THLD - Threshold Pharmaceuticals Inc.

Threshold Pharmaceuticals, Inc., a development stage company, engages in the discovery, development, and commercialization of small molecule therapeutics for the treatment of benign prostatic hyperplasia and cancer. Its product candidates include TH-070, a Phase II and III product, which is used for the treatment of symptomatic benign prostatic hyperplasia; Glufosfamide, a Phase II and III product, for the treatment of cancer; 2-deoxyglucose, or 2DG, a Phase I trial product, for the treatment of solid tumors. The company was founded by George F. Tidmarsh. Threshold Pharmaceuticals was incorporated in 2001 and is headquartered in Redwood City, California.

Shares Outstanding: 37.41M
Float: 32.25M
% Held by Insiders: 27.56%
% Held by Institutions: 35.70%

Threshold Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating Glufosfamide in Patients With Soft Tissue Sarcoma
Monday April 9, 9:00 am ET


REDWOOD CITY, Calif., April 9 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced that it has initiated patient enrollment for a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with previously treated, advanced, soft tissue sarcoma. Soft tissue sarcoma includes cancers of cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.

"The treatment of advanced, soft tissue sarcoma remains a major unmet medical need that disproportionately affects younger patients," said Lee Cranmer, M.D., Ph.D, Arizona Cancer Center, and a clinical investigator for the trial. "New agents are definitely needed. I am hopeful that glufosfamide may provide a new treatment option for these patients. I look forward to collaborating with this important exploratory trial."


Phase 2 Clinical Trial Design
Twenty-two patients with previously treated, advanced, soft tissue sarcoma are planned to enroll in the Phase 2, open-label, clinical trial at various sites in the United States. All patients are to receive 5000 mg/m^2 of glufosfamide every three weeks for up to six cycles.

The primary efficacy endpoint of the trial is objective response rate. The secondary endpoints of the trial include duration of response, progression- free survival, overall survival and various safety parameters. Tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). One exploratory objective of the trial is to evaluate the biological effects of glufosfamide on metabolic profile as determined by FDG-PET (fluorodeoxyglucose-positron emission tomography). The role of this procedure is to detect metabolically active malignant lesions and to monitor their metabolic response to glufosfamide therapy. An additional exploratory objective of the trial is to correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins.


About Soft Tissue Sarcoma
Soft tissue sarcomas are treated with surgery, chemotherapy and radiation. Usually a combination of these modalities offers the best chance to treat the disease successfully. Doxorubicin and ifosfamide are the most commonly used chemotherapeutic agents in patients with advanced soft tissue sarcoma, but response rates are low and toxicity is significant. The American Cancer Society estimates that 9,220 people will be diagnosed with a soft tissue sarcoma in the United States in 2007, and approximately 3,560 people will die from these diseases.


About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of small molecule therapeutics for the potential treatment of cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website (www.thresholdpharm.com).

AP
Threshold Pharma Down on Trial Results
Tuesday February 27, 6:04 pm ET
Threshold Pharma Stock Plumments on Disappointing Cancer-Drug Results


SAN FRANCISCO (AP) -- Threshold Pharmaceuticals Inc. stock lost more than half its value Tuesday, the day after the drug developer reported disappointing results from a late-stage clinical trial for its drug candidate glufosfamide.

Shares of the Redwood City, Calif.-based company fell $2.06, or 58 percent, to close at $1.52 on the Nasdaq Stock Market.

Late Monday, Threshold said that a Phase III clinical trial for glufosfamide failed to meet its goal of extending the lives of patients suffering from advanced pancreatic cancer.

The drug was tested on patients who had relapsed after being treated with gemicitabine, the generic form of Eli Lilly & Co.'s Gemzar, a standard chemotherapy drug for pancreatic cancer.

Threshold intends to persevere with additional testing of the drug. The company is currently running a Phase II clinical trial testing glufosfamide in combination with gemicitabine in patients who have never received chemotherapy for their condition. Results from that study are expected by the end of the third quarter 2007.

Threshold has also initiated Phase II trials to evaluate glufosfamide in the treatment of ovarian cancer and recurrent lung cancer. The company is also planning a study testing the drug in the treatment of cancerous tumors in soft tissue. Preliminary data from the studies is expected in 2008.

Threshold said Monday that it has enough cash to fund operations through the middle of 2008.