BOTHELL, WA, and VANCOUVER, May 30 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced preliminary results of a Phase 1 trial presented during an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results as of April 2009 showed that OGX-427 was well tolerated as a monotherapy. In addition, OGX-427 demonstrated declines in circulating tumor cells at all doses evaluated as well as evidence of reduction in tumor markers. Reductions in circulating tumor cells and tumor markers both suggest single-agent activity warranting further clinical investigation.
The Phase 1 trial has evaluated 41 patients with a variety of cancers to date; enrollment is ongoing. The first phase of the study evaluated increasing doses of OGX-427 as a single agent up to 1000 mg. A maximum tolerated dose was not identified up to and including the 1000-mg dose of OGX-427 monotherapy. Subsequently, as defined by the protocol, an 800-mg dose of OGX-427 in combination with docetaxel was evaluated, to be followed by a 1000-mg dose of OGX-427 plus docetaxel. OGX-427 is administered as three loading doses within the first 9 days and then continued weekly, with three weeks defined as a treatment cycle, until disease progression or toxicity. In those groups receiving OGX-427 in combination with docetaxel, 75mg/M(2) docetaxel was administered on Day 1 of every 3-week cycle starting after completion of the OGX-427 loading doses.
Patients enrolled had a diagnosis of breast, ovarian, prostate or non-small cell lung cancer and most had failed multiple prior chemotherapy treatments. A median of 2 cycles (range of 1-8 cycles) was administered with the following safety results for OGX-427 as monotherapy:
- Criteria for a maximum tolerated dose were
|SOURCE OncoGenex Pharmaceuticals, Inc.|
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