LONDON - Celltech plc has reported “promising“ results in the interim evaluation of 23 patients in a pivotal trial of its lead product, CMA 676, an antibody-cytotoxic drug, in the treatment of acute myeloid leukemia.
In the trial, conducted by Celltech's partner, American Home Products Corp. (AHP), of Madison, N.J., 43 percent of patients experienced major responses, characterized by complete clearance of leukemic cells.
Peter Fellner, Celltech CEO, said, “The safety profile of the drug appears excellent and is consistent with outpatient use.“
Celltech, based in Slough, U.K., anticipates the full follow-up, to be completed early in 1999, will support registration applications in the U.S. and elsewhere.
The study, in 15 centers in the U.S., is being conducted in patients who have relapsed following a first remission induced by conventional chemotherapy.
Celltech and AHP also have moved into Phase II trials with a second antibody conjugate, CMB 401, in ovarian cancer. A study in 34 patients with advanced ovarian cancer reported at last week's American Society of Clinical Oncology meeting, in Los Angeles, showed “encouraging evidence“ of antitumor response in some patients at higher doses.
Celltech also is carrying out a Phase I/II study of CMB 401 in non-small cell lung cancer patients in the U.K.
Fellner said, “The pioneering technology employed in these products is potentially applicable to treating many cancers, and AHP and Celltech are now pursuing a number of new programs aimed at novel cancer-related targets.“
Celltech also revealed results for the six months ended March 31, 1998, which demonstrate the growing commercial significance of monoclonal antibodies. The company's licensing income, at £5.7 million, was almost triple the £2.0 million for the same period in 1997.
This income consists of royalties on sales of ReoPro, the antiplatelet drug developed by Centocor Inc., of Malvern, Pa., and Eli Lilly and Co., of Indianapolis, and a further agreement with Centocor, which has licensed Celltech antibody technology for its antitumor necrosis factor product, Avakine.
Fellner said, “During the second half of the financial year further products on which Celltech will receive royalties are expected to be launched in the U.S. and Europe. As a consequence the flow of royalties is expected to grow further.“
In addition, Celltech has made progress with its technique for producing antibodies in bacteria. This is expected to cut manufacturing costs and give the market a further boost.
During the six months Celltech also received another £10.5 million from Alusuisse-Lonza Holding Ltd., of Basel, Switzerland, for its remaining stake in the antibody manufacturing business Lonza Biologics.
Overall, Celltech reported a net profit £2.5 million, against a loss of £5.9 million, for the first six months of 1997. Expenditures on R&D increased to £9.4 million from £8.9 million, and cash increased to £43.7 million from £36.3 million during the first six months. The company expects to be consistently profitable in two years' time. *