- OncoGenex presented at Wedbush conference on 8/17/11 - access webcast link on Past Events page.
- Complete stock research info on OGXI page.
- See my notes from the webcast below:
- 2 preclinical assets getting ready to go into clinic. Those will not be the focus of today's presentation
- SYNERGY trial - the phase 2 trial this was based on showed very early separation of curves. HR was 0.61, and based on prospective multivariate analysis HR = 0.49
- OGX-011 blocks production of clusterin (antisense drug), does not target clusterin protein itself, so the best surrogtate is circulating tumor cells expressing clusterin. Slide: in untreated patients, stress response from docetaxel treatment induces increase in serum clusterin levels
- SATURN trial - 2nd line prostate cancer patients, who have already had docetaxel. Then receive docetaxel retreatment with prednisone +/-custesen, now under SPA amendment process to also allow cabazataxel [because recruitment has been very poor]
- Expect both trials to complete in the latter portion of 2013
- phase 3 NSCLC program (yet to start) is based on single arm phase 2
- In both lung and prostate cancer patients- low average serum clusterin levels have been shown to correlate to better survival
- OGX427 - unpartnered asset. HSP27 is target for this antisense drug
- HSP27 is a chaperone protein that helps bring androgen receptor (AR) to nucleus (important in prostate cancer progression)
- Have seen dose dependent decrease in hsp27 levels with OGX-427
- Superficial baldder trial - extract tumor from patient, so get a read on PK/PD of drug
- Will be starting metastatic bladder cancer study based on data to date. gemcitabine/cisplatin +/- 427, 180 pts. this first line indication is an underserved population
- OGX427 also considering additional indications of pancreatic, lung, prostate cancers
- cash on hand sufficient to mid-2014
- NSCLC phase 2 trial was in combo with gemcitabine + platinum agent. 8-10.8 month OS is the relevant comparison in 1st line NSCLC
- More info on NSCLC issue with drug drug interaction? Teva has preclinical and human data. In human trial, used a surrogate (diabetes related drug) that is broken down by same enzymatic pathway. We have inconsistent and uninterpretable data. The studies did not clarifiy drug-drug interaction (between OGX-011 and paclitaxel chemo). We could move ahead right now in combo with gem/cis... but that is not necessarily the right way to go. We want to make sure to align with emerging standard of care (SOC)...very fractionated market, with different lead agents in US vs EU. We want to demonstrate activity across different combos [and left unsaid is that they don't want to pick the wrong combo agent and have no one enroll in their trial..this is the mistake the made with the SATURN prostate cancer trial]
- Question about impact of Provenge? Provenge patients are earlier stage than ogx011 candidates... asymptomatic, not yet into chemotherapy. Our pts have previous hormone ablation therapy that is not workling. Then move into chemo+/-custersen
- Addressable market size? Did not answer question. New therapies don't cannibalize our patient population, but they shift curve, delay time before these patients go on to first line chemotherapy
- Next newsflow milestone? Both prostate trials will have data in 2013. We will next be talking about enrollment and when its completed