Opexa initiated preclinical development activities for OPX-212, its drug development candidate for NMO, earlier this year and has achieved several regulatory and early development milestones to date. These include conducting a pre-IND meeting with the FDA and performing in-house manufacturing runs with NMO patient samples. The Company is continuing with preclinical development activities with a goal of filing an IND with the FDA by mid-2015 and then moving into clinical development with a Phase 1/2 proof-of-concept study. The Company believes OPX-212 will qualify for Orphan drug designation and plans also to apply for Fast Track designation for OPX-212.
We are pleased to announce our development activities in a second indication utilizing our novel T-cell technology platform, said Neil K. Warma, President and Chief Executive Officer of Opexa. NMO is a disease with a significant unmet medical need. We believe our approach to the treatment of NMO with OPX-212 is highly differentiated as we are directly targeting the T-cell component of the disease and, therefore, addressing the root cause.
We believe part of the value of our Precision ImmunotherapyTM T-cell platform comes from the ability to move relatively quickly and cost effectively into new autoimmune diseases. We do not expect our preclinical development activities related to the NMO program to materially affect the Companys cash burn through IND submission, Mr. Warma continued. We are enthusiastic about moving forward with our NMO development program, while remaining firmly committed to the conduct of our ongoing Phase 2b Abili-T clinical trial with Tcelna in Secondary Progressive MS patients.
Conference Call and Webcast Details
Opexa will host a virtual panel discussion with Benjamin Greenberg, M.D., Associate Professor of Neurology, University of Texas, Southwestern Medical Center, and Michael Levy, M.D., Ph.D., Assistant Professor of Neurology, The Johns Hopkins University and Staff Neurologist, The Johns Hopkins Hospital, to provide an overview of NMO and discuss Opexas differentiated T-cell treatment approach today at 9:30 a.m. EDT.
To listen to the conference call, dial in approximately ten minutes before the scheduled 9:30 a.m. EDT time to (253)237-1170 or toll free at (877) 372-0867. Please reference conference ID 84494085 or the Opexa Therapeutics Business Update.
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).
There will be a brief Question & Answer session following the panel discussion.
About Opexa
Opexa is a biopharmaceutical company developing personalized immunotherapies with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases, such as neuromyelitis optica (NMO). These therapies are based on Opexas proprietary T-cell technology. The Companys leading therapy candidate, Tcelna, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS. Tcelna is derived from T-cells isolated from the patients peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin. Opexas mission is to lead the field of Precision Immunotherapy by aligning the interests of patients, employees and shareholders.
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Opexa Therapeutics to Target Rare Disease Neuromyelitis Optica (NMO) as next Development Program
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