UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 22, 2014
THRESHOLD PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
Delaware |
001-32979 |
94-3409596 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
170 Harbor Way, Suite 300
South San Francisco, California 94080
(Address of principal executive offices)(Zip
Code)
(650) 474-8200
(Registrant’s telephone number,
including area code)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
On September 22, 2014, Threshold Pharmaceuticals, Inc. (the
“Company”) issued a press release announcing that the Independent Data Monitoring Committee (IDMC) has completed the
planned interim efficacy and safety analyses of unblinded data for the Company’s pivotal Phase 3 clinical trial of TH-302,
an investigational hypoxia-activated prodrug, in combination with doxorubicin versus doxorubicin alone in patients with locally
advanced unresectable or metastatic soft tissue sarcoma, and that the IDMC recommended that the trial should continue as planned
without modification to its natural conclusion
The press release is attached as an Exhibit 99.1 to this Form
8-K and is incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit 99.1 | Press release dated September 22, 2014. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
THRESHOLD
PHARMACEUTICALS, INC.
By: /s/
Joel A. Fernandes
Joel
A. Fernandes
Vice
President, Finance and Controller
Date: September 22, 2014
Exhibit
Index
| Exhibit 99.1 | Press release dated September 22, 2014. |
Exhibit 99.1
NEWS RELEASE
Threshold Pharmaceuticals Announces its
Phase 3 Trial of TH-302 in Patients with Advanced Soft Tissue Sarcoma Will Continue as Planned Following Protocol-Specified Interim
Analysis
SOUTH SAN FRANCISCO, CA – September
22, 2014 – Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the Independent Data Monitoring Committee
(IDMC) has completed the planned interim efficacy and safety analyses of unblinded data for the Company’s pivotal Phase 3
clinical trial of TH-302 in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable
or metastatic soft tissue sarcoma (STS). Based on their analyses, which included an assessment of both benefit and risk, the IDMC
recommended that the trial should continue as planned to its natural conclusion.
“The IDMC’s recommendation
to continue the trial is in line with our expectations and previous guidance that this was the likely outcome in light of the very
high statistical hurdle for demonstrating efficacy in the interim analyses,” said Barry Selick, Ph.D., Chief Executive Officer
of Threshold. “We look forward to the continuation of this important study with the goal of improving survival for patients
with advanced STS.”
Threshold and its partner Merck KGaA, Darmstadt,
Germany, have been and will remain blinded to the data from the trial. Based on projections derived from the interim analysis,
Threshold is revising its guidance on timing for the number of events (deaths) required for the primary efficacy analysis. Previously,
the Company projected the pre-specified number of events (n=434) would occur around the middle of 2015; the revised projections
suggest the requisite events will occur in the latter half of 2015.
About the Phase 3 trial
Threshold is conducting this international,
randomized pivotal Phase 3 clinical trial in partnership with the Sarcoma Alliance for Research through Collaboration (SARC) and
under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The trial is designed to
investigate the efficacy and safety of TH-302 in combination with doxorubicin, compared with doxorubicin alone, in previously untreated
patients with metastatic or locally advanced unresectable STS. The primary endpoint of the trial is overall survival. Secondary
endpoints include progression-free survival, overall response rate, pharmacokinetics and safety. Patients were randomized to either
doxorubicin alone or to receive TH-302 300 mg/m2 administered intravenously on Days 1 and 8 with doxorubicin 75 mg/m2
on Day 1 of each 21-day cycle. After six cycles, patients with stable and/or responding disease could receive maintenance monotherapy
with TH-302 according to the same dosing schedule, 300 mg/m2 Days 1 and 8 of each 21-day cycle. The trial enrolled a
total of 640 patients across 81 study sites in Europe, Israel, North America and the Russian Federation. A total of 256 deaths
were included in the interim analysis; the statistical hurdle for demonstrating efficacy required a one-sided p-value of <0.0035
with associated hazard ratio of about <0.71. The primary analysis, which will now be conducted after a minimum of 434 deaths,
will require a one-sided p-value of <0.0239 with associated hazard ratio of about <0.82 to reach statistical significance.
About Soft Tissue Sarcoma
Sarcomas are a group of aggressive
cancers of connective tissues of the body for which currently there are limited treatment options. STS is treated with
surgery, chemotherapy and radiation. A combination of these modalities usually offers the best option for treating the
disease successfully. Doxorubicin and ifosfamide are the most commonly used chemotherapeutic agents in patients with advanced
STS, but response rates are generally low and toxicity can be significant. The American Cancer Society has estimated that
about 12,020 new cases of STS will be diagnosed in 2014 (6,550 cases in males and 5,470 in females), and 4,740 Americans
(2,550 males and 2,190 females) are expected to die from STS.1
About TH-302
TH-302 is designed to be activated under
severe 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 advanced STS, and the other in
combination with gemcitabine versus gemcitabine and placebo in patients with advanced pancreatic cancer (the “MAESTRO”
trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the
European Commission have granted TH-302 Orphan Drug Designation for the treatment of STS and pancreatic cancer. TH-302 is also
being investigated in earlier-stage clinical trials of other solid tumors and hematological malignancies, in combination with chemotherapy
and antiangiogenic therapy; and for certain cancers, it is being investigated as a monotherapy.
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 Pharmaceuticals, Inc. is a biotechnology
company focused on the discovery and development of drugs targeting tumor hypoxia, the low oxygen condition found in the microenvironments
of most solid tumors as well as the bone marrows of some patients with 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 all statements regarding the continuation of the
Phase 3 clinical trial of TH-302 in patients with advanced STS, including potential outcomes thereof, the anticipated timing for
the number of events required for the primary efficacy analysis of the Phase 3 clinical trial of TH-302 in patients with advanced
STS, and the potential therapeutic uses and benefits of TH-302 to treat patients with advanced STS, advanced pancreatic cancer
and 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 of Threshold
and Merck KGaA, Darmstadt, Germany, to enroll or complete TH-302 clinical trials, including Threshold’s ability to complete
the Phase 3 clinical trial of TH-302 in patients with advanced STS; the time and expense required to conduct such clinical trials
and analyze data; issues arising in the regulatory or manufacturing process and the results of such clinical trials (including
product safety issues and interpretation of efficacy results by regulatory authorities); the risk that later trials, including
the Phase 3 clinical trial of TH-302 in patients with advanced STS, may not confirm the results of earlier trials; the risk that
the design of, or data collected from, the Phase 3 clinical trial of TH-302 in patients with advanced STS may be inadequate to
demonstrate safety and efficacy, or otherwise may be insufficient to support regulatory submissions and/or approvals, and that
despite the potential benefits of a SPA agreement with the FDA, significant uncertainty remains regarding the regulatory approval
process for TH-302 and that TH-302 may not receive any marketing approvals for the advanced STS indication or any other indications
in a timely manner or at all; the risk that because the timing of the primary efficacy analysis is event-driven, which Threshold
does not control, Threshold cannot predict with certainty when the primary efficacy analysis will occur; Threshold's and Merck
KGaA's (Darmstadt, Germany) dependence on single source suppliers, including the risk that these single source suppliers may be
unable to meet clinical supply demands for TH-302 which could significantly delay the development of TH-302; risks related to
Threshold's dependence on its collaborative relationship with Merck KGaA, Darmstadt, Germany, including its dependence on decisions
by Merck KGaA, Darmstadt, Germany regarding the amount and timing of resource expenditures for the development of TH-302; and
Threshold's need for and the availability of resources to develop TH-302 and to support Threshold's operations. 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 1, 2014 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.
Reference
| 1. | American Cancer Society. Sarcoma: Adult Soft Tissue Cancer.
Available at: http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-key-statistics.
Last accessed September 19, 2014. |
Contact
Laura Hansen, Ph.D.
Senior Director, Corporate Communications
Threshold Pharmaceuticals
Phone: 650-474-8206
E-mail: lhansen@thresholdpharm.com
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