Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced the initiation of two Phase 2 studies of ISIS-EIF4ERx in patients with non-small cell lung cancer and prostate cancer. These studies are part of Isis' broad Phase 2 development program designed to evaluate ISIS-EIF4ERx in multiple types of cancer. ISIS-EIF4ERx targets eukaryotic initiation factor-4E (eIF-4E), a traditionally "undruggable" target that is thought to promote tumor growth and metastasis in many cancers.

"eIF-4E may represent a novel and broadly applicable target for cancers because it promotes cancer cell growth in many types of cancer," said Brett P. Monia, Ph.D., Vice President, Drug Discovery & Corporate Development at Isis. "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. Initially, our Phase 2 program will evaluate ISIS-EIF4ERx in combination with first-line treatments in prostate cancer and non-small cell lung cancer. We plan to expand our Phase 2 program over time to evaluate ISIS-EIF4ERx in other cancers that over-express eIF-4E."

The first Phase 2 study is evaluating the safety and efficacy of ISIS-EIF4ERx in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer. 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. Each randomized, controlled study will enroll approximately 100 patients. The endpoints for both studies include progression-free survival, response rates, overall survival, time to progression and the reduction of a variety of biomarkers.

"We are very encouraged by results obtained by our partners with our antisense anti-cancer drugs. We and our partners have shown that antisense drugs have unique effects in cancer without exacerbating the toxicity of chemotherapeutic agents. Our technology allows us to approach the many 'undruggable' targets that are of interest to treat cancer," continued Dr. Monia. "Data from these initial Phase 2 ISIS-EIF4ERx studies will also help inform future development decisions for patients with other types of cancer."

ABOUT ISIS-EIF4ERx

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. eIF-4E facilitates the synthesis of tumor angiogenic factors, which are factors that facilitate the growth of new blood vessels to support the development and progression of tumors, growth factors and survival factors by selectively enhancing their translation. In preclinical studies, Isis and collaborators demonstrated marked anti-cancer activity in a broad range of animal models of cancer and provided the first in vivo evidence that tumor growth may be more susceptible to eIF-4E inhibition than growth of normal tissue. Eli Lilly and Company has certain rights to license ISIS-EIF4ERx.

Source: Isis Pharmaceuticals, Inc