Bapineuzumab

Testing

Bapineuzumab was being co-developed by the pharmaceutical companies Élan and Wyeth and entered Phase III trials in December 2007. In 2008 a Johnson & Johnson affiliate acquired a substantial portion of Élan's assets related to the Alzheimer's immunotherapy program, which Elan had shared with Wyeth. The program is continuing with Pfizer, which acquired Wyeth in 2009.

Bapineuzumab was the first antibody to be found to cause amyloid-related imaging abnormalities, including an accumulation of fluid in brain tissue (ARIA-E) in patients receiving the highest dose. No health risks were found in subjects receiving either 0.5 or 1 mg of bapineuzumab. Patients who have been receiving or have been scheduled to receive the highest dose will be either removed from the trials or switched to lower doses.

The efficacy of drugs targeted to brain plaques in Alzheimer's patients has been called into question, although such drugs may still be effective for prophylaxis if given to individuals who have not yet developed clinical symptoms.{{Cite news | vauthors = Berkrot B | title = Pfizer, J&J scrap Alzheimer's studies as drug fails | newspaper = Reuters | location = New York | date = August 7, 2012 | url = https://www.reuters.com/article/us-pfizer-alzheimers-idUSBRE8751F120120807 | access-date = August 7, 2012 }}

On August 6, 2012, Pfizer Inc. and Johnson & Johnson said they are ending development of an intravenous formulation of bapineuzumab. Testing showed the drug did not work better than placebo in two late-stage trials in patients who had mild to moderate Alzheimer's disease.

Élan announced that Johnson & Johnson, on July 16, 2013, had discontinued Phase 2 testing of the subcutaneous formulation of bapineuzumab.

Insider trading

Mathew Martoma, formerly of S.A.C. Capital Advisors, was convicted in February 2014 of insider trading on news passed by neurologist Sid Gilman of the cancellation of bapineuzumab's testing.

References

References

1. (Fall–Winter 2012). ""Team Babcock's" journey". The Penn Memory Center ([[Penn Medicine]]).
2. (2007-08-07). "New Alzheimer's drugs might help prevent glaucoma". [[The Guardian]].
3. (7 August 2012). "Pfizer, J&J scrap Alzheimer's research as drug fails". Reuters.
4. (7 August 2012). "Alzheimer's disease drug shelved after trial failure". BBC News.
5. (2013-02-18). "Bapineuzumab captures the N-terminus of the Alzheimer's disease amyloid-beta peptide in a helical conformation". Scientific Reports.
6. (2007). "Vaccination strategies for Alzheimer's disease: A new hope?". [[Adis International]].
7. (2008-06-17). "Elan and Wyeth Announce Encouraging Top-line Results from Phase 2 Clinical Trial of Bapineuzumab for Alzheimer's Disease". [[Elan Corporation]].
8. (2015-09-25). "Anti-Aβ Autoantibodies in Amyloid Related Imaging Abnormalities (ARIA): Candidate Biomarker for Immunotherapy in Alzheimer's Disease and Cerebral Amyloid Angiopathy". Frontiers in Neurology.
9. (2009-04-02). "Drug Makers Stop Top Dosage in Alzheimer's Trial". Drug Discovery & Development.
10. (May 12, 2010). "New theory of Alzheimer's explains drug failures". Reuters.
11. [http://www.elan.com/company/about_us Phase 2 testing of the subcutaneous formulation of bapineuzumab is to be discontinued.] {{Webarchive. link. (2013-08-11 Elan Corporation. Retrieved 2013-08-13.)
12. (February 7, 2014). "Ex-SAC Trader Convicted of Securities Fraud". [[The New York Times]].
13. (2013-01-26). "The Corruption of Sid Gilman-How a top U-M doc lost his way". [[Ann Arbor Observer]].