SIGA Completes Enrollment and Dosing in Final Cohort of Phase I Study of IV Formulation of TPOXX® (tecovirimat) to Treat Sma...
April 20 2017 - 7:30AM
SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company
specializing in the development and commercialization of solutions
for serious unmet medical needs and biothreats, today announced the
completion of enrollment and dosing in the final cohort of healthy
subjects in a Phase I clinical study of an intravenous (IV)
formulation of its lead drug candidate, TPOXX® (tecovirimat).
TPOXX is being developed for the treatment of smallpox, as well as
other orthopoxvirus infections. There were no drug-related Serious
Adverse Events (“SAEs”) reported.
The IV formulation of TPOXX provides an important additional
tool in smallpox preparedness for use in populations who cannot
take an oral formulation. This first in human single
ascending dose IV study was conducted at four sequentially
increasing doses. The study initiated at the lowest dose to
evaluate the drug for safety. The higher doses studied were
selected based on predicted exposures that would be safe and would
provide exposure levels in humans comparable to the exposure levels
after oral dosing at 600mg twice daily, which is the dose predicted
for efficacy based on animal models. The IV study demonstrated a
linear response that the Company expects will allow it to determine
the appropriate dose for the IV formulation and simplifies clinical
development of the product.
TPOXX (tecovirimat) is being developed under the U.S. Food &
Drug Administration’s “Animal Rule,” in which efficacy endpoints
are determined in animal studies, and human clinical studies are
conducted to determine safety and confirm dosing. This Phase
I study is wholly funded by the U.S. government’s Biomedical
Advanced Research and Development Authority (BARDA).
“We are very pleased to have completed dosing in this important
safety study for the IV formulation of TPOXX. The Phase I safety
data demonstrating the absence of drug-related Serious Adverse
Events are consistent with previous data from studies of our oral
formulation. These results position TPOXX for further
successful development and potential procurement of the IV
formulation in partnership with BARDA,” said Dr. Phil Gomez, Chief
Executive Officer of SIGA Technologies, Inc.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a company specializing in the
development and commercialization of solutions for serious unmet
medical needs and biothreats. The company’s lead product
is Tecovirimat, TPOXX®, also known as ST-246®, an orally
administered and IV formulation antiviral drug that
targets orthopoxvirus infections. While TPOXX® is
not yet approved as safe and effective by the U.S. Food &
Drug Administration, it is a novel small-molecule drug that is
being delivered to the Strategic National Stockpile under Project
BioShield. For more information about SIGA, please
visit www.siga.com.
About Smallpox1
Smallpox is a contagious, disfiguring and often deadly disease
that has affected humans for thousands of years. Naturally
occurring smallpox was eradicated worldwide by 1980, the result of
an unprecedented global immunization campaign. Samples of
smallpox virus have been kept for research purposes. This has led
to concerns that smallpox could someday be used as a biological
warfare agent. No cure or treatment for smallpox exists. A
vaccine can prevent smallpox, but the risk of the vaccine's side
effects is too high to justify routine vaccination for people at
low risk of exposure to the smallpox virus.
FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended, including statements relating to the
submission and approval of TPOXX® by the U.S. Food & Drug
Administration. Such forward-looking statements are subject to
various known and unknown risks and uncertainties and SIGA cautions
you that any forward-looking information provided by or on behalf
of SIGA is not a guarantee of future performance. SIGA's actual
results could differ materially from those anticipated by such
forward-looking statements due to a number of factors, some of
which are beyond SIGA's control, including, but not limited to, (i)
the risk that potential products that appear promising to SIGA or
its collaborators cannot be shown to be efficacious or safe in
subsequent pre-clinical or clinical trials, (ii) the risk that SIGA
or its collaborators will not obtain appropriate or necessary
governmental approvals to market these or other potential products,
(iii) the risk that SIGA may not be able to obtain anticipated
funding for its development projects or other needed funding,
including from anticipated governmental contracts and grants, (iv)
the risk that SIGA may not complete performance under the
Biomedical Advanced Research Development Authority (BARDA) Contract
on schedule or in accordance with contractual terms, (v) the risk
that SIGA may not be able to secure or enforce sufficient legal
rights in its products, including intellectual property protection,
(vi) the risk that any challenge to SIGA's patent and other
property rights, if adversely determined, could affect SIGA's
business and, even if determined favorably, could be costly, (vii)
the risk that regulatory requirements applicable to SIGA's products
may result in the need for further or additional testing or
documentation that will delay or prevent seeking or obtaining
needed approvals to market these products, (viii) the risk that one
or more protests could be filed and upheld in whole or in part or
other governmental action taken, in either case leading to a delay
of performance under the BARDA Contract or other governmental
contracts, (ix) the risk that the BARDA Contract is modified or
canceled at the request or requirement of the U.S. government, (x)
the risk that the volatile and competitive nature of the
biotechnology industry may hamper SIGA's efforts to develop or
market its products, (xi) the risk that the changes in domestic and
foreign economic and market conditions may affect SIGA's ability to
advance its research or may affect its products adversely, (xii)
the effect of federal, state, and foreign regulation, including
drug regulation and international trade regulation, on SIGA's
businesses, (xviii) the risk that our internal controls will not be
effective in detecting or preventing a misstatement in our
financial statements, (xiv) the risk that some amounts received and
recorded as deferred revenue may someday be determined to have been
more properly characterized as revenue when received, and (xv) the
risk that some amounts received and recorded as deferred revenue
ultimately may not be recognized as revenue. More detailed
information about SIGA and risk factors that may affect the
realization of forward-looking statements, including the
forward-looking statements in this press release, is set forth in
SIGA's filings with the Securities and Exchange Commission,
including SIGA's Annual Report on Form 10-K for the fiscal year
ended December 31, 2016, and in other documents that SIGA has filed
with the SEC. SIGA urges investors and security holders to read
those documents free of charge at the SEC's web site
at http://www.sec.gov. Interested parties may also obtain
those documents free of charge from SIGA. Forward-looking
statements are current only as of the date on which such statements
were made, and except for our ongoing obligations under the United
States of America federal securities laws, we undertake no
obligation to update publicly any forward-looking statements
whether as a result of new information, future events, or
otherwise.
____________________________
1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
Contacts
For SIGA:
Media
Lazar Partners
Glenn Silver, 646-871-8485
gsilver@lazarpartners.com
or
Investor Relations
KCSA Strategic Communications
Todd Fromer, 212-896-1215
tfromer@kcsa.com
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Mar 2024 to Apr 2024
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Apr 2023 to Apr 2024