ProMIS will leverage Parexel's significant data management and central nervous system (CNS) expertise for the study, which it will use as the historical control arm for its anticipated Phase 1 study of PMN310, a novel antibody that selectively targets the toxic oligomeric species of amyloid beta, a root cause of AD. The dataset will help ProMIS detect a treatment signal as early as Phase 1, potentially allowing for rapid proof-of-concept at a fraction of the expense associated with traditional clinical trials. The dataset will be made available as a communal resource for Alzheimer's researchers.
'Alzheimer's patients and their families have endured far too many late-stage therapy failures,' said
Parexel will support ProMIS on the assimilation and management of this large data set, aimed at helping the industry derive important insights to drive the development of future therapies.
'As a truly patient-focused CRO, it's an incredibly exciting time to be involved in Alzheimer's disease therapy research as we await
'The
Several highly sensitive biomarkers are currently in development that could measure neuronal injury more accurately and/or more conveniently than current standards. Significantly, this new generation of blood-based biomarkers may afford drug developers a convenient means to measure the effectiveness of potential disease-modifying therapies as early as Phase 1, sparing patients, investors and researchers the time, expense and anguish associated with late-stage clinical trial failures.
Toronto Memory Program will lead this non-interventional natural history study which will measure the concentrations of neurofilament light chain (NfL) and other blood-based biomarkers on a monthly basis for a period of six months in AD patients with early stage disease. Designed to support multiple centers and up to 100 patients, the study will evaluate the plasma concentration of these biomarkers over the course of the study as well as visit-to-visit variability. The monthly data collection mirrors the design of a Phase 1 interventional trial where monthly blood draws to evaluate plasma biomarker levels coincide with monthly treatments/infusions.
The depth of the biomarker data from the natural history study will offer a powerful historical reference group with multiple monthly data points per patient.
About
Contact:
Tel: 617 921-0808
Email: shanti.skiffington@gmail.com
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(C) 2020 Electronic News Publishing, source