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March 26, 2013
11:40 EDTTHLD, ZIOPThreshold higher after Ziopharm terminates STS drug development
Threshold Pharmaceuticals (THLD) shares are trading higher today after rival cancer drug discovery company Ziopharm (ZIOP) terminated its development of palifosfamide. WHAT'S NEW: Earlier today, Ziopharm announced that its Phase 3 trial of palifosfamide for the treatment of metastatic soft tissue sarcoma, or STS, in the first-line setting did not meet its primary endpoint of progression-free survival. Like Ziopharm, Threshold focuses on the discovery and development of cancer therapeutics and is also in the process of evaluating a drug to treat patients with soft tissue sarcoma with its development of TH-302. WHAT'S NOTABLE: Threshold's 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. Both Phase 3 trials are being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. TODAY'S PRICE ACTION: Shares of Threshold Pharmaceuticals are up 11c, or 2.3% to $4.90 in late morning trading. Meanwhile, shares of Ziopharm, which were downgraded by at least four analyst firms after its announcement, plunged 62% to $1.94.
News For THLD;ZIOP From The Last 14 Days
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November 30, 2015
15:53 EDTTHLDHigh option volume stocks
11:34 EDTTHLDOptions with increasing call volume; QUNR ASNA CIT THLD K ARO MON BURL SWN
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November 19, 2015
07:07 EDTZIOPZIOPHARM announces data highlighting Ad-RTS-hIL-12 activity in Glioma
ZIOPHARM Oncology announced that the company is presenting initial results from an ongoing Phase 1 dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma or grade III malignant glioma. The presentation, titled "Intratumoral Regulated Expression of IL-12 as a Gene Therapy Approach to Treatment of Glioma," will be delivered at 5:15 pm CT, Saturday, November 21, 2015 at the 20th Annual Society for Neuro-Oncology, or SNO, Annual Scientific Meeting in San Antonio, Texas. Ad-RTS-hIL-12 + the oral activator veledimex is a novel viral gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T-cell immune response. The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 + veledimex examines a gene therapy strategy for recurrent high grade gliomas, with the goal of generating a localized anti-tumor immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 + veledimex, and assessment of biologic response. The study is expected to enroll up to 72 subjects. Preclinically, the effects of Ad-RTS-mIL-12 + veledimex were studied in orthotopic glioma animal models, demonstrating veledimex crossed the blood-brain-barrier. In a standard orthotopic glioma mouse model that evaluated dexamethasone, bevacizumab, temozolamide and a PD-1 inhibitor, Ad-RTS-mIL-12 + veledimex demonstrated a dramatic dose-related increase in survival, without significant adverse events, that was superior to all other treatments. In the current, on-going Phase 1 study, five patients are available for initial assessment, two with recurrent grade III malignant glioma and three with grade IV. Results show IL-12 was detectable in peripheral blood along with downstream IFNg, indicating that veledimex crossed the blood brain barrier activating IL-12 expression from intra-tumorally administered Ad-RTS-hIL-12. Ad-RTS-hIL-12 + veledimex was well tolerated with minimal neurologic toxicity. The most common adverse events were headache, fever, hyponatremia and nausea/vomiting. Related serious adverse events were aseptic meningitis, neutropenia, thrombocytopenia, leukopenia, with all toxicity to date consistent with the "on-target" effects of immunotherapy.
November 18, 2015
07:01 EDTTHLDThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.

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