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8-K - Molecular Templates, Inc. | v208960_8k.htm |
Exhibit 99.1
PRESS
RELEASE
|
Contact:
Denise
T. Powell
Sr.
Director, Corporate Communications
Threshold
Pharmaceuticals, Inc.
650-474-8206
dpowell@thresholdpharm.com
THRESHOLD
PHARMACEUTICALS’ TH-302 CONTINUES TO DEMONSTRATE PROMISING ACTIVITY IN
PANCREATIC CANCER PHASE 1/2 CLINICAL TRIAL
Phase
2 Controlled Trial in Pancreatic Cancer Enrollment On Track
REDWOOD
CITY, CA – January 24, 2011 – Threshold Pharmaceuticals, Inc. (Nasdaq: THLD)
today announced updated Phase 1/2 clinical trial results related to the
Company’s clinical stage hypoxia-activated prodrug, TH-302. The results were
presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San
Francisco from January 20-22, 2011. Additionally, the Company announced that an
ongoing Phase 2, controlled, clinical trial in patients with pancreatic cancer
has reached the mid-way point in overall enrollment into the trial.
The
ASCO presentation summarized data from 47 patients with previously untreated
pancreatic adenocarcinoma treated with TH-302 in combination with gemcitabine as
part of the 402 trial, a Phase 1/2, three arm, multicenter, dose escalation and
dose expansion trial to determine the safety, efficacy and pharmacokinetics of
TH-302 in combination with gemcitabine (Gem), docetaxel or pemetrexed in
patients with various advanced solid tumors.
"The
results from this Phase 1/2 study are encouraging. The progression-free
survival, overall survival, CA19-9 and response data suggest that TH-302 is
contributing to the combination treatment. In particular, the durable responses
extending out over 10 months are promising," said Shantan G. Reddy, M.D.,
Director of G.I. Malignancies at LSU Health Sciences Center-Shreveport, and a
clinical investigator involved in the trial. “For patients with metastatic
pancreatic cancer receiving gemcitabine alone, median survival is about six
months. New agents are needed and we are hopeful and optimistic that TH-302 may
provide an additional treatment option for patients with this
disease."
Results,
as measured by RECIST (Response Evaluation Criteria In Solid
Tumors)
|
Gem+TH-302
240mg/m2
|
Gem+TH-302
340mg/m2
|
Gem+TH-302
480-575mg/m2
|
Total
|
||||
#
of Evaluable Patients
|
16
|
21
|
6
|
43*
|
||||
Complete
Response
|
1 (5%)
|
1 (2%)
|
||||||
Partial
Response
|
6 (29%)
|
2 (33%)
|
8 (19%)
|
|||||
Stable
Disease
|
13 (81%)
|
13 (62%)
|
4 (67%)
|
30 (70%)
|
||||
Progressive
Disease
|
3 (19%)
|
1 (5%)
|
4 (9%)
|
* Four patients not
assessed for tumor response (patient decision-2, adverse event-1, clinical
deterioration-1).
1300
Seaport Boulevard, Suite 500, Redwood City, CA 94063 tel:
650.474.8200 fax:
650.474.2529
www.thresholdpharm.com |
In the gemcitabine
plus TH-302 treatment arms, median progression free survival (PFS) was 5.9
months (95% CI: 4.8 months to not reached) and median overall survival was 8.5
months (95% CI: 6.9 to 13.4 months). Overall, hematologic toxicity was
acceptable and skin and mucosal toxicities were well managed at current
dose levels. A copy of the poster may be obtained by calling the Company.
Additional
Ongoing Clinical Trials
The
Company currently has three additional ongoing clinical trials.
The
404 trial is a multi-center, randomized, controlled, crossover Phase 2 clinical
trial of TH-302 in combination with gemcitabine in patients with first line
pancreatic cancer. Of the approximately 165 patients that the Company plans to
enroll in the clinical trial, half of the patients are now enrolled. The primary
endpoint of the trial is PFS. The secondary endpoints are overall response rate,
overall survival, event-free survival, CA 19-9 response rate as well as various
safety parameters. Tumor response will be evaluated at baseline and every six
weeks using RECIST. Patients for whom monotherapy with gemcitabine is considered
standard therapy are eligible for the trial. Patients will be randomized equally
into one of three cohorts: TH-302 at a dose of 240 mg/m2
plus gemcitabine or TH-302 at a dose of 340 mg/m2
plus gemcitabine or gemcitabine alone. Patients who successfully complete six
cycles of treatment without evidence of significant treatment-related toxicity
or progressive disease may continue to receive treatment. If a patient's cancer
progresses while on gemcitabine alone, the patient may crossover into one of the
TH-302 plus gemcitabine cohorts. Interim safety and efficacy analyses will
occur approximately every 25 events, and a final analysis will be performed
at a minimum of 122 events. If patient enrollment continues to go as planned,
enrollment should be completed by mid-2011 and interim and primary endpoint
results will be available quarterly during 2011.
The
403 trial is a Phase 1/2, multicenter, dose escalation trial to determine the
safety, efficacy and pharmacokinetics of TH-302 in combination with doxorubicin
in patients with advanced soft tissue sarcoma. The trial was initiated in
September 2008. The trial will enroll approximately 90 patients. TH-302 is
administered intravenously on days 1 and 8 of a 21 day cycle. Doxorubicin is
dosed according to its package insert (75 mg/m2
on day 1 of the 21 day cycle). This Phase 1/2 clinical trial has completed the
dose escalation component, reached the maximum tolerated dose (MTD) and
continues to enroll patients in the dose expansion cohort.
The
407 trial is a Phase 1, single center, dose escalation trial to determine the
safety, efficacy and pharmacokinetics of TH-302 in patients with advanced
leukemias. The objectives of the Phase 1 trial are to determine the MTD, dose
limiting toxicity, safety, tolerability, clinical activity and pharmacokinetics
of TH-302 in patients with advanced leukemia. The starting dose in the trial was
120mg/m2
daily for 5 days of a 21-day cycle. The second dose cohort was treated
with TH-302 at a dose of 170mg/m2
and the third dose cohort has completed enrollment at 240mg/m2.
The dose of TH-302 will continue to be escalated until the MTD is established.
As reported in December, preliminary efficacy assessments have demonstrated
activity in multiple subjects with relapsed/refractory AML and ALL.
1300
Seaport Boulevard, Suite 500, Redwood City, CA 94063 tel:
650.474.8200 fax:
650.474.2529
www.thresholdpharm.com |
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 complete its clinical trials, whether
future clinical trials will confirm the results of earlier trials based on small
numbers of patients or confirm the earlier results from the same 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 |