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Tcelna study still needs relapsing remitting multiple sclerosis patients

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Opexa Therapeutics has been enrolling patients with secondary progressive multiple sclerosis (SPMS) for their study on Tcelna but Tuesday’s reports show them having only 70% of the 180 needed enrollees.

The Phase 2 double blind, placebo controlled study to evaluate the efficacy (how well the medication will work) and safety of Tcelna in those with SPMS is taking place in multiple centers across the United States and Canada.

A map shows where to enroll with one of the facilities being in Ohio at the Neurology Specialists, Inc. in Dayton, Ohio

Tcelna is described as an anti-T cell therapeutic “vaccine” where a patient’s own T cells are removed from their blood and then reintroduced by injection “subcutaneously”.

T lymphocytes are a type of white blood cell that plays a role in cell-mediated immunity.

About 50% of those with relapsing-remitting MS (RRMS) will develop SPMS and this usually happens within 10 years, sometimes less, of initial diagnosis and although a patient will experience fewer relapses; the disability and symptoms do worsen.

Neil K. Warma, Opexa’s President and Chief Executive Officer, noted the lack of “treatment options available [for those suffering from SPMS] and, as a result, participating in the Abili-T trial gives SPMS patients access to Tcelna’s potentially cutting-edge treatment.”

[Get free email subscription to Lima Multiple Sclerosis Examiner to receive news and updates [click here].

The Dayton, Ohio facility is at Neurology Specialists, Inc. located at 1 Elizabeth Place, West Medical Plaza with Dr. Lawrence Goldstick heading up the study. They can be contacted there [see map] or at (937) 495-0000 if there are any questions.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684761

Criteria is as follows:

  • Diagnosed with MS as defined by the modified McDonald criteria
  • SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits
  • EDSS score 3.0 - 6.0, inclusively
  • Presence of myelin reactive T-cells

Exclusion Criteria:

  • Diagnosed with primary progressive MS
  • Treatment with beta-interferon or glatiramer acetate 30 days prior to starting study treatment
  • Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening
  • Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening
  • Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to screening
  • Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab
  • Previous treatment with any other investigational drug 1 year prior to screening
  • HIV or hepatitis infection
  • History of cancer

Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.

They accept those who are aged 18 to 60, both male and female but they do not accept “healthy” volunteers.

For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Google Maps

Multiple Sclerosis Community Support:

  • MS World ~ “We've come together from around the world to help each other cope with the challenges of living with Multiple Sclerosis.”
  • Patients like Me ~ “Our Promise PatientsLikeMe is committed to putting patients first. We do this by providing a better, more effective way for you to share your real-world health experiences in order to help yourself, other patients like you and organizations that focus on your conditions.”
  • Med Help, Multiple Sclerosis ~ “Today, MedHelp empowers over 12 million people each month to take control over their health and find answers to their medical questions. MedHelp, a privately-funded company, has over 16 years of accumulated information from doctors and other patients across hundreds of conditions. In addition, MedHelp has long-standing partnerships with the top medical institutions such as the Cleveland Clinic, National Jewish, Partners Health, and Mount Sinai. MedHelp's audience, archives, and partnerships make it a unique health destination on the Internet.”

Sources: http://www.clinicaltrials.gov/ct2/show/NCT01684761; http://www.msactivesource.com/types-of-ms.xml?utm_campaign=Forms-Specific&utm_source=msn&utm_medium=cpc&utm_content=SPMS&utm_term=secondary-progressive%20ms; http://bionews-tx.com/news/2013/12/17/multiple-sclerosis-treatment-study-70-enrolled-more-participants-needed-says-opexa-therapeutics/

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