Alzeca Biosciences announced successful preliminary results for ADx, its proprietary diagnostic imaging technology designed to enable diagnosis of Alzheimer’s Disease for the first time on conventional Magnetic Resonance Imaging (MRI), providing results a decade or more before the onset of symptoms of cognitive decline.

Successful development of ADx would make early and reliable Alzheimer’s testing available to millions, using scanning technology that is widely available, and at far lower cost and without the radiation of current Positron Emission Tomography (PET) scans. Earlier detection of Alzheimer’s could vastly improve the efficiency of clinical trials for new therapies by identifying appropriate candidates.

“Alzeca is building a pipeline with a multi-modality and multi-disease approach using our proprietary technology platform ADx,” Carlo Medici, Alzeca CEO, said. “Following these positive results, we will aggressively bring this unique technology to the next phase of development and pursue partnerships that will enable us to accelerate the company’s strategy.” 

Alzeca also is exploring a significant additional potential of the underlying platform of ADx, which can be modified to bind to different targets in the brain. With the modifications, the platform could be used to image and diagnose other serious neurodegenerative diseases, and even be used as a drug delivery system for those diseases. 

Related information: http://www.alzeca.com/

Initial Test Results

In peer-reviewed studies, the ADx nanoparticle demonstrated the ability to carry an encapsulated agent across the blood-brain barrier and bind precisely to amyloid plaques in the brains of test mice. Researchers were then able to obtain precise, high-resolution images of those plaques using ordinary MR equipment.

The results, along with successful preliminary toxicity studies, have prompted Alzeca to accelerate the development and testing of ADx with the goal of beginning human clinical trials in 2018. In May, the company was awarded a $322,000 grant from the Alzheimer’s Drug Discovery Foundation (ADDF) to fund the next phase of testing of ADx in canine subjects.

Related information: http://content.iospress.com/articles/journal-of-alzheimers-disease/jad151124 

Unmet Need

More than 27 million people suffer from Alzheimer’s disease today, and it is the sixth leading cause of death in the U.S. By 2050, the disease could result in a $1.1 trillion annual cost to the U.S. healthcare system. Yet there is no cost-effective, readily available, reliable way to diagnose the disease before the onset of cognitive decline – which is when current Alzheimer’s therapies have traditionally been most effective. 

ADx has the potential to confirm an Alzheimer’s diagnosis, as well as to rule out such a diagnosis. Misdiagnosed dementia patients not only receive the wrong therapies, but the cost of treating a misdiagnosed patient adds as much as $14,000 to the annual cost of treatment.

Related information: http://www.alz.org/facts/overview.asp

Powerful Technology

Alzeca’s innovative biodiagnostic platform is a nanoparticle that can encapsulate an imaging marker or other “payload” and pass through the normally impenetrable blood-brain barrier. The outside of each nanoparticle is designed to bind precisely to specific target substances in the brain, delivering the payload to that target.

ADx, the first product based on the platform, carries an MR imaging agent as its payload and targets the amyloid plaques that are the hallmark of the onset of Alzheimer’s disease, developing 10 or more years before cognitive impairment. Once ADx is bound to the plaques, beta-amyloid, the hallmark of the disease in its earliest stages, can be imaged in high resolution using a standard MRI scan.

Related information: http://www.alzeca.com/technology

MR scans are far less costly and far more readily available throughout the world than the only current alternative, a PET scan. PET scans also require the use of radioactive imaging agents that preclude routine use, while ADx would permit physicians to track the patient’s condition.