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Threshold Pharmaceuticals, Inc.

Partner : Merck KGaA

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Threshold Pharmaceuticals Reports First Quarter 2015 Financial and Operational Results

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 04/30/15 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today reported financial results for the first quarter 2015. Revenue for the first quarter ended March 31, 2015 was $3.7 million. The operating loss for the first quarter ended March 31, 2015 was $9.6 million. The net loss for the first quarter ended March 31, 2015 was $11.2 million, which included the operating loss of $9.6 million and non-cash expense of $1.5 million related to the changes in fair value of the Company's outstanding warrants and was classified as other income (expense). As of March 31, 2015, Threshold had $83.1 million in cash, cash equivalents and marketable securities, with no debt outstanding.

"Our two pivotal clinical trials with evofosfamide remain on track," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "Based on current projections, we expect that the number of protocol-specified events for the pivotal Phase 3 trials of evofosfamide in patients with advanced soft tissue sarcoma as well as in patients with advanced pancreatic cancer (MAESTRO) may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter. We look forward to providing clinical updates on earlier-stage programs with evofosfamide at upcoming medical meetings. In addition, we are pleased with the level of interest in our first data presentation on TH-4000, our proprietary hypoxia-activated epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), at the recent AACR annual meeting. We are looking forward to initiating two Phase 2 clinical trials of TH-4000 this year, the first in patients with EGFR-positive, T790M-negative non-small cell lung cancer and the second in patients with head and neck cancer."
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Source: press release, 4/30/15. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=909758

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November 3, 2014

Threshold Pharmaceuticals' Partner Merck KGaA, Darmstadt, Germany, Completes Target Enrollment in the TH-302 Phase 3 MAESTRO Study in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 11/03/14 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), today announced that Threshold's partner Merck KGaA, Darmstadt, Germany, through its biopharmaceutical division, has completed target enrollment of 660 patients in the global Phase 3 MAESTRO (MetastAtic or unrESectable pancreaTic adenocarcinoma) study assessing the efficacy and safety of TH-302 in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. Threshold has a global license and co-development agreement with Merck KGaA, Darmstadt, Germany for TH-302, which includes an option for Threshold to co-commercialize in the U.S.

"The MAESTRO trial of TH-302 for patients with advanced pancreatic cancer is the second of two pivotal Phase 3 trials of TH-302 to complete enrollment, the first being our trial for previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "We are pleased to have completed enrollment in both trials. We anticipate conducting the primary analysis of overall survival for our Phase 3 trial in patients with advanced soft tissue sarcoma in the first quarter of 2016 and having top-line data for MAESTRO in 2016."

MAESTRO is a randomized, placebo-controlled, international, multi-center, double-blind Phase 3 trial of TH-302 plus gemcitabine compared with placebo plus gemcitabine. The primary efficacy endpoint is overall survival; the secondary endpoints include efficacy measured by progression-free survival (PFS), overall response rate and disease control rate, as well as assessments of safety and tolerability, pharmacokinetics and biomarkers. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The study design was also discussed with the European Medicines Agency (EMA) during a scientific advice procedure.
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Source: press release, 11/03/14. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=879765

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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.
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Source: press release, 9/22/14. http://investor.thresholdpharm.com/secfiling.cfm?filingid=1144204-14-570...

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December 30, 2013

Threshold Pharmaceuticals Announces Target Enrollment of 620 Patients Achieved in Pivotal Phase 3 Trial of TH-302 in Advanced Soft Tissue Sarcoma

$12.5 Million USD Milestone to Be Paid by Merck KGaA

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 12/30/13 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the target enrollment of 620 patients with advanced soft tissue sarcoma has been achieved in the company's pivotal Phase 3 trial of TH-302, its investigational hypoxia-targeted drug. The enrollment achievement triggers a milestone payment of $12.5 million USD from Merck KGaA, Darmstadt, Germany. Threshold has a global license and co-development agreement with Merck for TH-302, which includes an option for Threshold to co-commercialize in the U.S.

"We are pleased to achieve this enrollment milestone in this pivotal trial of TH-302 for the treatment of patients with advanced soft tissue sarcoma," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "We hope that TH-302 will ultimately be shown to be both safe and efficacious in this patient population for which there is an urgent unmet medical need."

Threshold is conducting this international, randomized, pivotal Phase 3 trial in partnership with the Sarcoma Alliance for Research through Collaboration (SARC). The trial is enrolling patients with metastatic or locally advanced unresectable soft tissue sarcoma and is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone.

Though Threshold will remain blinded to the data from its ongoing Phase 3 trial, an Independent Data Monitoring Committee (IDMC), which monitors patient safety on an ongoing basis, will conduct an interim efficacy and safety analysis after 235 deaths are reported. The timing of the interim analysis, which is event-based and therefore dependent on the length of survival of patients, is currently projected to be conducted in mid-2014. The interim efficacy analysis is designed to allow for the early termination of the study based on achieving a pre-specified improvement in overall survival and the recommendation of the IDMC. If the IDMC recommends that the study continue as planned, Threshold will remain blinded to the data until the company conducts the primary analysis of overall survival after 434 deaths are reported. Unless the IDMC recommends that the study end early, top-line results of the primary efficacy analysis are currently projected to be reported in the first half of 2015.
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Source: press release, 12/30/13. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=816368

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Threshold Pharmaceuticals Announces Update on Its Phase 3 Trial in Soft Tissue Sarcoma
Company to Host Conference Call and Webcast Today, July 1, 2013 at 8:30 AM ET

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 07/01/13 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced a protocol amendment to the company's pivotal Phase 3 trial of TH-302, an investigational hypoxia-targeted drug, in patients with advanced soft tissue sarcoma (STS). The changes to the protocol are based on new assumptions related to the performance of current standard of care in STS, as well as a higher than anticipated rate of enrollment, and are intended to strengthen the ability of the study to detect a clinically meaningful and statistically significant effect of TH-302 on overall survival. The U.S. Food and Drug Administration (FDA) has agreed to the amendment under the existing Special Protocol Agreement.

The first change to the protocol is an increase in the number of patients (from 450 to 620). This increase is intended to adjust for new assumptions about the primary endpoint overall survival, based on the latest medical findings in STS clinical research. According to recently published data, patients who receive standard of care treatment being used in the control arm of Threshold's study may live longer than has historically been observed.1 The addition of patients to the trial is required to maintain the power of the study and the ability to detect a clinically meaningful effect of TH-302 with a robust level of statistical significance.

The second change to the protocol comprises the removal of an interim futility analysis of the secondary endpoint progression-free survival (PFS). Given the study's high rate of enrollment, an interim futility analysis would no longer serve its original purpose as the trial would be largely through its enrollment phase by the time the analysis would be completed. Safety will remain under regular review by an Independent Data Monitoring Committee (IDMC).

Though Threshold will remain blinded to the data from its ongoing Phase 3 trial, an IDMC, which monitors patient safety on an ongoing basis, will conduct an interim analysis for survival after 235 events are reached and data are ready for analysis. Although the timing is event-based, the interim analysis is projected to occur in the first half of 2014. The interim efficacy analysis is designed to allow for the early termination of the study based on achieving a pre-specified statistical outcome and recommendation of the IDMC. If the IDMC recommends that the study continue as planned, Threshold will remain blinded to the data until the company conducts the final analysis on overall survival when 434 events will have been reached. Unless the IDMC recommends that the study end early, Threshold expects to report top-line results following the final efficacy analysis on overall survival in the first half of 2015.

"We are pleased with the FDA's agreement on the protocol amendment, which is intended to strengthen our Phase 3 study," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "Importantly, at our current enrollment rate, we should be able to accommodate the increase in sample size while still completing enrollment of the study around the end of this year."

"The scientific and clinical data provide rationale for evaluating TH-302 as a potential new therapy for patients with STS," said William D. Tap, M.D., Section Chief, Sarcoma Oncology at Memorial Sloan-Kettering Cancer Center and Principle Investigator of the Phase 3 study. "TH-302 is activated under hypoxic conditions, a common feature of many solid tumors, which may be associated with worse outcomes in patients with soft tissue sarcoma. Importantly, the critical need remains for new therapies to improve outcomes for patients with soft tissue sarcoma, and we are looking forward to the outcome of this Phase 3 study."
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Source: press release, 7/01/13. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=774639

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Harold E. Selick, Ph.D., Chief Executive Officer, commented on the enrollment progress for the TH-302 phase-III soft tissue sarcoma trial. He stated, "Enrollment is actually ahead of projections, such that we are well on track to complete enrolling the 450 patients for this trial by the end of this year."
Source: Future Leaders in the Biotech Industry Conference, 4/5/13.

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TH-302 Phase 3 Programs: The most advanced clinical study of TH-302 is a pivotal Phase 3 trial of TH-302 plus doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma (the "406 trial"); enrollment in the 406 study is currently expected to be completed around the end of 2013. As announced in January 2013, Threshold's partner Merck KGaA, through its division Merck Serono, initiated the global Phase 3 MAESTRO (MetastAtic or unrESectable pancreaTic adenocaRcinOma) study assessing the efficacy and safety of TH-302 in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma.
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Source: press release, 3/07/13. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=746204

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Harold E. Selick, Ph.D., Chief Executive Officer, gave a review of upcoming milestones, including TH-302 for Sarcoma, Pancreatic cancer and Leukemia. He stated, "Starting at the top, Soft-tissue Sarcoma, as I mentioned, that trial is well underway. We will have an interim PFS futility analysis as soon as we have hit 113 PFS events, which we expect in the beginning of 2013. When we complete enrollment at the end of 2013, we will do another interim analysis, this time based on survival, with the final survival data expected some time toward the end of 2014. Pancreatic cancer, we have got the mature survival data coming up at the end of this month, with a presentation at ESMO. With respect to the Leukemia, the Sunitinib combination study and the Multiple Myeloma study, all of which are Threshold sponsored studies, we will expect data literally around the end of the year into 2013. Importantly, the ISPs that I mentioned, they are not controlled by Threshold, therefore they are not on this figure of milestones and timelines. I will point-out, however, that there is a poster that is being presented at ESMO by Andrew Brenner and his colleagues at CPRC in San Antonio, that will summarize some of the results we've seen to date looking at 302 in combination with Avastin."
Source: Stifel Nicolaus Healthcare Conference, 9/5/12.

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Harold E. Selick, Ph.D., Chief Executive Officer, gave guidance for the interim futility analysis for the phase III, TH-302 in Sarcoma trial (406 trial). He stated, "We expect to have an interim futility analysis based on a look at progression-free-survival some time around the end of this year, beginning of 2013."
Source: 32nd Annual Cowen Health Care Conference, 3/6/12.

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Threshold Pharmaceuticals Reports Further Promising Data With TH-302 in Soft Tissue Sarcoma
Update of Fully Enrolled Phase 1/2 Clinical Trial at the Connective Tissue Oncology Society Meeting

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 10/28/11 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) yesterday announced clinical trial results related to Threshold's Phase 3 clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the Connective Tissue Oncology Society (CTOS) Meeting in Chicago.

Sant P. Chawla, M.D., Sarcoma Oncology Center, Santa Monica and principal investigator for the study gave the oral presentation summarizing the Phase 2 results from the company's fully enrolled 403 trial. This single arm study investigated TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. The Phase 2 component of the multi-center trial enrolled patients with metastatic or locally advanced unresectable soft tissue sarcoma who have not previously received chemotherapy outside of the adjuvant or neoadjuvant setting. All patients were treated at the TH-302 maximum tolerated dose (MTD) of 300 mg/m2 in combination with 75 mg/m2 doxorubicin.

"The data from the complete set of patients in the large phase 2 portion of our study of TH-302 in combination with standard doxorubicin in soft tissue sarcoma patients is impressive," said Dr. Chawla. "Most notable, the data suggest a sizable improvement in efficacy over conventional doxorubicin alone. Combined with its tolerability, the regimen has the potential to establish a new standard-of-care for the treatment of soft tissue sarcomas and provides ample justification for pursuing the registration of TH-302 in the ongoing Phase 3 trial comparing TH-302 plus doxorubicin versus doxorubicin alone."

Ninety-one patients were included in the analyses including 89 patients with at least one evaluable post-treatment tumor assessment. Best responses were: 2 complete responses, 30 partial responses and 43 patients with stable disease for an overall response rate of 36% and a stable disease or better rate of 84%. In addition to the reported response rates, median progression free survival was 6.7 months (95% confidence interval: 6.2 to 8.1 months) and the 6-month progression-free rate was 63%. The median overall survival was 17.5 months (95% CI: 16.1 months to not reached) and the 12-month survival rate was 70%.

TH-302 continues to be well tolerated at the MTD of 300 mg/m2, including in patients receiving full dose doxorubicin. Nausea and fatigue were the most commonly reported adverse events and were reported in 70% and 67% of patients, respectively. Skin rash and hyperpigmentation were reported in 32% and 18% of patients respectively; and stomatitis, an inflammation of the mucous lining in the mouth and throat, was reported in 41% of patients. These events were all grade 1 or grade 2 and reversible. In regards to hematologic toxicity, at the MTD the frequency of grade 3/4 neutropenia and thrombocytopenia was 20% and 25%, respectively. Febrile neutropenia or neutropenic sepsis were reported in 10% of patients. There was no evidence of renal, hepatic or cardiotoxicity.

The 403 trial provided the basis for the ongoing pivotal Phase 3 study which will compare the same regimen investigated in the phase 2 portion of the 403 study against single agent doxorubicin. This past February 2011, Threshold Pharmaceuticals announced that it had reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment of the Phase 3 study which includes a primary efficacy endpoint of overall survival. The international, randomized, controlled clinical trial, being conducted in partnership with the Sarcoma Alliance for Research through Collaboration (SARC), was initiated in September 2011 and will enroll 450 patients with metastatic or locally advanced unresectable soft tissue sarcoma.
Source: press release, 10/28/11. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=618872

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Threshold Pharmaceuticals Initiates Phase 3 TH-302 Combination Trial in Advanced Soft Tissue Sarcoma

REDWOOD CITY, CA -- (MARKET WIRE) -- 09/30/11 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that Threshold, in collaboration with Sarcoma Alliance for Research through Collaboration (SARC), have initiated a Phase 3 randomized clinical trial of TH-302 in patients with soft tissue sarcoma. This international pivotal trial 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.

Following an end of Phase 2 meeting with the FDA, the Phase 3 protocol has been agreed upon under a Special Protocol Assessment (SPA). As part of that assessment, the FDA agreed that the design and planned analysis of the study adequately addresses the objectives necessary to support a regulatory submission for approval with enrollment expected to be completed by the end of 2013.

"Combining TH-302, a selective hypoxia-targeting prodrug, with doxorubicin, an agent with known activity in sarcoma, has a strong scientific rationale. TH-302 represents a novel concept in anti-cancer treatment. It was designed to deliver a cytotoxic agent to areas of a tumor that are often inaccessible to standard chemotherapies. We therefore expect that doxorubicin and TH-302 will complement one another by targeting the vascular components and hypoxic components, respectively, of a patient's sarcoma," said William D. Tap, M.D., Section Chief of Sarcoma Oncology at Memorial Sloan-Kettering Institute and principal investigator for this trial. "I'm excited to be a part of this collaboration between SARC and Threshold and I am looking forward to participating in this pivotal Phase 3 trial with the hope of establishing TH-302 as a new treatment for patients with sarcoma."

"The proposed study is designed to confirm the encouraging results that we have previously reported in the Phase 1/2 study of soft tissue sarcoma patients treated with TH-302 in combination with doxorubicin," said Sant P. Chawla, M.D., Sarcoma Oncology Center and principal investigator for the initial Phase 1/2 study. "The treatment of soft tissue sarcoma is a therapeutic challenge. Besides the approval of imatinib mesylate which was limited to gastrointestinal stromal tumors, there have been no new approved agents in first-line soft tissue sarcoma over the last 20 years. We look forward to working with Threshold and SARC."
Source: press release, 9/30/11. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=609818

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TH-CR-406 - A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Estimated Enrollment: 620
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01440088?term=TH-302&rank=3

Compound/DeviceSpecialtyIndicationCompound ClassTarget
TH-302 SarcomaOncologySarcomaAlkylating agent (prodrug)DNA

Mechanism of action: TH-302 is a hypoxia-activated prodrug consisting of a 2-nitroimidazole phosphoramidate conjugate with potential antineoplastic activity. The 2-nitroimidazole moiety of hypoxia-activated prodrug TH-302 acts as a hypoxic trigger, releasing the DNA-alkylating dibromo isophosphoramide mustard moiety within hypoxic regions of tumors. Normoxic tissues may be spared due to the hypoxia-specific activity of this agent, potentially reducing systemic toxicity.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-01-01 - 2016-03-31

Results:

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Threshold Pharmaceuticals Announces Its Two Phase 3 Studies Evaluating Evofosfamide Did Not Meet Primary Endpoints
Studies of Evofosfamide Combined With Chemotherapy in Advanced Pancreatic Cancer (MAESTRO) and Advanced Soft Tissue Sarcoma (TH-CR-406/SARC021) Did Not Meet Primary Endpoints of Improving Overall Survival With Statistical Significance
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 12/07/15 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced the outcomes of two Phase 3 cancer studies (MAESTRO and TH-CR-406/SARC021) of evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug, which is being evaluated for first-line treatment of advanced pancreatic adenocarcinoma and advanced soft tissue sarcoma, in combination with chemotherapy. The Phase 3 studies are being conducted under Threshold's collaboration with Merck KGaA, Darmstadt, Germany.

In the Phase 3 MAESTRO study, patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with evofosfamide in combination with gemcitabine did not demonstrate a statistically significant improvement in overall survival (OS) compared with gemcitabine plus placebo (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.71 - 1.01; p=0.0589).

In the Phase 3 TH-CR-406/SARC021 study being conducted in collaboration with the Sarcoma Alliance for Research through Collaboration (SARC), patients with locally advanced unresectable or metastatic soft tissue sarcoma treated with evofosfamide in combination with doxorubicin did not demonstrate a statistically significant improvement in OS compared with doxorubicin alone (HR: 1.06; 95% CI: 0.88 - 1.29).

Patient safety was monitored in MAESTRO and TH-CR-406/SARC021 by independent data monitoring committees throughout the conduct of each study. No new clinically significant safety findings were observed.

Detailed results from both studies will be submitted for presentation at upcoming international scientific meetings and for publication in peer-reviewed journals. Threshold will not be pursing further development of evofosfamide in soft tissue sarcoma and pancreatic cancer.

"We are surprised and disappointed that these studies did not show that evofosfamide could extend the lives of patients with these two difficult-to-treat diseases," said Barry Selick, Ph.D., Chief Executive Officer at Threshold. "Threshold has been pursuing evofosfamide for over ten years in collaboration with world-class scientists and investigators throughout the world. While we believe there remains substantial data to support the role of hypoxia in cancer treatment resistance, we are deeply frustrated with our inability in these trials to impact that in a meaningful way. I would like to thank all of the patients and their families, and the physicians, nurses, and support staff who participated in these studies."

Conference Call and Webcast
At 8:30 a.m. Eastern Time on Monday December 7, 2015, Threshold's management will host a conference call and a simultaneous webcast. The webcast can be accessed on the company's website in the Investors/Webcasts section http://investor.thresholdpharm.com/events.cfm. Alternatively, please call 1- (888) 767-9745 (U.S) or (440) 996-5547 (international). The conference ID number is 99761325. The webcast will be archived on Threshold's website for at least 30 days.
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Source: press release, 12/07/15. http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=945765

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