Posted 4/9/12 on The Street. From the sounds of it, embargoed data showing the EOT response with daclatasivr and GS-7977 combo was mistakenly published on the EASL website over the weekend, showing an encouraging 97% EOT response in tx-naive genotype 1 patients and 90% in genotype 2 and 3 subjects. An analyst picked this up and sent a research report to his clients. It's unclear at this time whether this was the arm with ribavirin or without... further speculation on my part says that if it is indeed without ribavirin, we need to keep a close eye on the relapse rates. EOT is, unfortunately, not SVR.
Bristol-Gilead Hep C Drug Data Leaks
Adam Feuerstein
04/09/12 - 09:29 AM EDT
Updated with a corrected research report from Jefferies, noting that the end-of-treatment response to daclatasvir and GS-7977 was actually 97%, not 93%.
BOSTON (TheStreet) -- An early peek at data from a closely watched mid-stage study combining hepatitis C drugs from Bristol-Myers Squibb(BMY) and Gilead Sciences(GILD) has leaked in advance of the European Association for the Study of the Liver (EASL) annual meeting.
Ninety-seven percent of genotype 1 hepatitis C patients treated with Bristol's daclatasvir and Gilead's GS-7977 has undetectable viral levels after 12 weeks of treatment. For genotype 2/3 patients, the 12-week response rate was 90%, according to a research note published Monday by Jefferies analyst Thomas Wei.
Wei called the end-of-treatment response to daclatasvir-GS-7977 "encouraging" and "positive."
These data from Bristol and Gilead were supposedly embargoed by EASL and were therefore not made available to the public when research abstracts for the EASL meeting were posted online on April 4.
In an email to clients Monday, Jefferies said the Bristol-Gilead abstract was "briefly posted" on EASL's web site over the weekend before being taken down.
Officials with EASL have not responded to questions regarding the leak of the research abstract.
Interim results from a phase II study combining Bristol's NS5a inhibitor daclatasvir (BMS-52) with Gilead's GS-7977 in genotypes 1, 2, and 3 is the most highly anticipated data presentation at the EASL meeting this year. The study is important because it will be one of the first glimpses at the Hep C-killing potency of these two classes of direct-acting antivirals combined into a single, all-oral therapy.
Early cure rates from the dacalatasvir-GS-7977 study -- defined as the percent of patients with undetectable viral loads four weeks after cessation of treatment -- will be presented at the EASL meeting, which takes place April 18-22.
--Written by Adam Feuerstein in Boston.
Posts
No comments:
Post a Comment