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Despite regulatory hurdles, PET drugs may give molecular imaging a boost

by Olga Deshchenko, DOTmed News Reporter | June 27, 2011
From the June 2011 issue of HealthCare Business News magazine

Just last month, Lantheus presented data on the full results from its Phase 2 clinical trial of Flurpiridaz at the International Conference of Non-Invasive Cardiovascular Imaging in Amsterdam.

[Read an exclusive Q & A with Dr. Jamshid Maddahi about the full results of Flurpiridaz's Phase 2 clinical trial]

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And later this year, the company plans to launch the first part of its Phase 3 trial for the agent, which will be global and involve about 100 sites.

There are currently no similar cardiac PET imaging agents at the same advanced stages of development as Flurpiridaz.

A focus on a neurodegenerative disease
Another PET agent aims to change the grim statistics around the only cause of death among the top 10 in the United States that at this point cannot be prevented, cured or slowed in its progression.

Nationwide, 5.4 million people are living with Alzheimer’s disease and the care for those who are sick will cost Americans about $183 billion in 2011, according to the Alzheimer’s Association.

Avid Radiopharmaceuticals, Inc., bought by pharma giant Eli Lilly and Company last year, is looking to bring its agent Amyvid (a Florbetapir F 18 injection) to market.

Amyvid is currently under investigation for PET imaging of beta-amyloid plaque in the brain. The drug’s value is rooted in the amyloid hypothesis, which argues that accumulated levels of beta-amyloid in the brain lead to Alzheimer’s disease.

If approved, Amyvid will be the first drug to measure amyloid deposits in the brains of living patients, potentially providing clinicians with the means for early diagnosis and intervention.

The drug got its start in 1999 at the University of Pennsylvania, where Avid founder and CEO Dr. Daniel Skovronsky began working on its development.

Skovronsky and his team first looked at dyes that were used to stain cadaver tissue to see the amyloid plaque. They then worked on a way to translate the dyes into an imaging test.

After years of medicinal chemistry research, the scientists got to Florbetapir, “a small molecule that binds very avidly to the target of amyloid plaques,” says Skovronsky.

It’s no secret that drug development is a time-consuming, expensive and complex process but Amyvid also faced a unique challenge – the absence of a readily available truth standard to validate the newly developed test.

After a lot of discussion and work with the FDA, the researchers came up with a solution. They would image volunteers who are near the end of life and who had agreed to donate their brains to research upon death. “We would compare the amyloid actually found postmortem to the amyloid that we found in the scan, and thus develop a pathology truth standard,” says Skovronsky.

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