CADEMA's DY-165 FOR RHEUMATOID ARTHRITIS: NDA FILING
CADEMA's DY-165 FOR RHEUMATOID ARTHRITIS: NDA FILING for RA of the knee is planned for the fourth quarter of 1988, according to the company's 1986 annual report. Under development for use in radiation synovectomy (direct injection), dysprosium-165 ferric hydroxide microaggregate has been in clinicals since April. "If these clinical trials are successful, the company expects to file its NDA for Dy-165 in the fall of 1988," the annual report states. The radiopharmaceutical product has been in development for 10 years by Clement Sledge, MD, Chairman of Orthopedic Surgery at Harvard Medical School and Brigham and Women's Hospital. Approximately 200 rheumatoid arthritis patients have received radiation synovectomy using Dy-165. One study published in the Journal of the American Rheumatism Association reported that of 74 treated knees 59-72% "showed good results depending on the stage of the disease," Cadema said. The company estimates the cost of treatment at $2,000-$2,500. According to the annual report, Dy-165 is not a patentable drug. Under an agreement with Brigham and Women's Hospital, Cadema is providing approximately $150,000 for clinical development as well as 29,895 shares o common stock. Brigham also has rights to 5% of all profits derived from product sales for a seven-year period. A second agreement, covering research on radiation synovectomy, gives MIT 18,935 shares and about $100,000. "Because of its short half-life, Dy-165 is effectively potent for a maximum of 12 hours after its manufacture," the annual report states. "Because the company believes this limits the commercial potential of Dy-165, the company is developing an alternative compound for treatment of rheumatoid arthritis of the knee that has a half-life several times longer than that of Dy-165 and which, if successfully developed, may be feasible for wider use." Originally engaged in gold exploration as Nevada Resources, the company took its present name and moved into the medical technology area with the 1986 acquisition of Cadema. The firm still retains rights to one undeveloped gold property located near Mt. Shasta, California. Other Cadema compounds that have not reached the clinic include: a radioactive agent for treatment of rheumatoid arthritis in the hand; a diphosphonate product in combination with a low-energy radioisotope for treatment of metastatic bone cancer; and radiopharmaceuticals for treatment of malignant ascites. In the diagnostic area, the company currently markets a disposable aerosol inhalation apparatus, which accounted for about $800,000 of the company's total $1 mil. in 1986 revenues. Two other diagnostic products are also in development -- a red blood cell kit for diagnosing heart disorders and gastrointestinal bleeding, and a Tc-99m antimony trisulfide colloid kit for imaging a patient's regional lymph system. The rights to the latter were acquired in 1982 from Roche subsidiary Cintichem.
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