Isis Pharmaceuticals Statement Regarding UBS Warburg Report
Friday December 6, 4:44 pm ET
Isis and Lilly Remain Blinded to Affinitak(TM) Phase III Clinical Trial
CARLSBAD, Calif., Dec. 6 /PRNewswire-FirstCall/ -- In response to a research note published today by a UBS Warburg analyst, which downgraded the company's stock based on anecdotal information obtained from clinical investigators, Isis Pharmaceuticals, Inc., (Nasdaq: ISIS - News) issues the following statement regarding the status of the 600-patient Phase III clinical trial of Affinitak in combination with chemotherapy in patients with non-small cell lung cancer:The Phase III clinical trial remains blinded to both companies. No clinical investigator nor company representative has access to all the data. Further, no analysis of any kind has been initiated.
-- The Phase III study design prevents insights.
The study and data management systems have been designed to make it impossible for any clinical investigator to have sufficient information to draw any inference about the trial. In fact, the trial design prevents any single site from enrolling more than 5% of the total number of patients. Therefore, no clinical investigator could have sufficient experience to draw any conclusions about the performance of Affinitak.
-- The trial database is secure.
The database is maintained at Isis only. All Isis employees are blinded. No one at the company has sufficient access to unblind the data. We have confirmed that there has been no breach of security. We further confirm that no one at Isis or Lilly has unblinded information about this trial.
-- The analysis and new drug application (NDA) plans have been finalized.
Isis and Lilly have just completed important meetings that finalized the analysis plan for this trial, and the strategy for compiling a NDA should the results be sufficiently positive to support a single study filing. The companies plan to conduct the analysis of the Phase III data in March 2003. Based on detailed planning, the March timeframe has been adopted to support the maturation of the study and to coincide with the preparation of the CMC, or manufacturing section, of the NDA.
-- Isis and Lilly remain enthusiastic about the potential for Affinitak in cancer.
The Lilly Phase III trial of Affinitak in combination with Gemzar/cisplatin in patients with non-small cell lung cancer continues to enroll well. Additional Phase II trials of Affinitak are in progress and the work necessary to support a single study NDA is well underway. |
