Key Developments For Threshold Pharmaceuticals, Inc.
Threshold Pharmaceuticals, Inc. (THLD.O) (Consolidated Issue listed on NASDAQ Capital Market)
Threshold Pharmaceuticals, Inc. Announces Clinical Development Results For Cancer Candidate TH-302
Threshold Pharmaceuticals, Inc. announced a presentation related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. The presentation was made at the Chemotherapy Foundation Symposium taking place in New York City from November 10 to 14, 2009. The presentation, Targeting Tumor Hypoxia with TH-302: Phase I Results with Monotherapy and in Combination with Chemotherapy, was given by Dr. Sant P. Chawla, M.D., Director of the Sarcoma Oncology Center in Santa Monica, California, and a clinical investigator for the trial. The presentation summarized the interim clinical trial results from three ongoing clinical trials being conducted with TH-302. Over the last several months, interim data from each of these studies has been presented at various oncology conferences focused on the treatment of lung cancer, melanoma, soft tissue sarcoma, and solid tumors in general. Dr. Chawla's presentation provided an overview of these data which are discussed in previous Company news releases.
Threshold Pharmaceuticals, Inc. Presents Interim Data From Phase 1/2 Clinical Trial Of TH-302
Threshold Pharmaceuticals, Inc. announced clinical trial results related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. Today's presentation focused on a clinical trial, the 403 trial, which is investigating TH-302 in combination with doxorubicin in patients with soft tissue sarcoma who have not received prior doxorubicin. Twelve patients have had at least one evaluable post-treatment tumor assessment, including 3 (25%) with a partial response (PR) as measured by RECIST (Response Evaluation Criteria In Solid Tumors). Two of the PRs are confirmed, including one patient who has remained on study for 33 weeks. One of the PRs was unconfirmed due to progression at the subsequent assessment. Five of the 12 patients continue to receive TH-302 after receiving TH-302 for 3 to 13 three-week cycles. Seven (58%) patients achieved stable disease while 2 (17%) had progressive disease. Additional patients are being enrolled to better define the extent of the tumor response activity. TH-302 continues to be tolerated and there have been no new unexpected adverse events in the 14 patients assessed for safety. Nausea was the most commonly reported adverse event and was reported in 8 (57%) patients. After observing significant, but not dose limiting toxicity at a TH-302 dose of 240 mg/m2, prophylactic growth factor support was initiated.
Threshold Pharmaceuticals, Inc. Licenses Glufosfamide to Eleison Pharmaceuticals
Threshold Pharmaceuticals, Inc. and Eleison Pharmaceuticals, Inc. announced the execution of a licensing agreement granting Eleison Pharmaceuticals exclusive worldwide rights to glufosfamide. Glufosfamide is a novel small molecule that has been evaluated by Threshold in a Phase 3 clinical trial and multiple Phase 2 clinical trials. Under the agreement, Eleison is responsible for the development, manufacturing and marketing of glufosfamide. Eleison and Threshold will share in the profits of commercialization, if the further clinical development of glufosfamide leads to regulatory approval and marketing. Eleison intends to secure funding for the clinical development of glufosfamide. The agreement between Threshold and Eleison contemplates that Eleison, to satisfy its diligence obligations, will raise sufficient funds to commence clinical development activities with glufosfamide.
Threshold Pharmaceuticals, Inc. Announces Selected Study Data From Midstage Cancer Study-AP
The Associated Press reported that Threshold Pharmaceuticals, Inc. has highlighted select data from a midstage cancer study of its drug candidate TH-302. There are currently 78 patients in an expansion component of the trial with various types of cancer, including skin and lung cancer. The Company only focused on the first nine patients with metastatic melanoma, or skin cancer, who are part of the study's dose escalation expansion. Out of those nine patients, it said only 8 could be evaluated. It said 6 of those patients had stable disease or better. Additional patients are being enrolled to better define the extent of the tumor response activity. The Company said that fatigue was the most common reported side effect.
Threshold Pharmaceuticals, Inc. Completes $35 Million Private Equity Financing
Threshold Pharmaceuticals, Inc. announced the completion of its previously announced private placement of common stock and warrants. Investors in the offering purchased units consisting of one share of common stock and a warrant to purchase 0.4 of a share of common stock at a purchase price of $1.91, which is equal to the consolidated closing bid price of the common stock as reported on the NASDAQ Capital Market for September 29, 2009, plus $0.05. The warrants have an exercise price equal to $2.23 per share, subject to adjustment under certain circumstances, and an expiration date of October 5, 2014. The Company raised gross proceeds of approximately $35 million and issued approximately 18.3 million shares of common stock and warrants to purchase approximately 7.3 million shares of common stock. The Company intends to use the net proceeds of this private placement for research and development, working capital and general corporate purposes. MTS Securities, LLC, an affiliate of MTS Health Partners and Reedland Capital Partners, an institutional division of Financial West Group served as co-placement agents in the offering.
