Navigation Links
NovaRx Corporation Announces FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix(R) Study in Non-Small Cell Lung Cancer (NSCLC)
Date:11/4/2009

SAN DIEGO, Nov. 4 /PRNewswire/ -- NovaRx Corporation announced today that the Company has successfully negotiated and received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to the pivotal Lucanix® Phase III clinical trial in patients with Non-Small Cell Lung Cancer (NSCLC). The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, thus the amendment will make significantly more patients eligible for the trial. Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels.

"We are very excited by the approval of this protocol amendment," stated Justin Murdock, CEO of NovaRx. "It confirms the FDA's willingness to work with us in the Phase III process, enables the trial's clinical sites and investigators to screen more patients, and, most importantly, will make far more patients eligible for the study. Reaching and potentially benefitting as many patients as possible is NovaRx's utmost priority."

"The protocol amendment will strengthen the Lucanix®( )Phase III study greatly," said Dr. Habib Fakhrai, Executive Vice Chairman of the Board and Chief Scientific Officer of NovaRx. "We thank the FDA for the speed in which they approved the amendment and look forward to continuing to successfully work with them and our clinical sites throughout this pivotal Phase III trial."

According to the American Cancer Society (ACS), lung cancer is the single largest cause of cancer deaths among men and women in the United States and is responsible for nearly 30 percent of all cancer deaths. The ACS estimates that in 2009 more than 200,000 Americans were diagnosed with lung cancer and close to 160,000 died of the disease. NSCLC is the most common type of lung cancer.

About Luca
'/>"/>

SOURCE NovaRx Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Amerigroup Corporation to Present at the 18th Annual Credit Suisse Healthcare Conference on November 12
2. MDS Inc. and Danaher Corporation Receive Second Request for Information from U.S. Federal Trade Commission for MDS Analytical Technologies Sale
3. Triple-S Management Corporation Reports Third Quarter 2009 Results
4. Service Corporation International Announces Schedule for Its Third Quarter 2009 Earnings Release and Conference Call
5. COMFORCE Corporation to Hold Conference Call to Discuss Third Quarter 2009 Results
6. Addus HomeCare Corporation Prices Initial Public Offering
7. Zix Corporation Hits High End of Financial Guidance as Company Announces Third Quarter 2009 Financial Results
8. HLTH Corporation Announces Completion of Sale of Porex Unit to Aurora Capital Group
9. China Medicine Corporations Levocarnitine Dried Powder Injection Was Registered with the Ministry of Health of Pakistan
10. Micro-Waste Corporation Ordered to Pay Sanitecs Attorney Fees
11. Kimberly-Clark Announces Definitive Agreement to Acquire I-Flow Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)... The report “Micronutrient Market by ... (Chelated & Non Chelated), Application Mode (Soil, Foliar, ... and Forecast to 2018” defines and segments the ... forecasting of the global value and volume for ... restraining factors for the global agriculture micronutrients market ...
(Date:7/13/2014)... 13, 2014 A Massachusetts couple who ... cancer risks associated with power morcellators ( http://www.gynecaremorcellatorlawsuit.com/ ) ... to federal regulators, as they presented poignant testimony on ... Drug Administration (FDA) advisory panel meeting convened to address ... the Rochester Democrat and Chronicle, Dr. Hooman Noorchashm and ...
(Date:7/13/2014)... Recently, 2014QuinceaneraDresses.com, the distinguished special ... new range of gorgeous Quinceanera dresses . ... for elegant Quinceanera outfits is huge. Therefore, 2014QuinceaneraDresses.com ... the company’s newly released dresses are made according ... elegant and vivid. , It is worthy ...
(Date:7/13/2014)... imaging device developed at Cedars-Sinai can provide early ... brain and are a classic sign of Alzheimer,s ... a clinical trial in Australia. , The researchers ... oral presentation at the Alzheimer,s Association International Conference ... by conference organizers to participate in a "breaking ...
(Date:7/13/2014)... 13, 2014 Celebrity fitness trainer and ... a promotional partnership with Aqua Health Labs for their ... EPA supplement . The collaboration was recently announced live ... fitness trainer , actor, model, and a two time ... A-List celebrities, he has prepared stars including Demi Moore, ...
Breaking Medicine News(10 mins):Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 2Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 3Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 4Health News:Couple Who Brought Attention to Morcellator Cancer Risks Testify on Second Day of FDA Advisory Panel Meeting, Bernstein Liebhard LLP Reports 2Health News:Couple Who Brought Attention to Morcellator Cancer Risks Testify on Second Day of FDA Advisory Panel Meeting, Bernstein Liebhard LLP Reports 3Health News:Couple Who Brought Attention to Morcellator Cancer Risks Testify on Second Day of FDA Advisory Panel Meeting, Bernstein Liebhard LLP Reports 4Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Study of noninvasive retinal imaging device presented at Alzheimer's conference 2Health News:Study of noninvasive retinal imaging device presented at Alzheimer's conference 3Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2
... states, CDC report shows, , TUESDAY, March 2 (HealthDay ... States, a new government study shows, but certain states ... The overall rate of asthma is currently estimated to ... about 0.5 percent every three years. But, the report ...
... , ... ... ... ...
... , ... ... ... ...
... ... ... , ... , , , ...
... ... into the exploding field of neuroscience, what this means for leadership and how it ... to motivate and generate transformation in organisations – all leading to better organisations and ... ...
... ... Software Developers. , ... RSA San Francisco, CA (PRWEB) March 2, 2010 -- GlobalSign Inc ... in supplying Digital Identities used to authenticate the publisher of software and produce ...
Cached Medicine News:Health News:Asthma Rates Rising Across the U.S. 2Health News:Asthma Rates Rising Across the U.S. 3Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 2Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 3Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 4Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 5Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 6Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 7Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 8Health News:Yongye International to Present at Rodman & Renshaw Annual China Investment Conference 9Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 2Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 3Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 4Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 5Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 6Health News:ReportsandReports : The Gastrointestinal Market Outlook to 2014: Market Dynamics, Competitive Landscape, Emerging Therapies 7Health News:InterAmerican College Announces Certification of Master of Science in Nursing - Family Nurse Practitioner Program 2Health News:InterAmerican College Announces Certification of Master of Science in Nursing - Family Nurse Practitioner Program 3Health News:Key Leadership Seminar: Maximizing Profit through Social Intelligence - What Neuroscience Tells Us 2Health News:GlobalSign Releases Code Signing Certificates for Individual Software Developers 2Health News:GlobalSign Releases Code Signing Certificates for Individual Software Developers 3
(Date:7/13/2014)... , July 13, 2014  Eli Lilly and ... results from its non-clinical study in genetically engineered ... of the beta-amyloid antibody N3pG and beta-secretase inhibitor ... was more effective in removing clumps of amyloid-beta ... is thought to lead to Alzheimer,s disease (AD) ...
(Date:7/11/2014)... 11, 2014 The consumer marketing playbook ... industry sectors to better identify winning tools and ... engage with and understand consumers, as new technologies ... critical purchasing decisions. According to ... one area where organizations can observe a deep ...
(Date:7/11/2014)... According to a new ... Material, Application (Healthcare, Homeland security, Industrial application, Nuclear ... Hand-Held Instruments, Fixed, and Installed Instruments) & Geography ... by MarketsandMarkets, the Scintillator Market is expected to ... to 2020, and reach $479.16 Million in 2020. ...
Breaking Medicine Technology:New Data Shows Combination Therapy is More Effective than Monotherapy in Removing Beta-Amyloid Plaques from the Brains of Mice 2New Data Shows Combination Therapy is More Effective than Monotherapy in Removing Beta-Amyloid Plaques from the Brains of Mice 3New Technologies Transforming Consumer Marketing Research Playbook 2Scintillator Market will be worth $479.16 Million by 2020 2Scintillator Market will be worth $479.16 Million by 2020 3Scintillator Market will be worth $479.16 Million by 2020 4
... Israel, November 12 Surgeons,at the University of ... can be converted to an endovascular simulator,(ANGIO Mentor(TM), ... agreed" that the simulation improved the operative flow,increased ... operative and fluoroscopy time and the amount of ...
... New Data Suggesting Need for Improved ... Annual Meeting -, EXTON, Pa., Nov. 12 ViroPharma ... from its ongoing,open-label study, showing that in this study Cinryze(TM) ... (HAE),attacks seen in the study through the date of analysis. ...
Cached Medicine Technology:Vascular Surgeons Agree: Case Rehearsal Improves Outcomes 2ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema 2ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema 3ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema 4ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema 5ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema 6
The Pan Retinal® 2.2 uniquely combines magnification nearly that of the 20D lens with a field of view approaching that of the 30D lens. Excellent for virtually every examination procedure, includ...
The 14D provides high magnification along with an optimized working distance from the cornea. With its 4.30x magnification, it is also well suited for optic disc and macular observation....
This excellent mid-power lens provides medium field and magnification, with an ideal diameter for grip andmanipulation in the orbital area....
The Professional ophthalmoscope has been designed to ensure ultimate control. Lenses, graticules and filters can all be introduced at the touch of a fingertip without the need to pull away from the p...
Medicine Products: