December 19, 2002
Data presented at the 6th National Institutes of Health Therapeutic Oligonucleotide Interest Group Symposium support advancement of ISIS-2503 into controlled trials designed to establish its magnitude of therapeutic effect for people with locally advanced or metastatic pancreatic cancer who have yet to receive chemotherapy. ISIS-2503 plus gemcitabine generated data exceeding the primary median survival endpoint in a 48-patient, open-label, phase II investigation.
ISIS-2503 is an antisense construct that blocks the production of H-ras, a small G-protein important for transmitting signals inside of cells. The new results amplify the importance of the ISIS-2503 clinical trial program, especially in light of the devastating nature of pancreatic cancer. Isis (NASDAQ:
ISIS) continues to be the industry leader in development of antisense drugs.
ISIS-2503 was given by continuous intravenous infusion for two weeks of a three-week cycle in combination with usual gemcitabine dosing on days one and eight. Investigators will present complete results from the study at the 2003 Annual Meeting of the American Society of Clinical Oncology (ASCO). Salient data thus far released include:
- median survival time of more than six months in patients with pancreatic cancer
- 57.5% of ISIS-2503 plus gemcitabine recipients survived six months or longer
- a potential treatment effect advantage over gemcitabine alone based upon historical control.
Isis has strong expertise in improving the chemistry of antisense compounds to increase their half-life and potency. Isis also has a broad intellectual property portfolio that includes over 100 gene patents and a key patent relating to the mechanism of antisense inhibition by RNAse H (an enzyme that cleaves mRNA when antisense is bound). In addition to developing antisense drugs, Isis has a target validation arm called GeneTrove and a small molecule drug discovery arm called Ibis. GeneTrove offers custom antisense molecules for target validation as well as a database of antisense compounds with a battery of functional tests. Ibis is also targeting RNA molecules, but with small molecules instead of antisense. The small molecules target different regions of mRNA (structured vs. linear), and thus should be complementary to its antisense program.
Isis’s approach has been validated with major deals with Eli Lilly and Amgen. However, recent interest in the scientific community has shifted from antisense to RNA interference. Isis has stated that it is not pursuing development of this related technology, but several small biotech companies, including startup Anylam, are well positioned to capitalize on this new trend.
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