GAITHERSBURG, Md., Jan. 17 /PRNewswire/ -- Panacea Pharmaceuticals,
Inc. announced the initiation of the pivotal, prospective multi-center
clinical study to evaluate the diagnostic performance of PC Detect(SM), the
Company's prostate cancer screening test. Patients are currently being
enrolled in this study at 15 sites in the U.S. to demonstrate that the
performance of PC Detect(SM), a simple blood test, will serve as an aid in
the detection of prostate cancer in men 50 years and older who are referred
for biopsy because of a tPSA > 4.0 ng/mL and/or an abnormal digital rectal
exam. The addition of PC Detect(SM) to the current screening methods should
reduce the number of men recommended to undergo prostate biopsies and
subsequently found to be cancer- free. PC Detect(SM) will soon be available
from Panacea Laboratories (http://www.panacea-labs.com), a division of
Panacea Pharmaceuticals, which is fully compliant with the requirements of
the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Company
anticipates submission of a Pre-Market Application (PMA) to the U.S. Food
and Drug Administration later in 2007 to facilitate development of a PC
Detect(SM) kit, which will be commercialized through clinical laboratories
around the country.
Prostate cancer is currently the most prevalent form of cancer in men
and the second leading cause of male cancer death in the United States. The
major screening tools for prostate cancer used by physicians to determine
whether to refer a patient for a prostate biopsy are the prostate-specific
antigen (PSA) and the digital rectal examination (DRE). The American Cancer
Society (ACS) recommends a PSA blood test and DRE yearly, beginning at age
50. However, some controversy exists as to the utility and predictive
validity of PSA for prostate cancer. PSA is a tissue-specific protein and
has been shown to be elevated in both benign prostate conditions as well as
prostate cancer. According to the ACS, patients with a PSA > 10 ng/mL are
recommended to have a biopsy since >50% of these men have been found to
have biopsies positive for cancer. A biopsy may be recommended for a
non-suspicious DRE result and a PSA result of between 4-10 ng/mL as 25% of
these men will also be positive for prostate cancer. DRE has a reported
sensitivity of 55%-68% in asymptomatic men, but values as low as 18%-22%
have been reported. The reported positive predictive value of DRE is
6%-33%. A cutoff value of a PSA 4.0 ng/mL at base- line has been found to
have a sensitivity of 46% with respect to the identification of cases of
prostate cancer that would occur within the next 10 years. The reported
positive predictive value of PSA in asymptomatic men is 28%-35%.
PC Detect(SM), a CLIA laboratory service, is a new method for screening
a patient's serum with a simple blood draw to help determine the likelihood
that prostate cancer is present. PC Detect(SM) is recommended for men who
have an elevated PSA and/or an abnormal DRE. PC Detect(SM) provides
information to differentiate prostate cancer from benign conditions, and to
help guide both the physician and patient regarding further diagnostic
testing and management. Human Aspartyl (Asparaginyl) Beta-Hydroxylase
(HAAH) is a cancer biomarker. HAAH has been established as an excellent
biomarker for many cancer diagnoses based upon its biochemical/cellular
properties and its known biological function. The protein is undetectable
in sera from cancer-free individuals; thus, an elevated serum protein level
of HAAH is highly diagnostic for cancer. Low/undetectable levels of HAAH,
when measured with PC Detect(SM), may obviate the need for a prostate
biopsy, despite a slightly elevated PSA. Thereby, a patient could avoid an
unnecessary biopsy with its associated morbidity and cost.
"PC Detect(SM), in combination with PSA and DRE, should significantly
enhance our ability to identify men with a high likelihood of having
prostate cancer as compared to screening with PSA and DRE alone," commented
Neal Shore, MD, of the Carolina Urologic Research Center and Grand Strand
Urology, Myrtle Beach, South Carolina, who serves as Principal Investigator
for the study. "As a practicing urologist, I look forward to using PC
Detect(SM) to enhance the quality of care for my patients and reduce the
number of unnecessary prostate biopsies."
"Initiation of the pivotal PC Detect(SM) marks a significant milestone
for Panacea. This test should improve the physician's ability to identify
men with a high likelihood of having prostate cancer, and avoid biopsies
for those with a negligible risk of cancer," observed Stephen N. Keith, MD,
MSPH, President and Chief Operating Officer at Panacea. "The addition of PC
Detect(SM) to the list of diagnostic tests offered by Panacea Laboratories;
and the FDA approval of this test and subsequent development of a kit,
provide further evidence that Panacea is a leading research, product
development and commercial life science company."
About Panacea's Oncology Platform
Panacea is pursuing the development of antibodies directed against
human aspartyl (asparaginyl) beta-hydroxylase (HAAH) as novel agents for
the treatment of cancer with liver cancer as its first intended indication.
The Company is exploring both naked anti-HAAH antibodies as well as HAAH
antibodies conjugated to chemotherapeutic agents. Panacea is also pursuing
the development of diagnostic products based on HAAH gene expression and
anti- HAAH antibodies. A test to determine responsiveness to a current
therapy of choice in patients with chronic myelogenous leukemia utilizing
HAAH gene expression is available through Panacea Laboratories. A
proprietary blood- based assay has shown high sensitivity and specificity
in the detection of a range of cancers, thus facilitating the diagnosis and
therapeutic management of disease. Initial targets for the blood-based
diagnostic products include prostate and liver cancers.
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.
More 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.
Contact:
Panacea Pharmaceuticals, Inc.
Stephen N. Keith, MD, MSPH
President & COO
Phone 240-243-8000; FAX 240-465-0450
skeith@panaceapharma.com
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, skeith@panaceapharma.com
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