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Adlyfe Study on the Detection of Misfolded Proteins Published in the Journal Transfusion

Misfolded Protein Diagnostic (MPD) Shown to be Sensitive and Specific Technology Applicable for the Detection of a Host of Amyloid Neurological

Diseases including Creutzfeldt-Jakob Disease (CJD), Alzheimer's, and

Parkinson Disease

ROCKVILLE, Md., Aug. 29 /PRNewswire/ -- Adlyfe, a private company developing novel diagnostic testing technologies for early targets of amyloid diseases, announced today the publication of a study, "Detection of misfolded prion protein in blood with conformationally sensitive peptides," in the August 2007 issue of the journal Transfusion. The monthly publication is the official peer-reviewed journal of the AABB, formerly known as the American Association of Blood Banks.

The published study examined the ability of Adlyfe's Misfolded Protein Diagnostic (MPD) to detect the presence of misfolded proteins in brain, serum and plasma. Study results demonstrated that Adlyfe's MPD assay is a sensitive and specific test for the detection misfolded prion proteins that may be useful in both preclinical and clinical diagnosis transmissible spongiform encephalopathy (TSE) diseases in both animals and humans.

Scientists have tried to develop a preclinical diagnostic test for TSE since the discovery that humans with variant Creutzfeldt-Jakob disease can transmit disease via blood transfusions, though there are several challenges to detecting misfolded proteins in the blood. The coexistence of a large amount of the protein in its normally folded shape and the fact that misfolded proteins do not trigger an immune system response that would enable diagnosis based on the detection of antibodies. In addition, most standard detection methods are not sensitive enough to detect the low level of misfolded proteins in the blood, especially during early disease stages. These challenges have largely restricted diagnostic tests for amyloid diseases to the use of postmortem tissue.

Adlyfe's novel technology is based on the synthesis of conformationally sensitive peptides (chains of amino acids that are smaller than proteins) which are created to target specific protein shapes associated with various diseases. The interaction of the target protein with Adlyfe's proprietary peptides produces a conformational change that transduces a fluorescent signal. Further amplification of the signal is generated as additional ligands undergo conformational changes. This is the basis for the tests' sensitivity and ability to detect very low amyloid protein levels before symptoms occur.

"The publication of this study validates the utility and sensitivity of our MPD assay in detecting misfolded proteins in TSE, even at low levels," said Chief Executive Officer Alan S. Rudolph, Ph.D. "We believe our test meets the dual diagnostic demands of confirmatory testing in symptomatic subjects suspected of having the disease and as a screening test to identify infection in its earliest phases. Our unique diagnostic approach and technology is applicable to a number of neurological diseases associated with protein buildup in tissues such as Creutzfeldt-Jakob disease (CJD), Alzheimer's, and Parkinson Disease."

About Adlyfe

Adlyfe Inc. was established early in 2003 to develop novel technologies for blood testing for early targets of amyloid diseases. Adlyfe is developing a novel test for the detection and amplification of amyloid proteins as early biomarkers of fatal brain and amyloid diseases such as Alzheimer's disease, Parkinson's disease, Creutzfeldt-Jacob disease, Huntington's disease, systemic amyloidosis, diabetes and other diseases.

The Company's novel technology is based on the synthesis of small peptide, or Pronucleon(TM) ligands, that are amino acid sequence matched to target amyloids of interest. Ligand sequences are selected based on regions of the target protein known to undergo conformational changes (structural changes in shape) associated with amyloid aggregation (and eventual amyloid plaque formation). These aggregates are associated with disease state progression in a number of brain-wasting and amyloid diseases.

Adlyfe, a privately-held corporation, was initially funded by the Defense Advanced Research Projects Agency (DARPA), the U.S. Army Medical Research and Materiel Command, the National Heart, Lung and Blood Institute, and Britain's Department for Environment, Food and Rural Affairs. More recently, Adlyfe raised additional funding with venture capital firms Canaan Venture Partners and Burrill Associates.

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Janine McCargo


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