Phase 2a Trial Update of Archexin for Metastatic Pancreatic Cancer

Rexahn Pharmaceuticals announced top-line results from a Phase 2 clinical study of Archexin in patients with metastatic pancreatic cancer.

The open label 2-stage study was designed to assess the safety and efficacy of Archexin in combination with gemcitabine (Gemzar; Lilly). 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. 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.

Archexin is being developed as an Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers.

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