UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 1, 2015
ONCOGENEX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 033-80623 | 95-4343413 | ||
| (State or other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 19820 North Creek Parkway Bothell, Washington |
98011 | |||
| (Address of Principal Executive Offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (425) 686-1500
N/A
(Former name or former address if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events. |
On December 1, 2015, OncoGenex Pharmaceuticals, Inc. (the “Company”) announced that its Phase 3 AFFINITY trial is continuing based on the pre-planned interim futility analysis of the intent-to-treat population. In the final safety review, no new safety issues were identified by the Data Monitoring Committee. Separately, an analysis of a prospectively defined subpopulation of men in the AFFINITY trial who had multiple poor prognostic risk factors revealed that the combination of custirsen and cabazitaxel did not meet the rigorous criteria required to demonstrate an improvement in overall survival (hypothesized hazard ratio <0.69, one-sided p value <0.015). Both the Data Monitoring Committee and the Company remain blinded to all analyses, and final results are expected in the second half of 2016, depending on timing of the event-driven final analysis.
A copy of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by OncoGenex Pharmaceuticals, Inc. dated December 1, 2015 | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ONCOGENEX PHARMACEUTICALS, INC. | ||
| Date: December 1, 2015 | /s/ John Bencich | |
| John Bencich Chief Financial Officer | ||
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EXHIBIT INDEX
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by OncoGenex Pharmaceuticals, Inc. dated December 1, 2015 | |
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