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ASCO: NovantroneŽ (Mitoxantrone for Injection Concentrate) May Help in Prostate Cancer SEATTLE, WA -- May 18, 2001 -- A study of Novantrone® (mitoxantrone for injection concentrate) in hormone naive patients with prostate cancer who had failed radiation or surgery, demonstrated that Novantrone improved a standard measure for prostate cancer, the prostate specific antigen (PSA) test. Data were presented at the American Society of Clinical Oncology meeting in San Francisco this week. "I am encouraged by the improvement of PSA scores that Novantrone has elicited in these patients," said E. David Crawford, M.D., Professor of Surgery and Radiation Oncology, University of Colorado, Denver, Colorado. "The results of this study support the need for further evaluation of this new approach to the treatment of hormone naive prostate cancer patients." PSA is a protein produced by prostate cells. A small amount of PSA enters the circulation, and its presence can be measured in the blood. The higher the PSA level, the greater the chance that cancer is present and has spread beyond the prostate. In the study presented, 22 patients who had undergone radical prostatectomy or radiation therapy and failed treatment as demonstrated by a PSA blood test, were treated with 10 mg/m2 of Novantrone initially, followed by a 12 mg/m2 dose every 21 days for a maximum of eight cycles. A PSA blood test was then performed to determine if therapy was effective. The study demonstrated an average decrease in PSA of 42.5 percent after six months of treatment. In addition, four of 22 patients experienced a PSA decrease of greater than 50 percent. (The clinical significance of a fall in PSA concentration after chemotherapy is unclear.) Novantrone was generally well-tolerated in this study. No grade 3 or 4 non-hematologic toxicity was reported. Three patients had grade 3 or 4 neutropenia without fever. "The improvement in PSA scores indicates that Novantrone should be studied further to see if it can control prostate cancer, in addition to reducing pain associated with prostate cancer, for which it is already used in combination with corticosteroids," said Richard Stead, M.D., Immunex vice president, clinical development. "We are pleased with the results of the study presented this week at ASCO, and now Novantrone is being tested in two larger-scale clinical studies, that we hope will show whether it offers additional benefit in this devastating disease." The Southwest Oncology Group has two ongoing clinical trials with Novantrone. The first is recruiting men at high risk of failing radical prostatectomy. The combination of six cycles of Novantrone and hormone therapy is being compared to hormone therapy alone. A second clinical trial is evaluating Taxotere® plus Emcyt®, in comparison to the standard of care, Novantrone plus prednisone, in symptomatic hormone refractory prostate cancer patients. Hormonal therapy is the most common treatment for prostate cancer that has recurred or spread beyond the prostate. Because the spread of prostate cancer is promoted by the male hormone testosterone, this therapy aims to curb the production of testosterone, thereby denying the cancer cells what they need to grow. This treatment may slow cancer growth and reduce tumor size and also may be accompanied by side effects including hot flashes and impotence. Novantrone is a chemotherapy developed more than 10 years ago to treat certain types of cancer. It is approved, in combination with corticosteroids, to treat pain associated with advanced hormone-refractory prostate cancer, and as a first-line therapy to treat adult acute myelogenous leukemia (AML) in combination with other approved agents. Novantrone was approved in October 2000 by the U.S. Food and Drug Administration as the first therapy to treat secondary progressive multiple sclerosis (MS). In a Phase 3 clinical trial, the most common nonhematologic adverse events in patients with hormone refractory prostate cancer treated with Novantrone were nausea (61 percent), fatigue (39 percent), alopecia (29 percent), anorexia (25 percent), constipation (16 percent), and dyspnea (11 percent); however, most were mild to moderate. Myelosuppression induced by Novantrone may be severe and requires frequent monitoring. Functional cardiac changes can occur with Novantrone treatment including decreases in left ventricular ejection fraction (LVEF) and irreversible congestive heart failure (CHF). Cancer patients who received up to a cumulative dose of 140 mg/m2 had a 2.6 percent probability of CHF. Novantrone is not recommended for patients with abnormal liver function tests. Novantrone should be given into a freely flowing intravenous infusion. Novantrone should not be given by subcutaneous, intramuscular, intrathecal, or intra-arterial injection. Severe permanent injury can result from these forms of administration. SOURCE: Immunex Corporation Related Link: Immunex Corporation. E-mail this page to a friend or colleague! To print, use this version