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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Maurice Winn who wrote (1607)	10/29/1998 12:56:00 AM
From: Bob L	Read Replies (1) \| Respond to of 1762

Maurice, isn't the purpose of a phase I trial to determine the maximum safe dosage? By say that the low response rate means they could have risked more radiation exposure, do you mean they botched the phase I trial? I think you are underestimating the problem of radiation damage to healthy organs, particularly bone marrow. The published research on the radioisotope-labeled antibodies says this is the limiting factor. Of course, the published research lags a couple of years behind the press releases of preliminary results, but nothing in the recent announcements suggests otherwise. Maybe they will get better at screening patients for risk. For example, if they were sure there was no lymphoma in the bone marrow, they could give higher doses. But it might not be easy to be sure of the degree of bone marrow involvement. I think they get marrow samples from the hip bones, but is that representative of the entire marrow or a spot check at best? Put another way, if they overdose someone and wipe out their marrow, it wouldn't look so good on the FDA application.