November 14, 2007 - Gaithersburg, Maryland - Panacea Pharmaceuticals, Inc. announced today that CC Detect®, the Company's serum-based colon cancer diagnostic test, is now available from Panacea Laboratories. CC Detect® 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 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® 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® 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 PC Detect®, Panacea offers, CC Detect®, a diagnostic test to aide in the detection of colo-rectal cancer, LC Detect®, a diagnostic test to aide in the detection of patients with lung cancer, BC Detect®, a diagnostic test to aide in the detection of recurrence of breast cancer, and TK Sense®, 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 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