TetraLogic Announces the Opening of an IND for SHAPE Gel in Alopecia Areata
02 Noviembre 2015 - 6:00AM
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today
announced that it has an open U.S. Investigational New Drug
application in support of a Phase 2 clinical trial of
suberohydroxamic acid (4-methoxycarbonyl) phenyl ester (SHAPE) in
approximately forty patients with alopecia areata.
SHAPE is a novel HDAC inhibitor being developed for topical
treatment of cutaneous T-cell lymphoma, or CTCL, and is currently
being evaluated in a Phase 2 clinical trial. SHAPE is designed
to maximize HDAC inhibition locally in the skin with limited
systemic exposure.
Alopecia areata is an autoimmune skin disease resulting in the
loss of hair on the scalp and elsewhere on the body. Alopecia
areata occurs in males and females of all ages, but onset often
occurs in childhood. Over 6.6 million people in the United States
have or will develop alopecia areata at some point in their
lives. FDA has identified alopecia areata to be one of the few
disease states to be developed under the Patient-Focused Drug
Development Initiative based upon multiple criteria including
disease severity and unmet medical needs.
"We are excited to advance SHAPE into a second indication and
another Phase 2 trial," said J. Kevin Buchi, President and Chief
Executive Officer of TetraLogic. "A topical therapy which minimizes
systemic exposure could provide an attractive new treatment option
to the millions of alopecia areata sufferers."
About SHAPE
SHAPE is an HDAC inhibitor being developed for topical use for
the treatment of CTCL, and alopecia areata. 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. TetraLogic owns 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 myelodysplastic syndromes (MDS) and solid tumors. SHAPE is
currently being tested in a Phase 2 clinical trial for early-stage
Cutaneous T-cell Lymphoma (CTCL).
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 and in our Form 10-Q filed with the SEC on August 5,
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: Company 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)
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