Cerulean Pharma is moving on to a Phase 2 clinical trial of its new lung cancer drug, CRLX101, boosted by early clinical results suggesting that the treatment is well-tolerated and possibly stops the disease from advancing.
The Cambridge, MA, company said it plans to enroll 150 patients for the new trial at clinical sites in Russia and Ukraine. The randomized trial will involve non-small cell lung cancer patients who have had up to two prior chemotherapy regimens. Cerulean will measure overall survival rates with CRLX101.
Cerulean announced the news Nov. 14 during the AACR-NCI-EORTC International Conference in San Francisco.
Additionally, the company said 38 patients in a Phase2a study of the maximum dose said they tolerated the drug well. Also, 21 of those patients receiving the drug, all of whom had an average of more than three previous chemotherapy treatments, survived an average of more than four months without the cancer progressing.
The company said its drug demonstrates anti-tumor activity in "xenograft tumor models of highly treatment refractory subtypes of lung cancer." The drug is designed to work by releasing its cytotoxic treatment once it penetrates deep inside tumor tissue. Specifically, it is a tumor-targeted nanopharmaceutical that inhibits topoisomerase 2 and hypoxia-inducible factor-1 alpha, according to Cerulean. CRLX101 concentrates in tumor tissue and tumor cells, creating a longer-term drug exposure.
- here's the release
- check out Cerulean's upcoming trial details
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