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Digilab Expects Patent for Alzheimer's Peptide Marker in Two Months; Eyes Dx

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Digilab BioVision last week said it may soon receive patent protection for one of 30 peptide biomarkers it discovered that it believes can help diagnose Alzheimer’s disease.
While numerous researchers and companies hunt for protein biomarkers linked to neurodegenerative diseases, less work has been done to identify peptide biomarkers, even though some experts assert that peptides can provide greater indication of disease.
 
Digilab researchers culled the biomarkers from nine protein molecules using the company’s proprietary Peptidomics technology. The team analyzed 312 cerebrospinal fluid samples taken from Alzheimer’s disease patients; patients suffering with primary dementia disorder; and patients with normal cognitive profiles.
 
The company, based in Hannover, Germany, received a Note of Allowance from the US Patent and Trademark Office last week and expects to receive a patent for one of the the 30 biomarkers within the next two months, said Leif Honda, director of business developer for Digilab.
 
Company officials said they are now in the process of searching for a partner to develop a blood-based diagnostic based on the biomarkers to be used in clinical settings.
 
It’s the Peptides, Stupid
 
Digilab’s discovery comes as the search for neurodegenerative disease biomarkers approaches fever pitch. During the past few months, two studies, in particular, caught the attention of the protein and proteomic research community.
 
In August, scientists from the University of Washington, Oregon Health and Science University in Portland, Baylor College of Medicine in Houston, the Fred Hutchinson Cancer Research Center in Seattle, and Applied Biosystems said they had discovered biomarkers that could differentiate Alzheimer’s disease from Parkinson’s disease and dementia with Lewy body disease [See PM 08/17/06].
 
Then in December, researchers at Cornell University said they had found 23 biomarkers in CSF associated with Alzheimer’s [See PM 12/21/06].
 
Those two studies, however, looked at protein biomarkers and were based on proteomic techniques. By contrast, Digilab did a peptidomic study on its CSF samples.
 
“Alzheimer’s is a disease which is connected with degenerative processes,” said Hartmut Selle, a project manager at Digilab. “The hypothesis was that the product of degeneration should show up in cerebrospinal fluid, and what are degraded are proteins, and the resulting product is peptides.”
 
In 2004, researchers using Ciphergen’s SELDI ProteinChip platform discovered N-terminally truncated Abeta42 peptides in CSF. To date, that research has not progressed into anything material, but Digilab officials said peptide biomarkers, nonetheless, offer advantages over protein biomarkers.
 
By taking a peptidomic approach, Digilab researchers were able to analyze the CSF samples at the cellular level, according to Andrew Peck, director of medical research and applications for the company’s North American operations.
 
“The proteomic research tends to look a little further up the spectrum,” Peck said. “We’re looking at the lower part of the spectrum. There’s a lot of cellular dynamics that are expressed, or there’s information about cellular dynamics at that lower end of that spectrum.
 

While numerous researchers and companies hunt for protein biomarkers linked to neurodegenerative diseases, less work has been done to identify peptide biomarkers, even though some experts assert that peptides can provide greater indication of disease.

“Peptides can be bioactive molecules, but they also are indicative of the actual protein synthesis process,” he said. “Looking at posttranslational modification, typically peptides are released during that process, so we have information about what’s going on in terms of protein synthesis at the cellular level.
 
“And the third component why we’re pursuing peptidomics and why we think this gives us a little bit of a competitive advantage is that peptides are also produced during the degradation of proteins,” said Peck.
 
The upshot of it all is that peptide biomarkers have the potential to diagnose Alzheimer’s disease earlier and characterize it better, Digilab officials said. Treatments can then be individually tailored based on the disease stage of a patient and the type of treatment to which the patient best responds.
 
“That really opens up the gates for personalized medicine, to be able to use the actual indications of the body through the peptides to fine-tune the therapy or diagnostic to support the patient’s needs,” said Honda, the business development director.
 
Digilab is now looking for a partner to try to turn the biomarkers into a point-of-care diagnostic test — a step that will take years with no guarantee of success. Honda said the company has been in discussion with undisclosed drug and diagnostic firms.
 
The company has a track record with big pharma. In late August Digilab said it had renewed a peptide biomarker-discovery and -validation partnership with Novartis, building on an agreement begun in 2004 [See PM 08/31/06].
 
Digilab also signed on with Boehringer Ingelheim in March to identify new biomarkers, and in 2005 it said it would help Abbott identify biomarkers for lung cancer.
 
Digilab has about 15 areas on which it is focusing its research, Honda said. The major ones are Alzheimer’s disease, breast and lung cancer, and diabetes.

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