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December 18, 2013 (Gold Coast, Australia): Today Griffith University, on their Alzheimer’s trial website, announced that the Griffith University Alzheimer’s Study has recently been granted full approval by the Human Research Ethics Committee as the first randomized double blind clinical trial to test perispinal etanercept for dementia in Australian patients. More information here, on the Griffith website. The INR congratulates Griffith University and its scientists and physicians for their diligence and outstanding efforts that have enabled the initiation of this new study. The approval and initiation of this new study represents independent scientific support for the scientific rationale underlying this treatment approach that was invented and pioneered at the INR in Los Angeles.
November 1, 2013: A new randomized study published in the November 1, 2013 issue of the journal Spine (Freeman, B.J., et al., Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation. Spine (Phila Pa 1976), 2013. 38(23): p. 1986-94) provides new evidence for the efficacy of a TNF inhibitor for relief of persistent sciatica associated with lumbar disc herniation. Etanercept is a potent anti-inflammatory drug that is a selective blocker of an immune signaling molecule called TNF. Local perilesional methods of administration of etanercept, including epidural injection for treating sciatica associated with lumbar disc herniation were invented by Edward Tobinick M.D. more than a decade earlier (U.S. patent 6,419,944; 6,537,549; and others).
The new Spine study now constitutes the third published favorable clinical trial providing randomized, controlled trial (RCT) data of the efficacy of etanercept for treating sciatica. Dr. Tobinick was the first to publish human data reporting the effectiveness of etanercept for this indication in 2003, with a larger study published in 2004 (Tobinick, E. and S. Davoodifar, Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients. Curr Med Res Opin, 2004. 20(7): p. 1075-85).
November 4, 2013:
U.S. patent 6,419,944 (inventor Edward Tobinick M.D., filed April 5, 2001) contained the first clinical report of rapid improvement in disc-related pain following the administration of perispinal etanercept. Now, more than a decade later, there are four favorable clinical trials that provide randomized, controlled trial (RCT) data supporting the efficacy of etanercept for treating disc-related pain. In 2013, data from two of these RCTs have been presented: the Nov 1 study by Freeman published in Spine; and the study conducted at Chiba University in Japan(Sainoh, T., et al., Intradiscal Administration of Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Clinically Improves Intractable Discogenic Low Back Pain: A Prospective Randomized Study, in International Society for the Study of the Lumbar Spine 40th Annual Meeting, May 2013). In 2012 the RCT by Ohtori reported positive etanercept data (Ohtori, S., et al., Epidural administration of spinal nerves with the tumor necrosis factor-alpha inhibitor, etanercept, compared with dexamethasone for treatment of sciatica in patients with lumbar spinal stenosis: a prospective randomized study. Spine (Phila Pa 1976), 2012. 37(6): p. 439-44). In 2009 the RCT performed at Walter Reed Army Medical Center provided favorable efficacy and human and animal safety data (Cohen, S.P., et al., Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology, 2009. 110(5): p. 1116-26).
August 20, 2013: