Patients have now entered the screening process for VEN 209, and Ventrus expects that the dosing of the first patients will begin the week of August 22 2011, and that the remaining 5 sites will be initiated in the current quarter.
Russell H. Ellison MD, Chairman and CEO of Ventrus stated in the press release:
"We are excited to begin the pivotal Phase III trial for VEN 309 for the treatment of hemorrhoids, particularly as this is the first Phase III trial in the U.S. for a drug treatment for patients with this condition, for whom there are currently no FDA-approved prescription drugs available."
The Phase III trial of VEN 309 has been designed to include approximately 600 patients in a double-blind, 3-arm design. Iferanserin (0.5%) ointment, applied intra-anally twice per day, using a single-use tube and applicator, will be compared with matching placebo ointment in the following cohorts:
1. Iferanserin for 14 days,
2. Iferanserin for 7 days followed by placebo for 7 days, and
3. placebo for 14 days.
All patients will be evaluated in the double blind period for follow-up at 28 days, and subsequently all patients will enter a 12 month open label extension part of the study where they will have access to treatment with active drug if they have a recurrence of symptoms, to assess longer term safety and recurrence rates. The primary endpoint of this trial will be cessation of bleeding on days 7 to 14 and the secondary endpoints are cessation of pain and itching days 7 to 14. Data from the double-blind part of the study, and recurrence rates up to that point, are expected in the first quarter of 2012.
More details about the trial VEN309-Hem-SE3-001 may be found at www.clintrials.gov, and for more information on Ventrus Bio, see www.ventrusbio.com and follow them on Facebook.
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