Threshold Pharmaceuticals Achieves Target Enrollment in Phase III Sarcoma Trial

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Announces of 620 Patients Achieved in Pivotal 3 of TH-302 in Advanced Soft Tissue

$ 12.5 Million USD Milestone to Be Paid by Merck KGaA

SOUTH SAN FRANCISCO, CA–(Marketwired – Dec 30, 2013) – Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the target enrollment of 620 patients with advanced soft tissue sarcoma has been achieved in the company’s pivotal Phase 3 trial of TH-302, its investigational hypoxia-targeted drug. The enrollment achievement triggers a milestone payment of $ 12.5 million USD from Merck KGaA, Darmstadt, Germany. Threshold has a global license and co-development agreement with Merck for TH-302, which includes an option for Threshold to co-commercialize in the U.S.

“We are pleased to achieve this enrollment milestone in this pivotal trial of TH-302 for the treatment of patients with advanced soft tissue sarcoma,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “We hope that TH-302 will ultimately be shown to be both safe and efficacious in this patient population for which there is an urgent unmet medical need.”

Threshold is conducting this international, randomized, pivotal Phase 3 trial in partnership with the Sarcoma Alliance for Research through Collaboration (SARC). The trial is enrolling patients with metastatic or locally advanced unresectable soft tissue sarcoma and is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone.

Though Threshold will remain blinded to the data from its ongoing Phase 3 trial, an Independent Data Monitoring Committee (IDMC), which monitors patient safety on an ongoing basis, will conduct an interim efficacy and safety analysis after 235 deaths are reported. The timing of the interim analysis, which is event-based and therefore dependent on the length of survival of patients, is currently projected to be…Read more

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