GAITHERSBURG, Md., Nov. 14 /PRNewswire-FirstCall/ -- Panacea
Pharmaceuticals, Inc. announced today that CC Detect(SM), the Company's
serum- based colon cancer diagnostic test, is now available from Panacea
Laboratories. CC Detect(SM) is a simple blood test that should facilitate
the identification of individuals with cancer of the colon and rectum when
used in conjunction with standard screening methods. Panacea Laboratories,
a division of Panacea Pharmaceuticals, is certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). The blood sample can be
ordered by any physician and sent to Panacea for testing; sample and
shipping requirements are available at http://www.panacea-labs.com.
Colorectal cancer -- cancer of the colon or rectum -- is the third most
common type of cancer diagnosed in the US. 153,760 new colorectal cancer
cases and 52,180 deaths due to colorectal cancer are expected in 2007. In
an effort to detect colorectal cancer in its earliest stages, The American
Cancer Society (ACS) and similar organizations have published guidelines
for colorectal screening. It is recommended that most people begin
colorectal screening at age 50 and that this screening be repeated at
specific time intervals. Approximately, 5-10% of all colorectal cancers
occur in people who are at "high risk," defined as much greater than twice
the average risk. An additional 15-20% of colorectal cancers occur in
people at "increased risk," defined as approximately twice average risk. It
is recommended that people at high and increased risk for colorectal cancer
begin screening at a younger age and have screening repeated more
frequently. Factors associated with an increased or high risk of colorectal
cancer can be divided into two categories: personal, and hereditary or
familial. Personal risk factors include: a history of colorectal cancer
that has been completely removed and, to a lesser extent, a history of
ovarian, uterine or breast cancer; a history of polyps, especially large
adenomatous polyps; a history of inflammatory bowel disease, particularly
ulcerative colitis and Crohn's disease; a high fat, low-fiber diet; a
sedentary life-style; obesity; cigarette smoking, both currently and in the
past; heavy alcohol use; and diabetes. Other possible personal risk factors
for colorectal cancer include a history of working the night-shift several
nights a week for at least 15 years and previous radiation treatment for
prostate cancer. Familial and hereditary risk factors include: having a
close relative who had colorectal cancer before age 60; family history of
polyposis syndromes and hereditary non-polyposis syndromes;
African-American background; and Ashkenazi Jewish background. Frequent
testing with colonoscopy, sigmoidoscopy, double contrast barium enemas and
fecal occult blood tests are performed in these high-and increased risk
populations. The age at which this intensive screening should begin depends
on the actual risk factors. For example, it should begin at puberty for
those with a history of familial adenomatous polyposis, at 12 -15 years
after the onset of left- sided inflammatory bowel disease and, if an
immediate relative has had colorectal cancer, at 10 years before the age
that the relative was diagnosed.
Failure to diagnose colorectal cancer before it has spread can have
disastrous consequences. The 5 year relative survival rates are 89.8% for
localized disease, 67.7% for regional disease, and 10.3% for metastatic
disease. Even persons who know that they are at high risk and increased
risk for colorectal cancer, however, are often non-compliant or poorly
compliant with screening recommendations because they perceive the tests to
be embarrassing, unpleasant and time-consuming. In addition, many people
who are at higher-than-average risk do not know that they are particularly
at risk nor do their physicians always inform them of their risk.
Furthermore, each test has its drawbacks in terms of sensitivity and
specificity, and some tests are associated with potential complications.
CC Detect(SM) measures levels of human aspartyl (asparaginyl) beta-
hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been
detected by immunohistochemical staining (IHC) in a broad range of cancers
including colon cancer. In addition, HAAH protein levels in serum have been
demonstrated to be highly sensitive and specific for cancer in hundreds of
patients with a range of cancer types, including colon cancer. Increased
levels of HAAH have been found in the serum of 99% of individuals with
colorectal cancer (n=145). In individuals not known to have cancer, HAAH
was essentially undetectable in serum. HAAH was elevated in serum from
individuals with all stages of colorectal cancer; mean serum HAAH levels
for stages I - IV were 33, 29, 24 and 34 ng/ml, respectively.
"CC Detect(SM) provides information to differentiate individuals who
have colorectal cancer from those who do not have cancer; it should be
performed in individuals at increased and high risk as per the ACS
recommendations for their particular risk factors," commented Pamela Jo
Harris, MD, Vice President, Medical and Clinical Affairs at Panacea. "An
elevated HAAH value should be interpreted by the physician in conjunction
with a physical exam and the results of the screening tests recommended by
the ACS, which should facilitate earlier identification of recurrent
disease and prompt initiation of appropriate therapy. Detection and prompt
treatment of early colorectal cancer is likely to result in improved
outcomes and fewer deaths attributable to the disease."
About Panacea's Oncology Platform
In addition to CC Detect(SM), Panacea offers, PC Detect(SM), a
diagnostic test used in conjunction with PSA and digital rectal exam to
identify patients with prostate cancer, LC Detect(SM), a diagnostic test to
aide in the detection of patients with lung cancer, BC Detect(SM), a
diagnostic test to aide in the detection of recurrence of breast cancer,
and TK Sense(SM), which determines whether white blood cells from patients
with chronic myelogenous leukemia (CML) are sensitive or resistant to
imatinib, the therapy of first choice for CML patients, prior to initiation
of therapy. The HAAH serum assay will be further developed as a diagnostic
test for other types of cancer.
Panacea is also pursuing the development of antibodies directed against
HAAH as novel agents for the treatment of cancer with liver cancer as the
first therapeutic indication. The Company is exploring both naked anti-HAAH
antibodies as well as HAAH antibodies conjugated to chemotherapeutic agents
and toxins. PAN-622 is an all-human sequence anti-HAAH monoclonal antibody
that has demonstrated excellent efficacy in animals, and is currently in
development as a cancer therapeutic.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is a privately-held biopharmaceutical
company focused on the development and commercialization of therapeutics
and diagnostics for diseases with substantial, unmet clinical needs. The
Company's product development strategy is based on novel therapeutic agents
and approaches for cancer treatment, as well as acute and chronic
neurodegenerative conditions, such as hypoxia-induced neurological insult,
Parkinson's Disease, and Alzheimer's Disease. Panacea has an extensive
patent portfolio covering its neurodegenerative and oncology technologies.
Panacea Laboratories is a division of Panacea Pharmaceuticals, Inc.
Additional information about the Company 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.
SOURCE Panacea Pharmaceuticals, Inc.
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Related links:
http://www.panaceapharma.com
http://www.panacea-labs.com
CONTACT:
Stephen N. Keith, MD, MSPH, President & COO
of Panacea Pharmaceuticals, Inc., +1-240-243-8000, Fax,
+1-240-465-0450, keith@panaceapharma.com
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