Rexahn to initiate Ph II trial of Archexin

The USA's Rexahn Pharmaceuticals has received Food and Drug Administration approval to initiate a Phase II trial of its lead oncology drug, Archexin (RX-0201), in patients with renal cell carcinoma. Enrollment is expected to begin in the third quarter of the year.

The Phase II non-blind, multicenter study is designed to assess the efficacy of Archexin in patients with advanced RCC who have failed previous treatment or are unwilling or unable to be treated with standard systematic line therapy.

The agent is a first-in-class signal inhibitor that directly blocks the production of AKT, a protein kinase that plays a key role in cancer progression by stimulating cell proliferation and cell survival, and promoting angiogenesis. In both preclinical and Phase I clinical trials, Archexin has demonstrated effectiveness at inhibiting the proliferation of various cancer cells at nanomolar concentrations and regulating the growth of tumors, with its only dose-limiting toxicity being fatigue at a dosage of 315mg/m2, the firm noted.