The company reported today the start of a Phase 2 clinical trial to evaluate the safety and efficacy of its TH-302 investigational hypoxia-targeted drug in patients with melanoma. The study will look at a range of biomarkers including serum, tumor biopsy, and PET-imaging hypoxia biomarkers that may predict treatment outcomes and see exactly what the tumors’ response is to the drug.
Regions of low oxygen is a key hallmark in many solid tumors and is often associated with a poor prognosis for the patient. Cells in these regions exhibit increased potential for invasion by cancer, metastasis, and resistance to treatment. Hypoxia may also suppress the body’s immune system response to cancer.
In the previous Phase 1 trial, response to TH-302 was good. Out of 34 patients, seven (21%) achieved a partial response including patients with BRAF mutant and wild-type tumors. In addition, 12 patients (35%) achieved stable disease, yielding a clinical benefit rate of 56%. Median progression-free survival was 3.5 months.
The Phase 2 study will be important to the overall TH-302 development program for Threshold Pharmaceuticals. The development costs associated with the clinical trial will be 70% funded by the company’s partner on TH-302, Merck KGaA, the German Pharmaceutical giant. The agreement between the two firms includes an option for Threshold to jointly commercialize the drug in the U.S. with Merck KGaA.
For further information about Threshold Pharmaceuticals and its TH-302 hypoxia drug, visit www.thresholdpharm.com
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