Ventrus Biosciences Completes Enrollment of Pivotal Phase 3 Trial of Iferanserin (VEN 309) in Patients With Hemorrhoidal Disease
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- Category: Small Molecules
- Published on Monday, 30 April 2012 18:08
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Results Are Anticipated in Late June to Early July - 2012
NEW YORK, NY, USA I April 30, 2012 I Ventrus Biosciences, Inc. (VTUS - News) announced that it has completed patient enrollment and randomization in the first Phase 3 clinical trial of iferanserin (VEN 309) in patients with grade 1-3 hemorrhoids. Data from the Phase 3 study are anticipated to be available in late June or early July 2012.
The Phase 3 study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of iferanserin ointment in subjects with grade 1-3 hemorrhoids and is being conducted in more than 70 centers in the US. Elimination of bleeding from day 7 through day 14 of treatment is the primary endpoint, with elimination of itching and pain from day 7 through day 14 as the secondary endpoints. All patients were required to show meaningful symptoms (bleeding, plus either itching or pain for 2 consecutive days immediately prior to randomization) to be enrolled. Consistent with the protocol for this trial, 604 patients have been randomized to one of three twice daily treatment groups: 7 days of active treatment followed by 7 days of placebo, 14 days of active treatment, or 14 days of placebo treatment. Enrollment into this large trial began in August 2011, and was completed in only 8 months.
"This is an important milestone in the clinical development of VEN 309, and marks completion of enrollment in the largest-known randomized, placebo-controlled clinical trial for the treatment of hemorrhoidal disease," said Dr. Russell Ellison, Chairman and Chief Executive Officer of Ventrus Biosciences, Inc. "Ventrus is focused on bringing the treatment of hemorrhoidal disease into the modern medical era by developing the first prescription pharmaceutical treatment for FDA approval, for the relief of symptoms -- an advancement which could benefit millions of patients who suffer from hemorrhoids."
SOURCE: Ventrus Biosciences