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Biotech / Medical : CYTO -- Ignore unavailable to you. Want to Upgrade?

To: Rod who wrote (7110)	3/30/1998 5:02:00 PM
From: Webhead	Read Replies (1) \| Respond to of 8116

Here is the article (from Dupont-Merck I believe). I hope that this is the early data from the study looking at enhanced survival of Breast Cancer patients! Ed --------- Landmark Study Points to Key Role of Quadramet In Relieving Cancer Bone Pain PR Newswire - March 30, 1998 16:03 %MTC V%PRN P%PRN Jump to first matched term Findings Also Suggest that Quadramet May Lead to Decreased Use of Opioid Analgesics N. BILLERICA, Mass., March 30 /PRNewswire/ -- A newly published multi- center study confirms that the cancer therapy agent Quadramet(R) (Samarium Sm 153 Lexidronam Injection) provides significant pain relief from metastatic prostate and breast cancer that has spread to bone. The study also concludes that Quadramet(R) may lead to the decreased use of opioid analgesics which often are associated with undesirable side effects. The landmark study appears in the April issue of the Journal of Clinical Oncology. Quadramet(R) offers new hope to the estimated 200,000 cancer patients who every year experience the severe and debilitating pain associated with bone metastases -- resulting from the spread of cancer throughout the body. Quadramet(R) is indicated for the relief of pain in patients with confirmed osteoblastic bone lesions that enhance on radionuclide bone scan. These patients often survive for long periods of time and therefore face prolonged periods of pain. According to the study, a single injection of Quadramet(R) may relieve the pain caused by multiple osteoblastic (bone-forming) lesions. "Traditional therapies -- including opioid analgesics and external beam radiation therapy -- are rarely adequate or appropriate for the long-term management of metastatic bone pain," said Aldo Serafini, M.D., the principal investigator of the study and professor of radiology and medicine at the University of Miami/Sylvester Comprehensive Cancer Center. "The positive results of this study should serve as a call-to-action, encouraging all physicians and patients to evaluate the ways in which they are treating cancer bone pain. With the availability of Quadramet(R), physicians have a much- needed new option for those patients who meet the treatment's indication." This publication contains information that is not included in the prescribing information for Quadramet(R). The following information is not contained in the prescribing information: use of Physicians Global Assessment (PGA) as a measure of efficacy, efficacy data beyond the four-week time point, the percentage of patients who experience pain relief, the time of onset of pain relief, and stratification of pain score changes by primary cancer with a finding of a greater change for patients with breast cancer. Please consult the Package Insert for the full prescribing information for Quadramet(R). The study involved 118 patients at 10 institutions in North America and seven in Europe. Each study participant received either 0.5 or 1.0 mCi/kg of Quadramet(R) or a placebo as a single intravenous injection. Key findings include: -- Patients receiving 1.0 mCi/kg of Quadramet(R) experienced a rapid onset of pain relief which persisted up to 16 weeks in the majority of patients who responded to treatment. -- Patients receiving 1.0 mCi/kg of Quadramet(R) showed significant improvements over the placebo group in each of the first four weeks following administration. In contrast, the group receiving 0.5 mCi/kg showed no consistent improvements. -- In patients who received 1.0 mCi/kg of Quadramet(R), there was a significant correlation between relief of pain and decreased use of opioid analgesics. This is the first published report of a multi-center, double-blind, randomized, placebo-controlled study involving Quadramet(R). Throughout the study, patients kept a daily diary, recording their pain intensity for 13 body regions and rating the pain on a scale from zero (no pain) to 10 (worst possible pain). The type and dose of all opioid analgesic medications also were recorded daily in the pain diary. Any Quadramet(R) not taken up by the bone is excreted from the body within six to 12 hours. Quadramet(R) causes a transient and reversible suppression of bone marrow. In clinical trials, patients' white blood cell and platelet counts tended to return to pretreatment levels by week eight. This recovery allows a patient's physician to better plan the timing of appropriate cancer treatments. Before administering Quadramet(R), the patient's current clinical and hematological status and history of bone marrow response to treatment with myelotoxic agents should be considered, and the clinical benefit should outweigh the risks. Please consult the Package Insert for additional information on adverse events. Quadramet(R) is manufactured and marketed by the Radiopharmaceuticals Division of The DuPont Merck Pharmaceutical Company under the DuPont Pharma name through an exclusive license from CYTOGEN Corporation. CYTOGEN developed the agent under a license from The Dow Chemical Company. The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical and radiopharmaceutical company established in 1991 as a partnership between DuPont and Merck and Co. The Company is headquartered in Wilmington, Delaware; the Radiopharmaceuticals Division is headquartered in North Billerica, Massachusetts. The Company markets its products under the DuPont Pharma name. More information on Quadramet(R) including the Package Insert is available by calling 800-635-2683 or by visiting DuPont Pharma's web site at "www.radiopharm.com". CYTOGEN is a biopharmaceutical company engaged in the development, manufacture and commercialization of products for the targeted delivery of diagnostics and therapeutic substances directly to the disease sites. CYTOGEN has demonstrated its ability to develop new technology from early discovery through clinical development, regulatory approval and commercial-scale biologic manufacturing. SOURCE DuPont Merck Pharmaceutical Company /CONTACT: Lili Gordon of DuPont Merck, 978-671-8924 or Stacey Minton of BBK Communications, 617-630-4477, ext. 246/ /Web site: radiopharm.com