Threshold Pharmaceuticals Highlights Multiple Presentations at the 2016 ASCO Annual Meeting
June 06 2016 - 8:30AM
Threshold Pharmaceuticals, Inc. (NASDAQ:THLD) today announced
multiple presentations on clinical trials on its hypoxia-activated
prodrugs, evofosfamide and tarloxotinib at the American Society of
Clinical Oncology (ASCO) Annual Meeting being held June 3 through
7, 2016 in Chicago, Ill.
Today, Threshold presented additional data from its analysis of
the randomized, double-blind Phase 3 MAESTRO clinical trial of
evofosfamide (TH-302) in combination with gemcitabine in previously
untreated patients with metastatic or locally advanced unresectable
pancreatic ductal adenocarcinoma conducted by Merck KGaA. A
meaningful improvement in overall survival was reported for the
subgroup of 123 Asian patients enrolled at Japanese and South
Korean sites in which the risk of death was reduced by 48 percent
for patients on the treatment arm compared to patients on the
control arm with an associated stratified hazard ratio of 0.52 (95%
CI: 0.32 - 0.85). The patients from Asia also had significant
improvements in PFS, objective response rates, and reductions in
the pancreatic cancer biomarker, CA19-9 (abstract 4007). As
previously reported in January 2016, the primary efficacy endpoint
of this study of overall survival narrowly missed statistical
significance based on specified intent-to-treat analysis while
showing improvements in secondary efficacy endpoints of
progression-free survival (PFS) and response.
On June 4, 2016, the following posters were displayed:
Randomized, Double-Blind, Placebo-Controlled Trial of
Evofosfamide and Pemetrexed in Second Line Advanced Non-Squamous
Non-Small Cell Lung Cancer. Csoszi et al. (abstract 9075). As
reported in January 2016, the study was stopped early based on a
futility analysis of overall survival conducted by the study Data
and Safety Monitoring Board (DSMB). The study enrolled 265 patients
of a planned 440 patients. The response rate with evofosfamide plus
pemetrexed was 18.0 percent and significantly higher compared to
8.1 percent with placebo plus pemetrexed. The median PFS with
evofosfamide plus pemetrexed was 4.5 months (95% CI: 4.0 to 6.4
months) and significantly higher compared to 2.9 (95% CI: 2.6 to
4.1) months with placebo plus pemetrexed. Hematologic toxicity was
greater in the evofosfamide plus pemetrexed arm, while
non-hematologic toxicity was similar across treatment arms. No new
safety signals were identified.
Evofosfamide combined with gemcitabine/nab-paclitaxel in
patients with previously untreated locally advanced or metastatic
pancreatic adenocarcinoma (PAC): results of a phase I trial. Borad
et al. (abstract 4114). Nineteen patients were treated for a median
of 6 cycles. The maximum tolerated dose of evofosfamide was
established at 340 mg/m2 in combination with 800 mg/m2 gemcitabine
and 100 mg/m2 nab-paclitaxel. No new safety signals were identified
with myelosuppression being the primary dose limiting toxicity. The
best response rate was 53 percent and the confirmed response rate
was 37 percent.
Two additional trials-in-progress posters were also
displayed:
A Phase 2 Study of Tarloxotinib Bromide (TRLX) in Patients with
Recurrant or Metastatic Squamous Cell Carcinoma of the Head and
Neck (SCCHN) or Skin (SCCS). Rischin et al. (abstract TPS6105)
A Phase 2 Study (NCT02454842) of Tarloxotinib Bromide (TH-4000)
in Patients with EGFR Mutant, T790M-Negative, Advanced NSCLC
Progressing on an EGFR TKI. Liu et al. (abstract TPS9100)
Copies of the posters may be obtained from Threshold's website,
www.thresholdpharm.com, under Scientific Publications.
About EvofosfamideEvofosfamide (previously
known as TH-302) is an investigational hypoxia-activated prodrug of
a bis-alkylating agent that is preferentially activated under
severe hypoxic tumor conditions, a feature of many solid tumors.
Areas of low oxygen levels (hypoxia) in solid tumors are due to
insufficient blood vessel supply. Similarly, the bone marrow of
patients with hematological malignancies has also been shown, in
some cases, to be severely hypoxic. On December 6, 2015, the
Company announced the outcomes of two Phase 3 studies (MAESTRO and
TH-CR-406/SARC021) of evofosfamide stating that neither study met
its primary endpoint.
About Tarloxotinib BromideTarloxotinib bromide
(the proposed International Nonproprietary Name, previously known
as TH-4000), or "tarloxotinib", is a prodrug designed to
selectively release a covalent (irreversible) EGFR tyrosine kinase
inhibitor under severe hypoxia, a feature of many solid tumors.
Accordingly, tarloxotinib has the potential to effectively shut
down aberrant EGFR signaling in a tumor-selective manner, thus
potentially avoiding or reducing the systemic side effects
associated with currently available EGFR tyrosine kinase
inhibitors. Tarloxotinib is currently being evaluated in two Phase
2 proof-of-concept trials: one for the treatment of patients with
mutant EGFR-positive, T790M-negative advanced non-small cell lung
cancer progressing on an EGFR tyrosine kinase inhibitor, and the
other for patients with recurrent or metastatic squamous cell
carcinomas of the head and neck or skin. Threshold licensed
exclusive worldwide rights to tarloxotinib from the University of
Auckland, New Zealand, in September 2014.
About Threshold Pharmaceuticals Threshold is a
clinical-stage biopharmaceutical company focused on the discovery
and development of drugs and diagnostic agents 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 the Company's
website.
Forward-Looking Statements Except for
statements of historical fact, the statements in this press release
are forward-looking statements, including statements regarding the
potential therapeutic uses and benefits of its product candidates,
evofosfamide and tarloxotinib, including statements related to
potential clinical and regulatory paths forward for our product
candidates. 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 difficulty and uncertainty of
pharmaceutical product development, including the time and expense
required to conduct clinical trials and analyze data, and the
uncertainty of clinical success and regulatory
approval; issues arising in the regulatory or manufacturing
process and the results of such clinical trials (including safety
issues and efficacy results); the dependence of Threshold on single
source suppliers for evofosfamide, including the risk that these
single source suppliers may be unable to meet clinical supply
demands for evofosfamide which could significantly delay the
development of evofosfamide; the amount and timing of resource
expenditures for the development of evofosfamide; the commencement
of additional clinical trials; and Threshold's need for and the
availability of resources to develop its drug candidates 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 May 5, 2016 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
Denise Powell
denise@redhousecomms.com
510.703.9491
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