TetraLogic Announces Publication of Two Papers Describing Birinapant's Preclinical Activity in Chronic Hepatitis B
April 21 2015 - 8:00AM
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a
clinical-stage biopharmaceutical company focused on discovering and
developing novel small molecule therapeutics in oncology and
infectious diseases, today announced that research describing
birinapant's preclinical activity in a mouse model of chronic human
hepatitis B virus (HBV) has been published in the journal
Proceedings of the National Academy of Sciences.
Cellular inhibitor of apoptosis proteins prevent
clearance of hepatitis B virus
http://www.pnas.org/content/early/2015/04/15/1502390112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
Eliminating hepatitis B by antagonizing cellular
inhibitors of apoptosis
http://www.pnas.org/content/early/2015/04/15/1502400112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
The publication reports preclinical studies performed at the
Walter and Eliza Hall Institute of Medical Research (WEHI),
Melbourne, Australia in collaboration with TetraLogic
Pharmaceuticals. In studies performed by Dr. Marc Pellegrini and
his colleagues in mouse models of human hepatitis B, administration
of birinapant resulted in loss of HBV-DNA, loss of HBsAg and the
appearance of anti-HBsAg antibodies. A second paper describes
similar results in mice where the targets of birinapant, cIAP1 and
cIAP2, were ablated in the liver ("knock-out mice"). That result
provides independent genetic confirmation of birinapant's mechanism
of action.
These experiments provided the scientific rationale for
TetraLogic's ongoing multiple ascending dose study of birinapant in
subjects with chronic HBV. The trial is being conducted in subjects
over the age of 18 with chronic HBV who are receiving treatment
with either tenofovir or entecavir and who are HBsAg positive. The
trial is expected to enroll approximately 6 cohorts of 8 subjects
each, who will receive 4 weekly treatments with either birinapant
or placebo in a 3:1 ratio. The study is being conducted at multiple
clinical sites in Australia. Although predominantly a safety and
tolerability study, patients will also be monitored for reductions
in HBsAg and formation of antibodies to HBsAg as indications of
therapeutic activity.
About Birinapant
Cancer and chronically infected cells are able to evade a
critical mechanism by which the immune system normally kills
abnormal or genetically modified cells. They do this by
upregulating the Inhibitors of Apoptosis (IAP)
Proteins. Birinapant (TL32711) is a potent, bivalent
SMAC-mimetic that binds with differential affinity to multiple
members of the IAP family in order to re-establish the immune
system's ability to kill abnormal cells via an extracellular TNF
signal. Birinapant has been studied in over 350 patients, and
is currently in Phase 1 and Phase 2 trials for Myelodysplastic
Syndrome (MDS), Ovarian Cancer and Hepatitis B.
About the Walter and Eliza Hall Institute of Medical
Research
The Walter and Eliza Hall Institute of Medical Research is
Australia's oldest medical research institute. It is home to more
than 750 researchers who are working to understand, prevent and
treat diseases including infectious diseases, cancers and immune
disorders. It is located in Parkville, Melbourne, and is closely
associated with The University of Melbourne and The Royal Melbourne
Hospital.
About TetraLogic Pharmaceuticals
Corporation
TetraLogic is a clinical-stage biopharmaceutical company focused
on discovering and developing novel small molecule therapeutics in
oncology and infectious diseases. TetraLogic has two clinical-stage
product candidates in development: birinapant and SHAPE. Birinapant
is currently being tested in Phase 1 and Phase 2 clinical trials
for hematological malignancies and solid tumors, and is also being
tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is
currently being tested in a Phase 2 clinical trial for early-stage
cutaneous T‑cell lymphoma.
Forward Looking Statements
Some of the statements in this release are forward looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements relate to future
events or TetraLogic's pre-clinical and clinical development of
birinapant, SHAPE and other clinical programs, future expectations,
plans and prospects. Although TetraLogic believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. TetraLogic has attempted to
identify forward looking statements by terminology including
"believes," "estimates," "anticipates," "expects," "plans,"
"projects," "intends," "potential," "may," "could," "might,"
"will," "should," "approximately" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are only
predictions and involve known and unknown risks, uncertainties, and
other factors, including those discussed under the heading "Risk
Factors" in our Annual Report on Form 10-K filed with the U.S.
Securities and Exchange Commission (SEC) on February 26,
2015. Any forward-looking statements contained in this release
speak only as of its date. We undertake no obligation to
update any forward-looking statements contained in this release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
CONTACT: Pete A. Meyers
Chief Financial Officer and Treasurer
TetraLogic Pharmaceuticals Corporation
(610) 889-9900, x103
pete.meyers@tlog.com
TetraLogic Pharmaceuticals (CE) (USOTC:TLOG)
Historical Stock Chart
From Mar 2024 to Apr 2024
TetraLogic Pharmaceuticals (CE) (USOTC:TLOG)
Historical Stock Chart
From Apr 2023 to Apr 2024