- OncoGenex held its 2q2011 earnings conference call on August 4, 2011 - click here for results press release.
- For detailed information on the company's programs, visit the OGXI research page.
- For future OGXI analyst conference presentations, visit the master calendar of Upcoming Events.
- My notes from the webcast are after the jump:
- Re custersen (antisense against clusterin, licensed from ISIS and partnered w/ TEVA)
- SYNERGY is primary registrational phase 3 trial, in combination with docetaxel. In recent discussions w/ the FDA about amended protocol, they indicated that a filing containing this trial's data alone would be acceptable, independent of SATURN trial completion. This verifies that a single, adequately controlled, well-designed trial showing overall survival (OS) benefit, and also supported by phase 2 trial data with a survival benefit can be acceptable.
- SATURN trial - pain palliation endpoint. Protocol revision would expand patient population. Any patient with pain and considering 2nd line chemotherapy can participate. This would align the trial with current 2nd line market. We have received comments on the revised protocol and have amended protocol to incorporate these comments. We are awaiting the written SPA amendment approval from FDA. We have already received approval in Canada and expect the same from EU this month. So far very few patients have enrolled because of the restrictive entry criteria...if the amndedment fixes the problem, now expect topline data 4q2013 instead of 2q2013 previous guidance. [This the update, along w/ NSCLC delay described below, that sent OGXI shares plunging on the date or earnings release..they have since recovered quite a bit of the losses]
- SYNERGY trial data will also be reported ~4q2013
- Initiation of NSCLC phase 3 combo trial has been delayed. Issue is needing to decide on which chemotherapy regimen. Teva has been conducting routine drug-drug interaction studies to see if custersen interferes with the metabolism of one of the potential chemo agents (paclitaxel). A cell line study showed inhibition of the enzyme that breaks down the chemo agent, but preclinical studies show induction of the same pathway. [see below...there was a clinical study with healthy human volunteers also] So they are completing additional studies. In parallel we are considering other frequently used agents for the combination...such as gemcitabine, cisplatin, docetaxel and haven't observed any interactions. We remain committed to advancing the drug for this population. [Count me as skeptical at this point. I could see this trial never starting. Hopefully TEVA doesn't drop OGXI deal due to these multiple issues, because then OncoGenex would be in deep trouble with no way to pay for completion of studies]
- OGX-427: phase 2 prostate cancer trial enrollment continues, and phase 1 ongoing in baldder cancer...expect data reports for both trials in 2012.
- Expect 180 patient phase 2 randomized trial to intiate later in 2011
- 2q2011 net loss $6.5m
- Expect low end of $31-35m cash burn for 2011
- Expect high end of cash balance $50-54m ye2011 [I assume the "improved" cash use results is due to lack of NSCLC trial cost sharing in 2011]
1) [Analyst is confused about SATURN trial changes]. There is no change in trial size. We are just adding cabazitaxel as option for 2nd line chemotherapy agent.
Re the bladder cancer trial. Are other treatments allowed? This trial will be starting around the end of this year. First line gemcitabine-cisplatin chemo. It will have 3 arms. Gem-Cis as well as two doses of OGX-427 added to this combo.
2) Impact on abiraterone or your trials, reducing retreatment? Not sure we can address that, don't have clarity on its impact in this patient population [Why not? weak answer]
Clarify re drug drug interaction study? It is pretty complicated...the preclinical work was with paclitaxel. Clinical trial used another agent that is metabolized by the same enzymes (can't use chemotherapy on healthy volunteers)
Lung cancer trial- will you accept all comers vs phenotype screening? Custersen has activity across broad array of patients, the vast majority overexpress clusterin, so we don't need to screen. But we are focusing on adenocarcinoma vs squamous cell carcinoma type.