Clinical Trials for Biotech Products

Isis Pharmaceuticals was pleased to be included in the “Biotech Blues” (July 9) article depicting the challenges biotechnology faces in raising the necessary capital to fund research and development.

We would like to correct some information that was referenced in the article concerning the timing of clinical trials for two of the company’s compounds. The drug discovery and development process is a high-risk venture, and it is difficult to predict the timelines for when compounds will move from one phase of clinical testing to another, and for when each of those phases will be completed. This is especially true in the later phases of testing.

Isis currently has three compounds in clinical development, two of which are referenced in the article. The compound in development as a treatment for cytomegalovirus retinitis is in Phase III trials. Some of these trials may be completed toward the end of 1996, and decisions concerning the compound’s efficacy will be made following completion of these trials. If the results of these trials are positive, Isis plans to aggressively pursue U.S. and European registration of this compound in 1997.

The compound in development for genital warts is currently in a Phase II clinical trial. Results from that trial will be available toward the end of 1995. If the results of the Phase II trial support further development, Isis plans to proceed with pivotal quality studies on this compound.

B. LYNNE PARSHALL

Senior Vice President, Chief Financial Officer, Chief Counsel

Isis Pharmaceuticals

Carlsbad