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Author: marsuculix One star, 50 posts Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 659  
Subject: Clinical update - 11/14/2012 Date: 11/15/2012 12:12 PM
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Fools, as promised, my update on the clinical development with cabozantinib:

1) Trials in MTC (EXAM) completed and submitted - PDUFA date 11/29/2012

2) COMET trials (COMET-1 and COMET-2) in castration resistant prostate cancer patients (CRPC) have a high focus for entire company. CRPC indication landscape is very dynamic and gets more crowded with time. BUT, non of the patients treated with one of the multiple agents really got cured.
2a) COMET-1: overall survival end-point. Enrollment of 960 patients planned across 280 sites; pretreated with docetaxel, abiraterone or enzalutamide in either order; 100mg cabozantinib
2b) COMET-2: pain palliation end-point. Envisioned to enroll 246 patients in 50 centers; +/- the same patient population with bone pain >4 on the brief pain inventory; 100mg cabozantinib
2c) Non-randomized expansion cohort; 51 patients on 40mg regimen; interim data are consistent with 100mg cohort, but adverse events were less frequent - there were no great 5 AEs.

3) Next clincal focus: Hepatocellular Carcinoma (HCC) and/or Renal Cell Carcinoma (RCC)

Since MET and VEGF pathways are implicated in a broad number of tumor indications, Exelixis has clinical activities in 12 different tumor indications to-date.

Various trials are performed under Exelixis' CTEP (NCI-sponsored) and Investigator Sponsored Trial programs (11 studies). Cost burdens of these programs are marginal - roughly $ 20'000 per study.
According to Frank A. Karbe, Exelixis seems to be in a strong financial situation - the company ended 3q2012 with $ 675 million in cash.

Update on Exelixis' future gems besides cabo (my summary earlier today was incomplete):
1) GDC-0973 / XL518
2) Two PI3K inhibitors XL147 and XL765, which are in collaboration with Sanofi
3) XL880 similar compound to Cabo (also VEGF and MET inhibitor), partnered with GSK.
4) XL139 partnered with BMS
5) XL550; Exel's MR program for whitch the company received a $ 5.5 million milestone payment in 3q2012

marsuclix, impressed by the broad bunch of studies...
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