Bayer Announces Leukine(R) Data Presentations At 45th American Society Of Clinical Oncology (ASCO) Annual Meeting

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 30 May 2009 - 1:00 PDT

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Bayer Healthcare Pharmaceuticals Inc. announced that several studies evaluating the use of Leukine(R) (sargramostim) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting.

"We are excited to see that several studies of Leukine have been accepted at ASCO," said Pam Cyrus, MD, vice president, Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals.

Leukine data highlights include the following:

Chemotherapy-Induced Neutropenia

-- Budget impact analysis of sargramostim use in patients with chemotherapy-induced neutropenia

-- Lead investigator: M. Duh, Analysis Group, Inc., Boston, MA

-- Abstract e20596, Publication only

Melanoma

-- Immunological effects and clinical outcomes in patients with high-risk melanoma given adjuvant therapy with granulocyte-macrophage colony stimulating factor (GM-CSF, sargramostim)

-- Lead investigator: Lynn Spitler, Northern California Melanoma Center, Saint Mary's Medical Center, San Francisco, CA

-- Abstract e20004, Publication only

Follicular Lymphoma

-- Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results

-- Lead investigator: S. J. Schuster, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA

-- Abstract 2, Plenary Presentation, Sunday, May 31, 1:00 PM to 4:00 PM, Level 2, West Hall D2

Neuroblastoma

-- A phase III randomized trial of the chimeric anti-GD2 antibody ch14.18 with GM-CSF and IL2 as immunotherapy following dose intensive chemotherapy for high-risk neuroblastoma: Children's Oncology Group (COG) study ANBL0032

-- Lead investigator: A. L. Yu, Children's Oncology Group

-- Abstract 10067z, Oral Presentation, Tuesday, June 2, 8:00 AM to 10:45 AM, Level 3, W304E

About Leukine(R)

Leukine(R) (sargramostim) is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults (older than 55) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the U.S. for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation and bone marrow transplantation failure or engraftment delay. Leukine is available in two formulations, both of which are suitable for IV infusion and subcutaneous injection:

-- Liquid: 500 mcg/mL sterile solution in multi-use vial

-- Lyophilized powder: 250 mcg in single-use vial ready for sterile reconstitution

Among its indications, Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML.

Important Safety Considerations

Leukine is contraindicated in patients with excessive leukemic blasts in bone marrow or peripheral blood (10 percent), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated. Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration. Adverse events occurring in 10 percent of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, and anorexia. If ANC 20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed. Leukine therapy should be discontinued if disease progression is detected during treatment.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-looking Statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Source: Bayer Healthcare Pharmaceuticals Inc

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