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Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma

- Phase II Trial Shows Increase in Mature Dendritic Cells -

WAYNE, N.J., June 30 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals today confirmed that results of a Phase II trial were published in the July 1 edition of the Journal of Clinical Oncology. The study showed that Leukine(R) (sargramostim) demonstrated a median overall survival of 65 months and increased mature dendritic cells in high-risk melanoma patients. Dendritic cells are special antigen-presenting cells that help the immune system recognize cancer cells and are the most effective antigen-presenting cells known. Study authors concluded that this increase in dendritic cell counts may also correlate with delayed recurrence of disease.

"These data provide early signals that Leukine may offer clinical benefit in this patient group by increasing and differentiating dendritic cells and perhaps by benefiting patients who have lowered baseline levels of dendritic cells," said Dr. Adil Daud, first author of the study and Associate Professor, Director, Clinical Research, University of California, San Francisco Melanoma Center. "Patients who experienced an increase of dendritic cells were more likely to demonstrate delayed disease recurrence."

In this Phase II prospective trial, 42 patients with resected high-risk (Stage IIIB, IIIC or IV) melanoma were treated with Leukine (125 mcg/m2/day for 14 consecutive days followed by 14 days of no treatment). This regimen was repeated for 13 cycles unless patients had unacceptable toxicity or showed evidence of disease recurrence. Patients had no evidence of disease at the start of the trial as measured by imaging. Patients underwent restaging every four months. The most common adverse events found in the study were injection site reactions (88 percent), pain (61 percent), arthralgia/myalgia (61 percent), fatigue (61 percent), flu-like symptoms (39 percent) and insomnia (27 percent).

Of the 42 enrolled patients, 39 were available for clinical outcome and dendritic cell analysis. Results showed that the median overall survival was 65 months (95 percent, CI 43-67 months). Median recurrence-free survival was 5.6 months (95 percent, CI 3.7-11 months). Additionally, 11 patients who relapsed within three months of starting Leukine had lower dendritic cell counts at two weeks compared to those who relapsed after three months and those who remained in remission throughout the course of the study. However, the ability of Leukine to induce mature dendritic cells appeared to be confined to those patients who had low dendritic cell count before the start of treatment.

"We are encouraged about the potential of Leukine in high-risk melanoma in this trial," said Paul MacCarthy, M.D., F.R.C.P.I., vice president and head of U.S. Medical Affairs for Bayer HealthCare Pharmaceuticals. "We look forward to additional research supporting Leukine's promise in this area as part of our ongoing commitment to provide patients with effective and safe medicines."

About The Study

In addition to clinical outcomes, patients underwent phenotype analysis of dendritic cells. Dendritic cell phenotypic analysis was performed at baseline and again at two, four, eight and 12 weeks. Control values for this analysis were established prior to the trial using eight healthy volunteers. Two weeks of treatment with Leukine resulted in a significant increase in the proportion of total mature dendritic cells as defined by expression of CD86, CD83, CCR7 and CD40 molecules. Further, results show that Leukine increased dendritic cell populations in patients who started the study with lower than normal levels of dendritic cells, but had no effect on patients who started the trial with normal levels.

About Leukine(R)

Leukine(R) (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991, and is marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults 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

Leukine has been used to treat nearly 250,000 cancer patients in the U.S. since 1991. 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/mm(3) or if platelet counts 500,000 mm(3), 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 business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. 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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