Threshold Pharmaceuticals is
a biotechnology company focused on discovering and developing drugs targeting
tumor hypoxia. This malady is a low oxygen condition found in the
micro-environments of most solid tumors as well as the bone marrows of some
patients with hematologic malignancies.
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
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website