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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


The most exciting thing about such pharmaceuticals is the potential to use them earlier in the progress of the disease. “That’s the shift in the therapeutic world that we’re probably going to see this decade,” says Carrillo.

Another company working on a PET imaging drug to detect amyloid plaque is GE Healthcare. Its flutemetamol agent is close to finishing the Phase 3 program and the company plans to file an application with the FDA later this year.
According to Allis, GE is looking at an integrated approach to Alzheimer’s disease. “We’re particularly interested in how PET and MRI will be used together in both the diagnosis of Alzheimer’s disease and also in therapy monitoring of the disease,” he says.

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GE is also collaborating with Johnson & Johnson in developing a biosignature for Alzheimer’s, a project that’s in its early stages. The companies hope to develop a blood-based test that can help determine who should be specifically tested with a more complex imaging test for the disease, Allis says.

As for Amyvid, Skovronsky refrains from speculating on a timeline for the agent’s approval, only saying that Avid and Lilly are working with the FDA to complete the training program “as quickly as possible.”

In development for oncology
In addition to neurodegeneration, GE is also working on several PET agents for imaging cancer. One of its drugs, fluciclatide, could be used for imaging angiogenesis, and is currently in Phase 2 trials.

There is a huge class of anti-angiogenic drugs, says Allis, worth about $8 billion. If and when GE’s angiogenesis agent gains approval, it can be used to track changes in response to a specific therapy.

Instead of having a patient take a particular drug for months only to find it’s not effective, a PET exam with the agent can determine the response within weeks, explains Allis, thus reducing both the potential of unpleasant side effects for the patients and the associated costs.

GE plans to progress fluciclatide into Phase 3 next year.

Researchers within Siemens’ Molecular Imaging Biomarker Research facility are also developing a number of novel oncology PET biomarkers “that image the key hallmarks of cancer,” says PETNET’s Plut. Several Siemens’ agents are currently in Phase 1 or 2 clinical trials, with a cellular proliferation agent preparing to start Phase 3 trials.

A class of their own?
Although many PET drugs are currently on track to FDA approval, the journey is complicated and, increasingly, costly.

Dr. Mark Hibberd, senior medical director, global medical affairs and pharmacovigilance with Lantheus, has been in the clinical trial research industry for about 20 years. He says drug development costs have gone up and are likely to keep climbing.

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