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As of 1:05 PM 07/30/14 All times are local (Market data is delayed by at least 15 minutes).

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threshold pharmaceuticals (THLD) Details

Threshold Pharmaceuticals, Inc., a biotechnology company, discovers and develops therapeutic agents that target tumor cells for the treatment of patients living with cancer in the United States. Its lead investigational small molecule, TH-302, is being evaluated in two pivotal Phase III clinical trials for the treatment of soft tissue sarcoma indication and pancreatic cancer; and various earlier-stage clinical trials for therapeutic areas, including advanced leukemias, multiple myeloma, advanced renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors. Threshold Pharmaceuticals, Inc. has a license and co-development agreement with Merck KGaA to co-develop and commercialize TH-302; and license agreement with Eleison Pharmaceuticals, Inc. for the development and commercialization of glufosfamide for the treatment of cancer in humans and animals. The company was founded in 2001 and is headquartered in South San Francisco, California.

57 Employees
Last Reported Date: 05/1/14
Founded in 2001

threshold pharmaceuticals (THLD) Top Compensated Officers

Executive Chairman and Chief Executive Office...
Total Annual Compensation: $575.0K
Principal Financial Officer, Principal Accoun...
Total Annual Compensation: $263.0K
Senior Vice President of Clinical Operations ...
Total Annual Compensation: $418.4K
Senior Vice President of Discovery Research
Total Annual Compensation: $398.4K
Chief Medical Officer
Total Annual Compensation: $361.0K
Compensation as of Fiscal Year 2013.

threshold pharmaceuticals (THLD) Key Developments

Threshold Pharmaceuticals, Inc. Announces Initiation of Dosing with TH-302/Bortezomib (Velcade(R))/Dexamethasone in Final Stage of Ongoing Phase 1/2 Trial of Patients with Relapsed/Refractory Multiple Myeloma

Threshold Pharmaceuticals Inc. announced that dosing has started in the final stage of an ongoing Phase 1/2 trial of its investigational hypoxia-activated prodrug, TH-302, in combination with the proteasome inhibitor bortezomib (Velcade(R)) and low-dose dexamethasone (TBorD) in patients with relapsed/refractory multiple myeloma, a cancer of the bone marrow. Initial results from the dose-escalation and dose-expansion stages of the trial evaluating TH-302 and low-dose dexamethasone without bortezomib were recently presented at the 50(th) Annual Meeting of the American Society of Clinical Oncology (ASCO). As reported at ASCO, patients were heavily-pretreated (median 6.5 prior systemic therapies), and objective responses were observed in 5/16 (31%) patients (three partial responses and two minimal responses) treated at the maximum-tolerated dose of TH-302 (340 mg/m(2)). About the phase 1/2 trial: The objectives of the ongoing Phase 1/2 trial combining TH-302 and dexamethasone with or without bortezomib include assessment of safety and tolerability, determination of dose-limiting toxicities and the maximum-tolerated dose of TH-302, and assessment of preliminary efficacy in patients with relapsed/refractory multiple myeloma. The ASCO 2014 presentation included preliminary data from 24 patients in the dose-escalation and dose-expansion portions of the study who initiated treatment with TH-302 and low-dose dexamethasone prior to March 1, 2014; analyses reflected the clinical database as of May 19, 2014. Of these 24 patients, 17 were treated at the maximum tolerated dose of TH-302 (340 mg/m(2)). In these patients, the most common adverse events related to TH-302 were nausea and fatigue that occurred in at least 25% of the patients. The most common Grade 3/4 hematologic adverse events related to TH-302 were thrombocytopenia (29%) and leukopenia (25%). Dose-limiting toxicities of Grade 3 stomatitis were reported during the first treatment cycle for the first two patients treated at 480 mg/m(2) TH-302; therefore, the maximum tolerated dose of TH-302 in combination with low-dose dexamethasone was established at 340 mg/m(2), as previously reported. Of the 24 patients included in the ASCO presentation, 23 were evaluable for response. Best responses included four partial responses (4 PR), two minimal responses (2 MR), and 15 stable disease (15 SD) assessments; two patients had progressive disease (2 PD). The clinical benefit rate for patients treated at the maximum tolerated dose of TH-302 (340 mg/m(2), n=16 evaluable patients) was 31% (comprised of 3 PR and 2 MR). In the final stage of the trial to evaluate TH-302, bortezomib, and low-dose dexamethasone ("TBorD"), an initial dose of TH-302 of 240 mg/m(2) will be administered twice weekly for the first two weeks of a three-week treatment cycle. The dose of TH-302 will be escalated in cohorts of 3-6 patients. The dose of bortezomib will remain fixed at 1.3 mg/m(2). TH-302 is an investigational hypoxia-activated prodrug that is designed to be activated under 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 soft tissue sarcoma, 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 Agreements with the U.S. Food and Drug Administration (FDA). The FDA and the European Commission have granted TH-302 Orphan Drug Designation for the treatment of soft tissue sarcoma 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, 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.

Threshold Pharmaceuticals, Inc. Initiates Trial of Th-302 in Combination with Pemetrexed in Advanced Non-Squamous Non-Small Cell Lung Cancer

Threshold Pharmaceuticals Inc. announced initiation of a 440-patient, randomized, double-blind, placebo-controlled trial of its investigational hypoxia-activated prodrug, TH-302, in combination with pemetrexed in advanced non-squamous non-small cell lung cancer. The international Phase 2 trial is designed to compare the combination of TH-302 and pemetrexed versus the combination of pemetrexed and placebo as second-line therapy in this patient population. A TH-302 dose of 400 mg/m will be utilized in combination with full-dose pemetrexed. Overall survival is the primary endpoint; secondary endpoints include safety and assessment of anti-tumor activity as determined by progression-free survival and objective response rate. In a completed Phase 1/2 study that evaluated TH-302 in combination with full-dose pemetrexed in 18 patients with relapsed/refractory non-squamous NSCLC, median progression-free survival was 7.0 months and median overall survival was 14.9 months. Of 15 patients evaluable for response, 6 achieved a partial response including 4 confirmed responses, 6 achieved stable disease, and 3 had progressive disease. The most common adverse events following combination therapy of TH-302 and pemetrexed were fatigue, anemia, stomatitis and nausea.

Threshold Pharmaceuticals, Inc. Announces Data from Ongoing Phase 1/2 Trial of TH-302 Plus Bevacizumab (Avastin(R)) in Patients with Recurrent Glioblastoma

Threshold Pharmaceuticals Inc. announced new clinical data from an ongoing investigator-sponsored Phase 1/2 trial of its investigational hypoxia-activated prodrug, TH-302, in combination with bevacizumab (Avastin(R)) in patients with recurrent glioblastoma following progression on single-agent bevacizumab. The objectives of the ongoing Phase 1/2 investigator-sponsored trial include evaluating the safety and tolerability of TH-302, determining the dose-limiting toxicities and the maximum-tolerated dose of TH-302, and assessing preliminary signals of clinical activity in patients with bevacizumab-refractory recurrent glioblastoma. The ASCO poster reports on a total of 17 patients treated with bevacizumab 10 mg/kg every two weeks and TH-302 dose escalated 240-670 mg/m(2) every two weeks (four-week cycle) until disease progression. Patients had received a median of three prior systemic anticancer regimens including both chemoradiation and bevacizumab. Key findings to be reported at ASCO are: Preliminary assessment of safety and tolerability: No Grade 4 adverse events were observed at any dose. Three Grade 3 adverse events were observed: skin ulceration at 340 mg/m(2), oral mucositis at 670 mg/m, and thrombocytopenia at 670 mg/m. The primary TH-302 related toxicities were mucosal: rectal/anal mucositis in one of four patients at 480 mg/m(2) (Grade 2) and six of seven patients at 670 mg/m(2) (all Grade 1 or 2). Limited oral mucositis was observed. Preliminary assessment of clinical activity: In 17 patients evaluable for response according to Response Assessment in Neuro-Oncology (RANO) criteria, best responses included one complete response (1CR) and three partial responses (3PR) for a response rate of 24%, and eight stable disease (8 SD) assessments for a clinical benefit rate of 65%; five patients had progressive disease (5 PD). The longest disease stabilization is ongoing at 30 months. The median progression-free survival (PFS) for patients treated with TH-302 plus bevacizumab was 3.1 months, while these patients experienced PFS of 2.4 months on their first bevacizumab regimen. The 4-month PFS rate was 26%. Median overall survival of patients treated with TH-302 plus bevacizumab was 4.9 months.


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