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ISIS-3521. Isis Pharmaceuticals
Abstract:
ISIS-3521 is a 20-mer antisense phosphorothioate oligonucleotide PKCa expression inhibitor, under development by Isis (formerly in collaboration with Novartis) for the potential treatment of solid tumors that are refractory to, or recurrent with, standard treatment regimens [175741]. In November 1999, Novartis announced that it would end its codevelopment of ISIS-3521 [348221], [348222]. In August 2001, Eli Lilly in-licensed ISIS-3521 [420062]. In October 2000, phase III trials of ISIS-3521, in combination with carboplatin and paclitaxel, were initiated for the treatment of non-small cell lung cancer (NSCLC) [386128]. The FDA granted ISIS-3521 Fast Track review status for NSCLC in November 2000 [388930]. In April 2001, Bear Sterns & Co predicted US approval of ISIS-3521 in 2002 [411081]. In August 2001, Eli Lilly and Isis entered into a four-year strategic alliance that includes ISIS-3521. For the license of ISIS-3521, Isis will receive $25 million in upfront fees and will be reimbursed for remaining phase III development and registration costs [420062].
Insights
ISIS-3521, an investigational drug, is being developed as a treatment for solid tumors. Phase III trials are underway for non-small cell lung cancer (NSCLC).
Area of Science:
- Oncology
- Pharmacology
- Molecular Biology
Background:
- ISIS-3521 is an antisense oligonucleotide inhibitor of protein kinase C alpha (PKCa) expression.
- It is being developed for solid tumors refractory to standard treatments.
Purpose of the Study:
- To evaluate ISIS-3521 for the treatment of solid tumors, particularly non-small cell lung cancer (NSCLC).
Main Methods:
- Phase III clinical trials initiated in October 2000 for ISIS-3521 in combination with carboplatin and paclitaxel for NSCLC.
- FDA granted Fast Track review status for NSCLC in November 2000.
Main Results:
- Eli Lilly in-licensed ISIS-3521 in August 2001.
- A strategic alliance between Eli Lilly and Isis includes ISIS-3521, with Isis receiving $25 million upfront and reimbursement for phase III costs.
Conclusions:
- ISIS-3521 shows potential for treating solid tumors, especially NSCLC.
- Regulatory and commercial developments indicate ongoing progress in its development.