Navigation Links
Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer
Date:1/17/2008

Trial will also Support a Marketing Authorization Application in the

European Union

HOUSTON, Jan. 17 /PRNewswire/ -- Agennix Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer (NSCLC) under the Special Protocol Assessment (SPA) process. Separately, Agennix received Scientific Advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a Marketing Authorization Application (MAA) in the European Union. Agennix had previously received Fast Track designation from the FDA for this indication.

"The Special Protocol Assessment agreement with the FDA is an important step for advancing the investigation of talactoferrin in NSCLC," said Dr. Roman Perez-Soler, Director, Division of Medical Oncology, Albert Einstein College of Medicine, New York City. "The Phase 2 data from the two separate randomized, double-blind, placebo-controlled NSCLC trials are very promising. I look forward to participating in the Phase 3 talactoferrin trials for both NSCLC indications -- first-line in combination with chemotherapy, and talactoferrin monotherapy in patients who have failed two or more previous therapies."

In the randomized, double-blind, placebo-controlled Phase 2 NSCLC trials, talactoferrin (or placebo) was administered either in combination with chemotherapy in chemo-naive patients, or as monotherapy in patients who had failed previous chemotherapy. Both trials met their prospectively defined primary endpoints -- improvement in response rate (first-line combination trial) and improvement in survival (monotherapy trial), with supporting trends on secondary efficacy endpoints. Both trials also showed statistically significant reductions in total adverse
'/>"/>

SOURCE Agennix Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... 2013 SoundConnect is pleased to announce ... for customers in Canada. Lync is the next ... allow businesses and organizations to collaborate and communicate much ... Lync in the United States. With the progressive rollout ... release in Canada, SoundConnect now offers a complete Microsoft ...
(Date:5/21/2013)... (PRWEB) May 21, 2013 The Formulate ... display solution for sales and marketing teams looking for a ... describes the kit as “everything you’ll need to put together ... Display Kit comes with a number of displays and accessories ... booth 20 feet by 20 feet in size. These components ...
(Date:5/20/2013)... , May 20, 2013 ... Agricultural Research Service (ARS) in treatment of mastitis ... , Trials to begin in the second ... delivery technology company Phosphagenics Limited (ASX: POH, ... Agriculture,s (USDA) Agricultural Research Service (ARS) to develop and ...
(Date:5/20/2013)... Mechanicsburg, Pa (PRWEB) May 20, 2013 ... controller with ramp/soak capabilities. The 5R6-900 benchtop controller ... enclosure, the device can be plugged into the wall ... own power supply. This distinctive detail makes the device ... , The laboratory temperature controller can also be ...
Breaking Biology Technology:SoundConnect Announces Microsoft Lync Release in Canada 2SoundConnect Announces Microsoft Lync Release in Canada 3GLM Displays Announces All-in-One Formulate Fusion Fabric Display Kit 2Phosphagenics Signs Research Agreement with the Agricultural Research Service 2New Laboratory Temperature Controller by Oven Industries 2
... and Europe, Reported Net Sales of $76.5 Million ... Company Revises Revenue Guidance Upward and Expense Guidance Downward,and ... Progress in Hematology, Oncology, Transplant, Neurology, Third Quarter ... sales of $76.5 million in Q3,2008 consisted of $71.2 ...
... visualizing vast networks of information and deepening understanding of content. ... ... (PRWEB) October 23, 2008 -- TheBrain® Technologies, the leading provider ... on its social networking site to connect the dots between ...
... A multi-institution team, funded by the National Human Genome ... (NIH), today reported results of the largest effort to ... most common form of lung cancer, lung adenocarcinoma. The ... approaches for detecting and treating the nation,s leading cause ...
Cached Biology Technology:Alexion Reports Third Quarter 2008 Results 2Alexion Reports Third Quarter 2008 Results 3Alexion Reports Third Quarter 2008 Results 4Alexion Reports Third Quarter 2008 Results 5Alexion Reports Third Quarter 2008 Results 6Alexion Reports Third Quarter 2008 Results 7Alexion Reports Third Quarter 2008 Results 8Alexion Reports Third Quarter 2008 Results 9Alexion Reports Third Quarter 2008 Results 10Alexion Reports Third Quarter 2008 Results 11Alexion Reports Third Quarter 2008 Results 12Alexion Reports Third Quarter 2008 Results 13Alexion Reports Third Quarter 2008 Results 14MedTechIQ Selects TheBrain to Visualize Expansive Biointellingence Database and Connect the Dots Between Life Sciences, Medicine and Venture Capital 2MedTechIQ Selects TheBrain to Visualize Expansive Biointellingence Database and Connect the Dots Between Life Sciences, Medicine and Venture Capital 3MedTechIQ Selects TheBrain to Visualize Expansive Biointellingence Database and Connect the Dots Between Life Sciences, Medicine and Venture Capital 4Large-scale genetic study sheds new light on lung cancer 2Large-scale genetic study sheds new light on lung cancer 3Large-scale genetic study sheds new light on lung cancer 4Large-scale genetic study sheds new light on lung cancer 5
(Date:5/20/2013)... planning grant will help establish the Center for Advanced ... University of Illinois at Urbana-Champaign and Worcester Polytechnic Institute ... to research in drying moist, porous materials such as ... chemical products; textiles; and biopharmaceuticals," said Hao Feng, a ... nutrition and the Illinois site director. , According to ...
(Date:5/19/2013)... men and women of European descent inherit common foot ... deformities, including hammer or claw toe. Findings from the ... foot disorders in humansappear in Arthritis Care & ... of the American College of Rheumatology (ACR). , ... older adults have foot disorders which may limit mobility ...
(Date:5/18/2013)... FL (May 18, 2013) Research presented today at ... disease research, with findings about the impact of coffee ... , While coffee consumption recently has been associated ... that even a few more cups of java each ... autoimmune liver disease. Researchers at the Mayo Clinic, Rochester, ...
Breaking Biology News(10 mins):NSF approves planning grant for Center for Advanced Research in Drying 2Blame your parents for bunion woes 2Coffee consumption associated with reduced risk of autoimmune liver disease 2
... Enigmols suppress the growth of human cell lines representing ... and blood, and reduce tumors in three animal studies, ... show side effects at effective doses, according to the ... University and Wayne State University. The studies were funded ...
... Enjoying spring flowers? Flowers have flourished ?their beauty evolving ... McGuire, associate professor of genetics at Rutgers and co-author ... the whys and wherefores of flowering plants in an ... scene to attract potential pollinators like bugs and birds, ...
... A novel delivery system that transports gene silencing nanoparticles ... sarcoma in an animal model of the disease. , ... transferrin that normally delivers iron into cells is modified ... RNA) encased in nano-sized sugar polymers. The siRNA was ...
Cached Biology News:Researchers find promising cancer-fighting power of synthetic cell-signaling molecule 2Researchers find promising cancer-fighting power of synthetic cell-signaling molecule 3The evolutionary triumph of flower power 2Novel gene-silencing nanoparticles shown to inhibit Ewing's sarcoma 2Novel gene-silencing nanoparticles shown to inhibit Ewing's sarcoma 3
Concentration: 1mg/ml. Antigen: Propidium Iodide ...
Anti-Mouse Qa.m7, Ascites (Clone 5035-50.1) (mouse IgM)...
Barcoded Slides, 5 Packs of 5 Slides (25/Case)...
Anti-Mouse Qa.m8, Ascites (Clone 5035-24.1) (mouse IgG3)...
Biology Products: