Navigation Links
Threshold Pharmaceuticals to Stop Enrollment in Clinical Trial
Date:10/11/2007

REDWOOD CITY, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD), today announced that, as part of a planned interim analysis, it would stop enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive small cell lung cancer.

The clinical trial utilized a two stage design to ensure there would be an adequate response rate to justify complete enrollment. Tumor response was evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). The first stage enrolled 21 patients as planned, but only one confirmed partial response was observed. If three or more responses were observed, an additional 29 patients would have been enrolled. Patients currently enrolled in the clinical trial will be given the option to continue in the trial.

"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. We had hoped to develop a better treatment option for patients with this disease, for whom the quality of life and treatment outcomes need improvement," said Barry Selick, Ph.D., chief executive officer of Threshold. "We want to thank the investigators, patients and their families for their participation in the study."

Phase 2 Clinical Trial Design

Approximately 50 patients with extensive recurrent sensitive small cell lung cancer, who had progressed at least 60 days after completing chemotherapy, were planned to enroll in the Phase 2, open-label, clinical trial at various sites in the United States, Ukraine and Russia. All patients were to receive glufosfamide every three weeks for up to six cycles. The study utilized a Simon two-stage design which was designed to stop development if the true response rate was 10% or less and to continue development if the true response rate was 25% or higher.

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. The study also evaluated the effects of glufosfamide on lung cancer symptoms utilizing the Lung Cancer Symptom Scale (LCSS).

About Small Cell Lung Cancer

The National Cancer Institute estimates that 174,470 people were diagnosed with lung cancer in the United States in 2006, and approximately 160,000 people will die each year from the disease. Small cell lung cancer is less common than non-small cell 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.

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 (http://www.thresholdpharm.com).

Forward-Looking Statements

Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates, clinical trial progress and results, and potential therapeutic uses and benefits of our product candidates. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to commence, enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on August 7, 2007 and is available from the SEC's website (http://www.sec.gov) and on our website (http://www.thresholdpharm.com) under the heading "Investors." We do not intend to update any forward-looking statement made in this news release.

Contact:

Denise T. Powell

Sr. Director, Corporate Communications

Threshold Pharmaceuticals, Inc.

650-474-8206

dpowell@thresholdpharm.com


'/>"/>
SOURCE Threshold Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Threshold Pharmaceuticals Announces Multiple Presentations on Oncology Pipeline at the 2007 American Association for Cancer Research (AACR) Annual Meeting
2. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
3. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
10. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
11. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/2/2017)... Aug. 2, 2017 CaryRx, a next-generation full-service pharmacy, ... service for patients in the Washington D.C. ... pharmacy by providing delivery of medications through the convenience of ... delivery or delivered within one hour to any location in ... to bring this invaluable service to Washington D.C. ...
(Date:7/28/2017)... July 28, 2017 Hill-Rom Holdings, Inc. ("Hill-Rom") ... third quarter ended June 30, 2017, and updated its ... For the fiscal third quarter, Hill-Rom ... $0.68 per diluted share in the prior-year period. These ... $0.39 per diluted share primarily related to the non-cash ...
(Date:7/26/2017)... 2017  Radium Medical Aesthetics, a leading medical aesthetic clinic in ... by effectively addressing several skin conditions from the inside. ... and more fragile. The skin becomes more transparent due to the ... harmful UV rays from the sun contributes to aging skin, causing ... ...
Breaking Medicine Technology:
(Date:8/19/2017)... ... 19, 2017 , ... DMG Productions, producers of the award ... an upcoming episode, slated to air fourth quarter 2017. Check your local listings ... a company committed to supporting dentistry using the most technologically advanced restorative materials ...
(Date:8/19/2017)... (PRWEB) , ... August 19, 2017 , ... Curl Keeper® ... of NaturallyCurly.com® The Curl Leaders, Editors’ Choice 2017 Award for the second year in ... for hair stylists and curlies alike was voted Best Moisturizer for Type 2 Wavies ...
(Date:8/19/2017)... ... August 19, 2017 , ... “Congratulations! It's A Boy! God’s Gift: ... both their parents and God. “Congratulations! It's A Boy! God’s Gift: A Story of ... from Long Island, New York. , Published by Christian Faith Publishing, Dale Anthony and ...
(Date:8/18/2017)... NY (PRWEB) , ... August 18, 2017 , ... ... of “Vision & Hearing” campaign, advocating for active, healthy lifestyles and highlighting the ... available for individuals with hearing impairments and shares the latest innovations in hearing ...
(Date:8/18/2017)... VA (PRWEB) , ... August 18, 2017 , ... ... asset protection services and financial consultations to communities throughout the greater DC region, ... K9 with the goal of rescuing local animals and training them to be ...
Breaking Medicine News(10 mins):