Genzyme Corp. said Wednesday that its thyroid stimulatinghormone (TSH) Thyrogen may enable thyroid cancer patientsundergoing periodic diagnostic tests to continue takingreplacement hormone without interruption.
Thyroid cancer patients who stop thyroid hormone treatmentin the weeks prior to diagnostic tests often experiencehypothyroidism, which is characterized by weakness, weightgain, constipation, lethargy and depression. Patients are usuallyadvised to stop taking the hormone from two to six weeksbefore such testing so the body can increase its production ofTSH, which prompts the uptake into thyroid tissue of a radio-iodine imaging agent used in the test.
"Patients who experience severe symptoms of hypothyroidismlose several days or possibly weeks of normal productivity,"said Henri A. Termeer, Genzyme's president and chief executiveofficer.
Based on positive data from a Phase I/II trial of Thyrogeninvolving 18 patients, Genzyme said it has started a Phase IIIstudy of the drug involving about 100 patients, said companyspokeswoman Donna LaVoie in Cambridge, Mass. That study isexpected to take nine months to a year to complete, she said.
The Phase I/II study showed no adverse effects fromThyrogen, which stimulated the uptake of radio-iodine,Genzyme said. Results from treatments of the study's initial 12patients was reported in the supplemental issue of the journalThyroid, released Wednesday. Additional data on all 18patients is scheduled to be presented later this month to theannual American Thyroid Association conference in Rochester,Minn.
An effective TSH product would have an estimated $75 millionmarket, according to analysts. Genzyme's stock (NASDAQ:GENZ)closed Wednesday at $42.13 a share, up 13 cents.
Genzyme has an orphan drug designation for Thyrogen as anadjunct to procedures for diagnosing, monitoring and treatingthyroid cancer. Development of the drug is being funded byNeozyme Corp. (NASDAQ:NEOZ), which was formed to financedevelopment of several products. Genzyme announced earlierthis year that it planned to repurchase rights to the productfrom Neozyme.
The National Cancer Institute estimates there areapproximately 12,100 new cases of thyroid cancer diagnosedeach year and a total of 169,000 cases in the U.S. Thyroidcancer is typically treated by the surgical removal of thethyroid gland, which is followed by a lifetime administration ofreplacement thyroid hormone. Patients are tested once or twiceannually during the five to 10 years following surgery. -- RayPotter
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