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Discoveries and Challenges in Early-Stage Apoptosis Drug Development
Decision Resources, Inc., Nov 2005, Pages: 14
Apoptosis, the major and best-studied pathway of programmed cell death, plays an important role in embryonic development, the immune system, and protection against mutations and cancer. As such, it has become an intriguing focus of investigation among pharmaceutical companies seeking to treat illnesses ranging from cancer to cirrhosis. In this report, we explain the apoptotic process, discuss several proteins within the apoptotic pathways that may represent potential targets for drug development, describe apoptosis modulators and inhibitors in development, and analyze the challenges associated with developing agents that target this pathway, especially those associated with caspase inhibitors
Business Implications
- Apoptosis is the major pathway of programmed cell death, or regulated cellular autodestruction, in which individual cells commit suicide. As a result of its role in cell development, the immune system, and protection against mutations and cancer, it has been an interesting target for drug developers since the early 1990s; however, no apoptosis drugs have yet reached the market.
- Most of the activity in the development of apoptosis drugs has centered on apoptosis inducers for the treatment of cancer. This work has been hampered by the fact that most targets are 'undruggable' protein-protein interactions. To circumvent the problem, researchers have focused on the development of antisense drugs. The antisense drug nearest to market is oblimersen (Genta's Genasense), a first-generation drug being submitted for approval in the United States and Europe.
- Tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL) is of particular interest to oncology drug developers because it has been found to selectively induce apoptosis in cancer cells independent of p53, which is usually inactivated in human cancers. Evidence suggests that TRAIL may be involved in tumor surveillance by natural killer cells and in defense against viral infection.
- Caspases are a class of proteases that constitute a key component of apoptotic pathways. The development of caspase inhibitors as therapeutics for conditions characterized by excessive apoptosis has been hampered by the existence of alternative pathways of cell death, which have only recently been elucidated. However, Idun, which was recently acquired by Pfizer, has an apoptosis inhibitor, IDN-6556, in Phase II clinical trials for liver disease, a condition in which these alternative pathways are not an issue.
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