Pfizer Bapineuzumab Fails, All Clinical Trials Discontinued
The clinical findings together with the determination to discontinue the bapineuzumab IV programme inward patients amongst mild-to-moderate Alzheimer’s affliction is some other setback for the Alzheimer's Community.
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Baca Juga
"We are evidently real disappointed inward the outcomes of this trial. We are too saddened yesteryear the lost chance to furnish a meaningful advance for patients afflicted amongst mild-to-moderate Alzheimer's affliction together with their caregivers," Steven Romano, caput of Pfizer's Medicines Development Group, said inward a statement.
Pfizer Announces Co-Primary Clinical Endpoints Not Met In Second Phase three Bapineuzumab Study In Mild-To-Moderate Alzheimer’s Disease Patients Who Do Not Carry The Apoe4 Genotype
Pfizer Inc. announced today that the co-primary clinical endpoints, modify inward cognitive together with functional functioning compared to placebo, were non met inward the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase three lawsuit of intravenous (IV) bapineuzumab inward patients amongst mild-to-moderate Alzheimer’s affliction who create non send the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 301).
Pfizer together with Janssen AI are partners inward the Alzheimer’s Immunotherapy Program (AIP).
Based on the topline results of this study, together amongst the topline results of a Janssen AI-led Phase three study inward patients who send the ApoE4 genotype (Study 302)announced on July 23rd, the Janssen AI together with Pfizer Joint Steering Committee for the AIP has decided to discontinue all other bapineuzumab IV studies inward patients amongst mild-to-moderate Alzheimer’s disease.
This includes non alone the Pfizer-led, Phase three studies (Study 3000 together with Study 3001), but too all follow-on extension studies inward patients amongst mild-to-moderate Alzheimer’s affliction receiving bapineuzumab IV. All patients inward the discontinued studies volition get got a follow-up evaluation together with the Alliance volition acquit concluding information analyses.
These clinical findings together with the determination to discontinue the bapineuzumab IV programme inward patients amongst mild-to-moderate Alzheimer’s affliction get got been shared amongst regulatory regime together with study investigators.
“We are evidently real disappointed inward the outcomes of this trial. We are too saddened yesteryear the lost chance to furnish a meaningful advance for patients afflicted amongst mild-to-moderate Alzheimer’s affliction together with their caregivers,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “Yet these data, together with the subgroup together with biomarker analyses underway, volition farther inform our agreement of this complex affliction together with advance inquiry inward this field.”
No novel security concerns were identified inward Study 301. The most unremarkably observed serious adverse events which occurred inward bapineuzumab-treated patients to a greater extent than unremarkably than inward placebo-treated patients, together with amongst an incidence of at to the lowest degree 1 pct inward the combined 0.5 mg/kg together with 1.0 mg/kg group, were pneumonia, ARIA-E (amyloid-related imaging abnormalities-edema or effusion), syncope, hip fracture together with convulsion.
Data from both Study 302 together with Study 301 get got been accepted every bit a late-breaker together with volition locomote presented inward September at the European Federation of Neurological Societies (EFNS) coming together inward Stockholm.
About the Bapineuzumab IV Phase three Studies
Four placebo-controlled Phase three studies comprised the bapineuzumab IV clinical evolution program. Janssen AI led the 2 completed 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy together with security studies of patients who are ApoE4 carriers (Study 302) together with ApoE4 non-carriers (Study 301). The 2 co-primary clinical endpoints were modify inward the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a validated stair out of cognition, together with the Disability Assessment for Dementia (DAD), a validated musical instrument to stair out function. Study 302 included roughly 1,100 patients who send the ApoE4 genotype. Additionally, Study 301 reported hither included roughly 1,300 patients who create non send the ApoE4 genotype.
In improver to the Janssen AI-led studies, Pfizer led 2 primarily ex-North American 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy together with security studies of patients amongst mild-to-moderate Alzheimer’s affliction who are ApoE4 non-carriers (Study 3000) together with carriers (Study 3001).
About Bapineuzumab IV
Bapineuzumab IV, an investigational therapy studied for the handling of mild-to-moderate Alzheimer’s disease, is an antibody that targets beta-amyloid (Aβ), a poly peptide that tin strength out exert toxic effects inward the encephalon together with is believed to play a fundamental role inward the pathology of Alzheimer’s disease.
About the Alzheimer’s Immunotherapy Program (AIP)
The Alzheimer's Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy together with Pfizer Inc. is an equal collaboration committed to researching together with developing selective products for the handling and/or prevention of neurodegenerative conditions, including Alzheimer’s disease.
We believe that it may locomote possible to cut back the burden of affliction through early on intervention inward the illness. The AIP is dedicated to delivering comprehensive together with integrated solutions that aid address the needs of people impacted yesteryear Alzheimer’s disease.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, nosotros utilize scientific discipline together with our global resources to improve wellness together with well-being at every phase of life. We strive to ready the measure for quality, security together with value inward the discovery, evolution together with manufacturing of medicines for people together with animals. Our diversified global wellness attention portfolio includes human together with beast biologic together with modest molecule medicines together with vaccines, every bit good every bit nutritional products together with many of the world’s best-known consumer products.
DISCLOSURE NOTICE: The information contained inward this liberate is every bit of August 6, 2012. Pfizer assumes no obligation to update forward-looking statements contained inward this liberate every bit the final result of novel information or hereafter events or developments.
This liberate contains forward-looking information close a production candidate, bapineuzumab, that involves substantial risks together with uncertainties including, amid other things, the uncertainties inherent inward inquiry together with development. Influenza A virus subtype H5N1 farther description of risks together with uncertainties tin strength out locomote constitute inward Pfizer’s Annual Report on Form 10-K for the financial yr ended Dec 31, 2011 together with inward its reports on Form 10-Q together with Form 8-K.
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