- focus on POC trials for 926. Two p2 initiated- clinically relevant endpts. addl trials begin 2011
- completing hsp90 trials- 4 ongoing 2x each 504 and 493 to determine future of program- data mid-yr (p1b w/ docetaxel in NSCLC) and program update.
- move 145 into clinic and ID new candidate- internal and external- focus on oncology and inflammation w/ POC data in hand or generated by ye2012
- 926 Smoothened inhibitor targets hedgehog pathway for cancer--recently completed p1b w/ metastatic pancreatic cancer once daily w/ gencitabine, now transitioned into p2 portion- multictr, doubleblind, 120 pts. primary endpt OS, 2ndry PFS, TTP, ORR. median survival ~6 months for gem (std of care). p1b data present later this yr
- p2 926 in met or locally advanced chondrosarcoma (cartalidge)-100 pts 2:1 vs placebo. endpt PFS, can crossover at progression. have met with fda and emea. first andomized trial in this indication. have us orphan and seeking in eu
- basal cell carcinoma- followup data 2011.
- FAAH expect 940 pain p2 studies to start by purdue in 2011
- 145 PI3K inhib p1 2h2011- infamm and oncology indications. pmol potency, delt and gamma duel specificity. haven't decided order of devel plan
- name new devel candidate for cancer this yr- further details at that time
- 99.2m r&d expenses- includes reimbursement and 13m license fee to acquire PI3k pgm from intellikine (25m devel milestones possible, undisclosed). end 2011 w/ 60-70m cash plus 50m line of credit and 120m mundi 2012 funding commitment=30-40m cash burn. cash into 2014.
- Q&A session:
- 926 guiding for p2 data by end of 2012 for both studies
- hsp90- filed abstracts for medical mtgs
- pain data timeline guidance will have to come from purdue
- PI3k pgm is included in relationship w/ purdue/mundi- INFI doesnt development at their cost, INFI commercializes in US, royalties up to 20% exUS
Just starting to research $INFI, so thought I would post my quick notes from listening to the 4q2010 results conference call.