Alzheimer's watchers are left for the moment focusing on small victories. Amarantus Bioscience Holdings recently accomplished one, completing enrollment in a planned study of 72 patients to assess the feasibility of LymPro, its Alzheimer's blood diagnostic test.
The study, known as "LP-002" was built to duplicate previous findings that showed LymPro could spot Alzheimer's disease patients (both severe and moderate cases) versus healthy controls. Amarantus released positive interim data on July 31, and the company plans to unveil full data on the predictive value of specific LymPro markers from the full trial in the weeks ahead.
LymPro measures peripheral blood lymphocytes to gauge neuronal cell function. Amarantus explains the concept as being based on the idea that Alzheimer's patients face messed up cellular mechanisms that lead to "aberrant cell cycle re-entry by neurons." The hope is that the diagnostic can eventually be launched commercially as a Laboratory Developed Test, or LDT, that can be used initially for research purposes.
|Amarantus CEO Gerald Commissiong|
Amarantus President and CEO Gerald Commissiong is clearly eager to get full results from the 72-patient trial out to the public. In a statement, he said that the company "believes this data set will further position Amarantus to successfully target our initial Research Use Only customer with LymPro as a stage-independent diagnostic."
There are plenty of obstacles ahead, however. FDA, officials are beefing up how they regulate LDTs, for one thing, which could delay use of the test. Regulators have also been hesitant to embrace Alzheimer's diagnostic tools as they come up for approval. The agency approved GE Healthcare's ($GE) Vizamyl imaging agent last year, for example, but only in conjunction with other tests in the quest for an Alzheimer's diagnosis. GE Healthcare had pursued its use as a direct diagnostic tool, and the limited approval has stunted its quest to obtain broad reimbursement. Eli Lilly ($LLY) won similar limited U.S. FDA approval for its own imaging agent Amyvid, though Medicare won't reimburse its use in most indications beyond clinical trials.
Still, others are trying. Among the concepts in the mix: U.K. researchers at King's College London and Proteome Sciences have identified 10 protein biomarkers that they believe may help predict the onset of Alzheimer's disease, and could form the basis of a blood diagnostic test.
Underscoring the challenges for all, a recent Cleveland Clinic study concluded that the failure rate for Alzheimer's disease drug development hit 99.6% from 2002-2012. In the wake of massive disappointment, researchers are focusing now on developing drugs that can hit Alzheimer's earlier, as well as diagnostics that could identify the disease early to enable the use of those new treatments.
Even so, hope remains. Amarantus licensed its LymPro test in late 2012 from MDx (formerly Provista Life Sciences), gaining technology developed by researchers at the University of Leipzig in Germany. Up until that point, it had U.S. development support including more than $3 million in National Institutes of Health grant money. At the time of that deal, Commissiong was publicly bullish about LymPro, noting in a statement that the company believed it had "significant and clinical potential as a diagnostic blood test for Alzheimer's disease."
In the coming weeks and months, we'll find out if testing data backs up that optimistic assessment.
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