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| |  Quadramet Receives Canadian Approval For Bone Pain PRINCETON, NJ -- June 25, 1998 -- The Therapeutic Products Programme of Health Canada has approved Cytogen Corp.'s Quadramet(R) for the relief of bone pain in cancer patients with multiple osteoblastic skeletal metastases confirmed by positive radionuclide bone scan. In the past 15 months, Quadramet has also been approved for marketing in the United States, Europe and Australia for the same indication. Quadramet consists of a radioactive isotope, Samarium-153 (Sm-153), which delivers cell-killing beta radiation and a targeting agent EDTMP which guides the isotope to sites of new bone formation. Osteoblastic, or bone forming lesions, are most commonly associated with advanced prostate, breast and lung cancer. Targeting the source of the cancer bone pain, Quadramet irradiates the osteoblastic tumour sites, alleviating the pain associated with metastatic disease. Quadramet is administered as a single intravenous injection on an outpatient basis. In Canada it is estimated that approximately 20,000 patients are suffering from pain due to cancer that has spread to bone and over 30,000 patients develop bone metastases each year. International clinical studies demonstrated that Quadramet is an effective treatment for cancer bone pain in patients with prostate, breast and other cancers. The overall response rate is 70 to 75 percent with approximately half of these responders having marked or complete relief of their pain. The use of opioid analgesics (morphine and morphine-like compounds) by patients is usually reduced or even discontinued. The onset of pain relief following Quadramet is rapid, generally occurring about one week after injection and lasts for 16 or more weeks in the majority of patients who respond. Quadramet administration is well tolerated and, with the exception of bone marrow suppression, adverse effects were similar to those reported for placebo. In clinical studies, reductions in the white blood cell and platelet counts were usually observed three to five weeks after treatment with values returning toward normal within eight weeks. This hematologic toxicity was generally mild to moderate in severity and did not usually require clinical intervention. More information on: Quadramet, Cytogen Corp.
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