Notes...
as fast as I could type and listen.... excuse spelling etc.
Did financing because felt it was better than what a "partner" (BP) would offer at this time. Phase II data historically dirves value, make better deals with this data. Soon have 6 PII trials.
$32MM on hand, most in history. Drive trials.
6 PhII planned
PH1B trial, 4th relapse, enrollment went well, 50% objective tumor response, 75% gemcibine OBT. Greater than 30% tumor shrinkage, safety same as just with chemo.
US trial, clinical data from India and US studies and preclinical, support moving Bavi into PHII. Implement 6PHII trials. First announced today.
India protocol submitted, 21 patients safety and efficacy, 2nd stage add 28.... total 49 patients.
Must be approved by India, hopefully initiate by fall.
Want to evaluate different cancers with diff. chemos, like DNA.
File protocols for 5 more with diff tumor types, chemo and radiation.
Interest in BP, but PHII data is where you drive value
Cotara PHII beginning soon, treat 40 patients, safety efficacy, clinical sites already identifying patients, start soon
MUSC Cotara, Dr. Patel already run pre clinical. Working with Media out reach.
Strong interest from partners on Cotara, positive data create value
HCV, 24 patients, 4 doses as solo, good safety and promising data, Duke looking at.
Bavi binding to HCV and HIV, support HIV/HCV trial. Pleased to announce trial. Dose escalation trial of 24 patients. Safety and viral load reduction. Weekly dosing for 8 weeks, longer treatment. Dr. Smith active involvement a plus.
Collab with Duke is strong, new insights on HIV. Look forward to reporting results.
Trial to get optimal Bavi dose for HCV. Data from HCV/HIV give data.
Test with HCV drugs.
We and advisors are very pleased with results to date
Summary.... look forward to FY 2008 (in FY 2008 now). Robust pipeline, 11 trials in FY 2008.
Cotara PHII trial
Expand clinical, IB on board to help, road shows, news flow broader media outreach. PHII better media coverage, improved PPS.
Q&A
Brandon Cox-Private Investor
Cotara... MRI every 2 months? Will it blow away Standard of Care. Fast Track status?
Excited, periodic MRIs. Median survival time. Median time to progression. Progress trial quickly, update when possible. Fast Track, if can get numbers like b4 may get fast track.
HOW SICK ARE PATIENTS IN LUNG CANCER?
PH1b study still on treatment, but do not get data.
Patient pop will be healthier than PHI, no data, will vary by patient
Robert Browell - PI
Joint Venture, No PIPEs, why no BP partner.
A: Raise money ourselves and be aggressive, Dilution with partner would have been more without PHII. Pleased with trials to date. Felt from data right move to do PIPE. No bonuses.
Merrill Lynch
Congrats on such a small co. starting 6 PHII trials.
Small cell lung why?
Natural with chemo, easier to get patients, encouraged by PH1 study.
Will see variety of diff types of cancer and chemos in other 5 trials
6 chemo doses and 8 bavi. Chemo every 3rd week, get bavi every week. 18 weeks, or until they progress (until cancer gets worse). Grow by more 30% or new lesions off trial. Monitor at 8 weeks to see if drug effects, 8 wks general test time
Saks Investment research
Avid, capacity, more deals to gen. cash.
A: Additional capacity, Avid drive Bavi. Believe uptick in Avid, revs excess of reported FY07.
Summary
Believe stongest position ever, financial, look forward to creating value.
