2/14/2011 Webcast
4/6/2011 Webcast
- OGXI is focused on addressing treatment resistance in cancer
- Phase 3 trial of OGX-011 in NSCLC is on track to initiate in 2011
- OGX-427 randomized phase 2 trial in metastatic bladder cancer will start later in 2011
- Cash on hand sufficient into 2014
- OGX-2310 is available for outlicensing because not related to treatment resistance focus- this is a formulation product of an existing drug
- Phase 3 trials have interim looks, mostly for safety and futility by DSMBs- OGXI has not disclosed the number of events (deaths) that trigger the interim analyses
4/6/2011 Webcast
- inhibit clusterin- fight off resistance and add to efficacy of other agents
- TV1011 is TEVA designation for OGX011
- SATURN trial initiated 2q10- bone mets is what are debilitating. primary endpt is pain paliation. 60% of p2 pts had paliation, 80% durable 12 wks of more-other agents reported about 10%
- SYNERGY trial in first line (follow on to randomized p2 design, combo w/ decoetaxel. 6.9m improvement 0.61 HR- cant find any imbalances, side biases, subsequent tx effects, etc to explain besides tx effect). SPA< OS primary endpt
- continue to enrol both above 011 trials thru 2011
- Upcoming NSCLC trial will be 950 pts, larger than previously thought (700), initiate 2h2011. chemotherapy-naive stage 4 patients. carbo-tax +/- 011. pfs, has 2 futility looks and one interim analysis. huge financial commitment by teva. (but no controlled p2 data). 14 month survival vs 8-11 m historical.
- cash into 2014- realize pc p3 trials and get 427 thru p2
- 427 bladder cancer randomized p2 start later 2011. 5th largest indication 160k in 7 largetst mkts. TTP 8 months, 13m median survival
- new therapies entering mkt are opportunities, not competitors
- AACR presentation: clusterin is survival mechanism that confers resistance. if you inhibit this, reduce hsp90 levels- could augment hsp90 inhibitors...Clusterin has direct role in EMT transition...migration and invasisveness/metastasis
- OGX-427: HSP27 interacts with AR and brings into nucleus, required for function. Knockdown leads to degration of receptor
- randomized p2 in prechemo space. Will test a combination w/ anti-androgen eventually
- superficial bladder cancer- direct infusion dose escalation
- 85m cash ye10, will burn $31-35m 2011, leaves cash at year end 2011 of $50-54m. 9.7m shares
- q&a
- OGXI employed a creative p1 clinical design. early prostate cancer pts. dosed for 5 wks w/ hormone ablation, then prostatectomy. Were able to answer questions like- how much drug got into prostate? how much target knockdown? saw 92% reduced HSP27 in prostate, 98% in LN. Note: prostate doesnt like to admit charged drugs, similar blocking mechanism to blood brain barrier
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