PRINCETON, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Cytogen Corporation , a product-driven biopharmaceutical company, today announced that researchers at Johns Hopkins Kimmel Cancer Center will investigate the use of QUADRAMET(R) (samarium Sm-153 lexidronam) in combination with docetaxel (Taxotere(R), Aventis Pharmaceuticals, a member of the sanofi-aventis Group) for the treatment of hormone refractory prostate cancer that has spread to bone. The clinical study will evaluate the safety profile and preliminary incidence and duration of clinical benefits of novel escalating dose and administration schedules of docetaxel in combination with multiple doses of QUADRAMET. The dosing schedules to be investigated are based on data from pre-clinical research carried out at Johns Hopkins.
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"We are appreciative of the support and interest generated by both medical researchers and pharmaceutical companies as evidenced by the fact that QUADRAMET is now the subject of several new clinical trials in a wide range of cancers," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "Due to its unique combination of nuclear, biologic and chemical properties, we expect to initiate additional studies throughout 2005 that are designed to systematically evaluate QUADRAMET's potential role as a targeted oncology product in various settings, including both higher dose applications and combinations with chemotherapeutics, bisphosphonates, and other potentially synergistic agents."
The principal investigator for this new study, which has received Institutional Review Board (IRB) approval, is Mario A. Eisenberger, MD, R. Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Kimmel Cancer Center. Dr. Eisenberger led a multicenter phase III trial comparing the combination of docetaxel and prednisone to the treatment regimen of mitoxantrone plus prednisone in patients with hormone refractory prostate cancer that enrolled patients at 105 sites in 24 countries. The results of that study contributed to the regulatory approval of docetaxel in combination with prednisone for men with advanced prostate cancer.
"Current clinical and preclinical data suggest that a bone targeted approach may represent a potentially useful added component for the treatment of metastatic prostate cancer," commented Dr. Eisenberger. "This trial represents a preliminary evaluation of the safety when combining QUADRAMET with docetaxel and may also provide important preliminary efficacy information."
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). Combined, these agents form an innovative molecule with a short radioactive half-life that selectively concentrates in osteoblastic sites (areas of new bone formation). Skeletal invasion by prostate, breast, multiple myeloma, and other cancers often creates an imbalance between the normal process of bone remodeling. QUADRAMET selectively targets such sites of imbalance, thereby delivering radioactivity to areas of the skeleton that have been invaded by metastatic tumor.
Many patients with advanced cancer develop metastatic bone disease, the spread of cancerous cells from the original tumor to bones. It is estimated that 350,000 people die with metastatic bone disease annually in the United States. Pain is one of the most common symptoms associated with metastatic bone disease. Studies have shown that many patients with cancer (especially older adults) do not receive adequate pain relief. Effective pain control can help patients stay involved not only in their cancer treatment but also in the activities of daily living.
Docetaxel, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Docetaxel promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.
Docetaxel also exhibits potent radiosensitizing capability that may be synergistic with QUADRAMET. For this reason, current and planned trials are exploring the optimal dose and schedule of administration of docetaxel with concurrent QUADRAMET radiotherapy.
QUADRAMET Indication Information
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 should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risk. QUADRAMET should not be given after either of these treatments until there has been time for adequate marrow recovery.
A copy of the full prescribing information for QUADRAMET may be obtained in the United States 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 product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises across multiple markets. Cytogen's marketed products include QUADRAMET(R) (samarium Sm-153 lexidronam injection) and PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran- 10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. COMBIDEX, an investigational molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and is under review by the U.S. Food and Drug Administration. Cytogen's development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of many solid tumors. Full prescribing information for the Company's products is available at http://www.cytogen.com/ or by calling 1-800-833-3533. 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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