Threshold Pharmaceuticals Announces Target Enrollment of 620 Patients Achieved in Pivotal Phase 3 Trial of TH-302 in Advanced

Threshold Pharmaceuticals Announces Target Enrollment of 620 Patients Achieved 
in Pivotal Phase 3 Trial of TH-302 in Advanced Soft Tissue
Sarcoma 
$12.5 Million USD Milestone to Be Paid by Merck KGaA 
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 12/30/13 --  Threshold
Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the target
enrollment of 620 patients with advanced soft tissue sarcoma has been
achieved in the company's pivotal Phase 3 trial of TH-302, its
investigational hypoxia-targeted drug. The enrollment achievement
triggers a milestone payment of $12.5 million USD from Merck KGaA,
Darmstadt, Germany. Threshold has a global license and co-development
agreement with Merck for TH-302, which includes an option for
Threshold to co-commercialize in the U.S. 
"We are pleased to achieve this enrollment milestone in this pivotal
trial of TH-302 for the treatment of patients with advanced soft
tissue sarcoma," said Barry Selick, Ph.D., Chief Executive Officer of
Threshold. "We hope that TH-302 will ultimately be shown to be both
safe and efficacious in this patient population for which there is an
urgent unmet medical need."  
Threshold is conducting this international, randomized, pivotal Phase
3 trial in partnership with the Sarcoma Alliance for Research through
Collaboration (SARC). The trial is enrolling patients with metastatic
or locally advanced unresectable soft tissue sarcoma and is designed
to evaluate the efficacy and safety of TH-302 in combination with
doxorubicin, compared to doxorubicin alone.  
Though Threshold will remain blinded to the data from its ongoing
Phase 3 trial, an Independent Data Monitoring Committee (IDMC), which
monitors patient safety on an ongoing basis, will conduct an interim
efficacy and safety analysis after 235 deaths are reported. The
timing of the interim analysis, which is event-based and therefore
dependent on the length of survival of patients, is currently
projected to be conducted in mid-2014. The interim efficacy analysis
is designed to allow for the early termination of the study based on
achieving a pre-specified improvement in overall survival and the
recommendation of the IDMC. If the IDMC recommends that the study
continue as planned, Threshold will remain blinded to the data until
the company conducts the primary analysis of overall survival after
434 deaths are reported. Unless the IDMC recommends that the study
end early, top-line results of the primary efficacy analysis are
currently projected to be reported in the first half of 2015. 
About Soft Tissue Sarcoma 
Sarcomas are a group of aggressive cancers of connective tissues of
the body for which there are currently limited treatment options.
Soft tissue sarcomas are treated with surgery, chemotherapy and
radiation. Usually a combination of these modalities offers the best
chance to treat the disease successfully. Doxorubicin and ifosfamide
are the most commonly used chemotherapeutic agents in patients with
advanced soft tissue sarcoma, but response rates are generally low
and toxicity can be significant. An estimated 36,000 new cases of
soft tissue sarcomas will be diagnosed in 2013 in the U.S. and
Europe. 
About TH-302 
TH-302 is an investigational hypoxia-targeted drug that is designed
to be activated under tumor hypoxic conditions, a hallmark of many
cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due
to insufficient blood supply as a result of aberrant vasculature.
Similarly, the bone marrow of patients with hematological
malignancies has also been shown, in some cases, to be severely
hypoxic. 
TH-302 is currently under evaluation in two Phase 3 trials: one in
combination with doxorubicin versus doxorubicin alone in patients
with soft tissue sarcoma, and the other in combination with
gemcitabine versus gemcitabine and placebo in patients with advanced
pancreatic cancer (MAESTRO). Both Phase 3 trials are being conducted
under Special Protocol Agreements with the U.S. Food and Drug
Administration (FDA). The FDA and the European Commission have
granted TH-302 Orphan Drug Designation for the treatment of soft
tissue sarcoma and pancreatic cancer. TH-302 is also being
investigated in hematological malignancies and in combination with
other therapies in a variety of solid tumors. 
Threshold has a global license and co-development agreement for
TH-302 with Merck KGaA, Darmstadt, Germany, which includes an option
for Threshold to co-commercialize in the U.S. 
About Threshold Pharmaceuticals  
Threshold is a biotechnology company focused on the discovery and
development of drugs targeting tumor hypoxia, the low oxygen
condition found in microenvironments of most solid tumors as well as
the bone marrows of some hematologic malignancies. This approach
offers broad potential to treat a variety of cancers. By selectively
targeting tumor cells, we are building a pipeline of drugs that hold
promise to be more effective and less toxic to healthy tissues than
conventional anticancer drugs. For additional information, please
visit our website (www.thresholdpharm.com). 
Forward-Looking Statements 
Except for statements of historical fact, the statements in this
press release are forward-looking statements, including statements
regarding the potential results of the Phase 3 trial of TH-302 in
patients with advanced soft tissue sarcoma, including a potential
interim analysis, and potential therapeutic uses and benefits of
TH-302 to treat patients with soft tissue sarcoma or other cancers.
These statements involve risks and uncertainties that can cause
actual results to differ materially from those in such
forward-looking statements. Potential risks and uncertainties
include, but are not limited to, the ability to enroll or complete
anticipated clinical trials, the time and expense required to conduct
such clinical trials and analyze data, whether later trials confirm
the results of earlier trials, whether the Phase 3 trial data is
sufficient to support regulatory approval to market TH-302, and
issues arising in the regulatory or manufacturing process and the
results of such clinical trials (including product safety issues and
efficacy results). Further information regarding these and other
risks is included under the heading "Risk Factors" in Threshold's
Quarterly Report on Form 10-Q, which has been filed with the
Securities and Exchange Commission on November 4, 2013 and is
available from the SEC's website (www.sec.gov) and on our website
(www.thresholdpharm.com) under the heading "Investors". We undertake
no duty to update any forward-looking statement made in this news
release. 
Contact: 
Laura Hansen, Ph.D.
Senior Director, Corporate Communications 
Phone: 650-474-8206 
E-mail: lhansen@thresholdpharm.com 
 
 
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