Today's Date: July 31, 2010

Elan at AD/PD: Continued Scientific Leadership

 

Elan scientists joined an international group of Alzheimer's and Parkinson's disease experts recently to debate current scientific literature, help to expand the knowledge base in both diseases, and share their unique insight and experience relative to anti-beta amyloid (Aß) approaches for Alzheimer’s disease.

Elan’s Chief Scientific Officer Dale Schenk, PhD, said the 9th Alzheimer's and Parkinson's Disease International Conference in Prague was an excellent opportunity to articulate Elan’s scientific research, development and goals.

“Our vision is to be the premiere neuroscience company in the world,” Schenk said. “Our scientists have been leaders in neurodegenerative disease research for more than two decades, and we believe our work in Alzheimer’s disease and Parkinson’s disease will help us achieve that vision.”

The AD/PD conference was marked by substantial discussions and debate concerning the underlying pathology and potential disease-modifying therapies for both Alzheimer’s and Parkinson’s disease. The meaning and effect of Aß plaques in the brain of Alzheimer’s patients – a long-established hallmark of the disease– was a prominent topic among more than 125 of the world’s leading scientists and clinicians who attended the conference.

Limited Study

Scientists at the conference discussed an article published last summer in The Lancet that questioned the role of beta amyloid plaques in Alzheimer’s disease.

The article’s conclusion was based on the fact that a select sub-group of eight patients – who had been previously treated with Elan and Wyeth’s AN 1792 many years earlier in a Phase 1b safety study – eventually died of Alzheimer’s disease. The autopsies of two patients, however, found plaque clearance.

Dr. Schenk said it was impossible to draw any meaningful conclusions from The Lancet article because of the limited nature of the study.

The Lancet study was an interesting new way to attempt to better understand the connection between brain pathology and clinical progression of Alzheimer’s disease,” Dr. Schenk said. “Unfortunately because of its small size, few, if any, hard conclusions can be drawn from the data and we must remain focused on the goal of obtaining meaningful findings from pivotal studies to truly understand the role of beta amyloid in Alzheimer’s disease.”

Schenk noted that during the four-day conference, many of the presentations and posters included “a great deal of important evidence supporting the Aß approach. They were very constructive and thoughtful.”

Elan is pursuing therapeutic approaches to disrupting three distinct aspects of the Aß cascade: clearing existing Aß from the brain (immunotherapies, in collaboration with Wyeth); preventing the aggregation of Aß (in collaboration with Transition Therapeutics); and preventing production of Aß (secretase inhibitors).

Numerous preclinical studies have supported the approach for anti-Aß immunotherapy. Bapineuzumab, an experimental humanized monoclonal antibody, is designed to bind and clear beta amyloid in the brain and reacts with multiple forms of Aß. Bapineuzumab is the most advanced anti-Aß antibody in clinical development, and patients are being currently enrolled in Phase 3 clinical trials.

Peter Seubert, an Elan neurodegeneration research biologist who attended the AD/PD conference, said most of the attendees “are very enthused by the Aß hypothesis. That’s why nearly every major drug company and many start-ups are working on Aß programs for Alzheimer’s disease.”

Thought Leadership

Other Elan scientific leaders – including Jeannie Giacchino, MD, Alzheimer’s Immunotherapy Program Leader and Cornel Pater, MD, Regional Medical Director – met with leaders in the European Alzheimer’s community to discuss Elan’s scientific platform/current pipeline, the latest thought-leadership on Aß and disease-modification, and gave an overview of ongoing clinical trials.

“Elan is clearly recognized as a leader in the field of Alzheimer’s disease research,” Dr. Giacchino said. “There is strong interest and support for our Alzheimer immunotherapy programs from key European clinicians and researchers.”

The meetings helped to identify Elan as one of the most proactive neuroscience-based companies in the world, and to ensure open, ongoing dialogue, said Dr. Pater, who is based in Sweden. "Our work at AD/PD advanced a wider knowledge of our science, and also helped lay the groundwork for a clear understanding and endorsement of our novel therapeutic agents in the future," he said.

Symposium and Presentations

Elan and Wyeth sponsored a well-attended continuing medical education (CME) symposium, “Targeting the Molecular Pathways of AD: Rationale and Outcomes for Disease Modification Strategies," which discussed some of the most recent advances in the treatment of Alzheimer’s disease.

The symposium included a session on “Emerging Therapies in Alzheimer’s Disease” by Rachelle S. Doody, MD, PhD, whose presentation included a topline summary of the Bapineuzumab Phase 2 clinical data. Dr. Doody reviewed the structure of the Phase 2 trial and discussed the efficacy and safety results, saying the data supported moving to the now-ongoing Phase 3 clinical trials.

Elan also submitted three abstracts that showcased current research:

  • Increasing dependence on others is associated with increased resource use in dementia
  • Promising Effects of Active Aß Immunotherapy in Non-Human Primates
  • Small molecule mediated inhibition of alpha synuclein aggregation-towards a rational drug design for intrinsically unstructured proteins

Presentations by other scientists supporting Aß immunotherapy “were very strong and made excellent points,” Seubert said.

He recalled presentations from two investigators – using different animal models – who demonstrated that neuronal cell loss was prevented with beta amyloid immunotherapy, which added to the scientific evidence supporting the approach.

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