six months (Gonzalez et al (2006) Lancet Neurology 5:493-500) and this follow-up period was another six months.
The follow-on results strengthen the position of this novel treatment modality for PPS by demonstrating a reduction of inflammatory cytokines in the cerebrospinal fluid and a significant reduction of symptoms of PPS while also showing that Xepol® is safe and well tolerated with few or no side-effects. Endpoints studied were pain, walking ability and SF-36 scores (a common self assessment scoring system that measures physical and psychological variables). All showed significant and clinically meaningful results. Full results are to be published in a peer review journal.
Xepol®, the first medical PPS treatment , is an injectable biologic product, administered once per 9-12 months, which down-regulates the inflammatory process in the nervous system of PPS patients. The concept and medical hypothesis was first developed by Dr Henrik Gonzalez and Professor Kristian Borg, scientists at the Karolinska Institute (Sweden). Pharmalink licensed the invention and is now working to bring the candidate towards registration.
"We are very encouraged by the outcome of the follow-up analysis as it is clear from the results that Xepol brings relief from pain and muscle weakness to PPS patients," said Johan Häggblad, Managing Director of Pharmalink. "We are very excited about this data as currently there is no medical treatment for PPS and patients in the treated group have experienced a reduction in disease symptoms after just 12 months."
"It is very rewarding to see that Xepol is demonstrating efficacy and the potential to help PPS patients,"said inventor and principal investigator Professor Kristian Borg. "We are looking forward to expanding the Xepol treatment procedure following product registration."
Pharmalink is actively seeking a partner to bring Xepol® to the market. More than 1000 PPS patients have been treated with the drug and many return on an annual basis for new treatment courses. Xepol® has already achieved Orphan Drug Designation in the US and is patented in the major markets.
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Pharmalink AB is a privately held Swedish specialty pharma company that develops proprietary pharmaceutical products in fields of unmet medical need. Pharmalink has adopted a reformulation/repurposing strategy and has a vast international network of physicians, biotech companies, CMO:s,CRO:s and specialist consultants. Pharmalink has a track record of introducing more than 15 pharmaceutical products to market. Pharmalink currently carries three clinical phase development projects, Nefecon®, Xepol® and Busulipo_, mature for out-licensing to a commercial partner and also seeks to refill its development pipeline by inlicensing. Xepol® is registered trademark of Pharmalink in Europe, US and certain other jurisdictions.
Posted: August 2008