Key Developments: Threshold Pharmaceuticals Inc (THLD.PH)

THLD.PH on Philadelphia Stock Exchange

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24 Apr 2015
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Latest Key Developments (Source: Significant Developments)

Threshold Pharmaceuticals Inc announces pricing of $30 mln offering of common stock and warrants
Thursday, 12 Feb 2015 06:00am EST 

Threshold Pharmaceuticals Inc:Says pricing of an underwritten offering of 8,300,000 shares of its common stock together with accompanying warrants to purchase an aggregate of 8,300,000 shares of common stock.Combined offering price of each share of common stock and accompanying warrant was $3.62.Says net proceeds to Threshold from this offering are expected to be about $28.2 mln, after deducting underwriting discounts and commissions and estimated offering expenses payable by company.Expects to use net proceeds from this offering for working capital and general corporate purposes, including research and development expenses, general and administrative expenses and manufacturing expenses.Jefferies LLC is acting as sole book-running manager for the offering. H.C. Wainwright & Co., LLC. is acting as lead manager for offering.Offering is expected to close on or about Feb 18 subject to satisfaction of customary closing conditions.  Full Article

Threshold Pharmaceuticals Inc announces phase 1/2 interim data signaling activity of TH-302 plus bevacizumab (Avastin) in patients with glioblastoma
Monday, 17 Nov 2014 07:00am EST 

Threshold Pharmaceuticals Inc:Says interim data from U.S. investigator-sponsored Phase 1/2 clinical trial of the investigational anticancer drug TH-302 in combination with bevacizumab (Avastin) for treatment of glioblastoma (GBM), most lethal form of brain cancer.Says all patients in study had previously progressed on single-agent bevacizumab, only U.S. Food and Drug Administration (FDA)-approved therapy for GBM patients with progressive disease following prior therapy.As reported by investigator, in total of 22 evaluable patients, best responses included one complete response and three partial responses for a response rate of 18 pct, and ten stable disease assessments for a clinical benefit rate of 64 pct; eight patients had progressive disease.Median progression-free survival was 2.8 months, and median overall survival was 4.6 months.  Full Article

Threshold Pharmaceuticals Inc receives FDA Fast Track Designation for TH-302
Tuesday, 11 Nov 2014 07:00am EST 

Threshold Pharmaceuticals Inc:Says U.S. Food and Drug Administration granted Fast Track designation for TH-302, an investigational anticancer drug.For treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS).FDA established Fast Track designation process to facilitate development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.  Full Article

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

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