December 11, 2007 - Gaithersburg, Maryland - Panacea Pharmaceuticals, Inc. has initiated manufacturing of PC Detect® kits, the Company's diagnostic test for prostate cancer, under GMP conditions. Data on the performance of the PC Detect® 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® has demonstrated sensitivity and specificity of greater than 90 percent in identifying men with prostate cancer. PC Detect® 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® 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 Detectsm kit in the U.S. and other countries.
The PC Detect® kit, as with the PC Detect® 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® 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® 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® 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® 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® 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 Detectsm 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®, 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.
Panacea Pharmaceuticals, Inc.
Stephen N. Keith, MD, MSPH
President & COO
Phone 240-243-8000; FAX 240-465