Opexa Reaches Enrollment Target in Phase IIb Trial of Personalized Immunotherapy for Secondary Progressive Multiple Sclerosis

THE WOODLANDS, Texas–(BUSINESS WIRE)–  

May 13, 2014

Opexa Therapeutics, Inc. (OPXA), a biotechnology company developing Tcelna® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today reported it has reached the targeted enrollment in its Phase IIb clinical trial in Secondary Progressive Multiple Sclerosis. As of today, 180 patients with Secondary Progressive MS have been randomized in the Phase IIb “Abili-T” clinical study of Tcelna. The Company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trial’s entry criteria to also be enrolled in the trial.

“Interest from physicians and patients to participate in the study was high, underscoring the need for innovative treatments for Secondary Progressive MS, an area of high unmet medical need,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “This is an important milestone for Opexa as we continue to work towards developing patient-specific immunotherapies for the treatment of Multiple Sclerosis.”

Mr. Warma credited the outstanding support of the clinical trial sites across the United States and Canada for helping the Company achieve its targeted enrollment. Even though the Company has reached the full 180-patient enrollment it sought for the Abili-T trial, the Company will continue to support those patients currently in the screening process. This likely means that the Abili-T trial will complete enrollment with a modest number of patients in excess of the 180 targeted as the Company believes it is important to support patients that had already started the enrollment process.

Edward Fox, M.D., Ph.D., one of the enrolling neurologists in the Abili-T trial, noted that there are few treatment options for patients with Secondary Progressive MS. “Achieving this significant milestone provides hope for this group and all individuals with MS.”

The Abili-T trial is a Phase IIb study of Tcelna in patients with Secondary Progressive MS in 35 leading clinical sites in the U.S. and Canada. Each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in Secondary Progressive Multiple Sclerosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, as well as fill an unmet medical need and get important new drugs to patients earlier.

In February 2013, Opexa entered into an option and license agreement for Tcelna with Merck Serono, one of the leading multinational companies focused on the treatment of MS. Merck Serono’s option is exercisable prior to or upon completion of the Abili-T trial. Under the agreement, Opexa could be eligible to receive up to $220 million in milestone payments, as well as 8 to 15 percent in royalties.

Mr. Warma will discuss the Abili-T trial progress during Opexa’s Q1 earnings call on Wednesday, May 14th at 5:00 P.M. EDT. To listen to the conference call, dial in approximately ten minutes before the scheduled 5:00 P.M. time to (253) 237-1170 or toll free at (877) 372-0867. Please reference conference ID 44945084 or the Opexa Therapeutics Earnings Call.

A live webcast of the call can also be accessed here or via the webcast link on the Investor Relations page of Opexa’s website (www.opexatherapeutics.com).

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