Navigation Links
Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma
Date:5/19/2009

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer).

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review which may result in an abbreviated review time of six months.

Additional Clinical Updates

Agennix also announced that two pivotal Phase III trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway at a number of leading U.S. clinical sites. FORTIS-M is a randomized, placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic anti-cancer therapies will be randomly assigned (2:1) to receive either oral talactoferrin or placebo in additional to standard supportive care. The trial is designed to detect an improvement in overall survival in patients receiving talactoferrin, and results are expected in 2011.

FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be randomly assigned (1:1) to receive standard first-line chemotherapy with carboplatin and paclitaxel plus either oral talactoferrin
'/>"/>

SOURCE Agennix
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Severe Sepsis
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2015)... , May 21, 2015 ... the addition of the "Market Assessment of ... report to their offering. ,     (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... the respiratory imaging diagnostics market in ... Europe . The service provides detailed analysis ...
(Date:5/21/2015)... , May 21, 2015  CryoLife, Inc. (NYSE: ... company focused on cardiac and vascular surgery, announced today ... cash dividend for the second quarter 2015 of $0.03 ... dividend of $0.03 per share will be paid on ... as of June 12, 2015.  The ex-dividend date for ...
(Date:5/21/2015)... 21, 2015  (MUSE Booth # 1510)What:Automating continuous ... (EHR) is invaluable in any hospital setting, but ... a requirement and mainstream in healthcare, the integration ... EHR is gaining traction in MEDITECH facilities.During MUSE ... Site Project Manager & Clinical Analyst at McLaren ...
Breaking Medicine Technology:United States and Europe Respiratory Diagnostics Market Assessment 2015 2CryoLife Announces Quarterly Cash Dividend for the Second Quarter 2015 2Hospital Streamlines ICU Efficiency with Timely Data Integration 2Hospital Streamlines ICU Efficiency with Timely Data Integration 3
(Date:5/22/2015)... A new program for the "In America" ... of Physical Therapy. , James Earl Jones will ... of physical therapy and discusses how the exercises can ... variety of ailments and injuries. Physical therapists work ... that enhances daily activities such as house cleaning and ...
(Date:5/22/2015)... Portland, Maine (PRWEB) May 22, 2015 ... in single-use swabs for the medical, diagnostic, environmental, ... their entire line of products in the US. ... moving their operations outside the US, Puritan remains ... of products at their Guilford, Maine facility. , ...
(Date:5/22/2015)... Yisrayl Hawkins, Pastor and Overseer at The House of ... on religious leaders to make changes in order to achieve ... blog, discusses the history of war, how it started, why ... says mankind was created to lead peaceful, joyful lives, very ... , “Yahweh created mankind, according to His Plan, which is ...
(Date:5/22/2015)... CA (PRWEB) May 22, 2015 ... lower thirds designed exclusively for Final Cut Pro X. ... with any design. , Intuitive on-screen-controls allow users ... lower third. Reflections, colors, layouts, and much more can ... window. , Pro3rd Impression comes packed ...
(Date:5/21/2015)... (PRWEB) May 21, 2015 World Patent ... products, launches the Troll Motor Guide, a boat patent ... boating. , "The recreational boating industry has reached an ... CEO and Creative Director of World Patent Marketing ... numbers and predicts continued steady growth of seven percent ...
Breaking Medicine News(10 mins):Health News:Maine Swab Company Celebrates 96 Years of American-made Products 2Health News:Yisrayl Hawkins Calls on All Religions to Wake Up and Make Drastic Changes to End Suffering in New Letter 2Health News:Developers at Pixel Film Studios Release Pro3rd Impression for Final Cut Pro X. 2Health News:Great Ways To Celebrate On Memorial Day Weekend- Starting With World Patent Marketing's New Boat Patent 2Health News:Great Ways To Celebrate On Memorial Day Weekend- Starting With World Patent Marketing's New Boat Patent 3
... for organically produced food increasing, scientists are reporting new ... do not have higher levels of healthful antioxidants and ... pesticides. Their study appears in ACS, bi-weekly Journal ... study, Pia Knuthsen and colleagues point out that there ...
... Reinberg HealthDay Reporter , TUESDAY, Nov. 2 (HealthDay ... not doing its job of properly monitoring the safety of ... The FDA has the authority to approve both drugs and ... for device approval and safety is lax in both its ...
... Researchers at the Ernest Gallo Clinic and Research Center ... Inc., have determined that two new compounds may be ... the same time. In a paper published ... , the researchers showed that alcohol consumption in rodents ...
... News) -- Anger can be a potent motivator in increasing ... While people generally regard anger as a negative emotion, ... brain that is associated with many positive emotions. And like ... explained the researchers at Utrecht University in the Netherlands. ...
... Patients report decreased pain and improved breathing following ... researchers say the therapy falls short of improving survival. ... Lombardi Comprehensive Cancer Center and presented today at the ... in Vancouver, BC, represents the first of its kind ...
... published in November 3 edition of Journal of ... MPH, MBA, professor of Health Policy and Management at ... for key improvements to primary care in order to ... adults with multiple chronic conditions. Boult and his co-author, ...
Cached Medicine News:Health News: FDA Failing to Monitor Safety of Medical Devices: Report 2Health News: FDA Failing to Monitor Safety of Medical Devices: Report 3Health News: FDA Failing to Monitor Safety of Medical Devices: Report 4Health News:New compounds may treat both alcohol and cigarette addictions 2Health News:Could Anger Make People Want Things More? 2Health News:Lombardi research: Robotic radiosurgery offers palliative care for hilar lung tumors 2Health News:Geriatrician advocates for improvements to primary care to meet the needs of older adults 2Health News:Geriatrician advocates for improvements to primary care to meet the needs of older adults 3
... and CVA for CELL-DYN are assayed linearity ... calibration and to verify patient reportable range ... kits also measure the linear performance of ... kits have customized ranges appropriate for each ...
... is a nucleated red blood cell (nRBC) control ... Coulter LH 750/LH 755 hematology analyzer in its ... for the Coulter LH 750/LH 755. nRBC-Chex for ... cap-pierceable vials. nRBC-Chex for LH has a 75-day ...
... negative whole blood control to test for ... tests and hemoglobin electrophoresis. Sickle-Chex is compatible ... solubility kits. Sickle-Chex is packaged in a ... dispenses an accurate sample volume. No pipeting ...
... Proprietary EX.P.R.T. Release Technology ... No stent shortening,, Unique anatomically designed ... the carotid bifurcation,, 0.014 Rapid Exchange ... profile and flexible atraumatic tip,, Radiopaque ...
Medicine Products: