Healthcare shares are flat in pre-market. Agenus Inc. (
) is soaring 22% at $33.34 after it said its Phase 2 trial in
patients with newly diagnosed glioblastoma multiforme, a form of
brain cancer, treated with Prophage Series G-100 in combination
with the current standard of care showed an almost 18-month median
progression free survival, a 160% increase versus current standard
of care alone.
Agenus plans to hold an end of Phase 2 meeting with the US Food
and Drug Administration to discuss a Phase 3 trial that could
potentially lead to marketing approval of the HSPPC-96 vaccine as a
treatment for patients with newly diagnosed GBM.
The shares are trading near the middle of their 52-week range of
$2.45 - $5.40.
And, Regado Biosciences (
) is up 11.4% after it said it has enrolled the first patient in
its REGULATE-PCI clinical trial. REGULATE-PCI is a Phase 3, PROBE
design superiority study.
The trial is designed to compare the effects of RGDO's REG1 to
bivalirudin in patients undergoing percutaneous coronary
intervention electively or for the treatment of unstable angina or
non-ST elevated myocardial infarction.
Should REGULATE-PCI be successful, the company will use it as
the basis for product registration applications, expected to be
filed in early 2016. The first of three key interim analyses in the
trial will occur after enrollment of the first 1,000 patients and
is expected to occur during Q2 of 2014.
Finally, BioLineRx (
) said it has received a Notice of Allowance from the United States
Patent and Trademark Office for BL-8020, an orally available,
interferon-free treatment for hepatitis C. The patent will be valid
until at least 2031.
BioLineRx is currently conducting a Phase 1/2, open-label study
at two sites in France to evaluate the efficacy, safety and
tolerability of BL-8020 in patients infected with HCV. The shares
trade in a 52-week range of $1.55 - $5.10.
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