Dr. Bugg: BioCryst is focused on the discovery and development of novel drugs for treating cancer, cardiovascular diseases and viral infections. Our drug candidates are small-molecule compounds that are designed to fit the active sites of key enzymes involved in disease processes, using the core technology of structure-based drug design. We identify an enzyme along a biological pathway that is critical for the disease process, isolate the enzyme, determine its structure, and use the three- dimensional structure of the enzyme to guide the design of highly specific molecules that block the activity of the enzyme and thereby block progression of the disease process. Our lead drug candidate is BCX-1777, which is an oncology drug that blocks an enzyme called PNP. When this enzyme is inhibited, it allows us to intervene in a specific, focused manner with certain types of cancer cells, with minimal bad effects on most other types of cells. We now have four different Phase I/II clinical trials in progress, focusing on different types of leukemias, lymphomas and solid tumors. These trials are underway at nine cancer centers in the United States. We believe that we are on track to move into a Phase II trial within the next six to12 months. Our second drug candidate is in the cardiovascular area. This compound, BCX-3607, is a potent, selective inhibitor of the tissue factor/factor VIIa complex. Tissue factor is an initiation point for both blood clotting and cardiovascular inflammation. Therefore, by blocking tissue factor, we expect to intervene in two of the major processes involved in cardiovascular disease. We plan to file our first IND for BCX-3607 for treatment of patients with acute unstable angina toward the end of this year. We have already completed a pre-IND review by the FDA and we are now finalizing the pre-clinical toxicology essential for filing the IND. BCX-3607 is our next drug candidate to enter clinical trials, probably during the first quarter of 2004. In the anti-viral area, we are focusing on hepatitis C and are developing inhibitors of key enzyme hepatitis C polymerase. The polymerase is essential for the virus to replicate. By blocking that enzyme, we feel that we can effectively intervene in this disease, which is now estimated to have infected 4 million people in the US. Our fourth drug program is focused on the complement cascade, which is a cascade of enzymes involved in inflammation. These enzymes cause extensive tissue damage when they are improperly activated. We are developing inhibitors of the enzyme that initiates the cascade, C1s. This program is a joint collaboration with 3-Dimensional Pharmaceuticals, a biotechnology company that was recently purchased by Johnson & Johnson. With both the hepatitis C polymerase and the complement programs, we are aiming to identify clinical candidates during the next six to 12 months.
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