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News Release - September 19, 2006
Cancer Patients Show Reduced Pain and Lower Analgesic Consumption Following Treatment with QUADRAMET(R)New data published in peer-reviewed journal Supportive Care in Cancer show treatment can reduce both pain associated with movement and that occurring at rest in patients with cancer that metastasizes to bone.
PRINCETON, N.J., Sept. 19 (HSMN NewsFeed) -- Cytogen Corporation (Nasdaq: CYTO ) today announced the publication of new data relating to the Company's QUADRAMET® (samarium Sm-153 lexidronam injection) product. The publication, "Incident pain and analgesic consumption decrease after samarium infusion: a pilot study" appears in a recent issue of the peer-reviewed journal Supportive Care in Cancer (Support Care Cancer. 2006 Sep 12).
While a number of controlled and uncontrolled studies have demonstrated that QUADRAMET is active in the relief of pain associated with metastatic bone lesions deriving from several tumor types in 73% to 86% of patients treated, no prospective studies specifically assessed the role of this class of drugs in preventing or reducing movement-related pain (incident pain). Incident pain is the most frequent pain in patients with cancer progression to bone.
In the study conducted by independent investigators, thirteen patients with hormone refractory prostate cancer and painful bone metastases received a single 1 mCi/kg dose of QUADRAMET. Variation of pain intensity on movement and at rest was measured by both a six-point Verbal Rating Scale (VRS) and reduction of analgesic drug consumption at week four following QUADRAMET infusion.
Pain intensity on movement at week four improved by at least two points on the VRS in eight of the eleven patients (72.7%) who reported such pain at baseline. In a similar manner, for patients with pain at rest, seven of the eleven patients (63.6%) reported an improvement of at least two points on the VRS. Nine out of ten patients who were taking analgesics at baseline reported a reduction in the consumption of drugs administered on a regular basis or as rescue doses.
"Incident pain or movement-related pain is considered a subtype of breakthrough pain which is particularly difficult to treat in patients with metastatic bone disease," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "Reduction in pain not only at rest but that which occurs with movement, as reported in this study, emphasizes the value of QUADRAMET as an important option for pain palliation. The decreases in consumption of analgesic medications observed along with the reduction in pain scores provide additional evidence of benefit for these patients."
About Incident Pain
Chronic pain associated with advanced cancer is commonly treated with strong opioid analgesics, such as fentanyl. Breakthrough pain (BP) episodes occur unexpectedly while a patient is receiving long-acting continuous treatment, such as a transdermal patch or a slow-release tablet. BP episodes are common in cancer patients, often occurring several times a day. Incident pain or movement-related pain is considered a subtype of BP. It is frequently of somatic origin and frequently caused by bone metastases. Pain may be absent or moderate at rest but may be exacerbated by different movements or positions, such as standing, walking, sitting, turning, lifting, deep breathing, or crouching.
About Metastatic Bone Disease
Each year, more than 100,000 patients in the U.S. develop bone metastases from spread of their primary cancer. Bone is the third most common site of metastatic disease after liver and lung, and spread to bone is associated with considerable morbidity. This includes bone pain and fracture, spinal cord compression, and hypercalcemia. The incidence of bone metastasis is expected to increase over the next decade as patient survival improves due to advances in anticancer therapy. This will make the treatment of this problem more important in the overall management of the surviving cancer patient. 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.
QUADRAMET is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
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
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 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.
A copy of the full prescribing information for QUADRAMET, including warnings, precautions, adverse events and other safety information, may be obtained in the U.S. from Cytogen Corporation by calling toll-free 800-833-3533 or by visiting the web site at http://www.cytogen.com, which is not part of this press release.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ, is a biopharmaceutical company dedicated to improving the lives of patients with cancer by acquiring, developing and commercializing innovative molecules targeting the sites and stages of cancer progression. Cytogen's marketed products include QUADRAMET® (samarium Sm-153 lexidronam injection), PROSTASCINT® (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide, and SOLTAMOX(TM) (tamoxifen citrate, oral solution 10mg/5mL) in the United States. Cytogen's development pipeline consists of CYT-500, a therapeutic radiolabeled antibody targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors. Cytogen also has exclusive United States marketing rights to COMBIDEX® (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. Full prescribing information for the Company's products is available at http://www.cytogen.com or by calling 800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com, which is not part of this press release.
This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. There are a number of important factors that could cause Cytogen's results to differ materially from those indicated by such forward-looking statements. In particular, Cytogen's business is subject to a number of significant risks, which include, but are not limited to: the risk of obtaining the necessary regulatory approvals; the risk of whether products result from development activities; the risk of shifts in the regulatory environment affecting sales of Cytogen's products such as third-party payor reimbursement issues; the risk associated with Cytogen's dependence on its partners for development of certain projects, as well as other factors expressed from time to time in Cytogen's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Cytogen's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and Cytogen undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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