ISIS-EIF4ERx targets the gene that is responsible for the production of a protein, eIF-4E, which is over-expressed in a variety of cancers, including prostate, lung, ovarian, liver, breast, head and neck, bladder, colon, thyroid and lymphoma.
According to Isis Pharma, the first Phase 2 study is investigating ISIS-EIF4ERx’ssafety and efficacy in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer.
However, the second Phase 2 study is evaluating the safety and efficacy of ISIS-EIF4ERx in combination with docetaxel and prednisone in patients with castrate-resistant prostate cancer.
The endpoints for both studies include progression-free survival, response rates, overall survival, time to progression and the reduction of a variety of biomarkers.
Isis Pharma Drug Discovery & Corporate Development vice president Brett Monia said that eIF-4E may represent a novel and applicable target for cancers because it promotes cancer cell growth in many types of cancer.
"In the Phase 1 study, ISIS-EIF4ERx reduced eIF-4E in tumors and was well tolerated at doses up to 1200 mg per week in patients with a variety of cancers," Monia said.
"Initially, our Phase 2 program will evaluate ISIS-EIF4ERx in combination with first-line treatments in prostate cancer and non-small cell lung cancer."