Navigation Links
Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Date:9/5/2007

and obtaining the approvals required to make picoplatin available to this severely underserved patient population."

About Fast Track Designation

The fast track programs of the FDA are designed to facilitate the development and expedite the review of drugs and biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation enables the product candidate to become approved and reach the market expeditiously. This may include priority review (i.e., six-month versus the standard ten-month review) and the option to submit a New Drug Application on a rolling basis, enabling FDA to begin reviewing sections of the application before receiving the complete application. According to the FDA, picoplatin is eligible for Fast Track designation due to the unmet medical need -- with no approved therapy for refractory disease, responses seen in two Phase 2 studies, and Poniard's randomized, controlled Phase 3 trial of picoplatin and best supportive care (BSC) versus BSC alone.

About Picoplatin

Picoplatin is a new generation platinum chemotherapy agent. It was designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemotherapeutics. Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC.

In addition to the SPEAR trial of intravenous picoplatin in SCLC, Poniard is also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial in combination with docetaxel (Taxotere(R)) and prednisone in patients with metastatic hormone-refractory prostate cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.

About Small Cell
'/>"/>

SOURCE Poniard Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Poniard Pharmaceuticals Announces Promising Data From Interim Safety Analysis of Phase 1 Combination Trials of Picoplatin in Colorectal and Prostate Cancers
2. Poniard Pharmaceuticals Announces Clinical Data from Picoplatin Phase 2 Small Cell Lung Cancer Trial To Be Presented at American Society of Clinical Oncology Annual Meeting
3. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
4. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
5. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
7. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
8. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
9. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
10. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
11. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... MONMOUTH JUNCTION, N.J. , May 4, 2015 ... critical care immunotherapy company commercializing its CytoSorb® extracorporeal ... patients in multiple countries worldwide, will report Q1 ... Monday, May 11, 2015.  CytoSorbents, ... presentation webcast that will recount both operational and ...
(Date:5/4/2015)... , May 4, 2015 Dynatronics ... manufacturer and marketer of rehabilitation and physical therapy ... definitive agreements to raise approximately $4,000,000 in a ... and certain of its affiliates (together with its ... on the healthcare industry. The financing will provide ...
(Date:5/4/2015)... ROCKVILLE, Md. , May 4, 2015   ... of pathogen-specific therapeutics focused on protecting the microbiome, as ... Shallcross has been appointed Chief Financial Officer, Treasurer ... C. Evan Ballantyne who will be leaving the ... Mr. Shallcross brings to Synthetic Biologics operational, financial and ...
Breaking Medicine Technology:CytoSorbents to Report Q1 2015 Operating and Financial Results 2CytoSorbents to Report Q1 2015 Operating and Financial Results 3Dynatronics Announces $4,000,000 Private Placement Led By Prettybrook Partners 2Dynatronics Announces $4,000,000 Private Placement Led By Prettybrook Partners 3Dynatronics Announces $4,000,000 Private Placement Led By Prettybrook Partners 4Steven Shallcross Named Chief Financial Officer of Synthetic Biologics 2Steven Shallcross Named Chief Financial Officer of Synthetic Biologics 3
... , Inc., a full-service contract research organization (CRO), and ... combat the growing issue of antibiotic resistance, have partnered ... walk to benefit the Cystic Fibrosis (CF) Foundation through ... Aptalis Pharma) are also working together on clinical trials ...
... May 2, 2012  Neurocrine Biosciences, Inc. (NASDAQ: NBIX ... March 31, 2012.  For the first quarter of 2012, the ... per share, compared with a net income of $2.9 million, ... 2011. This $3.8 million change in operating results is primarily ...
Cached Medicine Technology:Synteract and Rempex Partner in "Great Strides" Walk to Support Cystic Fibrosis Cure 2Neurocrine Biosciences Reports First Quarter 2012 Results 2Neurocrine Biosciences Reports First Quarter 2012 Results 3Neurocrine Biosciences Reports First Quarter 2012 Results 4Neurocrine Biosciences Reports First Quarter 2012 Results 5Neurocrine Biosciences Reports First Quarter 2012 Results 6
(Date:5/3/2015)... Birmingham, Lake Orion, Clarkston, Metamora, Michigan (PRWEB) May 03, 2015 ... . She has worked to enhance the well being of ... as a generalist in a hospital, followed by providing care for ... I worked with as an Adult Nurse Practitioner began wondering if ... coupled with the birth of my own children with my mentor ...
(Date:5/3/2015)... and LOS ANGELES, American Telemedicine Association 2015 Meeting ... vitaphone e-health solutions, a full-service telemedicine and ... of its new platform, VITA health services for ... VITA health services platform enables remote patient monitoring ... as congestive heart failure (CHF), diabetes, COPD, hypertension ...
(Date:5/3/2015)... 2015 " Bubbly Walrus ” was featured ... a look at the latest and coolest applications on the ... of AppWatch and technology expert, conducted the app review and ... game. , The best games to play on smartphones are ... users killing brain cells with a video game that just ...
(Date:5/3/2015)... (PRWEB) May 03, 2015 “ BolehVPN ” ... Report, which features the latest and coolest technology products available ... for NewsWatch, conducted the review and shared with viewers how ... everyone does these days is on computers and even more ... families and meet people all over the world. In terms ...
(Date:5/3/2015)... May 03, 2015 NuevaCare announced today ... two upcoming area seminars. The first event will take ... Regional Stroke Conference to be held at The Magnolia ... Wednesday, May 13 during the Dementia Conference to be ... “These seminars offer an excellent opportunity to learn about ...
Breaking Medicine News(10 mins):Health News:Women's Excellence In Midwifery Welcomes Barbara Crone 2Health News:vitaphone e-health solutions U.S. Announces VITA Health Services for Remote Chronic Disease Management 2Health News:vitaphone e-health solutions U.S. Announces VITA Health Services for Remote Chronic Disease Management 3Health News:An Application to Have Fun with Mathematics Was Featured on NewsWatch Television 2Health News:A Method to Keep Private Information Secure was Featured on NewsWatch Television 2Health News:NuevaCare Introduces MnemeTherapy® Approach to Care for Elderly Patients with Alzheimer’s, Stroke and Other Types of Neurodegenerative Conditions 2
... agent selumetinib has shown promising results in people with ... led by cancer researchers at The Ohio State University. ... protein called MEK, which cancer cells need to proliferate ... lining the bile ducts and gall bladder. About 100,000 ...
... By Kathleen Doheny HealthDay Reporter , MONDAY, ... that report the greatest number of satisfied inhabitants also ... Seemingly contradictory, the findings are probably explained by ... constantly compare oneself to others. "Deep down we ...
... will gather at Rice University,s Shepherd School of Music ... cognition and behavior and present the latest research findings ... a series of in-depth morning seminars, the scientific researchers ... the musicians learn concurrently about brain morphology, music perception ...
... MONDAY, April 25 (HealthDay News) -- New research suggests that ... regulating a brain wave known as the alpha rhythm, which ... small study, researchers found that those participants using meditation were ... told where to direct their attention -- after they finished ...
... association between computer and Internet use in adolescents and ... drunkenness and unprotected sex. "This research is based ... engaged in a behaviour is a way of learning ... candidate in School of Kinesiology and Health Studies. "Since ...
... examines the ion selectivity of cation-selective channels and transporters. ... the Journal of General Physiology ( www.jgp.org ... his introduction, a key tool in most recent studies ... which emphasize the fluid-like features of the selectivity filter ...
Cached Medicine News:Health News:Targeted agent selumetinib shows promise in biliary cancer 2Health News:'Happiest' States Show Highest Suicide Rates: Study 2Health News:'Happiest' States Show Highest Suicide Rates: Study 3Health News:Musicians and scientists to research mind and music at Rice University conference 2Health News:Meditation May Help Brain Block Out Distractions 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: