Navigation Links
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
Date:12/16/2009

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK pathway, which are pathways associated with programmed cell death, cell growth, ce
'/>"/>

SOURCE Keryx Biopharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
2. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
3. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
4. Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
5. Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint
6. Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
7. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
8. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
9. Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
10. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
11. Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401s Activity in the Treatment of Advanced Metastatic Renal Cell Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/6/2015)... , July 6, 2015 ... to drive bioinformatics market in Germany ... recently released TechSci Research report, " Germany Bioinformatics Market ... Germany is projected to register a ... expected to witness tremendous growth on account of rising ...
(Date:7/6/2015)... -- Hologic, Inc. (NASDAQ: HOLX ) announced today ... for the third quarter of fiscal 2015 on Wednesday, ... with the release, management will host a conference call ... Interested participants may listen to the call by dialing ... or 719-325-4804 (for international callers) and referencing access code ...
(Date:7/6/2015)... July 6, 2015 Moerae Matrix, a ... therapeutics that target inflammation and fibrosis, today announced ... PhD, as Chief Medical Officer. ... strategy and programs, which include a pipeline of ... fibrotic conditions.  Bill is an accomplished strategist and ...
Breaking Medicine Technology:Germany Bioinformatics Market to Grow at a CAGR Over 29% Through 2020 Says TechSci Research 2Germany Bioinformatics Market to Grow at a CAGR Over 29% Through 2020 Says TechSci Research 3Hologic to Announce Financial Results for the Third Quarter of Fiscal 2015 on Wednesday, July 29, 2015 2Moerae Matrix, Inc. (Moerae) Appoints Bill Bradford, M.D., PhD, as Chief Medical Officer 2
... Therapeutics, Inc. (Nasdaq: OREX ) today announced the ... consisted of one share of common stock and a warrant ... to the public of $1.45 per share of common stock ... stock, which together comprised the purchase price of $15.94 per ...
... organizations, community leaders, health care professionals, and people of ... today urged Express Scripts to get back to the ... access to pharmacy services for hundreds of millions of ... put the people of our communities at the forefront ...
Cached Medicine Technology:Orexigen® Therapeutics Completes Public Offering of Common Stock and Warrants to Purchase Common Stock 2Over 130 Community Leaders and Organizations Across the Nation Urge Express Scripts To Reach Agreement With Walgreens 2
(Date:7/6/2015)... Linda, CA (PRWEB) , ... July 06, 2015 ... ... biology into the pre-clinical stages of drug discovery. iPSCs are generated from adult ... to differentiate into any cell type in the human body. , ...
(Date:7/6/2015)... FL (PRWEB) , ... July 06, 2015 , ... ... key areas of orthopaedic sports medicine, the American Orthopaedic Society for Sports Medicine ... Annual Meeting, July 9-12 in Orlando, FL. As a leader in orthopaedic ...
(Date:7/6/2015)... ... July 06, 2015 , ... Hundreds of ... aesthetic reasons, which is why liposuction regularly ranks among the top five most ... reduction has become more than a way to slim down a silhouette for ...
(Date:7/6/2015)... ... July 06, 2015 , ... Longevity, the highest ... with Woodbridge Walk-In Urgent Care to offer on-site health screenings. These ultrasound screenings ... Screenings are affordable and accurate and run about an hour long with same ...
(Date:7/6/2015)... , ... July 06, 2015 , ... MD Now, the ... July 6. The newly constructed urgent care center will serve residents and visitors in ... addition to being MD Now’s 22nd South Florida location, the new facility will be ...
Breaking Medicine News(10 mins):Health News:Cellular Dynamics’ Webinar Underscores the Value of Using Human iPSC-derived Cardiomyocytes for Investigative in vitro Drug Toxicology 2Health News:Cellular Dynamics’ Webinar Underscores the Value of Using Human iPSC-derived Cardiomyocytes for Investigative in vitro Drug Toxicology 3Health News:Cellular Dynamics’ Webinar Underscores the Value of Using Human iPSC-derived Cardiomyocytes for Investigative in vitro Drug Toxicology 4Health News:American Orthopaedic Society for Sports Medicine (AOSSM) Presents Prestigious Research Awards at Annual Meeting 2Health News:American Orthopaedic Society for Sports Medicine (AOSSM) Presents Prestigious Research Awards at Annual Meeting 3Health News:American Orthopaedic Society for Sports Medicine (AOSSM) Presents Prestigious Research Awards at Annual Meeting 4Health News:American Orthopaedic Society for Sports Medicine (AOSSM) Presents Prestigious Research Awards at Annual Meeting 5Health News:American Orthopaedic Society for Sports Medicine (AOSSM) Presents Prestigious Research Awards at Annual Meeting 6Health News:Learn How CoolSculpting® and Liposuction in Virginia Beach Help Military Members Stay the Course 2Health News:Learn How CoolSculpting® and Liposuction in Virginia Beach Help Military Members Stay the Course 3Health News:Woodbridge Walk-In Offers Affordable Early Detection Health Screenings Through Longevity 2Health News:MD Now Urgent Care Opens its Fourth Miami-Dade County Facility in Cutler Bay 2Health News:MD Now Urgent Care Opens its Fourth Miami-Dade County Facility in Cutler Bay 3
... measuring bone strength , , TUESDAY, June 24 (HealthDay News) -- ... risk factors for osteoporotic fractures, Swiss researchers were better able ... fracture. , According to the study of more than 6,000 ... Radiology , 6.1 percent of women in the group identified ...
... 3000 International Charitable Foundation, honored for ... Ukrainian children, women -, WASHINGTON, June 24 ... awarded the first-ever MaxWell,International Public Health Award for ... The award is presented by MaxWell Biocorporation to ...
... Expand Scrub Club,s Reach Nationwide, WASHINGTON, June ... today announced a collaborative agreement that brings,together two ... protect,public health. Collectively, NSF, the Red Cross and ... and consistent handwashing.,The collaborative agreement gives the Red ...
... Anti-Aging Heart, Skeletal Muscle and ... Brain Health Benefits at Genetic Level, ... Gruss, M.D.,board-certified cardiologist and author of the best-selling book ... the latest research on resveratrol by a team of,scientists ...
... June 24 "Heart disease,the main killer in the ... and is largely treatable through diet, exercise and early,detection," ... Nearly 700,000 men and women die of cardiovascular disease ... heart disease can be elusive and patients may,have had ...
... Dr. Jerry Weichman -- a,popular Newport Beach based ... announced the publication of How to Deal, his,first ... pre-ordered by various,school administrators throughout Orange County, follows ... practical tools and,advice for dealing with the challenges ...
Cached Medicine News:Health News:Heel Ultrasound Helps Detect Fracture Risk 2Health News:Heel Ultrasound Helps Detect Fracture Risk 3Health News:Ukraine's First Lady Kateryna Yushchenko Receives Inaugural MaxWell International Public Health Award 2Health News:American Red Cross and NSF Scrub Club(R) Announce Collaborative Agreement 2Health News:Cardiologist Praises Latest Resveratrol/Red Wine Research 2Health News:Cardiologist Praises Latest Resveratrol/Red Wine Research 3Health News:Cardiologist Praises Latest Resveratrol/Red Wine Research 4Health News:Concerns About Heart Disease Voiced 2Health News:Dr. Jerry Weichman, Orange County Teen Psychologist and Parenting Expert, Publishes Book to Teach Teens 'How to Deal' 2
Anti-Gliadin IgG & IgA (Ab) EIA Gastrointestinal Markers 027-GD77 Celiac Disease Food Allergy...
... OCTEIA 25-Hydroxy Vitamin D kit is an ... and other hydroxylated metabolites in serum or ... with biotin labelled 25-OH D. The diluted ... are coated with a highly specific sheep ...
... principal hormone responsible for the control of glucose ... of the islets of Langerhans as the precursor, ... insulin. Both are secreted in equimolar amounts ... molecule is comprised of two polypeptide chains, the ...
... binding Proetin (RBP) is small (21kD) transport ... with pre-albumin in blood but loses its ... deliverd to the target cells. The free,RBP ... glomerulus and catabolized in the,renal tubules after ...
Medicine Products: