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| | | ![]() ProstaScint Recommended by the FDA for Prostate Cancer Patient PRINCETON, N.J., July 23, 1996 -- CYTOGEN Corporation (Nasdaq: CYTO) reported that the Medical Imaging Drug Advisory Committee (MIDAC) to the U.S. Food and Drug Administration (FDA) recommended by unanimous vote that ProstaScint, the Company's diagnostic imaging agent for prostate cancer, be approved for use in patients with prostate cancer in whom there is a high clinical suspicion of occult metastatic disease. The information provided by ProstaScint should be considered in conjunction with other available diagnostic information. There were sixteen voting members on the MIDAC panel. "We are extremely pleased with MIDAC's recommendation as there is a clear unmet medical need for additional information regarding the location of a patient's prostate cancer. ProstaScint has been developed to meet this need," said Thomas J. McKearn, CYTOGEN's Chairman of the Board, President and Chief Executive Officer. Dr. McKearn added, "Existing non-invasive diagnostic agents such as CT and MRI add little to the patient's or the physician's ability to predict whether the cancer has spread to areas outside the prostatic bed and into the patient's lymph nodes. This information is critical in determining how best to manage a patient's disease specifically, whether to treat the patient surgically or nonsurgically." Thomas M. Bruckman, Executive Director of the American Foundation for Urologic Disease, Inc., and a speaker during the open session of the meeting stated, "On behalf of the thousands of men who have prostate cancer today, and the thousands who will be diagnosed this year, we are extremely pleased with MIDAC's response to ProstaScint. It's clear the panel appreciated the need for additional information about this disease so that patients and physicians can make better educated treatment decisions. We are hopeful a formal FDA approval for marketing will soon follow given FDA's stated commitment to the acceleration and approval of new cancer products." The Product License Application (PLA) for ProstaScint was accepted as filed by FDA on March 13, 1995. The PLA included six studies and over 600 ProstaScint scans. In preparation for the commercialization of ProstaScint, CYTOGEN expects to secure a marketing partner with experience in urology as the urologist is the physician who will order ProstaScint. CYTOGEN will continue to focus on the nuclear medicine community to ensure the accuracy and reliability of the information provided by a ProstaScint scan. CYTOGEN is establishing a network of qualified nuclear medicine physicians through its Partners In Excellence (PIE(TM)) Program. The PIE Program includes rigorous training, testing and ongoing quality assurance protocols with active support and certification from the American College of Nuclear Physicians. About Prostate Cancer The American Cancer Society estimates there will be 317,000 new cases of prostate cancer in the United States in 1996, and 41,400 deaths. Prostate cancer is the most frequently diagnosed malignancy and second leading cause of cancer death in men. The incidence of prostate cancer increases with age; more than 80 percent of all prostate cancers are diagnosed in men over age 65. -- 113 advanced prostate cancer patients die every day. -- The incidence of new prostate cancer cases has increased 30% since last year. -- One in five men will have prostate cancer in their lifetime. Data show that patients whose cancer is completely contained in the prostate gland experience the lowest rate of recurrence; patients who have extra-capsular disease experience more frequent recurrence. CYTOGEN is a biopharmaceutical company engaged in the development, manufacture and commercialization of products for the targeted delivery of diagnostics and therapeutic substances directly to disease sites. CYTOGEN has demonstrated its ability to evolve novel technology from early discovery through clinical development, regulatory approval and commercial-scale biologic manufacturing, and is focused on leveraging these core capabilities to expand and build a profitable business. 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 timing and outcome of FDA approval, the Company's ability to attract, and the ultimate success of, the Company's strategic partners 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.
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