Xenetic Biosciences Partner Completes Dosing of Second Cohort in Phase 2a Study of ErepoXen® in Patients with Chronic Kidney Disease on Dialysis

Xenetic Biosciences Partner Completes Dosing of Second Cohort in Phase 2a Study of ErepoXen® in Patients with Chronic Kidney Disease on Dialysis

Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, announces that its license partner and shareholder Serum Institute of India Limited (SIIL) has completed dosing the 10 patients comprising the second cohort of its Phase 2a study with ErepoXen®, a polysialylated form of erythropoietin (EPO).

    “With this trial for patients on dialysis, ErepoXen is now in clinical trials for a majority of the anemia indications, which have a global market valued in excess of $7B. Relative to other marketed EPOs, our ‘bio-better’ EPO aims to provide a well-tolerated and effective longer-acting therapy”

A total of 20 patients have been dosed to date in this open-label, single escalating dose study underway in India to assess the efficacy, safety and tolerance of ErepoXen in patients with chronic kidney disease who are on dialysis. The third, and a possible fourth cohort, will enroll a further 10 patients each. Follow-up of all patients and data analysis is expected to be completed no later than the end of the third quarter of 2015.

The first cohort of 10 patients received a one-time intravenous dose of 0.5 ug/kg of ErepoXen. This dose was considered to be well tolerated with no drug-related serious adverse events. No clinically relevant or significant abnormalities or trends were observed. The second cohort of 10 patients received a one-time intravenous dose of 1.5 ug/kg of ErepoXen, and these patients too have not exhibited any serious adverse events. Eight of these patients have completed their 28-day follow up. Results from the second cohort are expected to be reported in the first quarter of 2015. Patient enrollment for the third cohort has started. Dependent upon the results from the third cohort, a fourth cohort may or may not have to be enrolled at a higher dose level.

“With this trial for patients on dialysis, ErepoXen is now in clinical trials for a majority of the anemia indications, which have a global market valued in excess of $7B. Relative to other marketed EPOs, our ‘bio-better’ EPO aims to provide a well-tolerated and effective longer-acting therapy,” said M. Scott Maguire, chief executive officer of Xenetic Biosciences. “As the Company generates additional clinical data, we will seek a license partner to take this drug forward in the U.S. and Europe. Clinical data to date has been very encouraging and we look forward to reporting more data this year from our Phase 2a company-sponsored studies in Australia and New Zealand − data which will be submitted to the U.S. Food and Drug Administration. We also expect to report on Phase 2b/3 clinical data from the trials being conducted Russia. We are pleased with the progress our partner Serum Institute of India has been making with its own trials, and the data generated by it in this indication will be very helpful in our own commercialization strategy, as well as providing the potential source of royalty revenues. We look forward to receiving final data from SIIL in 2015.”