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
- 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
|SOURCE OncoGenex Pharmaceuticals, Inc.|
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