– Patient dosing expected in Q3 2017 –
Xenetic Biosciences, Inc. (NASDAQ: XBIO) (“Xenetic” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the discovery, research and development of next-generation biologic
drugs and novel orphan oncology therapeutics, today announced that
patient enrollment has commenced in its Phase 2 clinical study of
XBIO-101 (sodium cridanimod) in conjunction with progestin therapy
for the treatment of endometrial cancer, in a population of
patients who have either failed progestin monotherapy or who have
been identified as having progesterone receptor negative (“PrR-”)
tumors.
XBIO-101, Xenetic’s lead product candidate in development, is a
small-molecule immunomodulator and interferon inducer which, in
preliminary studies, has been shown to increase progesterone
receptor (“PrR”) expression in endometrial tumor tissue.
“We are very pleased to commence patient enrollment in this
Phase 2 study with our flagship product candidate and believe this
trial is designed to provide greater understanding of XBIO-101 for
the treatment of progestin resistant endometrial cancer,” stated M.
Scott Maguire, Xenetic’s CEO. “Based on these preliminary findings,
we believe that XBIO-101 has the potential to increase the
expression of PrR on endometrial tumors thereby making them more
responsive to treatment with traditional progestin therapy, and
ultimately provide a much-needed solution for late stage
endometrial cancer patients.”
The primary objective of the open-label, multi-center,
single-arm, two-period Phase 2 study is to assess the antitumor
activity of XBIO-101 in conjunction with progestin therapy as
measured by Overall Disease Control Rate (“ODCR”) in women with
recurrent or persistent endometrial carcinoma not amenable to
surgical treatment or radiotherapy who have either failed progestin
monotherapy or who have been identified as PrR-. Secondary
objectives include assessments of efficacy and safety/tolerability
parameters.
The study is expected to enroll a total of 72 women with
recurrent or persistent endometrial cancer not amenable to surgical
treatment or radiotherapy but suitable to be treated with
progestins. All subjects determined to be PrR- at screening, as
well as those subjects who experience disease progression after at
least 4 weeks of progestin monotherapy, will receive XBIO-101 in
combination with continued progestin treatment. Subjects will
receive treatment until disease progression as defined according to
RECIST 1.1 criteria.
For more information about the Phase 2 clinical study of
XBIO-101 in conjunction with progestin therapy for the treatment of
endometrial cancer, please visit clinicaltrials.gov and reference
Identifier NCT03077698.
About Endometrial Cancer
Endometrial cancer is the most common malignancy of the female
genital tract and represents a major health concern, as overall
five-year survival rates have not improved over the past three
decades. Annually in the United States, an estimated 60,050
patients are diagnosed with endometrial cancer and 10,470 deaths
occur from this disease, representing 1.8% of all cancer deaths in
the US. The incidence of endometrial cancer is on the rise with a
lifetime risk of approximately 3% while the disease-specific
mortality of endometrial carcinoma has been rising in the last 25
years. Endometrial cancer patients whose tumors no longer express
progesterone receptors are not candidates for progestin-based
therapy. Patients who fail monotherapy with progestins have no
additional treatment options. XBIO-101 may improve sensitivity to
progestin therapy in subjects with advanced or recurrent PrR
tumors.
About XBIO-101
XBIO-101 is a small-molecule immunomodulator and interferon
inducer which, in preliminary studies, has been shown to increase
progesterone receptor (“PrR”) expression in endometrial tissue.
Restoration of PrR expression may re-sensitize endometrial tumor
tissue to progestin therapy in previously unresponsive tumors.
Xenetic has commenced patient enrollment in the Phase 2 clinical
study of XBIO-101 in conjunction with progestin therapy for the
treatment of progestin resistant endometrial cancer, and has filed
a protocol under its existing Investigational New Drug application
(“IND”) to expand the development of XBIO-101 into a biomarker
study for the treatment of triple negative breast cancer
(“TNBC”).
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a clinical-stage biopharmaceutical
company focused on the discovery, research and development of
next-generation biologic drugs and novel orphan oncology
therapeutics. Xenetic's proprietary drug development platforms
include PolyXen™, which enables next-generation biologic drugs by
improving their half-life and other pharmacological properties.
Xenetic's lead investigational product candidates include oncology
therapeutic XBIO-101 (sodium cridanimod) for the treatment of
progesterone resistant endometrial cancer (“EC”), and a
polysialylated form of erythropoietin for the treatment of anemia
in pre-dialysis patients with chronic kidney disease.
Xenetic is party to an agreement with Baxalta US Inc. and
Baxalta AB (wholly owned subsidiaries of Shire plc) covering the
development of a novel series of polysialylated blood coagulation
factors. This collaboration relies on Xenetic's PolyXen technology
to conjugate polysialic acid (“PSA”) to therapeutic blood-clotting
factors, with the goal of improving the pharmacokinetic profile and
extending the active life of these biologic molecules. Shire is a
significant stockholder of the Company, having invested $10 million
in the Company during 2014. The agreement is an exclusive research,
development and license agreement which grants Shire a worldwide,
exclusive, royalty-bearing license to Xenetic's PSA patented and
proprietary technology in combination with Shire's proprietary
molecules designed for the treatment of blood and bleeding
disorders. Under the agreement, Xenetic may receive regulatory and
sales target payments for total potential milestone receipts of up
to $100 million and additional royalties on sales. The first
program under this agreement was a next generation Factor VIII, and
this program was terminated by Shire following a Phase 1/2 trial.
Xenetic and Shire are currently exploring whether to engage in
further development of other blood coagulation factors.
Additionally, Xenetic has previously received strategic investments
from OPKO Health (Nasdaq: OPK), Serum Institute of India Limited
and Pharmsynthez.
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 and connect on Twitter, LinkedIn, Facebook and
Google+.
Forward-Looking Statements
This press release contains "forward-looking statements," as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), which statements may be identified by words
such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding
expected benefits of NGS cancer panels, the ability to accurately
determine the heritable factors increasing the risk of cancer,
permitting tailored treatment, screening and prevention of cancer
in patients, as well as other non-historical statements about our
expectations, beliefs or intentions regarding our business,
technologies and products, financial condition, strategies or
prospects. Many factors could cause our actual activities or
results to differ materially from the activities and results
anticipated in forward-looking statements. These factors include
those described in our filings with the Securities and Exchange
Commission, as well as the risks inherent in funding, developing
and obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments. In addition, forward-looking
statements may also be adversely affected by general market
factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that
may arise, patent positions and litigation, among other factors.
The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We
intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
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Jenene Thomas Communications, LLC.Jenene Thomas,
908-938-1475jenene@jenenethomascommunications.com
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