CYTOGEN TO ADD LOW-DOSE ONCO-SCINT STUDIES
Executive Summary
CYTOGEN TO ADD LOW-DOSE ONCO-SCINT STUDIES to Phase I/Phase II clinical trial program, the company announced Aug. 30. FDA requested a study of dosages between 0.2 mg and 2 mg of the tumor imaging agent following a review of Cytogen's clinical data at a mid-August meeting at FDA headquarters in Rockville, Maryland. To date, Cytogen has conducted Phase I and Phase II clinical trials on more than 80 patients using dosages containing 0.2, 2 and 20 milligrams of monoclonal antibody conjugate. Preliminary results of the study showed insignificant differences between 2 and 20 milligram dosages, the company said. The extended study will take place at some of the 20 sites now involved in PhaseI/Phase II testing and will include an additional 20 patients with colorectal cancer. "Although our dose-ranging studies will add approximately six months to our development program, we forsee commercializing a low dose Onco-Scint imaging agent which will provide additional patient benefits and a significant product advantage for Cytogen," said Thomas McKearn, MD, PhD, Cytogen senior vice president of scientific affairs. Cytogen reports that the lower dosage levels have reduced the formation of the human anti-mouse antibody, or HAMA, to about 8% of patients. HAMA formation can be a problem in up to 50% of patients being treated with monoclonal antibody-based products, according to the company. Onco-Scint employs Cytogen's proprietary "linker" technology to connect radio-isotopes to monoclonal antibodies for in vivo imaging of lung, breast, colorectal, ovarian, gastric and pancreatic cancer ("The Pink Sheet" June 15, 1987, T&G-1). Cytogen plans to seek FDA approval for the first Onco-Scint product for colorectal cancer imaging sometime in mid-1989, the company said. An imaging product for ovarian cancer will be next in line.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth