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.”
ErepoXen® is a polysialylated form of recombinant erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia. Chronic renal failure or chemotherapy can cause anemia. ErepoXen is designed to reduce the required frequency of dosage, side effects and to be less immunogenic than existing treatments. Clinical results of ErepoXen suggest that the drug candidate can be administered once a month. ErepoXen is currently in Phase 2/3 clinical development in collaboration with the Serum Institute of India and SynBio, Russia.
About Xenetic Biosciences
Xenetic Biosciences is a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary drug technology platforms include PolyXen® for creating next-generation biologic drugs by extending the efficacy, safety and half-life of biologic drugs, and OncoHist® for the development of novel oncology drugs focused on orphan indications. Xenetic's lead product candidates include ErepoXen®, an improved, polysialylated form of recombinant erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with chronic kidney disease, and OncoHist®, a recombinant human histone H1.3 molecule which Xenetic is developing for the treatment of refractory acute myeloid leukemia (AML). Xenetic is developing a novel series of polysialylated blood coagulation factors through its license agreement with Baxter International Inc. Xenetic is also developing a broad pipeline of clinical candidates for next-generation biologics and novel oncology therapeutics in a number of orphan disease indications. For more information, please visit www.xeneticbio.com.
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Press Release Code: XBIO-G