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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Biomaven who wrote (5340)7/16/1998 6:28:00 PM
From: Vector1  Read Replies (1) of 9719
 
Its amazing what you can find digging through SEC docs. The following is from CLTR's recenly filed reg statement. The expanded use permit by the FDA is quite significant in terms of what Bexxars label might look like when approved.

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In addition, a Phase II dose escalation clinical trial has commenced at the
University of Nebraska for the combined use of radiolabeled B-1 Antibody and
standard chemotherapy as preparation for autologous bone marrow transplant.

Other Clinical Trials and Developments. The Company is also conducting a
Phase II multi-center investigational trial in patients previously treated with
Bexxar. This open label trial include low-, intermediate- and high-grade NHL
patients who have relapsed from their initial Bexxar treatment.

The Company has received initial approval from the FDA to commence an
expanded access program. Through this program, additional patients may be
treated with Bexxar during the period prior to FDA marketing approval.
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