* Drug failed to meet goal of improving survival without the
cancer growing
* Drug also failed to meet secondary goal of showing
improved patient response
* ArQule shares down 15 pct
(Adds analyst comments, background; updates share movement)
Jan 11 (Reuters) ? An experimental colorectal cancer drug
being developed by ArQule Inc and Japan?s Daiichi
Sankyo Co Ltd failed to improve patient survival
without the cancer worsening, in a mid-stage trial, sending
ArQule?s shares down 18 percent.
ArQule shares were down 15 percent at $2.48 on the Nasdaq on
Friday morning. They touched a low of $2.39 earlier in the
session.
The trial, which enrolled 122 patients with refractory or
relapsed colorectal cancer, also failed to meet the secondary
goal of showing improved response to the drug tivantinib.
RBC Capital Markets analyst Adnan Butt said the stock fall
was an ?overreaction,? as Wall Street?s financial models did not
include the drug?s use in colorectal cancer.
?We attribute the majority of ArQule?s value to the
second-line liver cancer indication at this stage,? Butt wrote
in a note.
The drug tivantinib, ArQule?s lead candidate, is also being
developed as a potential treatment for hepatocellular carcinoma
or liver cancer.
ArQule and Daiichi in October said they reached an agreement
with the U.S. regulator on the design of a late-stage trial of
tivantinib in liver cancer.
Friday?s trial failure is the latest in a series of
drug-related bad news for the company in the past few months. It
discontinued a lung cancer trial in October and its Asian
partner Kyowa Hakko Kirin Co halted another trial in
August due to safety issues.
Both the trials were related to tivantinib.
The string of trial failures have dragged the company?s
shares, which have lost nearly 53 percent of their value over
the past six months.
MID-STAGE TRIAL FAILS
For the latest mid-stage trial, patients were either given
the drug, tivantinib, twice daily, in combination with older
cancer drugs irinotecan and cetuximab, or placebo plus
irinotecan and cetuximab.
The drug improved patients? progression-free survival (PFS),
or survival without the cancer growing, but the improvement was
not statistically significant.
PFS was 8.3 months for patients treated with the drug,
compared with 7.3 months for those receiving a placebo.
ArQule tied up with Daiichi Sankyo in December 2008 to
co-develop tivantinib in the United States, Europe, South
America and other regions.
The companies plan to continue discussions with colorectal
cancer experts to determine how to proceed with further
development of the drug for this cancer, Daiichi said.
(Reporting by Esha Dey in Bangalore; Editing by Supriya Kurane)
Source: http://drax29.info/update-2-arqule-daiichis-colorectal-cancer-drug-fails-trial
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