Navigation Links
Neurobiological Technologies Reaches Patient Enrollment Target For Interim Analysis of Viprinex(TM) Phase 3 Stroke Trials
Date:8/12/2008

EMERYVILLE, Calif., Aug. 12 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) today announced that enrollment into its two Phase 3 pivotal studies evaluating Viprinex(TM) (ancrod) for the treatment of acute ischemic stroke has reached the level of patients necessary to conduct a planned interim analysis across the two studies. NTI is currently studying whether Viprinex is safe and effective for treating acute ischemic stroke when given within six hours of stroke onset.

"We are very pleased to have reached the enrollment criteria to conduct the planned interim analysis," stated Paul E. Freiman, president and chief executive officer of NTI. "Our independent Data Safety Monitoring Board (DSMB) will meet to review the efficacy data on an unblinded basis for the first time. In addition, the DSMB will evaluate the safety of Viprinex, as they've been doing since the start of the studies."

Results of the interim analysis are expected in January 2009. The interim analysis will be based on the first 500 treated patients in the current trials who have completed their 90 day assessment. If the treatment effect observed for the ancrod patients is not better than that observed for the placebo patients, then the trials will be halted for futility, indicating that they are unlikely to demonstrate the benefit required for approval. If the trials are allowed to continue, NTI will not have access to any unblinded patient data until the trials are completed. The primary endpoint of the trials is the modified Rankin Score, a measure of disability.

"We believe that data from 500 patients is sufficient for the DSMB to conduct a thorough assessment of futility, and have accordingly moved up the interim analysis from earlier plans to conduct it at 650 patients," stated Warren W. Wasiewski, M.D., vice president and chief medical officer. "This is a significant milestone for the program and we are all looking forward to learning the outcome of this review."

About Ischemic Stroke

Ischemic stroke is caused by blockage of a blood vessel in the brain due to a clot. The lack of blood flow, or ischemia, leads to cell death. According to the American Heart Association, 87% of the 700,000 annual strokes in the United States are ischemic. Stroke is the third leading cause of death in the United States, behind heart disease and cancer, and the leading cause of disability. The only FDA-approved drug for the treatment of acute ischemic stroke is Activase(R) (alteplase), which currently must be given within three hours of stroke onset.

About Neurobiological Technologies, Inc.

Neurobiological Technologies, Inc., (Nasdaq: NTII) is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate, Viprinex(TM) (ancrod), is in Phase 3 clinical testing as a novel investigational drug for the treatment of acute ischemic stroke. Viprinex has multiple mechanisms of action and is specifically designed to double the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. NTI also has early-stage development programs for Alzheimer's and Huntington's diseases and rights to receive payments on an approved drug for Alzheimer's disease and an investigational drug in Phase 3 trials for brain swelling.

Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including uncertainties regarding the outcome of the interim analysis, obtaining approval for Viprinex, levels of future expenditures and capital resources needed to fund operations, as well as other risks detailed from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K as updated periodically in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release and we undertake no obligation to update these forward-looking statements.


'/>"/>
SOURCE Neurobiological Technologies, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurobiological Technologies, Inc. Presents Dosing Rationale for Viprinex(TM) (ancrod) at the European Stroke Conference
2. Fifth DSMB Meeting Supports Neurobiological Technologies Continuation of Phase 3 Stroke Trials With Viprinex(TM) (ancrod)
3. Neurobiological Technologies, Inc. and Buck Institute Partner to Develop Novel Treatment for Alzheimers Disease
4. New CyberKnife Technologies Demonstrate Dramatic Reduction in Treatment Times
5. MicroDose Technologies Announces Achievement of Phase I Clinical Milestone Triggering First Milestone Payment Under Collaboration with Merck & Co., Inc.
6. Wound Management Technologies, Inc. Announces Agreement for Evidence Based Study for Diabetic Venous Ulcers
7. Emisphere Technologies Announces the Launch of a Human Clinical Trial For Oral Parathyroid Hormone (PTH)
8. Duke Licenses ALPHADAS(R), Logos Technologies EDC System to Accelerate its Early Phase Clinical Trials
9. Fox Chase Cancer Center and VisEn Medical Announce Program to Advance First Clinical Trials of Novel Fluorescence Molecular Imaging Technologies
10. Disc Motion Technologies Announces First Human Implants of True TSMS(TM) Device
11. OxyBand Technologies, Inc. Hires a Leader in Medical Technology as Chief Technology Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)... BioLife Solutions , Inc. (NASDAQ: BLFS ), the ... and tissue hypothermic storage and cryopreservation freeze ... and CEO, will be presenting at two investment conferences in ... th Annual Global Investment Conference on Tuesday, September 12th, ... conference is being held at the New York Palace Hotel ...
(Date:9/6/2017)... , Sept. 6, 2017   PDI , a ... it will host an educational session focused on the ... infection (CLABSI) prevention at the 2017 Annual Scientific Meeting ... will take place at the Phoenix ... from Sept. 16-19, will also feature PDI,s ...
(Date:9/5/2017)... Colo. , Sept. 5, 2017 Sapheneia ... XR-29 DoseCheck solution. Scannerside DoseCheck is a third-party Vendor ... existing CT scanners and allows compliance with current MITA ... Sapheneia-Scannerside proprietary XR 29 DoseCheck solution is specifically designed ... and alerts of potential radiation doses over a predefined ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... September 22, 2017 , ... On Sunday, September 24, hundreds will gather ... Florence Joyner, still considered the fastest woman of all time. Flo Jo passed ... Joyner, will sing the National Anthem. Mary was a contestant on the 2012 ...
(Date:9/22/2017)... ... 22, 2017 , ... After a long health ordeal that ... lease on life with assistance from CreditAssociates. CreditAssociates provides debt relief and debt ... debt. The senior is one of the satisfied clients who expressed their appreciation ...
(Date:9/22/2017)... ... ... Pullano Law Offices, a Chicago personal injury law firm, is pleased to ... as President of the North Suburban Bar Association for 2017-2018. Mr. Pullano was installed ... NSBA at the North Shore Country Club in Glenview, IL, on September 13, 2017. ...
(Date:9/22/2017)... ... 22, 2017 , ... "Success Files," a short- and long-form ... is a disease estimated to affect the lives of more than 5 million ... Association, a leading voice in the fight for cure and research into the ...
(Date:9/22/2017)... ... September 22, 2017 , ... ... more products at customers’ doorstep. According to Smart Mart, customers can now order ... to offer wearable, and customers can find clothing at discounted prices. Apart from ...
Breaking Medicine News(10 mins):