Immunomedics Inc. said Tuesday that data from its pivotal Phase IIItrial of ImmuRAID-CEA will be re-evaluated by the FDA to identifypotentially approvable claims for the cancer imaging agent.In May, the Morris Plains, N.J.-based company reported that the FDA'sanalysis of the trial results for detection of colorectal cancer showedImmuRAID-CEA was not approvable. A product licensing applicationfor the imaging agent was filed three years ago.David Goldberg, Immunomedics' chairman, said that in meetings withthe FDA to clarify its May ruling, a decision was made to continueanalyzing the trial data to define claims both the company and the FDAcan accept.Goldberg said the discussions with the FDA determined thatImmunomedics did not have to conduct a new trial and that thecontinued analysis of the current results would focus on the same basicindications.Goldberg would not detail the reasons for the FDA's findings in May,nor would he specify the trial data that will be the focus of continuedanalysis. He also said he could not speculate on when an FDA approvalmay occur.When the FDA released its analysis two months ago, Immunomedicsstock (NASDAQ:IMMU) dropped 36 percent to $3.50 a share.Tuesday the stock closed at $3.25, up 6 cents.Goldberg told BioWorld his company has between $25 million and $27million in cash, which is enough to keep operating for up to two years.ImmuRAID-CEA consists of an antibody fragment labeled with theradioisotope technitium-99m, which attaches to the tumor marker,carcinoembryonic antigen.The objective of the Phase III trial was to compare the antibodyimaging to CAT scans and to surgical evaluations.Goldberg said, 'We continue to believe in the medical need forImmuRAID-CEA. Early and better detection (of cancer) will have animportant impact on management of the disease.'He added that clinical trials are under way involving multiple injectionsof ImmuRAID-CEA and the company plans to add other studies toexpand the product's uses in management of colorectal cancer.Immunomedics also is conducting clinical trials of ImmuRAID-CEAto detect lung and breast cancer. n
-- Charles Craig
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