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Executive Summary

CYTOGEN ONCOTHER IND WILL BE FILED BY END OF APRIL, the company announced April 12. The firm intends to investigate the targeted aminopterin product in patients with mucin-producing adenocarcinomas, including lung, breast and colorectal malignancies. Aminopterin is an analog of methotrexate. OncoTher will be Cytogen's third monoclonal agent to reach the clinic. OncoRad, a monoclonal antibody conjugate which targets the therapeutic radioisotope yttrium-90 to tumors, has been in Phase I study for ovarian cancer since late 1988 and just entered Phase I investigation for gastrointestinal cancer this month. OncoScint, a imaging product that uses the same pan-adenocarcinoma antibody as OncoRad, is in Phase III studies for colorectal and ovarian cancer. Cytogen said it is "on track" to submit in the third quarter of this year a product license application (PLA) for OncoScint use in imaging colorectal tumors. A PLA for the ovarian indication is anticipated for early 1990. The Princeton, New Jersey-based firm is planning to expand its clinical programs for both OncoScint and OncoRad to look at additional indications . . . The company said it "will soon begin evaluation of OncoRad in six different tumor types, including lung, breast and colorectal cancers." Phase I investigation in those tumors is covered by the firm's existing IND. Later this year, Cytogen plans to submit "three additional OncoScint INDs for prostate, lung and breast cancer," the release states. Oncoscint had originally been studied in a number of tumor types, but found to provide the best imaging in colorectal and ovarian cancer. The company is now looking at ways to modify the monoclonal antibody chemically for use in imaging the additional tumor types. The expanded clinical activity follows the recent appointment of former SmithKline President George Ebright as Cytogen president and chief executive officer ("The Pink Sheet" Feb. 27, T&G-7). Cytogen retains rights to both OncoScint and OncoTher. OncoRad, however, is being studied under the firm's agreement with Eastman Kodak for development of cytotoxic radioisotope products. The agreement gives Kodak exclusive rights to the products in Europe, while the two firms share rights for certain cancers in the U.S. Cytogen's other existing agreements include the licensure of the its monoclonal linkage technology to American Cyanamid for use with methotrexate and eight other chemotherapeutic agents and to Farmitalia Carlo Erba for use with anthracycline agents, such as doxorubicin.

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