A Phase 1 Study Evaluating A Second Generation Antisense Oligonucleotide (OGX 427) That Inhibits Heat Shock Protein 27 (Hsp27
This study is for patients with breast, prostate, ovarian, non-small cell lung (NSCL) or
bladder cancer who have failed potentially curative treatments or for whose disease a
curative treatment does not exist.
OGX-427 is a second-generation ASO that inhibits expression of Hsp27. Hsp27 is one of the
heat shock proteins. Hsp27 increases with cell stress, including cytotoxic chemotherapy,
radiation therapy and hormone therapy and has been shown to inhibit cell death. Thus,
decreasing Hsp27 as a cancer therapy is attractive as a therapy as it should result in down
regulation of pathways implicated in cancer progression and development of resistance to
A number of in vitro and in vivo pharmacological studies have demonstrated that OGX-427 has
single-agent activity in reducing Hsp27, inhibiting cell growth and inducing cell death in
several human cancer cell lines. OGX-427 has also demonstrated chemosensitizing activity in
studies using cell lines and animal models in combination with several cytotoxic drugs,
Docetaxel (Taxotere®) has anticancer activity in breast, prostate, ovarian, non-small cell
lung and bladder cancer. Docetaxel has been approved by Health Canada and the Food and Drug
Administration for the treatment of patients with breast, prostate, ovarian and non-small
cell lung cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• To determine the maximum tolerated dose (MTD) of OGX-427 when administered as a single agent, up to a 1000 mg dose level.
approximately 2 years
Kim Chi, M.D.
University of British Columbia
United States: Food and Drug Administration
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