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Prometheus to Present New Data on Proprietary Oncology Diagnostic Platform at ASCO Annual Meeting

Wednesday, June 2, 2010 General News J E 4
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Additional Data to be Presented from PROLEUKIN(R) and ProOnc TumorSourceDx Studies

SAN DIEGO, June 2 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced that it will report new data on its proprietary oncology diagnostic platform, a novel technology that forms the basis of the Company's recently announced collaboration with Bayer Schering Pharma AG. The new data will be highlighted in three separate presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago:

  • Analysis of truncated HER2 expression and activation in breast cancer, a poster presentation by Sharat Singh, Ph.D., Vice President of Diagnostic R&D for Prometheus, on Saturday, June 5 from 2:00 pm to 6:00 pm (CDT)
  • Use of SPARC, EGFR, and VEGFR expression to predict response to nab-paclitaxel (nabP)/carboplatin (C)/bevacizumab (B) chemotherapy in triple-negative metastatic breast cancer (TNMBC), a poster presentation by Erika Hamilton, M.D., Duke University Medical Center, on Saturday, June 5 from 2:00 pm to 6:00 pm (CDT)
  • Clinical relevance of HER2 expression/activation, as measured in circulating tumor cells by a multiplexed immunoassay, in women with HER2-negative (by FISH) metastatic breast cancer (MBC), a poster presentation by  John Hainsworth, M.D., Sarah Cannon Research Institute, on Monday, June 7 from 8:00 am to 12:00 noon (CDT)

Data will also be presented from independent studies of PROLEUKIN® (aldesleukin), a recombinant human interleukin-2 for treatment in adults with metastatic melanoma and metastatic renal cell carcinoma. Prometheus began selling Proleukin in the United States in February 2010 under a commercialization agreement with Novartis. The presentations include:

  • The high-dose aldesleukin (HD IL-2) "SELECT" trial in patients with metastatic renal cell carcinoma (mRCC), an oral presentation by David McDermott, M.D., Beth Israel Deaconess Medical Center, on Tuesday, June 8 at 10:15 am (CDT)
  • A phase II study of bevacizumab (B) and high-dose aldesleukin (IL-2) in patients (p) with metastatic renal cell carcinoma (mRCC): A Cytokine Working Group Study (CWGS), an oral presentation by Uday Dandamudi, M.D., Dartmouth-Hitchcock Medical Center, on Tuesday, June 8 at 10:30 am (CDT)

In addition, data from a study of ProOnc TumorSourceDx, one of three microRNA-based diagnostic tests promoted by Prometheus in the United States, will be highlighted:

  • Prospective gene signature study using microRNA to predict the tissue of origin (ToO) in pts with cancer of unknown primary site (CUP), a poster presentation by Gauri Varadhachary, M.D., University of Texas M.D. Anderson Cancer Center, on Sunday, June 6 from 2:00 pm to 6:00 pm (CDT)

About Prometheus' Oncology Diagnostic Platform

Prometheus' proprietary oncology diagnostic platform has the ability to measure the expression and activation of specific cancer pathways with high levels of sensitivity and specificity. In March 2010, the Company entered into a collaboration agreement with Bayer Schering Pharma AG in an effort to stratify patients to appropriate drug candidates and potentially accelerate the development of Bayer's novel oncology therapeutic products. In addition, Prometheus' proprietary oncology diagnostic platform may be used in the clinical setting to enable real-time molecular profiling, monitor drug effectiveness and direct the use of a growing number of targeted therapies.

About Proleukin

PROLEUKIN® (aldesleukin) for injection is a recombinant human interleukin-2 for treatment in adults with metastatic melanoma and metastatic kidney cancer. Proleukin therapy is a form of immunotherapy that enhances the body's natural immune system to help fight these types of cancer. Proleukin has been used for over 10 years in the treatment of metastatic melanoma and over 15 years in the treatment of metastatic kidney cancer (renal cell carcinoma). For complete prescribing information, please visit www.Proleukin.com.

Important Safety Information

Therapy with PROLEUKIN® (aldesleukin) for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

About ProOnc TumorSourceDx

ProOnc TumorSourceDx (sold as miRview(TM) mets outside the U.S.) helps identify the tissue-of-origin of a metastatic tumor. The test identifies 25 different tumor types, including colon, liver, brain, breast, kidney, lung, ovary, pancreas, prostate and testis, and measures the expression level of 48 microRNA biomarkers. ProOnc TumorSourceDx uses a proprietary classifier to assign a primary site to the cancer sample based on the microRNA expression in the tumor.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California.

PROLEUKIN is a registered trademark of Novartis.

ProOnc TumorSourceDx is a trademark of Prometheus Laboratories Inc.

miRview(TM) mets is a trademark of Rosetta Genomics Ltd.

SOURCE Prometheus Laboratories Inc.

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