RNN up big in pre-market on topline phase 2 data for pancreatic cancer
8:50AM Rexahn Pharmaceuticals announced earlier positive top-line Phase IIa data for Archexin in patients with metastatic pancreatic cancer (RNN) 0.47 : Co announced top-line results from a Phase II clinical study of Archexin, its clinical-stage oncology drug candidate. Archexin is being developed as a potential first-in-class inhibitor of the Akt protein kinase in cancer cells. The open label 2-stage study was designed to assess the safety and efficacy of Archexin in combination with gemcitabine. Stage 1 was the dose finding portion and stage 2 was the dose expansion portion using the dose identified in stage 1 to be administered with gemcitabine. The study enrolled 31 subjects aged 18-65 years with metastatic pancreatic cancer at four centers in the United States and five centers in India. The primary endpoint was overall survival following 4 cycles of therapy with a 6-month follow-up. For those evaluable patients according to the protocol, the study demonstrated that treatment with Archexin in combination with gemcitabine provided a median survival of 9.1 months compared to the historical survival data of 5.65 months for standard single agent gemcitabine therapy. The most frequently reported adverse events were constipation, nausea, abdominal pain, and pyrexia, regardless of relatedness.
