The FDA has told Alteon Inc. it can discontinue endoscopies forpossible gastrointestinal toxicity associated with a Phase III trial ofpimagedine, the company's lead compound, for treatment of patientswith overt diabetic nephropathy.The FDA had required the endoscopies to address potential toxicityconcerns, but after evaluating the first 31 patients enrolled in thestudies, an external safety monitoring committee has recommendedthat the tests are no longer needed. In addition, the FDA said Alteoncan include women of child bearing potential in the trials.The news sent Alteon's stock up $2.25 to close Tuesday at $7 a share, a47 percent increase. The Ramsey, N.J.-based company is collaboratingwith Marion Merrell Dow Inc., of Kansas City, Mo., on developmentof pimagedine.Susan M. Pietropaolo, Alteon's manager of corporate communications,said the trials began in January at 30 sites in the U.S.. and Canada.Another 15 sites are being added to speed up enrollment of 660patients, who will be treated and evaluated for two years.Pimagedine is designed to prevent formation of advanced glycosylationend-products (AGE) and progression of diabetic complications, such asnephropathy. _ Charles Craig
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