Panacea Pharmaceuticals' Test Predicts Response to Therapy in Chronic Myelogenous Leukemia
November 7, 2006 - Gaithersburg, Maryland - Panacea Pharmaceuticals, Inc. will present data on their novel and proprietary cancer biomarker during the Molecular Targets and Cancer Therapeutics meeting, sponsored by the European Organization for Research and Treatment of Cancer, the National Cancer Institute, and the American Association for Cancer Research, starting today in Prague, Czech Republic. Scientists from the Institute for Hematology and Blood Transfusion in Prague, along with Company scientists, will give a presentation describing an in vitro assay to reliably predict response to imatinib (Gleevec®, or Glivec, in Europe) prior to initiation of therapy in patients with Chronic Myelogenous Leukemia (CML). This assay measures gene expression of Human aspartyl (asparaginyl) Beta-hydroxylase (HAAH). Measuring levels of expression of the HAAH gene following exposure of the patient's leukocytes to imatinib using this simple and sensitive assay is an indicator of likely response to imatinib. As well, this assay may prove useful in screening new drug candidates against CML and other cancers targeted by tyrosine kinase inhibitors such as imatinib. The 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics will be held November 7-10, 2006, in Prague, Czech Republic. This multidisciplinary meeting will be attended by more than 2,200 individuals including basic scientists, clinical oncologists, and physician-scientists from academia, government and industry.
Panacea conducted a series of experiments using blood samples from patients with CML. Prior to treatment, all patient samples had increased HAAH gene expression. Leukocytes from 39 patients were isolated from fresh whole blood prior to initiation of therapy and cultured in the presence or absence of imatinib. HAAH gene expression and BCR/ABL transcript levels were determined by real-time PCR. The leukocytes of 27 patients displayed a 30-75 percent decrease in HAAH gene expression after culture in the presence of imatinib; all of these patients showed complete molecular remission following initiation of drug therapy. The leukocytes of the other 12 patients displayed 0-25 percent reduction in HAAH gene expression, and these patients did not respond to therapy with imatinib. BCR/ABL transcript levels prior to initiation of therapy did not correlate with response to imatinib.
Earlier this year the Company began offering TK SenseSM, a diagnostic test to reliably predict response to imatinib therapy in patients with CML. This test is performed by Panacea Laboratories (www.panacea-labs.com), a division of Panacea Pharmaceuticals, in our CLIA (Clinical Laboratory Improvement Amendments of 1988) compliant facility. The TK SenseSM assay is the same as the one utilized in the experiments to be reported during the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The Company expects to launch a serum-based diagnostic test to be used in conjunction with PSA to enhance the specificity of diagnosing prostate cancer by the end of 2006, along with other tests to detect and monitor liver, lung, breast and cervical cancers during 2007 and 2008.
"We are quite excited to present these results on our diagnostic test to predict response to therapy in patients with CML during the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Prague," commented Stephen Keith, MD, MSPH, President and Chief Operating Officer of Panacea Pharmaceuticals. "Reliable prediction of patients with CML who will or will not respond to imatinib may hasten initiation of optimal therapy and potentially improve outcomes. Further, identification of patients unlikely to respond to imatinib is important from a cost perspective; annual costs for imatinib have been estimated between $30,000 and $50,000. And most importantly, the majority of Gleevec® - treated patients experience adverse events at some time during their treatment. While most of the adverse events have been mild-to-moderate, some patients have experienced more serious adverse events including severe congestive heart failure and left ventricular dysfunction. We believe that patients unlikely to respond to imatinib should not be exposed to the risk of adverse events, including these serious cardiac complications."
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 antibody conjugates with various chemotherapeutic agents as lead candidates. 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.
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