TetraLogic Announces Initiation of a Randomized Phase 2 Clinical Trial of SHAPE in Subjects With Cutaneous T-Cell Lymphoma
18 December 2014 - 11:00PM
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today
announced the initiation of a randomized Phase 2 clinical trial of
SHAPE in subjects with early stage cutaneous T‑cell lymphoma
("CTCL").
SHAPE has been evaluated in a randomized, dose escalation,
placebo-controlled Phase 1 clinical trial in early-stage CTCL
subjects that met safety endpoints and demonstrated clinical
activity. Four of fifteen patients receiving SHAPE attained an
objective response as measured by a greater than 50% improvement in
their Composite Assessment of Index Lesion Severity, or CAILS,
score during and after 28 days of dosing. No placebo patients
responded.
The randomized Phase 2 trial will be conducted in
approximately sixty subjects with Stage IA-IIA CTCL. The
objectives of the Phase 2 clinical trial are to evaluate the dose,
clinical effect at 6 months (based on CAILS score), time to
response, and tolerability of treatment of >2% body surface
area.
"We are excited to advance our second molecule into a randomized
Phase 2 trial," said J. Kevin Buchi, President and Chief Executive
Officer of TetraLogic. "SHAPE's Phase 1 data suggests that it may
provide significant clinical benefit over existing CTCL therapies,
and we are hopeful that those data are replicated over a longer
duration and a broader body surface area."
About SHAPE
SHAPE is an HDAC inhibitor being developed for topical use for
the treatment of cutaneous T‑cell lymphoma, or CTCL. SHAPE is a
novel therapeutic designed to maximize HDAC inhibition locally in
the skin with limited systemic exposure. As a result, SHAPE has
characteristics that could allow it to be used topically over large
body surface areas with minimal systemic absorption. SHAPE's
composition of matter patent in the U.S. extends until at least
2028; in addition, SHAPE has been granted U.S. orphan drug
designation for CTCL. We have acquired worldwide development and
commercialization rights to SHAPE for all indications.
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 March 19, 2014 and in
our form 10-Q filed with the SEC on November 5, 2014. 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: Company Contact:
Pete A. Meyers
Chief Financial Officer and Treasurer
TetraLogic Pharmaceuticals Corporation
(610) 889 - 9900, x103
Pete.meyers@tlog.com
Investor Relations Contact:
Ami Bavishi
Burns McClellan, Inc.
(212) 213-0006
abavishi@burnsmc.com
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