Key Developments: Threshold Pharmaceuticals Inc (THLD.O)
5.45USD
20 May 2013
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$5.57
$5.53
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321,116
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Latest Key Developments (Source: Significant Developments)
Threshold Pharmaceuticals, Inc. Announces Initiation of Clinical Trial Evaluating TH-302 In Combination With Bevacizumab at University of Texas
Threshold Pharmaceuticals, Inc. announced that the University of Texas at San Antonio initiated a clinical trial of TH-302 in combination with bevacizumab in patients with recurrent high grade astrocytoma including glioblastoma. Bevacizumab, marketed by Roche under the brand name Avastin®, is a recombinant humanized monoclonal antibody that affects tumor vasculature which among its several approved indications is used to treat glioblastoma in patients whose cancer has progressed after prior treatment. Full Article
Threshold Pharmaceuticals, Inc. Initiates Clinical Trial Evaluating TH-302 in Combination with Sunitinib
Threshold Pharmaceuticals, Inc. announced the initiation of a Phase 1/2 dose escalation clinical trial of TH-302 in combination with sunitinib in patients with advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) and pancreatic neuroendocrine tumor (PNET). TH-302 is a tumor selective Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia. Sunitinib, marketed by Pfizer under the brand name Sutent, is an oral, small molecule angiogenesis inhibitor that is currently approved for the treatment of RCC, GIST and PNET. Full Article
Threshold Pharmaceuticals, Inc. Provides Update On Continued Promising Data From A Phase 1/2 Clinical Trial Of TH-302
Threshold Pharmaceuticals, Inc. announced clinical trial results related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. The presentation summarized the Phase 2 experience from the ongoing single arm Phase 1/2 clinical trial, the 403 trial, which is investigating TH-302 in combination with doxorubicin in patients with soft tissue sarcoma. The Phase 2 analysis included patients with first-line soft tissue sarcoma (adjuvant and neoadjuvant therapy accepted) treated at the TH-302 maximum tolerated dose (MTD) of 300 mg/m2 in combination with 75 mg/m2 doxorubicin. Sixty-two patients were included in the analyses including 60 patients with at least one evaluable post-treatment tumor assessment. Best responses were: 1 complete response, 18 partial responses and 32 patients with stable disease for an overall response rate of 32% and a stable disease or better rate of 85%. In addition to the reported response rates, median progression free survival was 6.4 months (95% confidence interval: 5.6 to 8.1 months). Six of the 60 patients continue on study after a median of 15 cycles. The median overall survival was 16.1 months (95% CI: 10.4 months to not reached). With the agreement in February with the U.S. Food and Drug Administration on a Special Protocol Assessment, the Company plans to initiate a Phase 3, randomized, controlled clinical trial comparing TH-302 in combination with doxorubicin with doxorubicin alone with a primary efficacy endpoint of overall survival. Full Article
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