The press release states:19 Dec 2014 14:20
LEXINGTON, Mass.--(BUSINESS WIRE)-- Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, announces that it has completed enrollment of the second cohort of its Phase 2a dose-escalation study with ErepoXen® for the treatment of anemia in pre-dialysis chronic kidney disease patients. The patients enrolled in this cohort receive a biweekly injection of ErepoXen until hemoglobin levels reach therapeutic levels. The patients then receive injections of ErepoXen every 4 weeks during maintenance for a total trial time of 17 weeks. Eight of the 12 patients enrolled in this cohort have completed treatment.
The data show that hemoglobin levels increased over time and rose into the therapeutic range. This compares with the first cohort of 12 patients, which showed an increase in hemoglobin levels over the course of the 17-week study but did not significantly penetrate the desired therapeutic level. In both cohorts ErepoXen was well tolerated and there were no significant adverse results deemed related to treatment. The study was conducted at 10 treatment sites, including eight in Australia and two in New Zealand.
Professor Simon D Roger M.D., FRACP, Director of Renal Medicine, Gosford Hospital, New South Wales, Australia and principal investigator of the study, said, "The results achieved with ErepoXen in these chronic kidney disease patients confirm the efficacy of this biopharmaceutical and should lead to continued study of this compound. We have begun the process of preparing for the third cohort and determining the dose and interval for administration to be studied in this group. We are very encouraged about the potential for ErepoXen to treat these patients and look forward to providing additional data on the third cohort in 2015."
"We have made tremendous progress with ErepoXen in the treatment of anemia in chronic kidney disease patients," said M. Scott Maguire, chief executive officer of Xenetic Biosciences. "We will provide the data generated in our study in Australia and New Zealand to the U.S. Food and Drug Administration to support a registration trial in the U.S. In addition, the work our license partners are doing in Russia and India provides us with additional confidence in our pathway seeking regulatory approval. The global market for anemia drugs exceeds $7 billion annually, and we believe ErepoXen will be a very attractive licensing asset in the U.S., Europe and Japan should data generated in current studies continue to be so compelling."