October 17, 2007: Gaithersburg, Maryland — Panacea Pharmaceuticals, Inc. announced today that BC Detect®, the Company’s serum-based breast cancer diagnostic test, is now available from Panacea Laboratories. BC Detect® is a simple blood test that should facilitate the identification of recurrence among women successfully treated for breast cancer. 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.
Breast cancer is the most common type of cancer in women accounting for 26% of female cancers. One in every eight women will develop breast cancer in their lifetime, placing the lifetime risk at 13%. More than 200,000 new cases of breast cancer will be diagnosed in the United States in 2007 and upwards of 2 million women are currently breast cancer survivors. Five-year survival rates for breast cancer are 98% for localized disease, 83% for regionally spread and 26% for distantly spread cancer. However, 25% of all metastases occur more than 5 years after the initial diagnosis and thus survival rates decrease as time goes out to 10 years due to disease recurrence. Methods to detect initial presentation of breast cancer as well as recurrence rely on imaging modalities, including mammography and MRI. No serum biomarkers have been approved for either primary breast cancer screening or monitoring for disease recurrence primarily due to relatively low specificities and sensitivities. In asymptomatic women in remission from breast cancer the guidelines of the major oncologic organizations only suggest annual mammography for detection of new tumors.
BC Detect® measures levels of human aspartyl (asparaginyl) β-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been detected by immunohistochemical staining (IHC) in a broad range of cancers including breast 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 breast cancer. Increased levels of HAAH have been found in the serum of 96% of women with breast cancer (n=157). In women not known to have cancer, HAAH was essentially undetectable in serum (n=32, specificity = 91%). HAAH was elevated in serum from women with all stages of breast cancer; mean serum HAAH levels for stages I — IV were 19, 13, 21 and 15 ng/ml, respectively. In addition, serum from women currently in remission (n=35) following treatment for breast cancer were also analyzed and found to be negative for HAAH.
"Measurement of serum HAAH levels using BC Detect® has great promise as a diagnostic tool to monitor women with a history of breast cancer for disease recurrence", commented Pamela Jo Harris, MD, Vice President, Medical and Clinical Affairs at Panacea. "BC Detect®, in conjunction with routine follow-up imaging modalities should facilitate earlier identification of recurrent disease and prompt initiation of appropriate therapy".
About Panacea's Oncology Platform
In addition to BC Detectsm, Panacea offers, PC Detect®, a diagnostic test used in conjunction with PSA and digital rectal exam to identify patients with prostate cancer, LC Detect®, a diagnostic test to aide in the detection of patients with lung 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 athttp://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