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2015-09-16

Xenetic Biosciences, Inc.: 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.

About ErepoXen

®

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 under investigation to reduce the required frequency of dosage
and 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 of
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®, designed to develop next generation
biologic drugs by extending the efficacy, safety and half-life of biologic
drugs, and OncoHist(TM) for the development of novel oncology drugs focused
on orphan indications.

Xenetic's lead product candidates include ErepoXen®, a polysialylated form of
erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients
with chronic kidney disease, and OncoHist(TM), a novel recombinant human
histone H1.3 molecule for the treatment of refractory Acute Myeloid Leukemia
(AML) with potential to treat numerous other cancer indications. Xenetic is
collaborating with Russian-based OJSC Pharmsynthez (who is an affiliate of a
significant shareholder in Xenetic) and the Serum Institute of India to test
additional drug candidates and to de-risk the development process with
clinical data generated in Russia and India before Xenetic takes these
candidates into the clinic in the Western markets.

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 the company's website
at www.xeneticbio.com.

Baxalta Incorporated:

Xenetic is working together with Baxalta to develop a novel series of
polysialylated blood coagulation factors, including a next generation Factor
VIII. This collaboration relies on the PolyXen technology to conjugate PSA to
therapeutic blood-clotting factors, with the goal of improving the
pharmacokinetic profile and extending the active life of these biologic
molecules. Baxalta is one of the Company's largest shareholders having
invested in a number of previous financing rounds, the most recent being an
equity investment of $10M completed in 2014. The agreement is an exclusive
research, development and license agreement which grants Baxalta a worldwide,
exclusive, royalty-bearing license to Xenetic's PSA patented and proprietary
technology in combination with Baxalta's proprietary molecules designed for
the treatment of blood and bleeding disorders. Under the agreement, Xenetic
may receive regulatory and sales target receipts for total potential
milestones of up to $100 million plus royalties on sales.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not limited
to, the potential safety, tolerability and efficacy of our product candidates
and the advancement of our clinical trials. Forward-looking statements can be
identified by terminology such as "anticipate," "believe," "could," "could
increase the likelihood," "estimate," "expect," "intend," "is planned,"
"may," "should," "will," "will enable," "would be expected," "designed to,"
"look forward," "may provide," "would" or similar terms, variations of such
terms or the negative of those terms. Any forward-looking statements in this
press release are based on management's current expectations of future events
and are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and uncertainties
include, but are not limited to, the risk of cessation or delay of any of the
ongoing or planned clinical trials and/or our development of our product
candidates, the risk that the results of previously conducted studies
involving similar product candidates will not be repeated or observed in
ongoing or future studies involving current product candidates, the risk that
our collaboration with Baxalta will not continue or will not be successful,
and the risk that any one or more of our product candidates will not be
successfully developed and commercialized. For a discussion of other risks
and uncertainties, and other important factors, any of which could cause our
actual results to differ from those contained in the forward-looking
statements, see the section entitled "Risk Factors" in our Annual Report on
Form 10-K, as well as discussions of potential risks, uncertainties, and
other important factors in our subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of the date
of the release, and Xenetic undertakes no duty to update this information
unless required by law.
Contact:
Xenetic Biosciences Inc.

www.xeneticbio.com
M. Scott Maguire, Chief Executive Officer
781 778 7720
j.mccusker@xeneticbio.com

UK/European contact:

Arlington Group Asset Management Limited
Ross Ainger
+44 (0)207 389 5012
rainger@agam.co.uk

Brokers and Analysts:

Chesapeake Group
+1-410-825-3930
info@chesapeakegp.com

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Xenetic Biosciences, Inc. via Globenewswire

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