A controlled, investigator-sponsored Phase II trial of OGX-427 (OncoGenex Pharmaceuticals, Inc) in men with metastatic prostate cancer designed to evaluate a new treatment for prostate cancer, is currently recruiting participants.

This trial will enrole up to72 patients who have minimally symptomatic or asymptomatic advanced prostate cancer and who have not yet received chemotherapy.

OGX-427 is a second-generation antisense drug that is designed to reduce production of Heat Shock Protein 27 (Hsp27), a cell-survival protein. Hsp27 is expressed in prostate cancer and a variety of other malignancies and can be induced by cell stress through chemotherapy, radiation therapy, and hormone therapy. Overexpression of Hsp27 confers broad resistance to commonly used anti-cancer therapies.

Phase I clinical data were presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting which evaluated OGX-427 for the systemic (intravenous) treatment of solid tumors including prostate, non-small cell lung, breast, and ovarian cancers. Investigators concluded that as a single agent, OGX-427 demonstrated anti-cancer activity and was safe and well tolerated.[1,2]

The new trial in is designed to determine the potential benefit of OGX-427 by evaluating the proportion of patients who are without disease progression at 12 weeks after study treatment with or without OGX-427. This Phase II trial will also measure the direct effect of OGX-427 on prostate specific antigen (PSA) levels, time to progression by PSA or measurable disease, numbers of circulating tumor cells (CTCs) and other relevant secondary endpoints.

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“Advanced prostate cancer involves the reactivation of the androgen receptor and, thus, many tumors are not uniformly ‘hormone refractory’ and may remain sensitive to therapies directed against the androgen receptor axis,” said Dr. Kim Chi, Principal Investigator of the OGX-427 Phase II trial. “OGX-427 is designed to offer a unique and novel approach to androgen receptor inhibition including decreasing levels of the androgen receptor itself and potentially filling an unmet need in the prostate cancer treatment continuum.”

As announced in January 2010, the source of funding for this trial will include grant funding. Such funds were awarded by an independent granting agency to Dr. Kim Chi, a medical oncologist at the BC Cancer Agency and Research Scientist at the Vancouver Prostate Centre.

For more information:
[1] Hotte SJ, Yu EY, Hirte HW, Higano CS, Gleave ME, et al. Phase I trial of OGX-427, a 2’methoxyethyl antisense oligonucleotide (ASO), against heat shock protein 27 (Hsp27): Final results. J Clin Oncol 28:15s, 2010 (suppl; abstr 3077)
[2] Hotte SJ, Yu EY, Hirte HW, Higano CS, Gleave ME et al.,OGX-427, a 2’methoxyethyl antisense oligonucleotide (ASO), against HSP27: Results of a first-in-human trial. J Clin Oncol 27:15s, 2009 (suppl; abstr 3506) See the presentation

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