Recent Corporate Highlights
-- Our preliminary planning for the Phase IIb trial of Cethrin called for us to enroll up to 100 subjects in 80 sites worldwide. Ongoing inputs, including the results to date in the Phase I/IIa trial, discussions with the regulatory authorities and our expert advisors, now indicate that a placebo-controlled trial to demonstrate the potential efficacy of Cethrin can be accomplished with fewer patients and sites, and provide us with results from the trial approximately a year earlier. We are now planning to initiate a randomized, double-blind, placebo-controlled, Phase IIb trial in subjects with acute cervical spinal cord injury (SCI) in the first quarter of 2009 at sites across North America.
-- Thomas H. Tulip, PhD has joined the Company to lead our molecular imaging business. Dr. Tulip has over 25 years of experience in the medical imaging industry and comes to us from Lantheus. Thom will focus on ensuring that the POET-2 program and the NDA submission for Altropane are completed. He will also support our partnering efforts and prepare Altropane for commercialization.
-- The first part of the POET-2 Phase III clinical program for Altropane began enrollment in December 2007. Enrollment of up to 80 subjects to generate the set of Altropane training images is planned. These images will be used to train the expert readers, as is customary for clinical trials of molecular imaging agents. With all trial sites now enrolling, we are noting increased subject recruitment and expect that we will complete enrollment early in 2009.
-- In June 2008, the Company entered into a convertible promissory note purchase agreement with Robert Gipson pursuant to which the Company could borrow up to $5,000,000. In June 2008, the Company issued a convertible promissory note in the aggregate principal amount of $5,000,000 to Robert Gipson.
Financial Highlights of the Second Quarter 2008
'/>"/>| SOURCE Alseres Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved |