Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today disclosed that the Company has commenced development in a second indication, Neuromyelitis optica (NMO). NMO is a rare autoimmune disorder, which is designated as an Orphan disease by the U.S. Food and Drug Administration (FDA). There is currently no cure and there are no FDA approved therapies for this disease.
“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.”
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 Company’s 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.”
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