Xenetic Biosciences 30 Jun 2014 13:19
Announces Ongoing Safety Data From Phase 2 Trial of ErepoXen(R)
LEXINGTON, Mass., June 30, 2014 (GLOBE NEWSWIRE) -- Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced results from its ongoing data analysis of the first cohort of its Phase 2, sequential multiple dose study evaluating the safety and efficacy of ErepoXen®, subcutaneously administered polysialylated erythropoietin (PSA-EPO), for the treatment of anemia in Chronic Kidney Disease (CKD) patients who are neither on dialysis nor receiving erythropoiesis stimulating agents. ErepoXen® was found safe and well tolerated to date, with no serious adverse events. This is the first data on repeat dosing of PSA-EPO in human subjects demonstrating its tolerability and safety in Western clinical trials. On this basis, the Safety Review Committee authorized a dose increase for the second cohort of the study, which is currently underway and demonstrating early signs of clinical efficacy. The Safety Review Committee intends to meet again in August 2014, and the Company expects additional results to be available in the third quarter of 2014.
"We are very pleased to announce these safety and tolerability data for ErepoXen®, our most advanced product candidate," said Scott Maguire, Chief Executive Officer of Xenetic. "This trial represents one of many currently on-going studies of the compound, and supports our continued testing of ErepoXen® as a potential treatment option for anemic patients in need of more effective therapies. We expect to seek a commercial partner to assist us in bringing this large market drug candidate through late stage clinical development and potential market launch."
ErepoXen® is an improved, polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia. ErepoXen® is designed to reduce the required frequency of dosage and side effects, and to be less immunogenic than existing treatments.
This open-label, sequential multiple dose finding study is designed to determine the dose of ErepoXen® that is safe and moves the patient's hemoglobin level into the 10-12 g/dL range. No serious adverse events were reported in the 15 patients evaluated. Gastrointestinal disorders and infections of mild to moderate intensity were reported by 13 patients. None of the events were assessed as being related to the study drug. In addition there is no indication of antibody formation against polysialic acid (PSA), EPO or PSA-EPO in any of the subjects tested to date.
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