Navigation Links
Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma
Date:8/3/2009

omib and dexamethasone in heavily pre-treated patients with relapsed and refractory disease. Given this positive data and our favorable experience overall with perifosine in this setting, we are hopeful that the upcoming Phase 3 trial will demonstrate clinical benefit for our patients with less advanced myeloma."

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We'd like to thank the FDA and Drs. Paul Richardson and Ken Anderson for their substantial input and guidance during this process. Achievement of this KRX-0401 SPA is a major developmental milestone for Keryx." Mr. Bentsur continued, "We are excited to be moving forward with this very promising compound which we believe is the most advanced PI3K/Akt pathway inhibitor in clinical development."

Phase 3 Design

The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of KRX-0401 to placebo when combined with bortezomib and dexamethasone in approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. Patients must have been previously treated with both bortezomib (VELCADE((R))) and an immunomodulatory agent (REVLIMID((R)) or THALIDOMID((R))), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,50
'/>"/>

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

Page: 1 2 3 4 5

Related medicine news :

1. Keryx Biopharmaceuticals Inc. Regains Compliance With NASDAQ Listing Requirements
2. Keryx Biopharmaceuticals, Inc. Receives Extension for Nasdaq Listing Compliance
3. Keryx Biopharmaceuticals, Inc. Announces First Quarter 2009 Financial Results
4. Keryx Biopharmaceuticals, Inc. Requests an Appeal Hearing After Receiving Notice of Delisting From Nasdaq
5. Keryx Biopharmaceuticals Receives Nasdaq Notification
6. Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2008 Financial Results
7. Keryx Biopharmaceuticals KRX-0401 (Perifosine) Data Selected for Oral Presentation at the 50th Annual Meeting of the American Society of Hematology
8. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Third Quarter 2008 Financial Results on Tuesday, November 11, at 8:30 A.M. EST
9. Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2008 Financial Results
10. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) to be Presented at the Upcoming American Society of Hematology Meeting in Atlanta, Georgia
11. Presentation Time Correction: Keryx Biopharmaceuticals Presents at 12:00pm, ET Tomorrow (Oct. 3) at William Blair & Company Small-Cap Growth Stock Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... BellasDress has launched its Christmas Sale, offering ... chosen their best-selling lace wedding dresses, vintage bridesmaid dresses ... , Now, BellasDress.com features popular women’s dresses, and ... prices. The business hopes everyone can have a memorable ... “All our elegant products are made with exquisite materials; ...
(Date:12/25/2014)... Dennis Thompson HealthDay Reporter ... children with complex chronic illnesses can receive effective, less expensive ... with easy access to a team of dedicated health care ... to become seriously ill and need either hospitalization or a ... an enhanced medical home clinic at the University of Texas ...
(Date:12/25/2014)... AngelWeddingDress.com tries its best to translate the experience of ... has introduced its new collection of 2015 prom dresses, ... new prom outfits are guaranteed to contain the perfect ... specially designed for 2015. Anyone who wants to buy ... website before Jan. 26, 2015, the deadline of the ...
(Date:12/25/2014)... Each year trauma accounts for approximately ... admissions across the nation (according to the Centers ... National Hospital Ambulatory Medical Care Survey collected data ... 2010. They estimated that there were between 3.5 and ... primary diagnosis of broken bone or fracture. , ...
Breaking Medicine News(10 mins):Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 3Health News:Angelweddingdress 2015 Prom Dresses Online Now 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4
... which suggests hormone suppression therapy could increase substantially ... free of the disease.Michel Bolla, a professor at ... suppressing the male hormone androgen, similar to the ... patients in advanced stages// of their prostate cancer, ...
... a good amount of fluids should be taken, in order ... far better than 'energy' drinks for keeping you hydrated during ... you'll be well aware of the need to keep your ... lot of so-called energy drinks around, which seem to promise ...
... proteins, which are protective substances, produced by the body ... the TB bacteria, researchers in the UK report. According ... journal Nature Medicine,// these heat-shock proteins, which are special ... times and bolster the immune system of the body. ...
... According to new study, a new type of antidepressant, ... anxiety disorder (SAD) people experience fear, anxiety and dread ... which can make both work //and social situations a ... mental health problems, like depression, and the condition can ...
... at the University of Texas, have shown that use of ... to 70 per cent of US women born since 1950 ... that use of the hormones in the Pill could raise ... failed to reveal a connection. The early Pill users are ...
... at the University of Texas has found that caffeine ... in preterm infants. Sleep apnea is a condition characterized ... infants. However, there is a growing concern over caffeine's ... Texas analyzed the effects of caffeine on cardiac output, ...
Cached Medicine News:Health News:Hormone Therapy applicable for Prostate Cancer 2Health News:Caffeine reduces infant blood flow 2
(Date:12/24/2014)... N.C. , Dec. 23, 2014  Endo Pharmaceuticals ... ENDP ) (TSX: ENL), and BioDelivery Sciences International, ... they have submitted a New Drug Application (NDA) for ... Drug Administration (FDA).  Buprenorphine HCl Buccal Film is under ... require daily, around-the-clock, long-term opioid treatment and for which ...
(Date:12/22/2014)... , Dec. 22, 2014 Research and Markets ... of the "US Self-monitoring Blood Glucose Market" ... http://photos.prnewswire.com/prnh/20130307/600769 This market insight focuses on ... the United States . Reimbursement analysis ... Thorough product analyses for more than 73 SMBG meters ...
(Date:12/22/2014)... and STOCKHOLM , Dec. ... (Sobi) and partner Auxilium Pharmaceuticals, Inc. today announced that ... of the European Medicines Agency (EMA) has adopted a ... histolyticum) for the treatment of adult men with Peyronie,s ... at least 30 degrees at the start of therapy. ...
Breaking Medicine Technology:Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 2Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 3Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 4Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 5US Self-monitoring Blood Glucose Market 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 3Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 4Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 5Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 6
Straight shafts with 1 x 2 teeth and serrated handle with polished finish....
Straight shafts with 1 x 2 teeth and 6 mm tying platform. Wide smooth handle with polished finish....
Smooth 90 degree jaws with locking screw maintain proper stretch of sleeve for securing silicone bands....
Ergotec Vetriretinal Instrument System. Extra fine angled tips (3 mm). 20 ga. shaft tapering to 23 ga., 10 mm from tip. Overall length from rear rotation knob to tip....
Medicine Products: