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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. 

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1 Oct 2014