Threshold Pharmaceuticals Announces Target Enrollment of 620 Patients Achieved in Pivotal Phase 3 Trial of TH-302 in Advanced...
December 30 2013 - 7:00AM
Marketwired
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 - Dec 30, 2013) -
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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