Repurposing Of Enbrel For Alzheimer's Disease

At Cambridge Healthtech Institute's Third Annual Drug Repositioning Summit on Monday, October 6 in Boston, the audience is scheduled to hear, as a Keynote Presentation, the story of how an individual physician has charted an entirely new course for a therapeutic which is already one of the most successful of all time.


Enbrel® (etanercept) has proven effective for treating a host of medical conditions, from rheumatoid arthritis to psoriasis, generating more than $4 billion dollars per year in revenue for its owner, Amgen. Yet despite this success Amgen has failed to initiate study of etanercept's emerging off-label uses in the field of neurology, which could potentially address enormous unmet medical needs and help people throughout the world. Etanercept is one of a new class of medications, produced through biotechnology, which specifically neutralize an immune signaling molecule called TNF. Excess TNF is centrally involved in scores of diseases, including rheumatoid arthritis, Alzheimer's, sciatica pain, and psoriasis. In Alzheimer's disease excess TNF has been documented in the cerebrospinal fluid, and the rationale for anti-TNF treatment is supported by genetic, epidemiologic, basic science, and clinical data (1-11).


The Keynote Presentation, entitled "Repurposing of Enbrel for Alzheimer's Disease" will be made by Edward Tobinick MD, Director of the Institute for Neurological Research, a private medical group, inc. in Los Angeles. Dr. Tobinick is the inventor and patent holder of the etanercept off-label indication for Alzheimer's Disease, as well as more than 200 different inventions involving new off-label uses of TNF blockers, such as etanercept, in neurology, opthalmology, and for a variety of additional innovative clinical indications(12-17). Many of the novel uses of etanercept which Dr. Tobinick invented, beginning nearly a decade ago, such as for sciatica, Alzheimer's, and myasthenia gravis, have subsequently been supported by peer-reviewed, published studies performed by independent researchers from academic centers across the globe(18-26).


As an example, a recently completed, double-blind, placebo-controlled study conducted by independent researchers at Johns Hopkins/Walter Reed Army Medical Center has confirmed the efficacy of etanercept for sciatica, using a patented, perispinal method of administration of etanercept which Dr. Tobinick invented(27).















Dr. Tobinick has been invited to and has presented his clinical and research findings at multiple prestigious medical research meetings, including this year's International Congress on Alzheimer's Disease (ICAD 2008), the 7th International Alzheimer's Drug Discovery Conference; at the Karolinska Institutet in Stockholm, Sweden, the home of the Nobel Prize in medicine; and in multiple, peer-reviewed, published medical articles(1-5, 27-31).


His published, peer-reviewed scientific articles have been cited by more than 150 scientific publications from around the world(1-6, 18, 20, 23-25, 32, 33). In addition, his groundbreaking work has been recognized by the Dana Alliance for Brain Initiatives, the world's leading organization of neuroscientists, which counts among its members ten Nobel Laureates(34); by leading journals, including Nature Clinical Practice Neurology(35); by the Faculty of 1000 Biology, the expert guide to the most important advances in biology(36); and featured in news articles from around the world(37-39). Despite the immense potential to help countless people, the great unmet medical need, and their enormous continuing revenue from etanercept sales, Amgen has yet to confirm its intention to begin even preliminary clinical study in this direction.


A failure to investigate is perhaps even more puzzling in view of the increasing scientific support from cutting edge research, which is in addition to the genetic studies which have identified excess TNF as a therapeutic target in Alzheimer's(9, 10, 33, 40-43). For example, scientists from the Trinity College Institute of Neuroscience in Ireland have demonstrated that defects in hippocampal learning and memory mechanisms created by forms of amyloid are mediated by TNF(41-43). Perhaps even more significant is the recent identification of TNF as a gliotransmitter which regulates synaptic transmission in the brain(39, 44, 45).


The synaptic effects of TNF which regulate learning, memory, and neurotransmission provide a most exciting area for scientific research. These synaptic effects, which may occur with extreme rapidity, provide a rational and scientifically plausible explanation for the rapid clinical effects of etanercept which have been documented in multiple, peer-reviewed scientific studies and in multiple patients(1-5, 18, 28, 30). To ignore this new direction in scientific thinking, which recognizes the role of TNF not just in inflammation but also as an immune regulator of synaptic communication and other aspects of brain function, would be to impede scientific progress.


Fortunately, with the expiration of Amgen's patents on etanercept approaching in 2012, other pharmaceutical companies will soon have the ability to explore these extraordinary discoveries which have the potential to help millions of patients around the world.


The Keynote Presentation will cover over ten years of research, highlighting the difficult hurdles which new breakthroughs in science and medicine must surmount before they are even considered by the scientific and medical communities.


For further information on this Keynote Presentation, please visit AlzheimerVideoNews , or the INR® website.

Institute for Neurological Research


View drug information on Enbrel.