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SANDOZ IL-3 WITH GM-CSF BEGINNING PHASE III TRIAL

Executive Summary

SANDOZ IL-3 WITH GM-CSF BEGINNING PHASE III TRIAL for the regeneration of white blood cells and platelets after autologous bone marrow transplant in patients with Hodgkin's disease or non- Hodgkin's lymphoma, the company announced May 12. The 11-center trial, expected to enroll about 150 patients, will compare interleukin-3 and GM-CSF administered sequentially to GM-CSF (Sandoz/Schering Plough's Leucomax) alone. Sandoz is completing a Phase II trial of the two biologicals in about 42 patients for the same indication this month. Patients in the trial have experienced neutrophil (white blood cell) engraftment in 15 days and platelet engraftment in 14 days, compared to 19 and 26 days, respectively, in a historical control using GM-CSF alone. The historical control was a study of Immunex' brand of GM-CSF (Leukine) versus placebo for the same indication, published in the New England Journal of Medicine in 1991. Principal investigator Joseph Fay, MD, Baylor University Medical Center, commented that the Phase II "findings are also substantiated by recent research, which demonstrates that IL-3 consistently stimulates the early stages of blood cell development, while GM-CSF regulates maturation in the later stages." Immunex' Pixykine, a GM-CSF/IL-3 combo product, is in Phase II/III trials for prevention of chemotherapy-induced neutropenia and thrombocytopenia. The combination therapy "appears to be safe and well tolerated," Sandoz noted. Side effects seen in IL-3 therapy include fever, nausea, vomiting, chills and headache. Sandoz' Cytokine Development Unit (CDU) is conducting the trials. The unit, a "functionally autonomous" group which focuses on cancer treatments, recently has been given increased visibility and scope by Sandoz. The group has been responsible for the development of IL-3 and IL-6 since its inception in August 1991. IL-6, currently in Phase I/II trials, is being studied as a "fast-acting platelet stimulator and potentially a primary treatment for cancer," Sandoz said. The CDU is now beginning work on the development of GM-CSF: in addition to the just-announced combination trial, the CDU plans to begin new Phase III trials of GM-CSF use in cancer next month. Details of the GM-CSF study were to be finalized at investigator meetings prior to the May 16-18 American Society of Clinical Oncology annual meeting in Orlando, Fla. In addition, the CDU "in the near future" will take over work on Sandostatin (octreotide), currently being studied for tumors, including breast and colon malignancies, and PSC-833, a possible adjunct in the treatment of drug resistant tumors, Sandoz said. Both agents are in Phase I studies. Sandostatin is currently approved for symptom control in patients with metastatic carcinoid and vasoactive peptide-secreting tumors (VIPomas). The unit has a staff of about 50, a number "increasing regularly but slowly," Sandoz said. Located at Sandoz' headquarters in East Hanover, N.J., the CDU is headed by Executive Director Dan Levitt, MD/PhD, and Associate Director Alain Delongchamp. The group reports directly to Sandoz Pharmaceuticals, Inc. CEO Tim Rothwell.
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