Q2 2012 Results (Opexa Therapeutics) - Aug 14, 2012 - Anticipated initiation of enrollment in US based sites for P2b trial in patients with secondary progressive MS in Q3 2012; Anticipated initiation of enrollment in Canada after finalization of regulatory approval
Anticipated enrollment status • Multiple Sclerosis
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Tcelna
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"The first half of the year was focused on advancing preparations for our Phase IIb clinical trial in patients with Secondary Progressive MS, including securing additional capital to enable the initiation of the trial," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "We advanced well in these two key priorities having submitted the complete manufacturing CMC package to the FDA and having closed a financing which raised just over $4 million. The most important task we face in the near term is to initiate the clinical trial and begin to treat patients who so desperately need new safe and effective treatments. SPMS patients currently have very limited treatment options so we are excited to be
preparing to initiate the trial with what we believe to be one of the safest and potentially most efficacious therapies for this disease."
"We have been diligently working to identifyand secure leading clinical trial sites across the U.S. and Canada that we believe provide a strong base of SPMS patients for recruitment and enrollment in the trial," continued Mr. Warma. "Contract negotiations with these sites are going well and we anticipate that the U.S.-based sites could be in a position to begin recruiting patients this quarter. The Canadian regulatory approvals should be finalized later in the quarter allowing us to expand enrollment in the clinical study at that time."
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(IR 6)
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