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Threshold announces mixed results from glufosfamide program

Threshold Pharmaceuticals has provided guidance on the clinical development of glufosfamide and announced mixed results from the Phase II clinical trials of glufosfamide for the treatment of patients with soft tissue sarcoma and platinum-resistant ovarian cancer.

The soft tissue sarcoma trial was completed and provided evidence of clinical activity. The initial analysis of the results supports continued development of the compound for this indication but suggests different dosing regimens would likely be required to improve the therapeutic index. In the ovarian cancer trial, due to a lack of efficacy and enrollment challenges, the company has decided to stop further enrollment and not pursue further clinical investigation in this indication. In the remaining ongoing clinical trial of glufosfamide, Threshold and its development partner in Japan, MediBIC continue to expect to complete an ongoing Phase I clinical trial for the treatment of solid tumors in the coming months.

Additionally, the company is focused on TH-302, a hypoxia-activated prodrug (HAP), which is currently under investigation in a Phase I clinical trial in patients with advanced solid tumors.

Barry Selick, CEO of Threshold, said: “With our recent shift in focus to TH-302 and its underlying pipeline of HAP product candidates, we will be seeking a partner with whom to continue development of glufosfamide in these and potentially other indications.”