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May 13, 2014
08:04 EDTOPXAOpexa Therapeutics reaches enrollment target in Phase IIb trial
Opexa Therapeutics 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 ďAbili-TĒ 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 trialís entry criteria to also be enrolled in the trial. 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 trialís primary efficacy outcome is the percentage of brain volume change at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. 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.
News For OPXA From The Last 14 Days
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September 1, 2015
06:08 EDTOPXAOpexa Therapeutics enters into $5M repurchase agreement to fund NMO program
Opexa Therapeutics announced that the Company has entered into a stock purchase agreement with a private investor to fund the Company's NMO program, including its planned Phase I/II trial, for up to $5M, upon achievement of certain pre-specified milestones. The funding is to be provided in five tranches, with the first tranche having been delivered today. For the first tranche, the company issued shares priced at 55c per share for a purchase amount of $500,000. The total number of shares delivered in the first tranche was 909,090. The first tranche also included a warrant to acquire an equal number of shares with an initial exercise price of 50c until June 30, 2016, and an exercise price of $1.50 through its expiration on April 9, 2018. Subsequent tranches totaling a possible $4.5M are based on the completion of the ongoing preclinical activities and subsequent submission of an IND for OPX-212 in NMO no later than February 15, 2016; the review and acceptance of the IND by the FDA no later than May 15, 2016; enrollment of the first patient in a planned Phase I/II study no later than August 30, 2016; and enrollment of 30% of the patients in the same Phase I/II study no later than December 31, 2016. Each subsequent tranche will include the sale of common stock only with such shares priced at 90% of the 10-day volume weighted average price of Opexa's common stock immediately preceding the occurrence of the related milestone. The Company has filed a Current Report on Form 8-K with the U.S. SEC. No bank was used in this transaction.
August 26, 2015
08:36 EDTOPXACryoport to support Opexa Therapeutics' T-cell immunotherapy programs
Cryoport's (CYRX) validated cryogenic logistics solution will support future clinical trials for Opexa Therapeutics' (OPXA) lead personalized T-cell immunotherapy programs for Multiple Sclerosis and Neuromyelitis Optica. Cryoport's global distribution network will provide the necessary cryogenic logistics support between Opexa and its clinical sites.

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