Navigation Links
Romark Announces Clinical Trial Results for New Influenza Drug Presented at IDSA Meeting 2011
Date:10/21/2011

Jason Haffizulla, Harvey Resnick, Aaron Hartman, Stefan Comhaire, Maria Carríon, Matthew Bardin. Presentation Number LB-35, Session 182a: Late Breaker Oral Abstracts - Clinical Virology and Treatment. Saturday, October 22, 2011, 6:30 PM.

About the US Clinical Trial

The clinical trial was conducted in 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season.  624 patients, 12 to 65 years of age, with influenza symptoms were enrolled in the study within 48 hours of symptom onset and received treatment with 300 mg NTZ, 600 mg NTZ or placebo twice daily for 5 days.  Patients who received an influenza vaccine after August 1, 2010 and patients at risk of complications of influenza based upon CDC or IDSA criteria were excluded from participation in the trial. The study was designed according to FDA Guidance and consistent with prior clinical trials of Tamiflu® and Relenza®. The primary efficacy endpoint of the study was time from first dose to alleviation of symptoms (all symptoms absent or mild and remain so for 24 hours).  

Two hundred and fifty-seven (257) of the 624 patients enrolled in the study (41%) had laboratory confirmed influenza infection by RT-PCR or viral culture at baseline. Approximately half of the influenza-infected patients enrolled in the US clinical trial were infected with influenza A subtype H1N1 ("swine flu") with approximately 30% being infected with influenza B and 20% with influenza A subtype H3N2. The trial achieved its primary endpoint showing that influenza-infected patients treated with NT-300 administered 600 mg twice daily for five days experienced statistically significant reduction in time from beginning treatment to alleviation of flu symptoms compared to influenza-infected patients receiving the placebo (P=0.008). Median time to alleviation of symptoms was 95.5 hours for the 600 mg dose group compared to 109.1 hours for the 300 mg do
'/>"/>

SOURCE Romark Laboratories, L.C.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
2. Romark Laboratories Raises $18 Million in Institutional Financing
3. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
4. Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008
5. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
6. Romark Initiates Clinical Trial of Alinia for Treatment of Influenza
7. NeuroFocus and New Scientist Magazine Apply Neuromarketing to Select Cover Design
8. Intercell and Romark Join Forces in Combining Therapies Against Hepatitis C
9. Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C
10. Romark Announces Data Presented at AASLD Meeting 2010
11. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2015)...   Intarcia Therapeutics, Inc. today announced the ... an equity conversion option at a $5.5 billion Company ... the initiation of additional head-to-head comparative and switch studies ... 2 diabetes therapies. In addition, proceeds from the financing ... launch ITCA 650 in the United States ...
(Date:4/27/2015)... 2015 Array BioPharma Inc. (Nasdaq: ... third quarter of fiscal 2015 and hold ... on Monday, May 4, 2015.  Ron Squarer, ... May 4, 2015Time:9:00 a.m. Eastern TimeToll-Free:(844) 464-3927Toll:(765) ... Conference Call Slides:  http://edge.media-server.com/m/p/8tsxszuw/lan/en ...
(Date:4/27/2015)... THE WOODLANDS, Texas , April 27, 2015 /PRNewswire/ ... a biopharmaceutical company focused on developing breakthrough treatments for ... results on Wednesday, April 29, 2015 after the financial ... and webcast to discuss clinical development progress and financial ... Eastern Time on April 29, 2015. The ...
Breaking Medicine Technology:Intarcia Therapeutics Closes Novel $225 Million Synthetic Royalty Financing With Equity Conversion Option At $5.5 Billion Valuation 2Intarcia Therapeutics Closes Novel $225 Million Synthetic Royalty Financing With Equity Conversion Option At $5.5 Billion Valuation 3Lexicon To Report First Quarter 2015 Financial Results On April 29, 2015 2
(Date:4/28/2015)... 28, 2015 A new survey from ... lung damage, 66 percent of Americans fear brain damage the ... Awareness Month in May, shed light on the need for ... help prevent a stroke. By controlling modifiable risk factors, ... stroke is a “ brain attack ” that occurs when ...
(Date:4/28/2015)... Hellen Chen, who is a bestselling author ... According to a study conducted by Washington University, ... 30 has increased by 20% while the number of unfaithful ... a report released this year from the Journal ... one or both spouses admit to infidelity, either physical or ...
(Date:4/28/2015)... Seattle, WA (PRWEB) April 28, 2015 It’s ... of Paul L. Schneiderman . For Schneiderman, a civil litigation ... a legal analyst on TV and radio networks, it’s also ... the Seattle native recently joined the Fred Hutchinson Cancer Research ... of work to do in the community, and lawyers can ...
(Date:4/28/2015)... (PRWEB) April 28, 2015 Enrollment ... dual eligibles reached 2.2 million in April, according ... (AIS) new Medicare-Medicaid Dual Eligibles Database , ... and plans serving the dual-eligible community. This is ... Database began tracking initiatives in January, but only ...
(Date:4/28/2015)... (PRWEB) April 28, 2015 The Awareness Counselor ... the common topic of judging. According to Awareness Counselor, there ... people, when directed outward, and to an individual who self-judges. ... new clients as a class or one one one talk. ... founder of Awareness Counselor, is that every being on earth ...
Breaking Medicine News(10 mins):Health News:National Stroke Association Survey Reveals Americans Fear Brain Damage the Most, but Few Take the Necessary Steps to Prevent a Stroke 2Health News:National Stroke Association Survey Reveals Americans Fear Brain Damage the Most, but Few Take the Necessary Steps to Prevent a Stroke 3Health News:Why Do Some Good Women and Men End Up Breaking Others' Marriages? 2Health News:Why Do Some Good Women and Men End Up Breaking Others' Marriages? 3Health News:Seattle Attorney Paul Schneiderman Helping to Combat Cancer 2Health News:Enrollment in Duals Programs Increases 14%, New AIS Database Finds 2Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 2Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 3
... to protect people against eating disorders, providing further evidence ... -- are linked to anorexia and bulimia, according to ... ongoing, six-year study of 538 sets of twins in ... with male twins have lower risk for eating disorder ...
... without approval , , MONDAY, March 3 (HealthDay News) ... prescription drugs increases the risk of drug abuse, says ... McCabe asked 3,639 college students, average age 19.9 years, ... of prescription drugs -- opioids, stimulants, sleeping aids and ...
... Management" or the "Company") (OTC: SMAN, SMANP), an,Indianapolis-based ... 14C,Information Statement pursuant to Section 14C of the ... directors approved an amendment to,increase the number of ... to 300,000,000 shares. In connection therewith, a resolution,will ...
... Assembly Bills Protecting State,s,Elderly from Price Gouging, ... March 3 California,seniors who feel price-gouged ... up with advocates and elected leaders to ... address serious problems with emergency,preparedness. Legislation introduced ...
... of Catholic Bishops (USCCB) welcomes the House Committee ... bipartisan bill to combat,HIV/AIDS, tuberculosis and malaria. House ... G. Wenski of Orlando, Florida, chairman of the ... Justin Rigali of,Philadelphia, chairman of the Committee on ...
... For the first,time, Beauty.com, Inc., a wholly owned ... Los Angeles-based women,s wear designer Jenni,Kayne to create a ... clutch. Customers receive the limited edition designer bag,filled with ... beauty,brands with a purchase of $75 or more on ...
Cached Medicine News:Health News:MSU research indicates testosterone could guard against eating disorders 2Health News:Non-Medical Use of Prescriptions Linked to Drug Abuse Risk 2Health News:Standard Management Seeks Additional Shares 2Health News:'Atria Bills' Get Support From Assisted Living Residents, Family Members, Senior Groups 2Health News:Catholic Bishops Welcome New Bill for Global HIV/AIDS Relief 2Health News:Beauty.com Partners With Fashion Designer Jenni Kayne 2Health News:Beauty.com Partners With Fashion Designer Jenni Kayne 3Health News:Beauty.com Partners With Fashion Designer Jenni Kayne 4
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: