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News Release - February 8, 2007
Seven-Year Survival Data Demonstrate use of Cytogen's PROSTASCINT(R) Independently Predicts Recurrence of Prostate CancerPeer-Reviewed Publication Further Reinforces PROSTASCINT's Emerging Potential as a Valuable Tool in Managing the Care of Prostate Cancer Patients
PRINCETON, N.J.--(HSMN NewsFeed)--Cytogen Corporation (NASDAQ: CYTO ) today reported the publication of a seven-year survival study that suggests PROSTASCINT® may help predict which patients are less likely to benefit from brachytherapy for prostate cancer. PROSTASCINT is the first and only commercial monoclonal antibody-based agent that targets prostate-specific membrane antigen (PSMA) to image the extent and spread of prostate cancer. The study, "Biochemical disease free survival rates following definitive low dose rate prostate brachytherapy with dose escalation to biologic target volumes identified with SPECT/CT Capromab Pendetide," by Ellis et al. appears in the online edition of the American Brachytherapy Society's peer-reviewed journal, Brachytherapy (Brachytherapy Volume 6, Issue 1, January-March 2007, Pages 16-25.)
The study evaluated the use of PROSTASCINT fusion imaging to define brachytherapy treatment regimens for 239 newly-diagnosed prostate cancer patients. PROSTASCINT fusion imaging combines anatomical images from computed tomography (CT) or magnetic resonance (MR) imaging with functional images from single-photon emission computed tomography (SPECT) using molecular imaging agents, such as PROSTASCINT. PROSTASCINT fusion imaging was used to assess local and distant disease and to alter the radiation dose to areas of suspected high tumor burden. PROSTASCINT was found to significantly and independently predict biochemical disease free survival (bDFS). Using the American Society for Therapeutic Radiation and Oncology (ASTRO) standard criteria to monitor PSA response for reporting disease free survival, the cure rate was 90.6% for patients whose fused PROSTASCINT scan showed local disease (n=217) versus 66.1% (n=22) for patients with distant disease (p=0.0005).
"The continued improvement in this type of imaging technology has now led to a refinement in treatment planning based on the fused images," said Rodney J. Ellis, M.D., a radiation oncologist and assistant professor of urology with the Case School of Medicine, and the lead author of the publication. "These data suggest that PROSTASCINT fusion imaging is emerging as an important tool to help determine patient-specific treatment regimens for prostate cancer patients."
Prostate brachytherapy is a form of radiation treatment in which tiny radioactive seeds are implanted directly into the prostate. This procedure offers the benefits of delivering high doses of radiation to the prostate while limiting the radiation exposure to the adjacent organs. Image-guided brachytherapy alone and in combination with external beam radiation is one of the first-line therapies for patients with localized prostate cancer. This study reports an approach that incorporates the PSMA-targeting imaging agent PROSTASCINT. PSMA is expressed in prostate cancer cells, with increased expression in high-grade cancers, metastatic disease and hormone-refractory prostate cancer.
About Prostate Cancer
Prostate cancer is the most common type of cancer found in American men, other than skin cancer. In 2006, the American Cancer Society estimates that there will be about 234,000 new cases of prostate cancer in the United States and that about 27,000 men will die from the disease. It is estimated that there are more than 2 million American men currently living with prostate cancer. Tests to determine the amount of prostate-specific antigen (PSA), a protein produced by the cells of the prostate gland, in the blood along with a digital rectal exam is used to help initially detect prostate cancer and is also used to monitor patients with a history of prostate cancer to see if the cancer has come back, or recurred. PSA levels cannot directly identify the extent or location of disease.
Cytogen's PROSTASCINT molecular imaging agent is the first and only commercial product targeting prostate-specific membrane antigen or PSMA. PROSTASCINT consists of Cytogen's proprietary PSMA-targeting monoclonal antibody, 7E11-C5, linked to the imaging radioisotope Indium-111. By targeting PSMA, the PROSTASCINT molecular imaging procedure can detect the extent and spread of prostate cancer using a standard gamma camera.
PROSTASCINT is indicated as a diagnostic imaging agent in newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized after standard diagnostic evaluation and who are thought to be at high risk for pelvic lymph node metastases. PROSTASCINT is also indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease.
This press release discusses the use of PROSTASCINT outside of its current labeled indications. A copy of the full prescribing information for PROSTASCINT, 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.
Founded in 1980, Cytogen is a biopharmaceutical company dedicated to advancing the care of cancer patients by building, developing, and commercializing a portfolio of specialty pharmaceutical products. The Company's specialized sales force currently markets QUADRAMET®, PROSTASCINT®, and SOLTAMOX(TM) to the U.S. oncology market. QUADRAMET is approved for the treatment of pain in patients whose cancer has spread to the bone, PROSTASCINT is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer, and SOLTAMOX is the first liquid hormonal therapy approved in the U.S. for the treatment of breast cancer in adjuvant and metastatic settings. In the first half of 2007, Cytogen plans to introduce its fourth approved oncology product to the U.S. market, CAPHOSOL®, a prescription medical device for the treatment of oral mucositis and dry mouth. The Company is also developing CYT-500, a third-generation radiolabeled antibody to treat prostate cancer. Cytogen's product-focused strategy focuses on attaining sustainable growth through clinical, commercial, and strategic initiatives.
A copy of the full prescribing information for CAPHOSOL, QUADRAMET, PROSTASCINT, and SOLTAMOX, including box warnings, may be obtained in the U.S. from Cytogen Corporation by calling toll free 800-833-3533 or by visiting Cytogen's web site at www.cytogen.com. The Company's website 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 successfully marketing PROSTASCINT; 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. All information in this press release, including 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 this information to reflect subsequent events or circumstances.
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