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
Except for historical information presented in this press release, matters
discussed herein may constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Forward-
looking statements are based on the opinions and estimates of management only
as of the date of this release and are subject to certain risks and
uncertainties that could cause actual results to differ materially from any
future results, performance, or achievements expressed or implied by such
statements. Factors that might cause such a difference include, but are not
limited to, uncertainties related to our access to capital, the progress,
costs, and results of any clinical trials undertaken by us, progress of our
research and development projects, and uncertainties related to whether our
product candidates would ultimately achieve commercial success. We do not
undertake any obligation to update publicly any forward-looking statement,
whether as a result of new information, future events, or otherwise unless
required by law.
Contact:
Panacea Pharmaceuticals, Inc.
Kasra Ghanbari, President
Phone 240-243-8000; FAX 240-465-0450
Kasra@PanaceaPharma.com
SOURCE Panacea Pharmaceuticals, Inc.
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Related links:
http://www.panaceapharma.com
CONTACT:
Kasra Ghanbari, President of Panacea
Pharmaceuticals, Inc., +1-240-243-8000, or fax: +1-240-465-0450,
or Kasra@PanaceaPharma.com
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