Cytogen Corp. announced Thursday that it has acquiredexclusive U.S. marketing rights to a radiopharmaceuticaldeveloped by The Dow Chemical Co. to alleviate the bone painassociated with metastatic cancer.
The compound, samarium-153-EDTMP, is currently inadvanced Phase III clinical trials in the U.S. and Europe inpatients with prostate, breast and lung carcinoma who havebone metastases. In a Phase I/II study of patients withmetastatic bone pain, the product demonstrated either partialor complete pain relief in a majority of evaluable patients,lasting an average of four months.
The responsibility for managing the ongoing Phase III trialstransfers immediately from Dow to Cytogen (NASDAQ:CYTO).The Princeton, N.J., company expects that it will complete theadvanced trials this year and file a new drug application (NDA)with the FDA in 1994.
Samarium-153-EDTMP(ethylenediaminetetramethylenephosphonic acid) has alreadybeen shown to have an affinity for skeletal tissue, andconcentrates in areas of bone that have been invaded withtumor. And it's also a short-lived isotope, with a half life of 46hours, so disposal is not a serious problem.
But what makes the particular isotope so attractive is that itemits both beta and gamma radiation. "The beta emission canbe used to treat the cancer cells, and the gamma allows you toget a scan if necessary," explained Michael Kurman, Cytogen'sdirector of clinical investigations.
This product is the first of a kind for Cytogen. It "expands ourtechnological foundation, while maintaining our focus on cancercare," said Thomas McKearn, the company's president. --Jennifer Van Brunt
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