Data from a Phase 2 Study Presented at the 2012 ASCO Annual Meeting Continues to Show Early Activity of OGX-427 in Patients with
Data from a Phase 2 Study Presented at the 2012 ASCO Annual Meeting Continues to Show Early Activity of OGX-427 in Patients with Prostate Cancer
BOTHELL, Wash. and VANCOUVER, British Columbia, June 4, 2012 /CNW/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today data from a Phase 2 study of its investigational compound OGX-427 in chemotherapy-naive metastatic castration resistant prostate cancer (mCRPC) patients will be presented during an oral presentation at the 2012 American Society of Clinical Oncology (ASCO) annual meeting on Tuesday, June 5. Preliminary results show a higher number of patients taking OGX-427 plus prednisone without disease progression at 12 weeks and with declines in prostate-specific antigen (PSA), compared with those taking prednisone alone.
Sixty-four of 72 planned patients have been randomized to the study and data on 42 patients [22 who received OGX-427 plus prednisone and 20 who received prednisone alone] are now available at or beyond the 12 week assessment time point. Highlights are as follows:
-- In the OGX-427 plus prednisone arm, 71% of patients were
progression-free at 12 weeks, compared to 40% in the prednisone
alone arm. The primary efficacy endpoint of this study is
defined as the proportion of patients without disease
progression at 12 weeks where disease progression is based on
any of the following parameters: PSA levels, measurable
disease, bone lesions, global deterioration or requiring
palliative radiation therapy.
-- Fifty percent of patients who received OGX-427 plus prednisone
experienced a >50% decline in PSA, versus 20% of patients who
received prednisone alone.
-- Among the 21 patients with baseline measurable disease, 44% (4
of 9) in the OGX-427 plus prednisone arm had a measureable
disease response compared to 0% (0 of 12) in the prednisone
alone arm. There was 1 complete response in the OGX-427 plus
prednisone arm.
-- Circulating tumor cell declines from greater than or equal to 5
to <5 occurred in 55% of patients receiving OGX-427 plus
prednisone compared to 41% of patients receiving prednisone
alone.
-- The authors concluded that OGX-427 appears to be
well-tolerated. Adverse events (AEs) have been predominately
grade 1-2 and related to infusion reactions. Three grade 4 AEs
have been reported and include dizziness, pulmonary embolus and
one case of hemolytic uremic syndrome.
"We are encouraged by these early data that further support the ability of
OGX-427 to suppress androgen receptor activity and tumor cell survival," said
Dr. Kim Chi, a medical oncologist at BC Cancer Agency, British Columbia,
Canada, and the primary investigator on the study. "This is important for both
the clinical development of OGX-427 and to also further our understanding of
how new and emerging therapies may work alone or in combination to treat mCRPC
and battle treatment resistance – a serious issue in this and other cancers."
OGX-427 is believed to work by inhibiting the production of Hsp27, a
cell-survival protein expressed in many types of cancers including prostate,
bladder, pancreas, breast and non-small cell lung cancer. Overexpression of
Hsp27 is thought to be an important factor leading to the development of
treatment resistance and is associated with negative clinical outcomes in
patients with various tumor types.
Along with this study, OGX-427 is currently being evaluated in a Phase 1 trial
in superficial or muscle-invasive bladder cancer and a large, randomized Phase
2 trial in metastatic bladder cancer. Initiation of a Phase 2 study of OGX-427
plus Zytiga® is planned for later this year.
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and
commercialization of new cancer therapies that address treatment resistance in
cancer patients. OncoGenex has a diverse oncology pipeline, with each product
candidate having a distinct mechanism of action and representing a unique
opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) have entered a global collaboration and license
agreement to develop and commercialize OncoGenex' lead drug candidate,
custirsen. Custirsen is currently in Phase 3 clinical development as a
treatment in men with metastatic castrate-resistant prostate cancer. Phase 3
development of custirsen in treatment of advanced, unresectable non-small cell
lung cancer is expected to be initiated in 2012. OGX-427 is in Phase 2
clinical development; OGX-225 is currently in pre-clinical development. More
information is available at www.OncoGenex.com.
OncoGenex Forward Looking Statements
This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, statements concerning our anticipated
product development activities, such as expected clinical trial initiation and
completion and statements regarding the potential benefits and potential
development of our product candidates. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. These statements are based on management's current expectations
and beliefs and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially from those
described in the forward-looking statements. Such forward-looking statements
are subject to risks and uncertainties, including, among others, the risk that
final trial results will not demonstrate the same or any potential benefit as
observed in preliminary trial results, the risk that subsequent studies may
not confirm earlier trial results, the risk of delays in our expected clinical
trials, the risk that new developments in the rapidly evolving cancer therapy
landscape require changes in our clinical trial plans or limit the potential
benefits of our product, the risk that our cash resources are insufficient to
fund our planned activities for the time period expected and the other factors
described in our risk factors set forth in our filings with the Securities and
Exchange Commission from time to time, including the Company's Annual Report
on Form 10-K. The Company undertakes no obligation to update the
forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof, other than as may be required
by applicable law.
Zytiga is a registered trademark of the Johnson & Johnson Corporation
SOURCE OncoGenex Pharmaceuticals, Inc.
Media Contact: Jaime Welch, jwelch@oncogenex.com, +1-604-630-5403; Investor Relations Contact: Susan Specht, sspecht@oncogenex.com, +1-425-686-1535
To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/June2012/04/c5516.html
CO: OncoGenex Pharmaceuticals, Inc. ST: Washington NI: HEA SHOW
-0- Jun/04/2012 12:01 GMT
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