Key Developments: Threshold Pharmaceuticals Inc (THLD.O)

THLD.O on Consolidated Issue listed on NASDAQ Capital Market

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Latest Key Developments (Source: Significant Developments)

Threshold Pharmaceuticals Inc announces Phase 3 Trial of TH-302 in patients with Advanced Soft Tissue Sarcoma will continue as planned
Monday, 22 Sep 2014 08:00am EDT 

Threshold Pharmaceuticals Inc:Says Independent Data Monitoring Committee (IDMC) has completed planned interim efficacy and safety analyses of unblinded data for company's pivotal Phase 3 clinical trial.Phase 3 Clinical traul 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.  Full Article

Threshold Pharmaceuticals Inc announces data from phase 1/2 Trial of TH-302 Plus Bevacizumab (Avastin) in patients with recurrent Glioblastoma
Friday, 30 May 2014 07:00am EDT 

Threshold Pharmaceuticals Inc:Clinical data from ongoing investigator-sponsored Phase 1/2 trial of investigational hypoxia-activated prodrug, TH-302, in combination with bevacizumab (Avastin) in patients with recurrent glioblastoma following progression on single-agent bevacizumab.In limited number of patients treated, it is notable that some patients experienced objective tumor shrinkage with TH-302 plus bevacizumab, particularly given that objective responses are rarely seen at this advanced stage of the disease.Moreover, median progression-free survival with TH-302 plus bevacizumab was longer than with prior single-agent bevacizumab.Based on these early signals of clinical activity, company continuing evaluation of TH-302 in this extremely challenging-to-treat population of patients with glioblastoma.Next steps are to further investigate 670 mg/m2 TH-302 dose given with bi-weekly bevacizumab in a multi-center study in this bevacizumab-refractory patient population.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.Says assessing preliminary signals of clinical activity in patients with bevacizumab-refractory recurrent glioblastoma.  Full Article

Threshold Pharmaceuticals Inc announces TH-302 Data at 55th annual meeting of the American Society of Hematology
Sunday, 8 Dec 2013 10:00am EST 

Threshold Pharmaceuticals Inc:Says that clinical data from two early-stage trials of TH-302, its investigational hypoxia-targeted drug, will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH).Says that results from the dose escalation component of a Phase 1/2 clinical trial of TH-302 in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma will be presented in a poster session on Dec. 8 evening.Says that courteen patients initiated therapy, all having received 3 to 11 prior treatments (median of 6.5) and all having received a regimen containing Velcade (bortezomib, a first-in-class proteasome inhibitor), an immunomodulatory agent and an alkylating agent.Says that preliminary results suggest that the combination of TH-302 with dexamethasone is active in some heavily pretreated patients who stop responding to conventional therapy.Says that thirteen patients were evaluable for response.Says that two patients achieved a partial response and three patients achieved a minimal response, with the combination of the two types of responses comprising a clinical benefit rate of 38 pct.Says that seven patients had stable disease and one patient had progressive disease.Says that one patient with a minimal response continues to receive therapy after about six months.  Full Article

Threshold Pharmaceuticals Inc Announces Data From Two Ongoing Phase 1/2 Trials of TH-302
Sunday, 2 Jun 2013 09:00am EDT 

Threshold Pharmaceuticals Inc announced data from two ongoing Phase 1/2 trials evaluating TH-302, an investigational hypoxia-targeted drug, at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held in Chicago, Ill., May 31 through June 4. Updated results from a Phase 1/2 study of TH-302 plus dexamethasone in patients with relapsed/refractory multiple myeloma were presented supplementing the data published in the meeting abstract (Abstract #8602). Of 12 evaluable patients, 2 achieved partial responses (PRs) and 2 minimal responses (MRs) for a clinical benefit rate (MR or better) of 33%. In a Phase 1/2 clinical trial of TH-302 administered in combination with the antiangiogenic therapy sunitinib, one of 4 patients with gastrointestinal stromal tumors (GIST) achieved a confirmed PR, and 3 of 4 patients with renal cell carcinoma (RCC) achieved PRs. A total of 13 patients with relapsed/refractory multiple myeloma and a median number of 6 prior therapies initiated treatment with TH-302 plus dexamethasone in an ongoing Phase 1/2 trial. All patients had received prior therapy with regimens containing a proteasome inhibitor, an immunomodulatory drug (IMiD), and an alkylating agent. TH-302 was dosed at 240 mg/m2 (n=5), 340 mg/m2 (n=6), and 480 mg/m2 (n=2) for a median of 5 cycles. TH-302 was administered with dexamethasone (fixed oral 40 mg dose) on days 1, 4, 8, and 11 of a 21-day cycle.  Full Article

Levi & Korsinsky, LLP Launches Investigation into Possible Breaches of Fiduciary Duty by Board of Directors of Threshold Pharmaceuticals Inc
Wednesday, 3 Apr 2013 05:42pm EDT 

Levi & Korsinsky, LLP announced that it is investigating Threshold Pharmaceuticals Inc, and its Board of Directors, in connection with possible claims of breaches of fiduciary duty.  Full Article

Threshold Pharmaceuticals Inc And Merck KGaA's Merck Serono Announce Initiation Of TH-302 Phase 3 MAESTRO Study In Patients With Locally Advanced Or Metastatic Pancreatic Adenocarcinoma
Friday, 25 Jan 2013 04:00am EST 

Threshold Pharmaceuticals Inc announced that Threshold's partner Merck KGaA, Darmstadt, Germany, through its division Merck Serono, initiated the global Phase 3 MAESTRO study assessing the efficacy and safety of investigational hypoxia-targeted drug TH-302 in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. The initiation of the Phase 3 MAESTRO study resulted in Threshold earning a $30 million payment from Merck KGaA pursuant to the terms of Threshold's license and co-development agreement with Merck KGaA, which includes an option for Threshold to co-commercialize in the U.S. MAESTRO stands for TH-302 in the treatment of MetastAtic or unrESectable pancreaTic adenocaRcinOma. MAESTRO is a randomized, placebo-controlled, international, multi-center, double-blind Phase 3 trial of TH-302 plus gemcitabine compared with placebo plus gemcitabine and is expected to enroll 660 patients. 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) with the U.S. Food and Drug Administration (FDA).  Full Article

Threshold Pharmaceuticals Inc Reports Updated Phase 2 Results Including Analyses of Maintenance Therapy With TH-302 Following Induction Therapy With TH-302 Plus Doxorubicin In Soft Tissue Sarcoma
Thursday, 15 Nov 2012 07:30am EST 

Threshold Pharmaceuticals Inc announced updated results from a Phase 2 study of TH-302, the Company's investigational hypoxia-targeted drug, in patients with soft tissue sarcoma, including additional results from patients who were administered TH-302 as single agent maintenance therapy following induction with TH-302 in combination with doxorubicin. In the single-arm Phase 2 component of the study (403 trial), previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcomas were treated with TH-302 (300 mg/m2 on days 1 and 8 of a 21-day cycle) and doxorubicin (75 mg/m2 on day 1) for a maximum of six cycles. After six cycles, patients with stable disease, partial or complete responses, and with acceptable toxicity, were eligible to receive TH-302 maintenance therapy (300 mg/m2 on days 1 and 8 of a 21-day cycle). Response was assessed using RECIST criteria. Results for Overall Study Population (N=91) Updated results for the 91 patients in the Phase 2 component of the study include: Median progression free survival (PFS) of 6.7 months (95% CI: 6.2 to 8.1 months). Median overall survival of 21.5 months (95% CI 16.0 to 27.6 months). One-year survival of 73% (95% CI: 63% to 82%), and two-year survival of 44% (95% CI: 32% to 55%). Overall best response (partial and complete responses, unconfirmed) of36%.  Full Article

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