QUADRAMET® with Docetaxel Demonstrate Good Palliative Effect in Prostate Cancer
May 17, 2005 - 9:07:00 AM
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"Two years ago at this meeting we published data from a pilot study showing the feasibility of combining taxane-based chemotherapy with QUADRAMET. The additional data from this phase II study demonstrate good palliative effect lasting five months after the first treatment cycle in response to this combination therapy, which was well tolerated and simple to administer."
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By Cytogen Corporation,
[RxPG] Cytogen Corporation (Nasdaq: CYTO - News), a product-driven biopharmaceutical company, today announced the publication of data from a phase II study of QUADRAMET® (samarium Sm-153 lexidronam injection), the Company's flagship product, in combination with docetaxel (Taxotere®, Aventis Pharmaceuticals, a member of the sanofi- aventis Group) for the treatment of patients with hormone refractory prostate cancer.
The published abstract is part of the proceedings at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 13- 17, 2005, at the Orange County Convention Center in Orlando, FL. The lead investigator was Anders Widmark, M.D., Ph.D., Professor, Department of Oncology, Umea University, Sweden.
"Two years ago at this meeting we published data from a pilot study showing the feasibility of combining taxane-based chemotherapy with QUADRAMET," said Dr. Widmark. "The additional data from this phase II study demonstrate good palliative effect lasting five months after the first treatment cycle in response to this combination therapy, which was well tolerated and simple to administer."
Study Details
The phase II study, known as the TAXSAM1 trial, was designed to evaluate the toxicity and efficacy of QUADRAMET in combination with docetaxel in 30 patients with progressive hormone refractory prostate cancer. Docetaxel was administered over a 30-minute infusion at a dose of 30 mg/m2. Eighteen to twenty-four hours prior to the fourth administration of docetaxel, the standard palliative dose of 1.0 mCi/kg of QUADRAMET was injected. Patients received a second cycle at PSA and/or clinical progression.
Results were reported for the first 20 patients in the study. Following the first cycle of therapy, grade 3 neutropenia was seen in two patients (at week two and four, respectively after QUADRAMET administration) and one patient had grade 4 neutropenia at week two after QUADRAMET. One patient had grade 2 thrombocytopenia four weeks after QUADRAMET. Upon progression, 14 patients received a second treatment cycle. The median interval between the beginning of the first and second treatment cycles was six months.
"Researchers at several leading cancer centers have recently initiated clinical studies to evaluate the combination of QUADRAMET and docetaxel for the treatment of patients with hormone refractory prostate cancer," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "These results from Dr. Widmark and his colleagues validate the growing interest in the role of QUADRAMET in combination with chemotherapy for the treatment of prostate and other tumors that have spread to bone."
About Prostate Cancer
According to the American Cancer Society, this year approximately 232,090 new cases of prostate cancer will be diagnosed in the United States and approximately 30,350 men will die of this disease. There is an unmet medical need for treating the disease, particularly for hormone refractory prostate cancer for which therapeutic options are limited.
About QUADRAMET
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 which the Company believes are advantageous for the treatment of metastatic bone disease, including early onset of pain relief, predictable and reversible bone marrow toxicity or myelosuppression, ease of administration, and length of pain relief, lasting, on average, four months with a single injection. QUADRAMET is administered as an intravenous injection on an outpatient basis, and exhibits selective uptake in bone with little or no detectable accumulation in soft tissue.
Publication:
The published abstract is part of the proceedings at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 13- 17, 2005, at the Orange County Convention Center in Orlando, FL.
On the web:
www.cytogen.com 
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Additional information about the news article
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NOTE:
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.
A copy of the full prescribing information for QUADRAMET 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 product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises. Cytogen's marketed products include QUADRAMET® (samarium Sm-153 lexidronam injection) and PROSTASCINT® (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® (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. 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 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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