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| |  Journal Article Reports New Data Regarding Administration of Quadramet(R) (Samarium Sm-153 Lexidronam Injection) with Chemotherapy in Hormone Refractory Prostate Cancer Patients Quadramet represents part of a multi-disciplinary medical approach enabling medical oncologists, radiation oncologists and nuclear medicine physicians to manage pain from metastatic bone disease PRINCETON, NJ -- January 25, 2007 -- Cytogen Corporation today reported the publication of a study by independent investigators evaluating the safety and efficacy of Quadramet(R) (samarium Sm-153 lexidronam injection) in combination with chemotherapy for the treatment of patients with hormone-refractory prostate cancer (HRPC). The publication, "Clinical benefit of bone-targeted radiometabolic therapy with 153Sm-EDTMP combined with chemotherapy in patients with metastatic hormone-refractory prostate cancer" by Ricci, S. et al., appeared in the online issue of the European Journal of Nuclear Medicine and Molecular Imaging (Eur J Nucl Med Mol Imaging. 2007 Jan 23), the official journal of the European Association of Nuclear Medicine (EANM). In the study, 45 patients were followed after treatment with Quadramet to evaluate the possible synergistic effect with chemotherapy. Assessments of clinical benefit included a comparison of palliative response, biochemical response and overall survival in the combination groups versus the non-combination group. Outcomes were analyzed from three different groups. Fifteen of the 45 patients received Quadramet without any subsequent chemotherapy (Group A), 14 patients initiated chemotherapy three to five months after receiving Quadramet (Group B), and 16 patients initiated chemotherapy within one month after receiving Quadramet (Group C). Patient demographics and baseline characteristics (histologic grade of the primary cancer, number of bone metastases, bone pain severity, and serum PSA levels) were well matched across treatment groups. Baseline hematologic parameters (hemoglobin levels, leukocyte/neutrophil counts, platelet counts) among the cohorts were also similar. The chemotherapies administered to patients in Groups B and C were very similar and consisted of mitoxantrone plus prednisone or estramustine phosphate. Key findings of the study are summarized as follows: -- Hematologic toxicity. No severe toxicities were observed and Quadramet had no additive effects on chemotherapy-related myelotoxicity. -- Palliative response. Overall, some degree of pain relief was observed in over 70% of the patients, with an almost 30% rate of complete response. The proportion of patients exhibiting a positive palliative response increased from 53.3% in Group A to 71.4% in Group B and 87.5% in Group C. The difference in the proportion of favorable palliative responders reached statistical significance for Group C versus Group A (p=0.0388). Average duration of bone pain palliation in patients of Group A was three to four months, while it was nine to 10 months in patients of Group C. -- Biochemical response. Patterns of biochemical response (change in serum PSA levels) were similar to those observed for palliative responses with the proportion of patients responding increasing from Group A to Group B and highest overall in Group C with the difference between Groups A and C reaching statistical significance (p=0.0235). -- Overall survival. Group C had a median survival of 30 months versus 11 months for Group B and 10 months for Group A. The increase for Group C was statistically significant over both Group A (p=0.008) and Group B (p=0.023). About Bone Metastases The majority of skeletal metastases arise from primary tumors of the thyroid, kidney, lung, prostate, and breast, with the latter two accounting for about 80% of metastatic bone disease. While all bones can be affected, the most common site of disease spread is the spine with the subsequent development of spinal cord compression. In advanced breast cancer, a majority of skeletal events will occur every three to four months resulting in significant morbidity and impaired quality of life. About Quadramet Quadramet is an oncology product indicated for pain relief that pairs the targeting ability of a small molecule, bone-seeking phosphonate (EDTMP) with the therapeutic potential of radiation (samarium Sm-153). Skeletal invasion by prostate, breast, multiple myeloma, and other cancers often creates an imbalance between the normal process of bone destruction and formation. Quadramet selectively targets such sites of imbalance, thereby delivering radioactivity to areas of the skeleton that have been invaded by metastatic tumor. Quadramet has demonstrated a range of characteristics that may be advantageous for the treatment of pain arising from metastatic bone disease, including early onset of pain relief (patients may experience pain relief within the first week with maximal relief generally occurring at three to four weeks after injection), length of pain relief, lasting a median of four months in responding patients, and predictable and reversible bone marrow toxicity or myelosuppression that tends to return to pretreatment levels after eight weeks. Quadramet is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in areas of bone formation with little or no detectable accumulation in soft tissue. Quadramet Safety Profile Non-hematologic adverse events that occurred in 5% or more of patients and greater than placebo were pain flare (7%), diarrhea (6%), infection (7%), spinal cord compression (6.5%), arrhythmias (5%), and hematuria (5%). Patients who receive Quadramet should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration.
SOURCE: Cytogen Corporation
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