Panacea Pharmaceuticals, Inc. Publishes New Findings on Diagnostic Applications of HAAH Oncology Program

GAITHERSBURG, Md., April 9 /PRNewswire/ -- Panacea Pharmaceuticals, Inc. announced today that new important findings on the diagnostic applications of its HAAH Oncology Program were published in the Proceedings of the 2003 Annual Meeting of the American Academy of Cancer Research. The findings were to be presented during that organization's recently cancelled annual meeting in Toronto, Ontario.

The HAAH Oncology Program targets the enzyme human aspartyl (asparaginyl) Beta-hydroxylase for the development of both therapeutic agents and diagnostics tests for multiple cancers.

The first paper, entitled, "Differential Expression of ASPH Gene Encoding Human Aspartyl (Asparaginyl) Beta-Hydroxylase in Cancer Versus Normal Tissues," presented findings relating to determining the differential regulation of the ASPH gene, the gene that codes for HAAH, in cancer versus normal tissues. The objective of the study was to determine whether differential regulation of the ASPH gene is consistent with observations of differential protein expression in various cancers. Differential gene expression data for 42 normal tissues (1,809 specimens) and 172 diseased tissues (2,206 specimens) were analyzed. Statistically significant up- regulation of the ASPH gene was observed in cancers of the lung, liver, urinary bladder, kidney, and ovary. Among all non-malignant tissues, only lipomas show statistically significant up-regulation. Measurement of ASPH regulation holds promise for use as a tool in the detection of cancer, potentially at an early stage. Additional studies are underway to elucidate the role of ASPH regulation in carcinogenesis, cancer progression, and cancer prognosis.

The second paper, entitled, "Human Aspartyl (Asparaginyl) Beta-Hydroxylase is a Serum Biomarker of Breast, Ovarian, and Prostate Cancer," presented the important novel finding that HAAH is detectable in the serum of individuals with cancer. The paper described the development of a highly reproducible and reliable sandwich ELISA with high specificity and sensitivity for HAAH. Initial findings showed no detectable signal in 13 of 14 normal sera with a sole positive signal of 21.1 ng/mL, positive signal for all sera from patients with ovarian (n=5) and prostate (n=5) cancers, and positive signal for 10 of 12 sera from patients with breast cancer. Of the positive cancer sera signals, 85% were greater than 67.0 ng/mL. The intra-assay variation coefficient was consistently below 5%, with a lower detection limit of 18.7 ng/mL. The company has developed an improved assay that is highly reproducible with a wide linear range. Tests to date with serum originating from prostate, ovarian, colon, and breast cancer patients have yielded a specificity of 97% (n=223) and sensitivity of 100% (n=24). The significant finding that HAAH can be detected in human sera coupled with the proven specificity of HAAH for malignant tumors as shown previously in tissue biopsies and now here in patient serum suggest that the development of HAAH-based immunoassays may provide useful diagnostic and prognostic tools for cancer patient management.

Hossein A. Ghanbari, Ph.D., CEO of Panacea stated, "We are excited by these preliminary findings and are currently conducting larger scale studies aimed at identifying specific applications of HAAH."

Background on HAAH Oncology Program

The enzyme human aspartyl (asparaginyl) Beta-hydroxylase (HAAH) is expressed on the cell surface of cancer cells and its over-expression is sufficient to induce cellular transformation, increase cell motility and invasiveness, and establish tumor formation in vivo. HAAH is found in low levels in the endoplasmic reticulum of normal liver cells where it catalyzes the Beta-hydroxylation of aspartyl and asparaginyl residues in EGF-like domains of certain proteins. Up-regulation of this enzyme in tumor cells was identified in experiments designed to characterize proteins over-expressed upon malignant transformation of human hepatocytes.

Using monoclonal antibodies directed against the enzyme, HAAH has been detected in primary tumor tissue by immunohistochemical staining in more than 99% of nearly 1000 human tumor specimens from all eighteen cancers tested to date including lung, liver, brain, colon and rectum, pancreas, prostate, ovary, bile duct, and breast. HAAH was not detected in adjacent normal tissue nor was it detected in tissue samples from normal heart, kidney, thyroid, small intestine, large intestine, pancreas, muscle, spleen, or lung.

Even partial inhibition of HAAH expression has been shown to have a beneficial effect on tumor cells, causing them to revert to a more normal phenotype as measured by the inhibition of growth, motility, and invasiveness. HAAH is over-expressed on the surface of cancer cells, potentially facilitating detection, drug delivery, and enzyme inhibition.

Panacea signed a Collaboration and License Agreement with MedImmune, Inc. in early 2002 to discover, develop, and commercialize therapeutic agents for the prevention or treatment of human disease based on Panacea's HAAH technology or its pathways. Panacea has retained all rights to develop and commercialize diagnostic products based on HAAH.

About Panacea Pharmaceuticals

Panacea Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on utilizing functional genomics and proteomics to develop therapeutics and diagnostics for diseases with substantial unmet clinical need. The Company's product development focus is on novel proteins and biochemical pathways related to cellular regulation and cell cycle abnormalities in oncology as well as neurodegenerative diseases, particularly Alzheimer's disease and Parkinson's disease.

More information is available at http://www.PanaceaPharma.com

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