Amorfix Life Sciences Ltd., an early-stage product development company developing therapeutic antibodies and diagnostics targeting misfolded protein diseases, has signed an agreement with a major global pharmaceutical company to use the human Alzheimer's disease diagnostic assay in phase 1 clinical studies.

Amorfix has granted its collaborator access to its proprietary EP-AD assay technology and the company will complete assay optimization and validation prior to using the assay as part of a clinical trial to investigate the effects of a novel therapeutic for the treatment of Alzheimer's disease. The terms of the agreement have not been disclosed.

"We are very excited to be working with a world-class pharmaceutical company with the resources and expertise to assist in the further development our human Alzheimer's disease diagnostic assay technology. The company has worked very hard to create a diagnostic test that can identify patients with early-stage disease and we are gratified to have the opportunity to assist in the clinical development of new therapeutics that may offer improved treatment options for Alzheimer's disease patients" said Dr Robert Gundel, Amorfix president and CEO. "In addition, this agreement is an example of our business plan to establish effective partnerships and strategic alliances with companies that have the resources and expertise to help advance our products to clinical development and commercialization".

The EP-AD diagnostic assay is capable of identifying early-stage Alzheimer's disease patients and patients with mild cognitive impairment (MCI) who are at high risk of developing Alzheimer's disease. The EP-AD assay measures levels of Abeta aggregates, a known biomarker of Alzheimer's disease, and can also be used to monitor the effects of Alzheimer's disease treatments on Abeta aggregates, the building blocks of plaques that form in the brains of people with Alzheimer's disease.

The EP-AD Assay detects levels of aggregated Abeta in cerebrospinal fluid (CSF) samples. Results with the assay show that there is a significant increase in aggregated Abeta levels in CSF samples from Alzheimer's disease patients and patients with mild cognitive impairment (MCI) compared to age-matched control subjects. Studies with nearly 200 CSF samples demonstrate that the EP-AD assay is able to identify early-stage patients with mild cognitive impairment (MCI) with a sensitivity of 94%, higher than the sensitivity achieved with other biomarkers used as comparators in the same study. In addition, there is a statistically significant correlation between aggregated Abeta levels and mini-mental state examination (MMSE) scores in normal aged individuals suggesting that the EP-AD test may be able to capture the transition from normal aging to MCI.

More than 35 million people worldwide have Alzheimer's disease or other types of dementia. Alzheimer's disease is the most common type of dementia and accounts for an estimated 60-80 percent of cases. As the population around the world ages, the incidence of Alzheimer's disease is predicted to increase significantly. Barring a significant medical breakthrough, predictions are that cases of dementia will nearly double every 20 years, and by 2040 the number of cases around the world will quadruple to approximately 81 million people. A major stumbling block to the development of effective therapies is the absence of robust biomarkers that can be used for early detection and monitoring during clinical trials. There is an obvious need for a diagnostic tool that can properly identify patients with Alzheimer's disease in order for current therapeutics to be effective, and for enrolment into clinical trials designed to target these biomarker proteins.