| Report final survival data with additional results from the Phase 2 clinical trial evaluating first-line docetaxel with and without OGX-011 treatment in patients with castrate resistant prostate cancer (CRPC); these data have been selected for presentation at the American Society of Clinical Oncology 2009 Annual Meeting in the second quarter. |
| In the second quarter, reach an agreement with the FDA via the Special Protocol Assessment process (SPA) on the design of a second Phase 3 registration trial evaluating durable pain palliation for OGX-011 in combination with docetaxel as second-line chemotherapy in patients with CRPC. |
| In the third quarter, discuss with the FDA a possible Phase 3 registration trial evaluating first-line docetaxel with and without OGX-011 and the strategy of combining the first-line registration trial with one of the second-line clinical trials for product marketing approval for patients with CRPC. |
| Secure a development and commercialization partnership for OGX-011 in 2009. |
| Report data from our ongoing Phase 1 clinical trial evaluating OGX-427 as a monotherapy in patients with solid tumors; these data have been selected for presentation at the American Society of Clinical Oncology 2009 Annual Meeting in the second quarter. |
| Initiate an investigator-sponsored Phase 1 clinical trial evaluating OGX-427 as a treatment in patients with bladder cancer, in the second quarter. |
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| First Line Prostate Cancer Potential Survival Advantage longer survival duration, estimated at 10.6 months, in a randomized Phase 2 clinical trial of OGX-011 in combination with docetaxel and prednisone (the OGX-011 arm) when compared to docetaxel alone (the control arm) for first-line treatment of metastatic CRPC. The median survival was 27.5 months for the patients in the OGX-011 arm and 16.9 months for those in the control arm. Results currently indicate that patients in the OGX-011 arm have a death rate of approximately 40% lower than patients in the control arm. Additional survival updates are needed before a mature median survival for the OGX-011 arm can be reported; however, based on the current results, OncoGenex has calculated that the final median survival for patients in the OGX-011 arm cannot be lower than 22.7 months, representing at least a 5.8 month median survival benefit. For comparison, docetaxel was approved for treatment of metastatic CRPC by the FDA based on a survival advantage of 2.4 months over mitoxantrone. |
| Second Line Prostate Cancer Potential Survival Advantage - longer than expected survival durations for patients receiving OGX-011 in combination with either mitoxantrone or docetaxel retreatment as second-line chemotherapy as compared to reported survival durations in two published studies of CRPC patients receiving second-line chemotherapy. As of January 14, 2009, the median survival duration for the randomized 20 patients receiving OGX-011 plus docetaxel retreatment was 15.8 months, whereas the median survival duration for the randomized 22 patients receiving OGX-011 plus mitoxantrone arm was 11.4 months, based on a median follow-up of 26 months. An amendment to the study provided for an additional 25 patients to be treated with OGX-011 and docetaxel retreatment as second-line chemotherapy. The median survival duration for all 45 patients (i.e., the 20 randomized plus the 25 enrolled after randomization) receiving OGX-011 plus docetaxel retreatment is 13.0 months, based on a median follow-up of 18 months. For comparison, results were published for patients who participated in the key registration study comparing first-line docetaxel to mitoxantrone in metastatic CRPC, referred to as the TAX 327 Study, and who later received second-line chemotherapy. The median survival duration for these patients treated with either docetaxel or mitoxantrone as second-line chemotherapy was approximately 10 months. A retrospective study from the British Columbia Cancer Agency reported a median survival duration of 9.6 months for patients who were retreated with docetaxel as second-line chemotherapy after receiving and responding to docetaxel as first-line chemotherapy. |
| Non-Small Cell Lung Cancer Potential Survival Advantage - longer than expected survival duration was observed when adding OGX-011 to first-line gemcitabine and a platinum-containing chemotherapy when compared to reported survival durations in prior published studies from randomized phase 3 trials evaluating first-line gemcitabine and a platinum-containing chemotherapy in patients with non-small cell lung cancer (NSCLC). At two years, 30% of |
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| Prostate Cancer Potential Pain Palliation Advantage - increased frequency and duration of pain palliation was observed when adding OGX-011 to either mitoxantrone or docetaxel retreatment as second-line chemotherapy even when compared to the frequency and duration of pain palliation observed in the TAX 327 Study for first-line chemotherapy in patients with CRPC. Durable pain responses defined as a duration of 12 weeks or greater were observed in 44% of evaluable patients in the OGX-011 plus docetaxel retreatment arm and in 38% of patients in the OGX-011 plus mitoxantrone arm. Responses in patients receiving second-line treatment would be expected to be worse than first-line. However, when compared to first-line treatment in the TAX 327 Study, 35% of patients treated with docetaxel had pain responses with a median duration of 3.5 months (not all durations were 12 weeks or greater) and 22% of patients treated with mitoxantrone had pain responses with a median duration of 4.8 months (all durations were 12 weeks or greater). |
| Potential Correlation of Clusterin Levels to Survival - preliminary analyses have shown that treatment with OGX-011 in combination with chemotherapy significantly lowers serum clusterin levels and that low average serum clusterin levels during OGX-011 treatment correlate to longer survival. |
| An agreement with the FDA was reached on the design of a Phase 3 registration trial featuring overall survival as the primary endpoint for OGX-011 in combination with docetaxel as second-line chemotherapy in men with CRPC, via the SPA process. In a letter from the FDA responding to the OncoGenex submission, the FDA stated that they agreed with the design and planned analyses proposed by OncoGenex, and that the study design adequately addressed the objectives necessary to support a regulatory submission. |
| Fast Track designation was received from the FDA for development of OGX-011 in combination with docetaxel for progressive metastatic prostate cancer. Fast Track designation was granted on the basis that OGX-011 may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life threatening disease. |
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| In a meeting with OncoGenex, the FDA agreed that durable pain palliation is an acceptable and desirable study endpoint to support a product marketing approval for OGX-011 in combination with docetaxel as second-line chemotherapy in men with CRPC. OncoGenex has revised the protocol based on the FDAs recommendations and has recently submitted the protocol to the FDA for an SPA featuring pain palliation as the primary endpoint. |
| OncoGenex completed patient enrollment in the portion of the Phase 1 clinical trial evaluating the safety of OGX-427 as a monotherapy in patients with solid tumors. |
| OncoGenex completed the Phase 1 clinical trial evaluating the safety of SN2310 in patients with advanced cancer. |
| Concurrent with the closing of the reverse takeover of Sonus, OncoGenex implemented an immediate workforce reduction of 49% in order to effectively utilize cash assets, while preserving the resources we believe are necessary to advance our priority clinical programs. The Company currently has 26 full-time employees. |
| In July 2008, OncoGenex increased its economic interest in the OGX-011 development program and assumed full responsibility for the development of OGX-011 through an amended development agreement with Isis Pharmaceuticals, Inc. |
| In August 2008, the Company signed an exclusive in-licensing agreement with Bayer HealthCare LLC for development of a family of compounds known as caspase activators presently in preclinical research. As the caspase family of proteases plays essential roles in apoptosis, the caspase activators offer the potential for the development of therapies in the treatment of various cancers. |
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Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
(unaudited) | ||||||||||||||||
Operating expenses |
||||||||||||||||
Research and development |
$ | 4,198 | $ | 1,060 | $ | 7,819 | $ | 4,135 | ||||||||
General and administrative |
1,050 | 831 | 3,293 | 3,540 | ||||||||||||
Total operating expenses |
5,248 | 1,891 | 11,112 | 7,675 | ||||||||||||
Other income (expense) |
334 | (192 | ) | 421 | (148 | ) | ||||||||||
Loss for the period before taxes |
4,914 | 2,083 | 10,691 | 7,823 | ||||||||||||
Income tax expense (recovery) |
41 | 140 | (2,059 | ) | 713 | |||||||||||
Operating loss before extraordinary gain |
4,955 | 2,223 | 8,632 | 8,536 | ||||||||||||
Extraordinary gain |
| | 4,428 | | ||||||||||||
Net loss |
4,955 | 2,223 | 4,204 | 8,536 | ||||||||||||
Redeemable convertible preferred share
accretion |
| 788 | 1,973 | 2,944 | ||||||||||||
Loss attributable to common shareholders |
$ | 4,955 | $ | 3,011 | $ | 6,177 | $ | 11,480 | ||||||||
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December 31, | December 31, | |||||||
2008 | 2007 | |||||||
Assets: |
||||||||
Cash, cash equivalents and short term investments |
$ | 12,419 | $ | 5,131 | ||||
Amounts and investment tax credit receivable |
1,243 | 1,813 | ||||||
Prepaid and other current assets |
587 | 295 | ||||||
Property, equipment and other assets |
541 | 111 | ||||||
Total assets |
$ | 14,790 | $ | 7,350 | ||||
Liabilities and stockholders equity: |
||||||||
Accounts payable and accrued expenses |
$ | 2,252 | $ | 1,048 | ||||
Other current liabilities |
632 | 4,665 | ||||||
Long term liabilities |
1,199 | 2,487 | ||||||
Redeemable convertible preferred shares |
| 37,373 | ||||||
Stockholders equity (deficiency) |
10,707 | (38,223 | ) | |||||
Total liabilities and stockholders equity (deficiency) |
$ | 14,790 | $ | 7,350 | ||||
OncoGenex Contact:
|
Media and Investor Contact: | |
Scott Cormack President & CEO (604) 630-5400 scormack@oncogenex.com |
Jason Spark Porter Novelli Life Sciences (619) 849-6005 jspark@pnlifesciences.com |
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