xbio news16 Sep 2015 13:23
Xenetic Biosciences Commences Third Cohort of Phase 2 Trials on Drug Candidate ErepoXen(R) for Anemia
Trial expands into South Africa
Compound uses Patented PolyXen® Technology for Recombinant Erythropoietin
LEXINGTON, Mass., Sept. 16, 2015 (GLOBE NEWSWIRE) -- Xenetic Biosciences, Inc. (OTCQB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, announced today that it has commenced the third cohort of its Phase 2 dose-escalation study with its lead drug candidate ErepoXen® for the treatment of anemia in pre-dialysis chronic kidney disease patients. In an effort to accelerate the recruitment rate, Xenetic has expanded the clinical research sites beyond Australia to now include locations in South Africa. Subjects from this third cohort study will receive injections of ErepoXen® every two weeks until hemoglobin levels reach therapeutic levels. The patients will then receive injections of ErepoXen® every 4 weeks (extended dosing interval) during maintenance for a total trial time of 17 weeks.
The data from the second cohort showed that 91% of the enrolled patients had an increase in hemoglobin levels over time, and that in 75% of the enrolled patients, hemoglobin levels rose into the therapeutic range. The third cohort is designed to further increase the patient's hemoglobin levels into mid-therapeutic range. The study is being performed at nine clinical sites in Australia and six new clinical sites in South Africa. Patient treatment has commenced in Australia. National and local regulatory approvals have been granted in South Africa and patient treatment is expected to start in September. This cohort is expected to be completed in Q2, 2016.
"We expect Cohort three to be the final leg of this phase II trial," said M. Scott Maguire, Chief Executive Officer of Xenetic. "We are excited to share this update with shareholders as the Company progresses along the developmental pathway of our ErepoXen® drug candidate.