ghp July 2015 pdf

10 | ghp July 2015 Trial Results Show New Treatment Could Rival Preparation-H Peritech’s PP-110 product granted US patent for composition and methods of treatment following positive pivotal trial results. The product is a novel over-the-counter anti-haemor- rhoidal product. PP-110 was found to be effective in treating haemorrhoids and superior to conventional treatment. The results were published on-line in Molecular and Cellular Therapies. The randomized, open label study compared the safety and efficacy of PP-110, with the US golden standard, Preparation-H Maximum Strength Cream, in the treatment of grade two to three haemorrhoids. Over 100 patients participated in the 14 day study that was conducted in seven sites by a team of physicians headed by Professor Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel. PP-110 (in gel and wipes form) was provided to some patients once daily, while other patients received Preparation-H Extra Strength according to label instructions (i.e. three to four times per day). Patients receiving PP-110 gel reported statistically significant better results in the three most prevalent clinical parameters relating to common symptoms of haemor- rhoids, namely pain, bleeding and itching, compared to patients treated with the Preparation-H. The head of the trial, Prof. Ehud Klein, made it clear that the results of the trial were exciting. ‘The pivotal trial results are very encouraging and exceed our expectations. We found that the unique formulation of PP-110 provides a long lasting effect, and were extremely pleased to see that even once-dai- ly application is sufficient, which offers patients a true improvement over current topical treatment.’ Peritech has received a U.S. Patent No. 9,072,747 from the United States Patent and Trademark Office, which includes claims protecting the use of PP-110’s compositions and methods of treatment for anorectal disorders. The granted patent has a term extending to March 2034. Dr. Eran Eilat, CEO of Peritech Pharma Ltd comment- ed on the results. ‘Our novel film-based formulation provides a slow-release mechanism, and as a consequence, a prolonged therapeutic window. We are very pleased with the pivotal trial results that clearly demonstrate the benefits our product offers hemorrhoid patients. Together with the recently granted US patent, and under the monograph regulatory track, PP-110 is ready to be marketed and is now well positioned to revolutionize the hemorrhoids OTC market, especially in the United States.’ news