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Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, today 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 (Akt) 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 (Burris et al., 1997, J. Clin Oncol 15:2403) for standard single agent gemcitabine therapy. The most frequently reported adverse events were constipation, nausea, abdominal pain, and pyrexia, regardless of relatedness.
Dr. Chang Ahn, Chief Executive Officer, Rexahn, said, “We are very pleased with the positive results of this early-stage clinical study to examine Archexin’s profile as a potential Akt inhibitor of solid tumors. With this supportive clinical outcome data, we look forward to progressing the clinical development of this exciting compound.”
Dr. Troy Guthrie, Baptist Medical Center in Jacksonville, FL, who was one of the investigators of the trial commented, “This study suggests that Archexin, in combination with gemcitabine, may be another treatment option for this difficult to treat cancer.”
Archexin is being developed as an Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. Phase I clinical trial data also suggest that Archexin was generally well tolerated by the patients in the clinical trial with fatigue being the only observed/reported side effect. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers. Due to this designation, Archexin is eligible for a 7-year period of market exclusivity upon final FDA approval of the product for the treatment of any of these orphan indications.