Outcomes Data Continue to Demonstrate Value of Cytogen's PROSTASCINT(R) to Predict Prognosis in Prostate Cancer.PRINCETON, N.J. -- Cytogen Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CYTO CYTO Croydon Youth Theatre Organisation (UK) ) today reported outcomes data from a large cohort study demonstrating the value of PROSTASCINT([R]) (capromab pendetide) in predicting prognosis in prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. .(i) The study evaluated the outcomes of patients whose PROSTASCINT images showed uptake in the central abdomen, a finding suggestive of suggestive of Decision making adjective Referring to a pattern by LM or imaging, that the interpreter associates with a particular–usually malignant lesion. See Aunt Millie approach, Defensive medicine. metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. disease, as compared to those without such findings. In the study, prostate cancer-specific death rates were 10 times higher in patients with central abdominal uptake (CAU (Controlled Access Unit) An intelligent hub from IBM for Token Ring networks. Failed nodes are identified by the hub and reported via IBM's LAN Network Manager software. ) than in patients without CAU (p=0.005).(i) These results further reinforce that PROSTASCINT offers a level of accuracy and detail to prostate cancer imaging that can aid clinicians in defining patients' prognoses and treatment regimens. PROSTASCINT is the first and only commercial monoclonal antibody-based agent that targets prostate-specific membrane antigen (PSMA PSMA Public Sector Mapping Agencies (Australia) PSMA Prostate-Specific Membrane Antigen PSMA Power Sources Manufacturers Association PSMA Pakistan Sugar Mills Association PSMA Professional Services Management Association ) to image the extent and spread of prostate cancer. The study, "Capromab pendetide (ProstaScint) imaging with central abdominal uptake: poor outcomes for prostate cancer patients," by Haseman, et al., was presented at the 2007 Annual Meeting of the American Urological Association taking place May 19-24, 2007 in Anaheim, California. "As the only functional imaging agent available for prostate cancer, PROSTASCINT brings greater clarity to prostate cancer imaging, enabling more precise assessment of disease," commented Michael J. Manyak, M.D., vice president of medical affairs with Cytogen. "The poor outcomes among men whose PROSTASCINT scan detected central abdominal activity support what has long been suspected -- that the detection of central abdominal activity on PROSTASCINT scans is indicative of metastatic activity. Following the presentation of eight-year outcomes data in February 2007, this outcomes study further demonstrates PROSTASCINT's utility for prognosis. The data presented here today reinforce the value of information obtained from PROSTASCINT scans to assist in selection of appropriate therapy." The investigators reviewed records of 341 men with prostate cancer who underwent PROSTASCINT imaging between 1994 and 1999 and were followed up for a median of 4.1 years.(i) Patients were divided into two groups based on whether CAU was present or absent.(i) CAU was detected in 69 (20%) patients. Of the 262 men who received pelvic radiotherapy after the PROSCASCINT scan, 57 (83%) had evidence of CAU and 205 (75%) did not (p=0.2). Five of the 69 patients (7.2%) in the CAU group died of prostate cancer, compared to two of the 272 (0.7%) CAU-negative patients (p=0.005).(i) The ten-fold increase in prostate cancer-specific death rates was independent of the use or timing of intervention with hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy . These outcomes data confirm that high signal intensity in the abdomen is a negative prognostic sign. About Prostate Cancer Prostate cancer is the most common type of cancer found in American men, other than skin cancer. In 2007, the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that there will be about 219,000 new cases of prostate cancer in the United States and that about 27,000 men will die from the disease.(ii) It is estimated that more than 2 million American men are currently living with prostate cancer.(iii) Tests to determine the amount of prostate-specific antigen prostate-specific antigen n. Abbr. PSA A protease secreted by the epithelial cells of the prostate gland. Serum levels are elevated in patients with benign prostatic hyperplasia and prostate cancer. (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ), a protein produced by the cells of the prostate gland, in the blood along with a digital rectal exam are used to help initially detect prostate cancer and also 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. About PROSTASCINT 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 monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , 7E11-C5, linked to the imaging radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. Indium-111. By targeting PSMA, the PROSTASCINT molecular imaging procedure can detect the extent and spread of prostate cancer using a standard gamma camera. Emerging data from several sources using the superimposition In graphics, superimposition is the placement of an image or video on top of an already-existing image or video, usually to add to the overall image effect, but also sometimes to conceal something (such as when a different face is superimposed over the original face in a , or fusion, of the PROSTASCINT functional study upon an anatomic image such as Computed Tomography (CT) Imaging or Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ), have generated renewed interest in the clinical value of PROSTASCINT imaging. In January 2007, the National Comprehensive Cancer Network, or NCCN NCCN National Comprehensive Cancer Network NCCN North Carolina Center for Nursing (Raleigh, NC) NCCN Nevada County Community Network , updated its clinical practice guidelines clinical practice guidelines Clinical policies, practice guidelines, practice parameters, practice policies Medtalk Systematically developed statements to assist practitioner and Pt decisions about appropriate health care for specific clinical circumstances. See Psychology. and expanded PROSTASCINT's role to include recurrent disease. The expanded NCCN guidelines reflect the growing awareness of the potential for PROSTASCINT fusion imaging to assess disease and plan individualized treatment regimens. 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 Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma . 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 clinical applications that differ from those reported in the PROSTASCINT package insert. About Cytogen Cytogen is a specialty pharmaceutical company dedicated to advancing the treatment and care of patients by building, developing, and commercializing a portfolio of oncology products. The Company's specialized sales force currently markets three therapeutic products and one diagnostic product to the U.S. oncology market. CAPHOSOL([R]) is an advanced electrolyte solution for the treatment of oral mucositis and dry mouth that is approved in the U.S. as a prescription medical device. QUADRAMET([R]) (samarium samarium (səmâr`ēəm), metallic chemical element; symbol Sm; at. no. 62; at. wt. 150.36; m.p. 1,072°C;; b.p. 1,791°C;; sp. gr. 7.54 at 20°C;; valence +2 or +3. Samarium is a lustrous silver-white metal. Sm-153 lexidronam injection) is approved for the treatment of pain in patients whose cancer has spread to the bone. PROSTASCINT([R]) (capromab pendetide) is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer and SOLTAMOX([TM]) (tamoxifen citrate) is the first liquid hormonal therapy approved in the U.S. for the treatment of breast cancer in adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. and metastatic settings. The Company is also developing CYT-500, a third-generation radiolabeled antibody to treat prostate cancer. Cytogen's product-focused strategy centers on attaining sustainable growth through clinical, commercial, and strategic initiatives. A copy of the full prescribing information for CAPHOSOL, QUADRAMET, PROSTASCINT and SOLTAMOX, including Boxed Warnings, 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. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Cytogen's ability to successfully execute strategic transactions for its technology platforms, 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 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. (i) Manyak MJ, Rosenthal SA, Haseman MK, Kipper SL, Trout JR. Capromab pendetide (ProstaScint) imaging with central abdominal uptake: poor outcomes for prostate cancer patients. Presented at the American Urological Association Annual Meeting, Anaheim, Calif., May 19-24, 2007 (abstract 1018). (lines 23-24) (ii) American Cancer Society. How Many Men Get Prostate Cancer? May 2006. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_ How_many_men_get_prostate_cancer_36.asp?sitearea=. Accessed April 2007. (iii) National Cancer Institute. SEER Cancer Statistics Review 1975-2003, Table I-17. September 2005. Available at: http://seer.cancer.gov/csr/1975_2003/results_single/sect_01_table. 17_2pgs.pdf. Accessed April 2007. (Due to their length, these URLs may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.) |
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