Knobias Clip Report (10-12-2007)
Sumbmited From Knobias ClipReport
THLD: Shares Decline After Ph II Trial of Glufosfamide Fails to Meet Endpoint
Shares of Threshold Pharmaceuticals, Inc. (THLD) declined in Friday's session after anouncing after the bell yesterday that it would stop enrollment in a Phase 2 clinical trial of its lead product candidate, glufosfamide, in patients with recurrent, sensitive small cell lung cancer. The Phase II trial failed to demonstrate efficacy endpoints. The primary efficacy endpoint of the trial was objective response rate. The secondary endpoints of the trial evaluated duration of response, progression-free survival, overall survival and various safety and pharmacokinetic parameters. There was only one partial tumor response.
"We are disappointed in the study results. While we recognize that response is not a perfect surrogate for survival, the low response rate indicates that glufosfamide is not sufficiently effective as a single agent for patients with small cell lung cancer," said Barry Selick, Ph.D., chief executive officer of Threshold.
Approximately 160,000 people will die each year from lung cancer. About 15 to 20 percent of all lung cancers are the small cell type. This cancer usually starts in the bronchi near the center of the chest but has often spread outside of the lung by the time of diagnosis. Small cell lung cancer is strongly associated with a history of cigarette smoking. Small cell lung cancer patients with a single small lung lesion may have 70 percent chance of 5-year survival after surgical removal of the tumor and adjuvant chemotherapy.
Small cell lung cancer is usually treated with chemotherapy or surgery. Radiation therapy may be combined with chemotherapy if the cancer is limited to the lung. GlaxoSmithKline's (GSK) Hycamtin(R)(topotecan) is currently approved to treat small cell lung cancer. Other promising drugs that may be effective include Bristol-Myers'(BMY) Taxol(R)(paclitaxel), Sanofi-Aventis' (SNY) Taxotere(R)(docetaxel), Pfizer's Camptosar(R)(irinotecan), and Genentech's (DNA), Avastin(R)(bevacizumab). Many vaccine studies that try to get the body’s immune system to fight the cancer are ongoing.
All of the Company's product candidates are based on Metabolic Targeting, a therapeutic approach that targets fundamental differences in energy metabolism between normal and certain diseased cells. The Company has ongoing clinical trials for glufosfamide in ovarian cancer and soft tissue sarcoma. A previous Phase 3 trial for glufosfamide as a second-line treatment of metastatic pancreatic cancer did not meet its primary endpoint for overall survival. TH-302 is a novel Phase 1 drug candidate for the treatment of solid tumors. 2DG is a Phase 1 product candidate for the potential treatment of cancer, alone and in combination with docetaxel as a combination therapy.
At June 30, 2007, the Company had an accumulated deficit of $151.4 million and cash on hand of $16.4 million. Cash requirements for 2007 were expected to be in the range of $30.0 million to $35.0 million.
Visit 1800blogger to see all of our industry leading blogs
Labels: Knobias, small cap stocks, THLD

0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home