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Newly Published Clinical Data Demonstrates Activity of Quadramet (samarium Sm-153 lexidronam injection) in Osteosarcoma Quadramet used in combination with radiosensitizing chemotherapeutic to improve the effectiveness of radiotherapy in the treatment of osteosarcoma PRINCETON, NJ -- October 7, 2005 -- Cytogen Corporation, a product-driven biopharmaceutical company, today announced the publication of data from a study of Quadramet(R) (samarium Sm-153 lexidronam injection), the company's flagship product, in combination with gemcitabine (Gemzar(R), Eli Lilly) a nucleoside analog which is known to be a radiation sensitizer. The majority of patients with advanced stage disease who were treated with the combination regimen demonstrated an improvement on imaging studies. Results were published today in the peer-reviewed journal Clinical Cancer Research (Volume 11(19): pages 6895-6900). The study was conducted by independent investigators who evaluated the use of high dose Quadramet in conjunction with gemcitabine for the treatment of osteosarcoma. The lead investigator was Peter Anderson, MD, PhD, a Pediatric Oncologist who performed the work at the Mayo Clinic and is now at The University of Texas MD Anderson Cancer Center, a leading center for the treatment of osteosarcoma. "Quadramet is the most specific agent currently available for targeting osteoblastic metastases of osteosarcoma," said Dr. Anderson. "Our previous studies have demonstrated that a regimen consisting of high dose Quadramet followed by stem cell transplant is well tolerated. These results indicate that a radiosensitizing chemotherapeutic can be added to such a regimen. The positive clinical responses observed in this study indicate that further evaluation of this combination strategy is warranted. Planned future directions using Quadramet in osteosarcoma will include repeated standard doses in combination with gemcitabine in an attempt to increase the durability of the clinical response." In the study, referenced by the company as GEMSAM, 14 patients with osteoblastic lesions of relapsed, resistant, and/or refractory osteosarcoma for which surgical control was not possible received 30 mCi/kg of Quadramet, significantly higher than the standard palliative dose of 1.0 mCi/kg. Gemcitabine (a single dose of 1500 mg/m2 in 12 patients and 250 mg/m2 daily for 4 or 5 days in the other 2 patients) was then administered one day later followed by stem cell (n=11) or bone marrow (n=3) support 2 weeks later to correct expected hematopoietic toxicity. Routine radionuclide bone and positron emission tomography (PET) imaging studies were used to assess response to therapy. At the 6- to 8-week follow-up period, 8 out of 14 patients had objective radiographic responses including six partial responses (persistence but improvement on bone and/or PET imaging studies), 2 mixed responses, four stable disease (no change), and 2 patients with progressive disease (appearance of new lesions or >25% increase in size of an indicator lesion measured using computerized tomography scan). Among the 12 patients followed for more than 1 year, the longest duration of response was 11 months. Pattern of failure was progression at previous site of disease in 11 of 14 patients and development of new or worse pulmonary metastases in the other three. In this very heavily pre-treated group of patients, no hemorrhagic cystitis, nephrotoxicity, or serious infections were reported and successful re-engraftment occurred in all patients. The treatment group had variable performance status before treatment. After treatment, all patients maintained stable or improved performance status except the single patient with poor initial performance status. About Osteosarcoma Osteogenic sarcoma, or osteosarcoma, is the most common primary malignancy of the bone in the United States. Osteosarcoma is slightly more common in males than in females. Teenagers are the most commonly affected age group, but it can occur at any age. There has been little improvement in results of osteosarcoma chemotherapy protocols in the past decade and most programs achieve 55% to 70% survival in nonmetastatic extremity tumors. With modern therapy, about 20% of relapses occur in bone. About Quadramet Quadramet is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. This press release describes clinical applications that differ from that reported in the Quadramet package insert. Quadramet is an oncology product 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 many characteristics that the company believes are 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), predictable and reversible bone marrow toxicity or myelosuppression, ease of administration, and length of pain relief, lasting an average of four months in responding patients. Quadramet is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in bone with little or no detectable accumulation in soft tissue. Quadramet Safety Profile Quadramet causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after Quadramet, and tended to return to pretreatment levels by 8 weeks. Because of the unknown potential for additive effects on bone marrow, Quadramet should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function. Non-hematologic adverse events that occurred in 5% or more of patients and greater than placebo were plain 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 E-mail this page to a friend or colleague! To print, use this version