Telcyta + carboplatinum phase II trial
- platinum refractory or resistant ovarian cancer fully enrolled with 53 patients
- recent gynecology society update (October) was 54% ORR with 26 enrolled (Includes 15% CR)
- median duration of survival of 52 weeks for responders
- progression free survival of 26 weeks
- additional objective responses have been seen since recent October update, including complete responses
Telcyta + doxil phase II trial
- platinum refractory / resistant ovarian cancer fully enrolled with 51 patients
- recent October update: 42% ORR, all PR, with 2 PRs showing greater than 95% tumour shrinkage. 19 patients evaluable
- 34 weeks median PFS (vs. 13 weeks for doxil); no median duration of response yet since all but 1 remain on therapy
Telcyta + cisplatin phase II trial
- expanded phase II stage right now; have achievedfull dose telcyta + full dose cisplatin
ASSIST-1
- Telcyta vs. Doxil / Hycamtin
- 3rd line setting in platinum refractory – resistant ovarian cancer that has failed 1 of 2 follow-up regimens (either doxil or hycamtin) and must have measurable disease
- Has SPA with FDA
- About 50% US, 50% International patients in Assist-1
- On track to complete enrollment by end of year (this was stressed a couple of times, likely due to questions in recent prudential report)
- Event driven survival endpoint.
- Assume median survival in 2nd line is typically 9 months, and therefore less in 3rd line, so top line data would be Q4 05
ASSIST-2
- Iressa vs Telcyta in 3rd line NSCLC; has SPA. International trial.
- Event driven survival analysis; Iressa expected to show 4.5-6.5 month median survial.
- All US sites open; final euro sites open end of November.
- Expect Q1 05 completion enrollment; Top line data Q4 05
ASSIST-3
- To begin 4Q 04.
- Carboplatin + Telcyta versus Doxil
- 244 patients expected; platinum refractory or resistant ovarian cancer; using ORR (primary) and PFS endpoints
- Enrolling only in US. Expect completion of enrollment by end of Q3 05
- Trial will complete when 244 patients have received at least 6 cycles of drug (unless progression is noted)
- To be clinically relevant, company is looking to double the response rate that Doxil shows in this setting, which is 12%. Company is using Doxil rather than Hycamtin for 2 reasons: 1) Efficacy of Doxil and Hycamtin in this setting are not significantly different, 2) Harvard trial typically site uses Doxil in this setting.
- Didn’t sound like they’ve received, or are looking for, SPA here… kind of odd to me. Wick was very insistent on their diligence in documenting the carboplatinum resistance in these patients
Telintra
- 2 Abstracts, one clinical, one preclinical at ASH
- working on IND enabling studies for oral formulation
Other
- Forecast: 72-75 million spending this year, down from 90-95 million
-Result of focusing resources on telcyta registration, underspending in manufacturing, and push back of oral Telintra formulation toxicology studies to 05
- Preparation of CMC section of Telcyta NDA are underway
Select Q&A tidbits
- Telintra P2: enrollment biased toward higher risk patients; about 35 patients expected for enrollment
- Lower spending driven by lower enrollment in ASSIST-1? No… underspending in manufacturing; difference also in timing of expenses. Basically unrelated to trials but rather to pure r/d and manufacturing.
(I believe this was focused as it again relates to the delay in enrollment that the Prudential report predicted)
- Oral Telintra filing planned for 05, that is part of savings in Q4 (toxicology studies pushed out, etc…)
- Marketing agreement? No new guidance, no comment
- 155 million at hand at end of Q3; enough cash to complete ASSIST-1,2,3… but you don’t want to end trials with 1 or 2 quarters of cash, read: we’ll need another round of financing
In the CC, Wick addressed some of the poor clinical trial comparisons that were made in the Prudential report. Also stressed, when possible, that enrollment for ASSIST-1 was on track to complete in Q4 04.
Looks like Q4 05 will be the Big Bang for Telik. |
