PRINCETON, N.J., Nov. 28 /PRNewswire-FirstCall/ -- Cytogen Corporation today announced the initiation of a multicenter Phase I clinical trial to investigate the use of QUADRAMET(R) (samarium Sm-153 lexidronam) in combination with bortezomib (Velcade(R), Millennium Pharmaceuticals, Inc.) for the treatment of multiple myeloma. The clinical study will evaluate the safety profile and preliminary incidence and duration of clinical benefits of bortezomib in combination with QUADRAMET.
(Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20041025/PHM011 )
The principal investigator for this new study, which has received Institutional Review Board (IRB) approval, is James Berenson M.D., a medical oncologist who previously served as the Director of the Multiple Myeloma and Bone Metastasis Programs at the Cedars-Sinai Medical Center and Professor of Medicine in Hematology/Oncology at the UCLA School of Medicine.
“Current clinical and preclinical data suggest that a bone-targeted approach may represent a potentially useful added component for the treatment of multiple myeloma,” commented Dr. Berenson. “This trial represents a preliminary evaluation of the safety when combining QUADRAMET with bortezomib and may also provide important preliminary efficacy information.”
The study is being conducted at 4-6 centers of excellence in myeloma therapy across the United States. It is anticipated that up to 36 patients will be enrolled in the study.
“We are encouraged by the positive preclinical data scheduled for presentation at the upcoming American Society of Hematology annual meeting on the combination use of QUADRAMET and bortezomib,” said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. “This new clinical study represents another step forward as we continue to pursue new opportunities to evaluate QUADRAMET’s potential role as a targeted oncology product in a wide range of cancers. We will also continue to advance research underway studying QUADRAMET in higher dose applications and in combinations with chemotherapeutics, biologics, and other potentially synergistic agents.”
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a reported worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 is about 60,000 worldwide.
About QUADRAMET
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 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 that the company believes are 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), predictable and reversible bone marrow toxicity or myelosuppression, ease of administration, and length of pain relief, lasting an average of four months in responding patients. QUADRAMET is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in bone 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 plain 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 Bortezomib
Bortezomib, a drug in the proteasome inhibitor class of agents, is cytotoxic to a variety of cancer cell types in vitro. The proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Disruption of normal homeostatic mechanisms can lead to cell death.
Bortezomib 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 bortezomib with concurrent QUADRAMET radiotherapy.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ is a biopharmaceutical company that acquires, develops and commercializes innovative molecules targeting the sites and stages of cancer progression. 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. 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 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 additional capital; 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.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20041025/PHM011PRN Photo Desk photodesk@prnewswire.comCytogen Corporation
CONTACT: Media/Investors - Jonathan Fassberg of The Trout Group,+1-212-477-9007 x16, for Cytogen Corporation
Web site: http://www.cytogen.com//
