Fact or Fiction: New Immune Approach for Treatment of Alzheimer's Print
By Lauren Myers   
Tuesday, 09 June 2009 11:02

Is it snake oil or a real advancement in the treatment for Alzheimer's disease? Medical professionals and scientists alike will have an opportunity to judge for themselves as a new approach for tackling the devastating disease will be discussed in detail this week at the inaugural Targeting Alzheimer's with Novel Therapeutics conference, to be held as part of the 8th annual World Pharmaceutical Congress in Philadelphia on June 10 and 11.

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On the second day of the conference, after presentations by researchers from Abbott Laboratories (NYSE:ABT), Medivation (Nasdaq: MDVN), Epix Pharmaceuticals (OTCBB: EPIX), the Buck Institute, Cleveland Clinic, and others, Edward Tobinick MD, Director of the Institute for Neurological Research® (INR®), a private medical group, inc. in Los Angeles, will present the latest data on a revolutionary new immune approach for treatment of Alzheimer's disease.

Dr. Tobinick's presentation, entitled TNF modulation for treatment of Alzheimer's Disease, will review the remarkable results which have been documented using perispinal administration of etanercept, a therapeutic developed through recombinant DNA biotechnology, for treatment of Alzheimer's disease (1-7). This patented (8) off-label treatment method, invented and developed at the INR, may produce clinical improvement within minutes (1-6).

Localized administration of etanercept for treatment of neurological disorders is a novel concept which was invented by Dr. Tobinick a decade ago (8). The proof-of-concept of these novel methods which Dr. Tobinick invented (8, 9), which include both perispinal and epidural etanercept for treatment of sciatica (see INR sciatica website) (8), are now supported by additional, independent studies from academic centers, including a new randomized, double-blind, placebo-controlled clinical trial from Johns Hopkins and Walter Reed Army Medical Center (10, 11).

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that growth in the Parkinson's disease drug market, fueled by the launch of several new therapies through 2018, will be offset by generic erosion of key currently-available agents. As a result, sales of Parkinson's disease therapies will increase modestly from $2.5 billion in 2008 to $2.8 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The new Pharmacor report entitled Parkinson's Disease finds that the majority of market sales will continue to be driven by the dopamine agonist drug class that includes Boehringer Ingelheim's Mirapex/Mirapexin/Sifrol, GlaxoSmithKline's Requip, GlaxoSmithKline/SkyePharma's Requip XL/LP/RP/Modutab and

UCB/Schwarz Pharma's Neupro. However, sales of some of these agents, including Mirapex/Mirapexin/Sifrol and

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Requip XL/LP/RP/Modutab, will be offset by increased uptake of generic equivalents. Market growth will also be constrained by the generic erosion of other key therapies, including Novartis/Orion Pharma's Comtan/Comtess/Stalevo and
Teva Pharmaceuticals/Lundbeck's Agilect/Azilect.

According to the report, market sales will also be driven by the emergence of novel agents, most notably Merck Serono/EMD Serono/Newron Pharmaceuticals' safinamide, Solvay Pharmaceuticals' pardoprunox, and Acadia Pharmaceuticals/Biovail Pharmaceuticals' pimavanserin, which will be used to treat niche Parkinson's disease populations.

The prospect of a new, immune-based approach for treatment of Alzheimer's is exciting. Recent reports of the ability of etanercept to penetrate rapidly into the cerebrospinal fluid within the brain in animal studies now provide new insight into the potential mechanisms underlying the rapid clinical effects of etanercept in patients with Alzheimer's disease (12).

References

1. Tobinick, E., Perispinal etanercept for neuroinflammatory disorders. Drug Discov Today, 2009. 14(3-4): p. 168-77.
2. Tobinick, E.L. and H. Gross, Rapid improvement in verbal fluency and aphasia following perispinal etanercept in Alzheimer's disease. BMC Neurol, 2008. 8: p. 27.
3. Tobinick, E.L. and H. Gross, Rapid cognitive improvement in Alzheimer's disease following perispinal etanercept administration. J Neuroinflammation, 2008. 5: p. 2.
4. Griffin, W.S., Perispinal etanercept: potential as an Alzheimer therapeutic. J Neuroinflammation, 2008. 5: p. 3.
5. Tobinick, E., Perispinal etanercept for treatment of Alzheimer's disease. Curr Alzheimer Res, 2007. 4(5): p. 550-2.
6. Tobinick, E., H. Gross, A. Weinberger, and H. Cohen, TNF-alpha modulation for treatment of Alzheimer's disease: a 6-month pilot study. MedGenMed, 2006. 8(2): p. 25.
7. McAlpine, F.E. and M.G. Tansey, Neuroinflammation and tumor necrosis factor signaling in the pathophysiology of Alzheimer's. J Inflammation Research, 2008. 1: p. 29-39.
8. U.S. patents 6,015,557; 6,177,077; 6,419,944; 6,537,549; 6,982,089; 7,214,658, and Australian patent 758,523 issued to Edward Tobinick MD and assigned to TACT IP, LLC, and additional patents and related applications, assigned to TACT IP, LLC.
9. 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.
10. Cohen, S.P., N. Bogduk, A. Dragovich, C.C. Buckenmaier, 3rd, S. Griffith, C. Kurihara, J. Raymond, P.J. Richter, N. Williams, and T.L. Yaksh, 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.
11. Kato, K., S. Kikuchi, V.I. Shubayev, and R.R. Myers, Distribution and tumor necrosis factor-alpha isoform binding specificity of locally administered etanercept into injured and uninjured rat sciatic nerve. Neuroscience, 2009. 160(2): p. 492-500.
12. Tobinick, E.L., K. Chen, and X. Chen, Rapid intracerebroventricular delivery of Cu-DOTA-etanercept after peripheral administration demonstrated by PET imaging. BMC Res Notes, 2009. 2: p. 28.




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