OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidat... ( FDA confirms appropriateness of ...)

OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011

Date:10/13/2008

FDA confirms appropriateness of durable pain palliation as a primary

endpoint for product marketing approval

Milestone achievement results in release of escrowed shares

BOTHELL, WA and VANCOUVER, Oct. 13 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals Inc. (NASDAQ: OGXI) today announced that it concluded a meeting with the U.S. Food and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that "durable pain palliation is an acceptable and desirable study endpoint" to support a product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer (HRPC). In addition, OncoGenex reported that the FDA provided guidance on the submitted protocol including recommendations on study endpoints, the appropriate patient population, entry criteria and study conduct. The company plans to revise and submit the protocol for completing a Special Protocol Assessment with the FDA prior to initiating the registration trial.

Based on the results of this meeting, the Board of Directors of OncoGenex Pharmaceuticals has approved the release of 25% (347,207) of the shares held in escrow pursuant to agreements related to Sonus Pharmaceuticals' merger with OncoGenex Technologies described in its Proxy Statement filed with the SEC on July 3, 2008. The escrow agreements provided for the release of 25% of the shares held in escrow following the occurrence of a meeting with the FDA to confirm that pain palliation is an appropriate primary endpoint to support a product marketing approval in prostate cancer. A total of 694,431 milestone shares remain in escrow.

"Our data combining OGX-011 with second line chemotherapy in patients with HRPC has shown potential improve
'/>"/>

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

0

GOOD

Page: 1 2 3 4
Related biology technology :

1. OncoGenex To Present At The BioContact Quebec 2008 Annual Conference
2. OncoGenex Pharmaceuticals announces out-license of TOCOSOL Paclitaxel to Eagle Pharmaceuticals
3. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
4. Sonus Pharmaceuticals and OncoGenex Technologies complete business combination; OncoGenex Pharmaceuticals to commence trading on NASDAQ Capital Market today
5. OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011
6. OncoGenex increases economic interest in lead cancer drug OGX-011
7. OncoGenex to present at the Needham & Company 7th Annual Biotechnology & Medical Technology Conference
8. Sonus Pharmaceuticals and OncoGenex Technologies to Merge
9. OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prostate cancer
10. Prominent Physician Achieves Success Using Topical Sinus Medications via Pulsitile Irrigation
11. Realtime Achieves ISO 13485:2003 Certification Targeting BioTech Quality Initiative

Post Your Comments:

(Date:6/19/2013)... TX (PRWEB) June 19, 2013 Applied ... application report that details the measurement of sulfur in ... NEX QC+ high resolution benchtop EDXRF analyzer . The ... standard test method ISO 13032. This International Standard ... for the determination of sulfur content in automotive gasoline. ...

(Date:6/19/2013)... MN (PRWEB) June 19, 2013 Express ... abuse tests, today announced that it has received Class ... market and sell its DrugCheck® NxStep Onsite Drug ... use of the rapid screening device in near-patient settings, ... Drug Screen Cup received Health Canada Class III approval ...

(Date:6/18/2013)... Clara, CA (PRWEB) June 18, 2013 ... to standard size SEMs but have limited performance and ... lower resolution. Full size SEMs would normally provide better ... more knowledge to operate and have a higher cost ... address the gap between these two types of ...

(Date:6/18/2013)... June 18, 2013 China Cord Blood Corporation ... China,s leading provider of cord blood collection, laboratory testing, ... today announced its preliminary unaudited financial results for the ... ended March 31, 2013. Fourth Quarter ... fourth quarter of fiscal 2013 increased by 33.3% to ...

[0] Rigaku Publishes New Application Note for Analysis of ULSD Per ISO 13032 [0] Express Diagnostics’ DrugCheck® On-site Test Cup Receives Health Canada Class III Medical Device Approval [0] Nanounity Introduces the Pemtron Range of Compact Scanning Electron Microscopes [0] China Cord Blood Corporation Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2013

... power they use. The more power they use, the hotter ... overheat. It doesn,t take a rocket scientist to understand what ... of electronics, thermal control is always one of the limiting ... to help cool down electronic components. However, Jeffrey ...

... BioStorage Technologies, the premier global provider of ... has opened its new state-of-the-art biorepository facility in ... company,s strategic growth plan, and represents a 4.6MM ... near the second largest FedEx hub in the ...

... 2011 Reportlinker.com announces that a new ... catalogue: Future Directions in ... Big Pharma has begun ... Pfizer and Novartis in 2009, and Cephalon ...

Cached Biology Technology:NASA is making hot, way cool 2 NASA is making hot, way cool 3 BioStorage Technologies Expands U.S. Operations with Opening of New Biorepository Facility 2 BioStorage Technologies Expands U.S. Operations with Opening of New Biorepository Facility 3 Reportlinker Adds Future Directions in Regenerative Medicine 2 Reportlinker Adds Future Directions in Regenerative Medicine 3 Reportlinker Adds Future Directions in Regenerative Medicine 4 Reportlinker Adds Future Directions in Regenerative Medicine 5 Reportlinker Adds Future Directions in Regenerative Medicine 6

NASA is making hot, way cool BioStorage Technologies Expands U.S. Operations with Opening of New Biorepository Facility Reportlinker Adds Future Directions in Regenerative Medicine

(Date:6/18/2013)... Bethesda, MD, June 18, 2013: The Association for Molecular ... Federation of American Societies for Experimental Biology (FASEB) on ... for membership on June 3, 2013. , The ... individuals and share a common vision for the advancement ... "Basic biomedical and translational research is more important now ...

(Date:6/18/2013)... Adelaide shows that weight gain and increased head size in ... higher IQ at early school age. , The study was led ... more than 13,800 children who were born full-term. , The results, ... babies who put on 40% of their birthweight in the first ... they were six years of age, compared with babies who only ...

(Date:6/17/2013)... eat their food may turn out to be just as ... out of St. Michael,s Hospital. , The study, led ... association between poor eating habits in kids ages three ... cholesterol, putting them at risk for cardiovascular disease later ... Canadian Medical Association Journal today. , "We know ...

Breaking Biology News(10 mins):IQ link to baby's weight gain in first month 2 Poor eating behaviors may put preschoolers at risk for later health problems 2

[0] AMP joins the Federation of American Societies for Experimental Biology [0] IQ link to baby's weight gain in first month [0] Poor eating behaviors may put preschoolers at risk for later health problems

... are killing head corals and adding stress to Caribbean ... from global climate change, coral diseases, hurricanes, pollution, and ... will take the pressure off the other corals, according ... PLoS ONE . The small, belligerently territorial, ...

... More than two million miles of the ... is nearing the end of its useful ... do not attract much attention because of ... associate professor of civil and environmental engineering ...

... attacks are most likely to occur on Sunday, in less ... involve surfers wearing black and white bathing suits, a first ... Researchers analyzed statistics from shark attacks that occurred in ... World," between 1956 and 2008. They also spent a year ...

Cached Biology News:Distressed damsels stress coral reefs 2 Efforts underway at Virginia Tech to address deterioration of nation's water pipes 2 Case study analyzes why, where and when of leading shark attack site 2 Case study analyzes why, where and when of leading shark attack site 3

Distressed damsels stress coral reefs Efforts underway at Virginia Tech to address deterioration of nation's water pipes Case study analyzes why, where and when of leading shark attack site

... Goat polyclonal to PAX3 This ... box (PAX) family of transcription factors. Members ... paired box domain and a paired-type homeodomain. ... development. Mutations in paired box gene 3 ...

Anti-Human alpha2-Antiplasmin Purified (Polyclonal) (goat IgG)...

Anti (porcine) Vitronectin...

Rabbit polyclonal to ErbB 2 (phospho Y1248) ( Abpromise for all tested applications). entrezGeneID: 2064 SwissProtID: P04626...

Biology Products:

Goat Anti-PAX3 Polyclonal Antibody, Unconjugated from GeneTex Goat Anti-Human Antiplasmin, a2 Antibody, Unconjugated from CEDARLANE Laboratories Limited Rabbit Anti-Porcine Vitronectin Antibody, Unconjugated from Cosmo Bio Co., Ltd.Rabbit Anti-ErbB2, phospho (Tyr1248) Polyclonal Antibody, Unconjugated from Abcam