Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) today announced that they had reached agreement with the FDA on a SPA (Special Protocol Assessment) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma. The 450 patient pivotal trial is expected to begin in the middle of 2011, and will enroll patients with metastatic or locally advanced unresectable soft tissue sarcoma who have not previously received chemotherapy. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone. The primary endpoint is overall survival. An interim analysis based on progression-free survival is expected to occur about half-way into enrollment and an interim analysis based on overall survival expected to occur at the end of enrollment.
Discovery Laboratories, Inc. (NASDAQ:DSCO) announced that it priced their offering of 10m units at $2.35 per unit for gross proceeds of $23.5 million. Each unit consists of one share of common stock, a five-year warrant to purchase 0.50 of a share of common stock and a 15-month warrant to purchase 0.50 of a share of common stock. The shares of common stock and warrants are immediately separable and will be issued separately such that no units will be issued. The five-year warrants are exercisable immediately upon issuance, have a five-year term and an exercise price of $3.20 per share. The fifteen-month warrants are exercisable immediately upon issuance, have a fifteen-month term and an exercise price of $2.94 per share.
Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the first patient received subcutaneous MabThera (rituximab) in a Phase 3 registration trial using Enhanze technology, for the treatment of follicular non-Hodgkin lymphoma (NHL). HALO receives a $5m milestone payment. MabThera is currently approved to treat NHL and chronic lymphocytic leukemia (CLL) intravenously.