Power3 Medical announced this week it has filed for a utility patent in the US covering a protein biomarker that the company says can distinguish Alzheimer’s disease from other neurodegenerative diseases.
Power3 also said that it plans to file patent applications for 46 other Alzheimer’s biomarkers, possibly next week. Headquartered in The Woodlands, Texas, Power3 is currently shopping for a partner to commercialize the biomarkers as blood-based diagnostics for Alzheimer’s disease, according to Steven Rash, Power3’s CEO and chairman.
If that happens, it would be the first such test to hit the market. But Rash backed away from a prediction he made in September that the test would be on the market by the end of the year.
Looking for protein biomarkers associated with neurodegenerative diseases is one of the hottest research areas in proteomics. But it also has been one of the most confounding because of the lack of biomarkers that can differentiate one disease, such as Alzheimer’s, from another, such as Parkinson’s, which has similar characteristics and symptoms.
Among the companies involved with Alzheimer’s biomarker research are SynX, before it was bought by Nanogen [See PM 05/20/02]; PerkinElmer and Predictive Diagnostics [See PM 04/22/05]; Proteome Sciences and Bayer [See PM 03/26/04]; and Athena Diagnostics which was purchased by Fisher Scientific in March .
During the summer researchers from Oregon Health and Science University in Portland; Baylor College of Medicine in Houston; the Fred Hutchinson Cancer Research Center in Seattle; and Applied Biosystems also said they had discovered panels of biomarkers that could segregate for specific neurodegenerative diseases, including Alzheimer’s [See PM 08/17/06].
However, no single test specifically for Alzheimer’s exists. According to the Alzheimer’s Association, an estimated 4.5 million Americans have the disease, and by 2050 that number is expected to climb to as high as 16 million. Currently, diagnosis is done primarily through observation, process of elimination, and imaging tests such as computed tomography and positron emission tomography scans.
Ira Goldknopf, director of proteomics for Power3, said the biomarker for which it has filed the patent application can specifically identify Alzheimer’s disease.
“It is able to distinguish certain Alzheimer’s-like diseases from Alzheimer’s disease,” he said. “So it’s one of 47 that have the particular ability to distinguish Alzheimer’s disease from similar disorders that have similar symptoms. This particular biomarker is the first in a series that has that capability.”
Because the biomarkers are blood-based, giving them greater utility in a potential diagnostic test, and have the ability to differentiate Alzheimer’s from other neurodegenerative disorders, they “can expedite diagnosis and offer opportunities for earlier treatment,” of the disease, Rash said.
“So it’s one of 47 that have the particular ability to distinguish Alzheimer’s disease from similar disorders that have similar symptoms. This particular biomarker is the first in a series that has that capability.”
The company continues to search for a manufacturing and marketing partner that can develop and market a diagnostic test based on its biomarkers.
“We are in discussions with numerous companies which we can’t disclose at the present time,” Rash said. He declined to say whether they were diagnostic firms or drug manufacturers.
In September the US Food and Drug Administration released draft guidance that could require homebrew tests such as the one Power3 has in mind to undergo regulatory approval. Rash told ProteoMonitor then that the company did not intend to seek US Food and Drug Administration clearance.
Rash also said then that an Alzheimer’s test could hit the market before the end of the year [See PM 09/14/06]. In an interview this week, however, he backed away from a timetable.
“It’ll happen when it happens,” he said.
In addition to Alzheimer’s biomarkers, Power3 is validating 11 biomarkers for Parkinson’s disease. The company said those biomarkers will allow researchers to differentiate Parkinson’s from other neurodegenerative diseases.
According to documents filed with the US Securities and Exchange Commission earlier this month, Power3’s IP portfolio includes 521 protein biomarkers, including biomarkers for breast cancer, leukemia, and gastrointestinal disorders, culled from more than 2,000 patient samples.
The company said it has 19 patents pending as of Sept. 30.