- Here are my notes from the 1q2011 OGXI conference call:
- SATURN trial in castration-resistant prostate cancer (CRPC aka HRPC) combines custersin and chemo- reduce pain as primary endpoint. Company submitted proposed revision to SPA to expand inclusion criteria to be either docetaxel retreatment or cabazitaxel as 2nd line therapy. This would then allow pts who progress during first line docetaxel (expanded pt pool) and would align development plan w/ current PC tx plans.
- cabazitaxel clinical trials showed pain paliation in 8% of pts. Custersin (OGX-011) p2 in similar population was 50% pain palliation in 2nd line
- SYNERGY trial- OS benefit in combo w/ 1st line docetaxel in 800 CRPC pts.
- OGX-011 program goal- show that they can extend and improve lives of PC pts
- OGX427- increased levels of unfolded protein often found in cancer cells, especially in treated patients/cells. When this reaches a critical level, it triggers apoptosis. HSP27 prevents this burden from being reached. Inhibiting HSP27 increases these levels, induces the "unfolded protein response", induces authophagy, higher PC cell death. These data expand potential clinical plans.
- Investigator sponsored trial (IST) p1 direct instillation into bladder cancer is enrolling. data early 2012
- IST randomized p2 monotherapy CRPC
- OGX-427 180 pts metastatic bladder cancer will intiate 2h2011
- AACR 2011- combo of HSP90 inhibitor w/ ogx-011 may enhance clinical activity
- AACR 2011- custersin is regulator of epithelial msenchymal transition (EMT), a process of multiple biochemical changes that allow migration, invasion, metastasis of tumor cells
- Click here for AACR complete presentation info on Past Events page
- Additional prelcinical data will be presented at AUA 5/2011 and ASCO june 2011
- Amortizing teva upfront ($30m) thru 4q2012
- net loss $3m 1q2011
- $81.1m cash 3/31/11 and 9.72m shares out
- q&a session:
- Was trial amendment due to enrollment problems or just trying to stay current? Didn't give a direct answer. No defned timeline for response from FDA re proposed revision
- Company won't comment on pt enrollment numbers
- New combo w/ cabaz- what work has been done so far? To date prelcinical PK work done. Presume that wil maintian 640mg dose of custersin and approved dose of cabaz (I'd be surprised if FDA lets them just right into this combo in the phase 3 program, and it is also risky in my opinion)
- In proposed revised trial- pts first randomized to ogx-011 or placebo blindly. Will straify based on choice of which taxane
- Next update on specifics of NSCLC trial will be when it starts
- No change to size or powering of study. cabaz and docet have both shown similar pain paliation results. Company statistical plan estimates 10% paliation in control arm
- OGXI currently has about 30 employees, will be up to and stable at mid 30s # for next 18-24 months
- Teva now pays for OGX-011 manufacturing- at this point does not run thru OGXI P&L statement
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