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).
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.”
About ErepoXen
ErepoXen® is a polysialylated form of
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 a polysialylated form of EPO
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 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.
Copyright Business Wire 2014