GAITHERSBURG, Md., Dec. 11 /PRNewswire/ -- Panacea Pharmaceuticals,
Inc. has initiated manufacturing of PC Detect(SM) kits, the Company's
diagnostic test for prostate cancer, under GMP conditions. Data on the
performance of the PC Detect(SM) kit will be included in a Premarket
Approval (PMA) application for this diagnostic test to be filed with the
U.S. Food and Drug Administration in early 2008. To date, PC Detect(SM) has
demonstrated sensitivity and specificity of greater than 90 percent in
identifying men with prostate cancer. PC Detect(SM) was initially launched
in May 2007 as a laboratory service by Panacea Laboratories, a division of
Panacea Pharmaceuticals; Panacea Laboratories is regulated under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform
high-complexity testing. FDA approval of a PC Detect(SM) kit will
facilitate the wider distribution and availability of this diagnostic test
through clinical laboratories and hospitals across the U.S. The Company is
seeking to identify one or more partner companies to facilitate the
distribution and commercialization of the PC Detect(SM) kit in the U.S. and
other countries.
The PC Detect(SM) kit, as with the PC Detect(SM) laboratory service,
requires a small serum sample and measures blood levels of Human Aspartyl
(Asparaginyl) Beta-Hydroxylase (HAAH), a cancer biomarker. HAAH has been
established as an excellent biomarker for many types of cancer, including
prostate cancer. The protein is typically undetectable in sera from
cancer-free individuals, thus, an elevated serum protein level of HAAH is
highly diagnostic for cancer. PC Detect(SM) is recommended as an adjunct to
the prostate specific antigen (PSA) test and the digital rectal examination
(DRE), the currently recommended prostate cancer screening methods. The
addition of PC Detect(SM) to the current screening methods should improve
the diagnosis of prostate cancer among men with prostate specific antigen
(PSA) values below the currently recommended level for prostate biopsy, and
enhance the identification of men recommended for prostate biopsy who are
likely to have prostate cancer.
Prostate cancer is currently the most prevalent form of cancer in men
and the second leading cause of male cancer deaths in the United States.
The standard-of-care screening tools for prostate cancer used by physicians
to determine whether to refer a patient for a prostate biopsy include the
prostate specific antigen (PSA) and the digital rectal examination (DRE).
The American Cancer Society (ACS) recommends that a PSA blood test and DRE
be performed annually in men > 50 years old. However, the predictive value
of an elevated PSA and/or an abnormal DRE is limited. PSA is a
tissue-specific protein and has been shown to be elevated in patients with
benign prostatic conditions as well as in patients with prostate cancer.
About 25% of men recommended for prostate biopsy with a PSA of 4-10 ng/mL
will be found to have cancer on biopsy, and a PSA > 4.0 ng/mL has a
sensitivity of 46% for identification of patients who will be found to have
prostate cancer over the next 10 years. According to the ACS, patients with
a PSA > 10 ng/mL should undergo a prostate biopsy since >50% of these men
are likely to have cancer.
However, men with PSA levels of 2-4 ng/mL are not routinely recommended
to have prostate biopsies, despite the fact that almost 24% of men with PSA
levels of 2.1 to 3.0 ng/mL will be diagnosed with prostate cancer as will
almost 27% of men with PSA levels of 3.1 to 4.0 ng/mL, according to a study
by Thompson et.al., published in 2004 in the New England Journal of
Medicine. PC Detect(SM) has demonstrated a sensitivity of greater than 90%
in identifying men with prostate cancer who have PSA levels of 2-4 ng/mL.
Punglia et.al. (2003) found that if prostate biopsies were performed only
when the PSA level is greater than 4.0 ng/mL, 82% of cancers would be
missed in those who are younger than 60 years of age, and 65% would be
missed in those who are 60 or older. As such, PC Detect(SM) may aid in the
identification of a significant number of men with prostate cancer at an
earlier stage and facilitate improved outcomes.
"Initiating manufacture of GMP PC Detect(SM) kits represents
achievement of a significant milestone in the development of Panacea's
HAAH-based cancer diagnostic tests," commented Hossein Ghanbari, Ph.D.,
Chairman, CEO and CSO at Panacea. "We are on schedule to submit the PMA for
PC Detect(SM) to FDA early next year, and we are aggressively seeking to
identify a partner for the commercialization of this along with our other
cancer diagnostic tests for distribution and commercialization in the U.S.
and other countries."
About Panacea's Oncology Platform
In addition to PC Detect(SM), Panacea offers, CC Detect(SM), a
diagnostic test to aide in the detection of colo-rectal 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
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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