Avid Announces Clinical Trial of Imaging Compound for Detection of Parkinson's Disease and Lewy Body Dementia.

* Enrollment begins at University of Michigan; study may provide insights into different causes of dementia

* AV-133 is first (18)F-labeled PET imaging compound for the specific target VMAT-2

* New program complements Avid's current development program for the early and accurate diagnosis of Alzheimer's Disease 

PHILADELPHIA -- Avid Radiopharmaceuticals, Inc. (Avid), a product-focused molecular imaging company, announced today that enrollment has begun in a proof-of-concept phase I clinical trial investigating Avid's development compound 18F-AV-133 for imaging patients with movement disorders, including Parkinson's Disease (PD) and essential tremor, and dementias, including Dementia with Lewy Bodies (DLB) and Alzheimer's Disease (AD). The compound, used with positron emission tomography (PET) imaging, targets vesicular monoamine transporters (VMAT2) in the brain and may enable more accurate and earlier diagnosis of neurodegenerative diseases. This new imaging compound may thus lead to improved disease management for patients and their caregivers. The study will be initially conducted at the University of Michigan and will involve 30 patients.

PD, a severe movement disorder, currently affects an estimated 1.5 million Americans, and DLB, one of the most common types of dementia, affects approximately 800,000 Americans. Both diseases result in losses of dopaminergic neurons in the brain. By binding to the VMAT2 transporter, Avid's 18F-AV-133 compound can image neuronal loss in the brain, making it a potentially effective biomarker for earlier detection and diagnosis of these diseases. Avid has an exclusive licensing agreement with the University of Michigan and University of Pennsylvania for use of its compounds for VMAT2 imaging.

Avid's 18F-AV-133 compound may also be useful for improved management of Alzheimer's Disease (AD) because up to 25% of AD patients also have a component of PD or DLB. The goal of this initial trial is to determine whether 18F-AV-133 PET imaging can detect losses in nigrostriatal neurons in the brains of patients with AD, PD and DLB. Patients with overlapping symptoms and disease pathology are often misdiagnosed today.

The VMAT2 study represents the second clinical stage program in Avid's development pipeline. The company, founded in 2004, is currently conducting a phase one clinical trial of its PET amyloid imaging compound for early detection of AD.

"We are very pleased to be the first clinical center to enroll subjects into this trial," said Kirk Frey, M.D., principal investigator at the University of Michigan. "Early imaging results appear to be very encouraging," he added.

The 18F-AV-133 compound is Avid's lead candidate for VMAT2 imaging in the brain, and was discovered after extensive research by Dr. Michael Kilbourn from the University of Michigan and Dr. Hank Kung from the University of Pennsylvania. "It is extremely gratifying for me to see these initial images with the 18F-AV-133 compound, based on my long-standing research in the area of VMAT2 imaging," commented Dr. Kilbourn. "The images achieved with this new generation of F-18 PET agents, as expected, appear to be superior to those obtained with earlier published PD imaging compounds," added Dr. Kung.

"This represents a critical new milestone for Avid and a successful start to our second major molecular imaging program," said Dr. Daniel Skovronsky, President and CEO of Avid. "It is also a significant step towards our goal of improving the diagnosis and management of devastating and costly neurodegenerative diseases that affect millions of people."

About Parkinson's Disease (PD)

Approximately 1% of the US population over 65 has PD (1.5 million people). PD is diagnosed by clinical criteria which can be inaccurate early in the disease course when many different movement disorders cause similar symptoms. For example, essential tremor (which affects 5 - 10 million Americans) can sometimes be confused with early PD, however therapy and prognosis of these two diseases are dramatically different. The definitive diagnosis of PD currently requires verification of degeneration of dopaminergic neurons in the brain at autopsy.

About Dementia with Lewy bodies (DLB)

DLB is one of the most common types of progressive dementia, with an estimated 800,000 people effected in the US alone. The central feature of DLB is progressive cognitive decline, combined with variations in alertness and attention, recurrent visual hallucinations, and Parkinsonian-like motor symptoms, such as rigidity and the loss of spontaneous movement. DLB subjects may also suffer from depression. DLB is closely related to Parkinson's disease dementia (PDD) which is also a Lewy body disease.

About Avid

Avid Radiopharmaceuticals, Inc. is a product-focused molecular imaging company which is developing novel diagnostic imaging agents to enable the early diagnosis, treatment selection and therapeutic monitoring of major medical disorders. The company is a pioneer in the development of molecular imaging agents for Alzheimer's disease. Avid's compounds may enable the earlier diagnosis of Alzheimer's disease and also allow researchers to better evaluate therapeutic drug candidates for the prevention or reversal of amyloid plaque build-up in the brain. Avid's technology can be used with imaging technologies such as positron emission tomography (PET) and single photon computed tomography (SPECT). Avid is currently enrolling patients in IND studies of 18F-PET agents for imaging amyloid plaques in Alzheimer's disease and for imaging the vesicular monoamine transporter (VMAT2) in diseases involving dopaminergic degeneration such as Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Recent research has shown that imaging VMAT2 may also be useful in monitoring the functional viability of beta cells of the pancreas, which is a major concern related to the status and progression of diabetes mellitus. The VMAT2 imaging program has grown out of a close collaboration with the University of Michigan as well as the University of Pennsylvania. For more information, visit www.avidrp.com.