Ventrus BioSciences (VTUS) Publishes Prior Phase 2b Study on the Safety and Efficacy of Iferanserin
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Ventrus BioSciences, Inc. (Nasdaq: VTUS), today announced the online publication of the prior Phase 2b study utilizing iferanserin (VEN 309), its novel investigational drug for the treatment of symptomatic hemorrhoids, in the peer reviewed journal Clinical Therapeutics. The article will appear in the February issue of Clinical Therapeutics and is currently available online at the following link http://www.sciencedirect.com/science/journal/aip/01492918. Data from this trial have been previously disclosed by the company.
The double-blind, placebo-controlled study, conducted between September 2001 and August 2002, randomized 121 patients at five colorectal surgery sites in Germany. The principal investigator and lead author of the paper is Prof. Dr. Alexander Herold of Mannheim, Germany. Compared with placebo, iferanserin significantly reduced patient-reported severity of daily bleeding beginning at day 1 and itching beginning at day 2 (P < 0.05). The effects were sustained throughout the 14-day treatment period. There was also a reduction in patient-reported severity of daily pain seen with iferanserin treatment. Adverse events were mild and infrequent and did not differ significantly between treatment groups.
The paper also presents the results from a post hoc analysis of the data using endpoints that Ventrus has adopted for its ongoing Phase 3 pivotal trial being conducted in 600 patients at 70 centers in the US. The primary endpoint in this ongoing Phase 3 study is cessation of bleeding by day 7 through day 14 (second week of treatment). In the German Phase 2b study, it was determined that 57% of iferanserin-treated patients had cessation of bleeding versus only 20% of placebo-controlled patients (P = 0.0001). The secondary endpoints of the ongoing Phase 3 study are cessation of itching and pain by day 7 through day 14. In the German Phase 2b study, the data showed that 59% of iferanserin-treated patients versus 32% of placebo-controlled patients (P = 0.034) had cessation of itching, while pain ceased at day 7 and did not return by day 14 in 50% of iferanserin-treated patients versus 18% of placebo-treated patients (P = 0.032).
The double-blind, placebo-controlled study, conducted between September 2001 and August 2002, randomized 121 patients at five colorectal surgery sites in Germany. The principal investigator and lead author of the paper is Prof. Dr. Alexander Herold of Mannheim, Germany. Compared with placebo, iferanserin significantly reduced patient-reported severity of daily bleeding beginning at day 1 and itching beginning at day 2 (P < 0.05). The effects were sustained throughout the 14-day treatment period. There was also a reduction in patient-reported severity of daily pain seen with iferanserin treatment. Adverse events were mild and infrequent and did not differ significantly between treatment groups.
The paper also presents the results from a post hoc analysis of the data using endpoints that Ventrus has adopted for its ongoing Phase 3 pivotal trial being conducted in 600 patients at 70 centers in the US. The primary endpoint in this ongoing Phase 3 study is cessation of bleeding by day 7 through day 14 (second week of treatment). In the German Phase 2b study, it was determined that 57% of iferanserin-treated patients had cessation of bleeding versus only 20% of placebo-controlled patients (P = 0.0001). The secondary endpoints of the ongoing Phase 3 study are cessation of itching and pain by day 7 through day 14. In the German Phase 2b study, the data showed that 59% of iferanserin-treated patients versus 32% of placebo-controlled patients (P = 0.034) had cessation of itching, while pain ceased at day 7 and did not return by day 14 in 50% of iferanserin-treated patients versus 18% of placebo-treated patients (P = 0.032).
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