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Executive Summary

ROCHE WILL OPEN DDC EXPANDED ACCESS PROGRAM by no longer requiring ddI interolerance as a criterion for access to ddC (Hivid), Hoffmann-La Roche announced Sept. 10. The company said it plans to submit its revised expanded access program protocol to FDA within the next few weeks; the deletion of the ddI intolerance requirement cannot be implemented until FDA gives the go-ahead. When the firm began its ddC expanded access program in June, patients receiving ddC for AIDS or ARC were required to have failed treatment with AZT (Burroughs Wellcome's Retrovir), be intolerant to that drug, and also be intolerant to ddI (Bristol-Myers Squibb's Videx) ("The Pink Sheet" June 2, p. 12). The firm now plans to eliminate the latter requirement, stating that safety data from the expanded access program and ddC clinical trials support wider availability of the drug. The protocol revision also is likely to include some modifications to the definitions of AZT intolerance and a streamlining of the data reporting paperwork for participating physicians. So far, about 100 patients are enrolled in the expanded access study. In addition, the company is permitting more physicians to administer ddC under the expanded access program. Previously, only physicians who had experience with ddC were allowed to provide the drug, in an effort to monitor patients closely and detect unanticipated drug-related toxicities. "After studying the first group of patients for one month and finding no serious toxicities," the company said it has "moved the program into its second phase in which any licensed physician who has experience in treating AIDS is eligible to participate." This planned expansion in physician eligibility was included in the original study protocol. Roche's two pivotal controlled clinical trials are a Phase II/III 26-site study comparing ddC versus AZT in patients with AIDS or AIDs-related complex, and a Phase II/III 12-site trial comparing the two drugs in patients who have already been treated with AZT for one year. Interim data analysis on the first trial is slated to get under way in October. However, Roche is seeking continued enrollment in both studies. Both are being conducted by the National Institute of Allergy and Infectious Diseases. The first open-label expanded access program was Bristol-Myers ddI access program, initiated a year ago ("The Pink Sheet" Oct. 2, p. 5). Both build upon the parallel track distribution concept, whereby an experimental AIDS drug outside of controlled trials to patients lacking other treatment alternatives.



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