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8-K - Molecular Templates, Inc. | v211762_8-k.htm |
Exhibit
99.1
Contact:
Denise T.
Powell
Sr.
Director, Corporate Communications
Threshold
Pharmaceuticals, Inc.
650-474-8206
dpowell@thresholdpharm.com
THRESHOLD
PHARMACEUTICALS ANNOUNCES AGREEMENT WITH THE FDA ON A SPECIAL PROTOCOL
ASSESSMENT FOR PLANNED PHASE 3 TH-302 COMBINATION TRIAL IN ADVANCED SOFT TISSUE
SARCOMA
REDWOOD
CITY, CA – February 16, 2011 -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD),
today announced that the Company reached agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3
randomized trial of TH-302 in patients with soft tissue sarcoma. This pivotal
trial is expected to begin in the middle of 2011, and will enroll patients with
metastatic or locally advanced unresectable soft tissue sarcoma who have not
previously received chemotherapy outside the adjuvant or neoadjuvant setting.
The trial is designed to evaluate the efficacy and safety of TH-302 in
combination with doxorubicin, compared to doxorubicin alone.
“With
this SPA, we have reached agreement with the FDA on the key features of our
Phase 3 trial design that will be necessary to support the registration of
TH-302,” said Stewart Kroll, Threshold’s Vice President, Biostatistics and
Clinical Operations. “The proposed trial is designed to confirm the encouraging
results that we have previously reported in our ongoing Phase 1/2 trial of soft
tissue sarcoma patients treated with TH-302 in combination with
doxorubicin.”
TH-302 Clinical
Development Rationale and Strategy
TH-302
has been investigated in over 400 patients with cancer as part of five clinical
trials. The TH-302 clinical development program includes an ongoing Phase 1/2
trial in patients with soft tissue sarcoma. As presented at the Connective
Tissue Oncology Society meeting in November 2010, fifty-four patients had at
least one evaluable post-treatment tumor assessment and 18 of 54 (33%) had a
partial response. The median progression free survival was 6.4 months (95%
confidence interval: 5.6 to 6.9 months). These data formed the basis for the
proposed Phase 3 study of TH-302 and doxorubicin compared to doxorubicin,
as covered by the SPA.
In
addition, Threshold is pursuing additional clinical trials in patients with
solid tumors as well as hematologic malignancies. TH-302 is currently being
evaluated in a Phase 2 randomized, controlled combination trial in patients with
metastatic or locally advanced pancreatic cancer as well as a Phase 1 open
label, monotherapy trial in patients with advanced leukemias.
About
the Phase 3 Sarcoma Trial
The Phase
3 trial will be a 450 patient, randomized, open-label, multi-center trial
comparing two treatment regimens for patients with metastatic and/or advanced
unresectable soft tissue sarcoma who have not received prior doxorubicin. This
trial is designed to demonstrate the clinical benefit of TH-302 in combination
with doxorubicin compared to doxorubicin alone based on a primary efficacy
endpoint of overall survival. The trial includes an interim analysis based on
progression-free survival expected to occur about half-way into enrollment and
an interim analysis based on overall survival expected to occur at the end of
enrollment. Patients will be randomized to receive TH-302 (300 mg/m2 on days
1 and 8 of a 21 day cycle) in addition to the standard dosing schedule of
doxorubicin (75 mg/m2 on day 1
of the 21 day cycle) compared to doxorubicin alone. The Company plans
to commence the trial in the middle of 2011.
1300
Seaport Boulevard, Suite 500, Redwood City, CA 94063 tel:
650.474.8200 fax:
650.474.2529 www.thresholdpharm.com
|
About
Soft Tissue Sarcoma
Sarcomas
are a group of aggressive cancers of connective tissue 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. The American Cancer Society estimates that 10,520
people were diagnosed with a soft tissue sarcoma in the United States in 2010,
and approximately 3,920 people died from the disease.
About
Special Protocol Assessments
A Special
Protocol Assessment is a written agreement with the FDA on the design and
planned analysis for a clinical trial. It is intended to form the basis for a
marketing application and may only be changed through a written agreement
between the sponsor and the FDA, or if the FDA becomes aware of new public
health concerns.
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. This approach offers broad potential to treat most solid
tumors. 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 TH-302 and its
potential therapeutic uses and benefits. 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 raise sufficient funding to conduct
the Phase 3 trial of TH-302 for patients with soft tissue sarcoma and to
successfully enroll patients in that trial as well as the ongoing clinical
trials of TH-302, whether the Company’s clinical trials will show results
predicted by the Company’s pre-clinical trials or confirm the results of earlier
trials, the time and expense required to conduct such clinical trials and
analyze data, issues arising in the regulatory or manufacturing process and any
unanticipated or increased side-effects observed in patients receiving TH-302.
Further information regarding these and other risks is included under the
heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was
filed with the Securities Exchange Commission on November 4, 2010 and is
available from the SEC's website (www.sec.gov) and on our website
(www.thresholdpharm.com) under the heading "Investors." We do not intend to
update any forward-looking statement made in this news release.
###
1300
Seaport Boulevard, Suite 500, Redwood City, CA 94063 tel:
650.474.8200 fax:
650.474.2529 www.thresholdpharm.com
|