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OncoGenex Reports Third Quarter Financial Results
Date:11/10/2008

FDA stated that it

agreed with the design and planned analysis proposed by OncoGenex,

and that the study design adequately addresses the objectives

necessary to support a regulatory submission.

- Sonus signed an exclusive in-licensing agreement with Bayer

HealthCare LLC for development of a family of compounds known as

caspase activators presently in preclinical research. As the caspase

family of proteases plays essential roles in apoptosis, the caspase

activators offer the potential for the development of therapies in

the treatment of various cancers.

- OncoGenex received Fast Track designation from the FDA for

development of OGX-011 in combination with docetaxel for progressive

metastatic prostate cancer. Fast Track designation was granted on the

basis that OGX-011 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.

- On October 7, 2008 OncoGenex and the FDA concluded a meeting whereby

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, the FDA provided guidance on the submitted protocol

including recommendations on study endpoints, the appropriate patient

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

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Related biology technology :

1. OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prostate cancer
2. Sonus Pharmaceuticals and OncoGenex Technologies to Merge
3. OncoGenex to present at the Needham & Company 7th Annual Biotechnology & Medical Technology Conference
4. OncoGenex increases economic interest in lead cancer drug OGX-011
5. OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011
6. Sonus Pharmaceuticals and OncoGenex Technologies complete business combination; OncoGenex Pharmaceuticals to commence trading on NASDAQ Capital Market today
7. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
8. OncoGenex Pharmaceuticals announces out-license of TOCOSOL Paclitaxel to Eagle Pharmaceuticals
9. OncoGenex To Present At The BioContact Quebec 2008 Annual Conference
10. OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011
11. OncoGenex Pharmaceuticals to Release Third Quarter Financial Results
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