Navigation Links
FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals' Lead Product Candidate OGX-011
Date:8/22/2008

BOTHELL, WA and VANCOUVER, Aug. 22 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals (NASDAQ: OGXI) announced today that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer. OGX-011 is currently completing five Phase 2 clinical studies in prostate, lung and breast cancer, and is designed to inhibit the production of a specific protein, clusterin, associated with treatment resistance.

Fast Track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Based on this designation, the FDA will take actions as appropriate to expedite the development and review of OGX-011 for approval. These actions include scheduled meetings to obtain FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

"Obtaining Fast Track designation for custirsen sodium while developing our Phase 3 program for hormone-refractory prostate cancer (HRPC) and in advance of initiating our Phase 3 study is very important and should help us move forward expeditiously on our pathway toward commercialization," said Scott Cormack, chief executive officer of OncoGenex Pharmaceuticals. "We welcome this designation as another example of our ability to rapidly advance our development programs."

The request for Fast Track designation was based on data from Phase 2 studies in HRPC as well as supporting data in non-small cell lung cancer (NSCLC) indicating that
'/>"/>

SOURCE OncoGenex Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. GlaxoSmithKline To Post Quarterly US Grants Report
2. FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
3. FDA Grants Epeius Biotechnologies Rexin-G a Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas
4. US FDA Grants Pediatric Exclusivity for UCBs Keppra(R)
5. Xceed Molecular Grants Gen-Probe License to Xceeds Flow-Thru Chip(R) Technology for Multiplex Molecular Diagnostics
6. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
7. Intellect Neurosciences, Inc. Grants License for Certain Patents and Patent Applications to Wyeth and Elan Pharma International Ltd.
8. Lentigen Corporation Receives Four Research Grants From the National Institutes of Health
9. Susan G. Komen for the Cure(R) Announces Largest Grants Slate Ever: $100 Million to Speed Delivery of Breast Cancer Discoveries, Cures
10. European Union, State of Brandenburg, Award Grants to Alcat Europe, GmbH
11. FDA Grants Market Clearance to Aerocrine Inc.s NIOX MINO(R): a New Hand-Held Device to Measure Airway Inflammation in Asthma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... 2014 The Americas Inorganic Refrigerants ... market in Americas with analysis and forecast of ... Americas Inorganic Refrigerants Market report, to get an ... provides a glimpse of the segmentation in the ... various tables and figures. , http://www.micromarketmonitor.com/market/americas-inorganic-refrigerants-4191654241.html ...
(Date:10/22/2014)... October 22, 2014 Currently offering ... A & D Weighing, Rice Lake, and Ohaus, ... Balance . The Sartorius CPA Semi-Micro Balance is ... high-quality, precise, and user-friendly laboratory balance. , Sartorius ... equipment, their laboratory balances are well known for ...
(Date:10/22/2014)... - iCo Therapeutics ("iCo" or "the Company") (TSX-V: ICO) ... Oral Amphotericin B program.  The company recently announced ... work involving samples from HIV/AIDS patients exposed to ... clinical studies and regulatory filings to move forward ... approximately $700,000 of funding and technological advice from ...
(Date:10/20/2014)... NEW YORK , Oct. 20, 2014 /PRNewswire/ ... of their experimental ZMapp™ antibody therapeutic to fight ... of how difficult and time-consuming the production of ... healthcare market research publisher said that while some ... cycle of this compound, those with industry knowledge ...
Breaking Biology Technology:The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 3iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 2iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 3Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 2Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 3
... 27 A copy of the Company,s December 31, 2008 ... may be obtained without charge at our website address, ... P. O. Box 14508, St. Louis, Missouri 63178. About ... Science and High Technology ...
... - Vasogen Inc. (NASDAQ: VSGN ; TSX:VAS) today reported ... 30, 2008. All dollar amounts referenced herein are in Canadian ... cash and cash equivalents totaled $8.6 million, compared with $23.5 ... 31, 2008. As of January 31, 2009, our cash balance ...
... option for millions of Americans with debilitating lung ... (NYSE: AZN ) today announced that ... approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for ... in patients with chronic obstructive pulmonary disease (COPD), ...
Cached Biology Technology:Vasogen Announces 2008 Year-End Results 2Vasogen Announces 2008 Year-End Results 3Vasogen Announces 2008 Year-End Results 4Vasogen Announces 2008 Year-End Results 5Vasogen Announces 2008 Year-End Results 6Vasogen Announces 2008 Year-End Results 7Vasogen Announces 2008 Year-End Results 8Vasogen Announces 2008 Year-End Results 9Vasogen Announces 2008 Year-End Results 10Vasogen Announces 2008 Year-End Results 11FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 2FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 3FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 4FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 5FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 6
(Date:10/16/2014)... of Marine Science have received a 3-year, $392,773 ... the streams and wetlands most vulnerable to sea-level ... governments and citizens conserve these important ecosystems. , ... tidal-marsh observations first gathered by VIMS scientists in ... today,s researchers accurately map the slow but inexorable ...
(Date:10/16/2014)... (October 16, 2014) – Post-menopausal women experienced improvements ... hormone levels or genital bleeding, after 12 weeks ... investigational fermented soy germ-based nutritional supplement previously shown ... a new peer-reviewed pilot study reported in a ... annual scientific meeting. , "These data documented ...
(Date:10/15/2014)... University Mainz (JGU) as a full member, ensuring ... a significant nationwide standing in the field of ... Gutenberg University Mainz as a full member of ... and international competition for the best minds and ... proud that Mainz University has been recognized as ...
Breaking Biology News(10 mins):EPA grant will help localities conserve headwater wetlands 2EPA grant will help localities conserve headwater wetlands 3S-equol supplements associated with improved measures of reproductive health in postmenopausal women 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 3
... Society for Microbiology (ASM) Merck Irving S. Sigal Memorial ... Professor, Department of Microbiology and Immunology at the Uniformed ... Sponsored by Merck Research Laboratories, the Merck Irving S. ... S. Sigal, who was instrumental in the early discovery ...
... 25, 2008 The 2008 American Society for Microbiology ... Walter Stamm, Associate Director, WWAMI Regional Center of ... Washington. Supported by an unrestricted grant from ... antimicrobial chemotherapy. Through his professional life, Dr. ...
... released the final "Integrated Science Assessment for Oxides of ... the scientific literature on the potential adverse human health ... nitrogen dioxide or NO2. There are significant new ... review document released in 1993. Oxides of ...
Cached Biology News:
... a partial recombinant IFNA2. Immunogen: ... is produced in E. coli. The biological ... OMIM: 147562, ... MM951100564 MA Code: ABV0P9DPB ...
... Researchers no longer need to perform time consuming ... With Mutation Surveyor, any found variants of the ... clearly indicated in our mutation electropherogram as a ... the bi-directional analysis mode is over 99%, with ...
...
... 220-240 V, is used for biolistic particle ... device employs an adjustable helium pulse to ... microcarriers from the inner wall of a ... This system has a 2 square-centimeter target ...
Biology Products: