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Prostate
QUADRAMET® with Docetaxel Demonstrate Good Palliative Effect in Prostate Cancer
By Cytogen Corporation
May 17, 2005, 09:07

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.

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