Threshold Pharmaceuticals Announces Agreement With U.S. FDA on

Threshold Pharmaceuticals Announces Agreement With U.S. FDA on a
Special Protocol Assessment for Planned Phase 3 Trial of TH-302 in
Combination With Gemcitabine in Advanced Pancreatic Cancer 
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 10/16/12 --   Threshold
Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the U.S.
Food and Drug Administration (FDA) has reached agreement with the
U.S. affiliate of Merck KGaA, Darmstadt, Germany, Threshold's partner
for the development and commercialization of TH-302, covering a
Special Protocol Assessment (SPA) for a Phase 3 randomized trial of
TH-302 in patients with metastatic or locally advanced unresectable
pancreatic cancer. The trial is designed to evaluate the efficacy and
safety of TH-302 in combination with gemcitabine compared with
gemcitabine therapy alone. Pursuant to Threshold's license and
co-development agreement with Merck, Merck will be responsible for
conducting the Phase 3 study under the SPA. 
A Special Protocol Assessment (SPA) is a written agreement with the
FDA that documents FDA's agreement that the design and planned
analysis of a study can adequately address objectives in support of a
regulatory submission. However, FDA's determinations for marketing
application approval are made after a complete review of a marketing
application and are based on the entire data in the application. 
"In light of the evolving landscape for the first-line treatment of
patients with advanced pancreatic cancer, we are pleased with the
FDA's agreement that the design and planned analysis of this study
adequately address the objectives necessary to support a regulatory
submission," said Barry Selick, Ph.D., Chief Executive Officer of
Threshold. "Given that the Phase 2 clinical trial met its primary
endpoint, which was presented earlier this year at the annual AACR
and ESMO medical meetings, we and our partner Merck are looking
forward to further investigating TH-302 in a Phase 3 study in
patients living with this extremely difficult to treat cancer." 
About Pancreatic Cancer
 Pancreatic cancer is a malignant neoplasm of
the pancreas with current treatment options including surgery,
radiotherapy and chemotherapy. Gemcitabine as a single agent or in
combination with other treatments is the most commonly used
chemoth
erapeutic agent in patients with advanced pancreatic cancer.
According to the American Cancer Society, an estimated 43,920 new
cases of pancreatic cancer and 37,390 deaths are expected to occur in
the U.S. in 2012. The targeted therapy erlotinib, the only other
agent approved for treatment of pancreatic cancer since gemcitabine,
received regulatory clearance based on results from a Phase 3 study
demonstrating a median overall survival of 6.4 months for patients
treated with erlotinib in combination with gemcitabine versus 6
months for gemcitabine alone. 
About TH-302
 TH-302 is a hypoxia-targeted drug designed to be
activated under tumor hypoxic conditions, a hallmark of many cancers.
Areas of low oxygen levels (hypoxia) are common in many solid tumors
due to insufficient blood vessel growth. Similarly, the bone marrow
of patients with hematological malignancies has also been shown, in
some cases, to be extremely hypoxic. 
TH-302 has been investigated in over 700 patients in Phase 1/2
clinical trials to date in a broad spectrum of tumor types, both as a
monotherapy and in combination with chemotherapy treatments and other
targeted cancer drugs. Threshold has several additional ongoing
clinical trials, the most advanced of which is a Phase 3 pivotal
study evaluating TH-302 in combination with doxorubicin versus
doxorubicin alone in patients with soft tissue sarcoma. Results of
the Phase 2 study of TH-302 in patients with pancreatic cancer were
reported at the American Association for Cancer Research (AACR)
Annual Meeting 2012 and the European Society for Medical Oncology
(ESMO) 2012 Congress. In February 2012, Threshold signed a global
license and co-development agreement for TH-302 with Merck KGaA,
Darmstadt, Germany. 
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 for regulatory approval
of TH-302 based on the trial that is the subject of the SPA and
potential therapeutic uses and benefits of TH-302 to treat patients
with cancer. 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, Threshold's ability to enroll or
complete its anticipated clinical trials, the time and expense
required to conduct such clinical trials and analyze data, whether
additional clinical data causes the FDA to revisit agreements
contained in the SPA, whether the FDA requires additional clinical
trials despite the agreements contained in the SPA and issues arising
in the regulatory or manufacturing process and the results of such
clinical trials (including product safety issues and whether efficacy
results are sufficient to support product approval). 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
August 6, 2012 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.
650-474-8206
lhansen@thresholdpharm.com 
 
 
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