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Biotech / Medical : TELK -- Telik, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (578)	1/21/2006 5:40:43 AM
From: zeta1961	Respond to of 887

Avastin 1st line NSCLC abstract [ASCO 2004..parking here for reference] Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial - E4599 Abstract No: 4 [ASCO 2004..parking here for reference] Author(s): A. B. Sandler, R. Gray, J. Brahmer, A. Dowlati, J. H. Schiller, M. C. Perry, D. H. Johnson Abstract: Background: Platinum-based chemotherapy doublets remain the standard of care for patients with stage IIIb (pleural effusion) & stage IV NSCLC. The results of a randomized phase II trial of PC ± bevacizumab (B) suggested improved activity for PCB compared to PC alone (Johnson, DH et al., JCO, 2004). Gr 5 hemoptysis was seen in the PCB arms; central tumor location & squamous histology were risk factors. Methods: The primary endpoint was to compare the effects of the addition of B to PC on overall survival in patients (pts) with previously untreated non-squamous NSCLC. Secondary endpoints included response rate, time to progression, & tolerability. Correlative studies included plasma VEGF, VCAM, E-selectin, & basic fibroblast growth factor. Eligibility criteria: ECOG PS 0 or 1, & adequate hematologic, renal, & hepatic function, no brain metastases. Pts were randomized to receive P 200 mg/m2 + C AUC=6 on day 1 every 3 wks or PC + B 15mg/kg day 1 (PCB) every 3 weeks. Pts on PCB continued B after 6 cycles until progressive disease or intolerable toxicity. With 842 pts entered & a total information of 650 deaths, this study was designed to have 91% (80.5%) power to detect a 30% (25%) improvement in median survival from 8 months on PC to 10.4 (10.0) months on PCB with an overall one-sided type I error of 2.5%. Results: From 7/01 - 4/04, 444 pts were assigned to PC & 434 to PCB. 14% were stage IIIB. This 2nd planned interim analysis was conducted with 469 of a planned 650 deaths (72.2%) for full analysis. Response rate (10% vs. 27%, p<0.0001); progression-free survival (4.5 mo. vs. 6.4 mo., p<0.0001); & median survival (10.2 mo. vs. 12.5 mo., p = 0.0075) all favoring PCB. Both regimens were well tolerated with selected toxicities: (PC vs. PCB): grade 4/5 neutropenia (16.4% vs. 24%); gr ¾ thrombosis/embolism (3% vs. 3.8%); & hemorrhage (1.0% vs 4.1%). There were 11 treatment-related deaths (arm PC: 2; arm PCB: 9); 5 due to hemoptysis, all on arm B. Conclusions: The addition of B to PC in pts with NSCLC (non-squamous) provides a statistically & clinically significant survival advantage with tolerable toxicity. PCB is ECOG's new treatment standard in this patient population.

To: Icebrg who wrote (578)	8/7/2006 11:32:19 AM
From: tuck	Read Replies (1) \| Respond to of 887

Now Mr. Webb doesn't like it when it's two bucks cheaper (now three thanks to his mercurial opinions), when basically nothing has changed. His firm downgraded it this morning. Were there any new disclosures in the recent CC that bothered anyone? Cheers, Tuck

To: Icebrg who wrote (578)	12/14/2006 1:01:20 PM
From: zeta1961	Read Replies (1) \| Respond to of 887

Erik, I found a Needham bullish report at YMB but I can't authenticate that it's real or recent...there's no date nor name of analyst attribution..it appears in line with Needham's take back in January(in the post I'm replying). Telik, Inc. (TELK) – Strong Buy TELK: Will the ASSIST Trials Work? Will TELCYTA be Approved? What is the Market Opportunity? Reviewing These Issues and Reiterating STRONG BUY, $33 Target Price Results from all three ASSIST trials are expected to be released simultaneously—we believe later this month. We maintain that Telik will be able to submit an NDA application if any of the three trials reaches the primary outcome in a statistically significant and clinically relevant manner. In this note, we review the market opportunity for TELCYTA and the basis for our confidence in Telik’s development strategy for TELCYTA. We believe the company has done its homework, testing TELCYTA in 13 Phase 1 and 2 trials. Based on the design of the three Phase 3 ASSIST trials, we are optimistic about TELCYTA’s potential. We also believe that the regulatory risk associated with ASSIST-3 is real, but may be overstated. Specifically, we believe the recent FDA workshop on ovarian cancer endpoints reflected the FDA’s recognition of the need for new therapies for platinum-resistant/refractory ovarian cancer patients. We also note the precedence for response rate as the basis for approval of Doxil and Hycamtin in ovarian cancer. Based on prior clinical data, we also believe ASSIST-3 has the highest probability of clinical trial success. We are optimistic towards ASSIST-1 given prior clinical data and note the minimal regulatory risk associated with this 3rd line ovarian cancer trial should it meet its primary endpoint. Finally, while we are encouraged by the Phase 2 NSCLC data, we note the hurdle for demonstrating a survival advantage in ASSIST-2 in the 3rd-line NSCLC setting is substantial. If the trials are positive, we project Telik’s peak revenues (WW sales) of TELCYTA in ovarian cancer to be ~$406 MM in the second-line setting, and $175 MM in the third-line ovarian setting. Likewise, we conservatively estimate ~$320 MM in peak US sales in the third line NSCLC setting. In all, we believe TELCYTA has the potential to reach more than $1B in WW peak sales, not including potential upside from a potentially positive outcome from ASSIST-5 in ovarian cancer (underway) and ASSIST-4 (planned in NSCLC) or trials in other settings (currently planned). Based on these assumptions in market opportunity, we believe the stock has substantial upside.