Navigation Links
Analysis of Earlier European Stroke Trial Supports Treatment Regimen for Viprinex(TM) in Current International Phase 3 Clinical Trials

EMERYVILLE, Calif., Sept. 25 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) today announced that previously found excess symptomatic intracranial hemorrhage in an earlier European trial of ancrod (now Viprinex(TM)) for the treatment of acute ischemic stroke may be minimized with avoidance of prolonged low levels of fibrinogen and use of common blood pressure entry criteria.

The data, presented today at the 6th World Stroke Conference in Vienna, Austria, are from a retrospective analysis led by NTI scientists of two previous Phase 3 clinical trials, known as STAT and ESTAT, which involved more than 1700 patients and were conducted before NTI acquired the rights to ancrod. The STAT trial in the United States showed ancrod-treated patients had a better outcome than placebo-treated patients, while the European ESTAT trial showed an ancrod treatment outcome similar to placebo, but a higher rate of symptomatic intracranial hemorrhages. When the drug safety information from the trials were compared, it was noted that patients treated with ancrod in ESTAT who had symptomatic intracranial hemorrhages were more likely to have had prolonged low fibrinogen blood levels, to have received higher doses of ancrod and to have had higher blood pressures at trial entry.

"The conclusions of this analysis provided NTI with the information needed to revise the dosing regimen to avoid prolonged low fibrinogen levels and launch new Phase 3 clinical trials using common blood pressure patient-entry criteria," says Gregory del Zoppo, M.D. of the University of Washington, chairman of the current ancrod clinical trials' steering committee, and a coauthor of the retrospective analysis.

"Earlier Viprinex trials used a dosing regimen that infused the drug over five to seven days, which kept blood fibrinogen levels low for too long," said David Levy, Vice President, Clinical Development of NTI, who led the analysis. "We changed the treatment paradigm to a three-hour infusion which has been designed to reduce fibrinogen levels quickly, while also avoiding prolonged low fibrinogen levels as seen in the ESTAT data."

Using the revised dosing regimen, NTI is currently conducting two Phase 3 clinical trials of Viprinex to investigate whether ancrod can safely and effectively reduce disability following an acute ischemic stroke. The trials are being conducted in 14 countries throughout the world, and to date have enrolled over 500 patients. NTI believes that Viprinex can be administered up to six hours after the onset of stroke symptoms, significantly expanding the number people who can be treated compared to the single currently approved drug for the treatment of stroke in the U.S.

Viprinex (ancrod) is a novel Fibrinogen Reducing Agent (FRA), the active ingredient of which is an enzyme that reduces blood levels of fibrinogen, the primary protein involved in blood clotting. It is derived from Malayan pit viper venom and is highly specific for fibrinogen.

Previous research suggests that Viprinex may work in three ways to improve blood flow to areas of the brain affected by the stroke by:

-- Interfering with fibrinogen's ability to participate in blood clot formation, which should limit clot growth and reduce odds of reocclusion due to new clots.

-- Reducing blood viscosity (resistance to flow), which should improve blood flow to areas of the brain affected by the stroke.

-- Indirectly activating the natural blood clot dissolving mechanism, which should restore blood flow further to areas of the brain affected by the stroke.

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 extend 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.

NOTE: 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 development of Viprinex for acute ischemic stroke, delays or other problems with our clinical trials, the outcome of the interim analysis, the time and costs for obtaining approval for Viprinex, and 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. Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis
2. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
3. New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
4. Immtech Announces Interim Analysis in Phase III African Sleeping Sickness Trial
5. Analysis Shows Vernakalant Hydrochloride Injection Increases Conversion to Normal Heart Rhythm in Acute Atrial Fibrillation Patients Treated Within 48 Hours of Onset
6. New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients
7. A Sociolinguistic Analysis of In-Office Dialogue Reveals Psychiatrists and Parents Have Significantly Different Perceptions on ADHD and Psychiatric Comorbidities
8. Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
9. Results Of VYVANSE(TM) (lisdexamfetamine dimesylate) Effect Size Analysis Presented at Major Scientific Meeting
10. Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
11. Retrospective Analysis Finds That Initiation of Insulin Glargine in Patients With Type 2 Diabetes was Associated With a Lower Incidence Rate of Myocardial Infarction as Compared With NPH Insulin
Post Your Comments:
(Date:11/30/2015)... November 30, 2015 global cell culture market ... bn to US$11.3 bn by 2022 at a CAGR of 7.1% ... to grow from its 2013 value of US$6.1 bn to US$11.3 ... Transparency Market Research has announced the release of a new ... the report, titled ,Cell Culture Market - Global Industry Analysis, Size, ...
(Date:11/30/2015)...   Royal Philips (NYSE: PHG ... MRI guided user interface and automatic scan parameter selection ... Conditional implants, such as knee and hip replacements, spine ... of North America Annual Meeting (RSNA) . The new ... of this growing patient population. ScanWise Implant adds to ...
(Date:11/30/2015)... RATON, Fla. , Nov. 30, 2015   ... (the Institute) announced today that it has finalized ... device start-up company with technology developed at Florida State ... publicly-funded research, and bridges early funding gaps for companies ... and research institutions. --> ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... According to Los Angeles bariatric surgeon ... are not necessarily caused by real hunger, but instead by a hormone called ... notes that, while many patients are aware that weight loss surgery can help patients ...
(Date:11/30/2015)... ... November 30, 2015 , ... RoamRight, a leading provider of ... Public Television’s Travel With Kids to promote family vacations around the world. ... they explore international destinations and educate families about the people and places of the ...
(Date:11/30/2015)... ... 2015 , ... At Grand Dental PC, their priority is to deliver quality ... dental problems, you need to turn to a dentist who listens and responds; an ... a friendly dentist who counsels you on the best ways to maintain and improve ...
(Date:11/30/2015)... ... 30, 2015 , ... Newly reviewed and approved “NJ Top ... He has both advanced training and considerable experience in reconstructive dentistry with ... in cosmetic dentistry. He is an active Spear Education member providing full ...
(Date:11/30/2015)... ... November 30, 2015 , ... ”Dying Words: The AIDS Reporting of Jeff Schmalz ... 2015, to coincide with World AIDS Day. The multi-media project will be in audio ... epidemic as he was dying of the disease. , A collaborative effort led by ...
Breaking Medicine News(10 mins):