Osta clinical study identifies biomarker for Alzheimer's disease

By Lisa Kerner

Charlotte, N.C., June 13 - Osta Biotechnologies Inc. said results of a scale up clinical study of 123 subjects for the development of a novel blood test for Alzheimer's disease confirmed results of a previous study identifying a biomarker for Alzheimer's disease.

Osta's clinical study uses technology based on a key protein called Heme Oxygenase-1 (HO-1). The presence of a plasma HO-1 suppressor (HOS) activity distinguishes Alzheimer's disease patients from normal young controls (NYC), normal elderly controls (NEC), people with mild cognitive impairment (MCI) and people suffering from Parkinson's disease (PD).

The mean percent HOS activity for the Alzheimer's disease group of 68.2% was significantly greater than that of the NYC (8.6%), NEC (24.9%), MCI (38.5%) and PD (29.1%) cohorts, according to a company news release.

Currently, there are no commercial blood tests with proven utility in the evaluation of patients with sporadic (non-familial) Alzheimer's disease.

Cognitive impairment in Alzheimer's disease is assessed using Mini-Mental State Examination scores, neuropsychological tests, blood tests and neuroimaging. Genetic markers such as Presenilin-1, Presenilin-2 and mutant APP can identify uncommon cases of familial Alzheimer's disease.

"We are quite pleased with these results and are continuing to further scale up our clinical study to validate the HOS measurement and the recently identified HOS factor as a novel biomarker for the diagnosis of AD and prognosis of subjects with MCI," principal investigator Hyman Schipper said in the release.

"The development of a blood test for the early diagnosis of sporadic AD would represent a breakthrough in the management of this devastating neurodegenerative condition."

Based in Montreal, Osta is a biopharmaceutical company developing novel diagnostics and therapeutics for the aging population.

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