Genzyme Corp. said Tuesday that it is beginning clinicaldevelopment of Thyrogen, its recombinant human thyroidstimulating hormone (TSH).

The recombinant protein will be marketed as an adjunct to thediagnosis and treatment of thyroid cancer, which the AmericanCancer Society estimates at 100,000 cases in the UnitedStates.

Patients who have had thyroid cancer must be monitored forrecurrence. TSH prompts recognition of the radioactive tracerby any remaining cancer cells following removal of the gland.

But TSH from cows has proved too immunogenic, so patientshave to suspend their thyroid replacement therapy for a coupleof weeks to allow their own TSH levels to rise. Genzyme saidits recombinant version will allow patients to remain onthyroid replacement while being tested for metastases,avoiding the side effects of hormone withdrawal.

Development of Thyrogen is funded by Neozyme Corp. (NASDAQ:NEOZ), a research and development company started a year agoby Cambridge, Mass.-based Genzyme (NASDAQ:GENZ).

Genzyme has an exclusive license to a patent application onThyrogen that is pending in the United States and Canada, andhas sublicensed all of its rights to Neozyme. No decisions onmarketing the compound have yet been made, saidspokeswoman Donna LaVoie.

Neozyme intends to file for designation of Thyrogen as anorphan drug. -- Roberta Friedman, Ph.D.

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