Genzyme Corp. and Neozyme Corp. on Friday said that the FDAhas granted orphan drug designation to Thyrogen as an adjunctin the diagnosis of thyroid cancer.
Thyrogen, a recombinant human thyroid stimulating hormone(TSH), is in Phase I/II trials for use in detecting cancerousthyroid tissue.
The National Cancer Institute estimates that about 12,000 newcases of thyroid cancer occur in the U.S. each year.
Patients who have had the cancer must be monitored forrecurrence. TSH prompts recognition of the radioactive tracerby any remaining cancer cells following removal of the gland.
Bovine TSH can't be used because it's too immunogenic, sopatients have to suspend their thyroid replacement therapy fora couple of weeks to allow their own TSH levels to rise.Genzyme (NASDAQ:GENZ) hopes its recombinant version willallow patients to remain on thyroid replacement while beingtested for metastases, avoiding the side effects of hormonewithdrawal.
Development of Thyrogen is funded by Neozyme(NASDAQ:NEOZ), an R&D company started last year byCambridge, Mass.-based Genzyme.
Genzyme rose 25 cents Friday to $46 and Neozyme gained 50cents to $27. -- KB
(c) 1997 American Health Consultants. All rights reserved.