If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ProstaScint, Prostate Cancer Imaging Product Licensed by FDA PRINCETON, N.J., Oct. 29, 1996 -- CYTOGEN Corporation (Nasdaq: CYTO) today announced that the Food and Drug Administration (FDA) has given the company a license to market its monoclonal antibody-based imaging product known as ProstaScint(TM) (capromab pendetide). The product, which will be commercially available in early 1997, is licensed for use in two clinical settings: First, 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 at high risk for spread of their disease to pelvic lymph nodes; and second, the product is also indicated for use in post-prostatectomy patients in whom there is a high suspicion of undetected cancer recurrence. The American Cancer Society estimates that over 300,000 men in the U.S. will be diagnosed with prostate cancer this year. Annually over 40,000 of those already diagnosed will die of the disease. Studies conducted at Johns Hopkins University show that of the newly diagnosed prostate cancer patients at high risk of having advanced disease who are treated surgically, about 30 percent have recurrent disease within three years and as many as 50 percent experience disease recurrence within 10 years. ProstaScint is intended for patients considered at high risk for cancer spread outside the prostate. The risk for both newly diagnosed and recurrent disease patients is determined by several factors, including the stage of the disease when initially diagnosed, the microscopic evaluation of the primary tumor, and the prostate specific antigen (PSA) level. PSA is a widely used blood test currently used for detecting and monitoring prostate cancer. ProstaScint is administered intravenously. The product circulates throughout the body and attaches to an antigen produced by prostate cancer cells and some normal prostate cells, as well. Using a scanner, nuclear medicine physicians can evaluate the distribution of ProstaScint throughout the body, which can help determine if the cancer is still localized in the prostate or has spread beyond it. "Early detection of the spread of prostate cancer to lymph nodes can only be accurately determined by surgery," said Thomas J. McKearn, M.D., Ph.D., chairman, president and chief executive officer of CYTOGEN. "ProstaScint may provide additional information about high risk patients with no evidence of metastatic disease using standard diagnostic procedures and gives physicians an opportunity to locate and confirm these newly identified cancer sites. Upon appropriate confirmation of positive scan findings, the most suitable course of treatment for each patient can be determined. This individualized approach may enhance the success of the treatment." Treatment options may include surgery, radiation, hormonal therapy or a combination of these, depending on the extent of the patient's disease. Images should be interpreted only by physicians specifically trained in ProstaScint image interpretation. CYTOGEN is establishing a network of qualified nuclear medicine physicians through a program of training, testing and eventual certification by the American College of Nuclear Physicians. CYTOGEN previously announced that it has signed a definitive agreement With C.R. Bard, Inc. to co-market ProstaScint to urologists through the Bard Urologic Division (BUD). Based in Covington, Georgia, BUD is a leader in the development, production and marketing of urological products for the urology community for more than 75 years. CYTOGEN will retain responsibility for marketing to the medical imaging community. According to the Biotechnology Industry Organization (BIO), there are over 1300 biopharmaceutical firms in the U.S. CYTOGEN is one of eight to have received FDA licensure for more than one pharmaceutical product. CYTOGEN has demonstrated its ability to develop new technology from early discovery through clinical development, regulatory approval and commercial-scale biologic manufacturing. Except for the historical information contained herein, the matters discussed in this press release, contain forward looking statements that involve risks and uncertainties, including the Company's ability to attract strategic partners, and the ultimate success of, the Company's strategic partners and marketing and development programs, and the other risks detailed from time to time in the Company's SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 1995.
|
