Flamel Technologies Medusa(R)-Formulated Interferon-Alpha Demonstrates Favorable Antiviral Activity and Safety in a Phase 2 C...
25 6월 2012 - 9:30PM
Marketwired
Flamel Technologies (NASDAQ: FLML) today announced that its
Medusa-formulated interferon-alpha ("IFN a-2b XL") was featured in
a lecture and an oral presentation on June 25 at the 14th
International Symposium on Viral Hepatitis and Liver Disease
(ISVHLD) held June 22-25, 2012 in Shanghai, China. The abstracts
are entitled "Aggregate report on safety and efficacy of a new
sustained release IFN (IFN XL) as compared to standard of care" and
"Medusa formulated Interferon-alpha-2b Shows a Favorable Efficacy /
Tolerability Profile vs. PEGylated IFN-alpha-2b in Hepatitis C
Patients in the Phase 2 Study ANRS HC23 COAT-IFN." The abstracts
presented by Professor Christian Trepo of Hôpital de la Croix
Rousse, Lyon, France, and Roger Kravtzoff, Preclinical and Clinical
Director at Flamel Technologies, demonstrated a favorable antiviral
activity and safety profile as compared with ViraferonPeg™
(marketed in the U.S. as PegIntron™).
The abstracts presented the background, rationale and design of
the on-going studies which are evaluating the therapeutic potential
and safety of Flamel's Medusa-formulated IFN a-2b XL, a long
acting, unmodified (in contrast to PEGylated interferons), fully
active interferon injected once weekly in patients with chronic
hepatitis C virus ("HCV") infection. The full presentation is
available on Flamel's website at
http://www.flamel.com/technology-platforms/medusa/.
In addition, Flamel Technologies announced that it has reached
its enrollment objective of 84 patients in its ongoing Phase 2
clinical study: ANRS HC23 COAT-IFN.
The principal investigator of the study, Professor Christian
Trepo, remarked, "Preliminary results of this Phase 2 study are
very consistent with those of Phase 1 and support the proof of
concept of an improved tolerance without loss of efficacy of IFN
XL. We believe this fulfills one of the most awaited needs for a
future combination therapy."
Mike Anderson, Flamel's chief executive officer, stated, "Within
the next five years, the number of HBV/HCV patients treated is
expected to grow. In this context, the development of a new
interferon formulation with good efficacy and better tolerance will
be an important factor in hepatitis C treatment. Our formulation of
Interferon-Alpha XL, a long acting formulation of Interferon-Alpha,
is one of our more important development programs and is an example
of the potential of the Medusa platform to improve the safety and
efficacy of therapeutic proteins. In addition to seeing positive
clinical data with our Medusa-formulated product candidate, we are
grateful for the commitment of our clinical investigators to this
important work and we look forward to their on-going participation
in the trial."
Phase 2 Study Design 84 HCV patients have
been treated in the on-going Phase 2 clinical study, randomized,
three parallel-arm, comparative, open-label, multi-center study and
were allocated to either IFN-a-2b XL, or PegIntron 1.5 µg/Kg, both
in combination with weight based Ribavirin. Patients were each
injected over a twelve-week period to compare the therapeutic
potential and safety of IFN-a2b XL versus PegIntron in patients
with chronic hepatitis C virus (HCV) infection (genotypes 1 and 4).
This study was conducted on both naïve and non-responder
patients.
This Phase 2 clinical study is sponsored by Inserm-ANRS (French
National Institute of Health and Medical Research -- French
National Agency for Research on AIDS and Viral Hepatitis).
Summary of Results In the Phase 2 clinical
study, the Medusa-formulated IFNa-2bXL at 27MIU has demonstrated a
remarkably consistent safety profile across all available data.
Improved tolerability of IFNa-2bXL was obtained in addition to good
efficacy since the antiviral activity of IFNa-2bXL appears at least
similar to that of reference Peg-IFNa-2b in a 3-month course of
combined therapy.
Safety and Tolerability The available
study data confirms the results obtained from previous clinical
studies, indicating an improved tolerability of Medusa-formulated
IFNa-2bXL at 27MIU compared to PegIntron. No serious adverse events
were reported as definitely or probably attributable to
Medusa-formulated IFN a-2b XL.
About IFN-alpha-2b XL IFN-alpha-2b XL is a
new formulation of recombinant Interferon alpha-2b based on
Flamel's proprietary Medusa hydrogel delivery system. Medusa is a
versatile biodegradable carrier for the development of a wide range
of novel and second-generation long-acting protein and peptide
products. IFN-alpha-2b XL is designed to provide patients with a
longer acting and more tolerable approach to interferon therapy
compared with approved interferon regimens.
About Hepatitis C Hepatitis C virus is a
blood-borne pathogen that causes inflammation of the liver.
According to the U.S. Centers for Disease Control and Prevention
(CDC), more than 75 percent of people infected with HCV will
develop chronic infections, and 60 to 70 percent of these people
will subsequently develop chronic hepatitis. HCV infection is the
most common blood-borne viral infection in the United States.
Approximately 4 million people in the United States are infected
with HCV and the World Health Organization estimates that 170
million people worldwide -- 3 percent of the world's population --
are infected with HCV.
About Flamel Technologies Flamel
Technologies SA (NASDAQ: FLML) is a leading drug delivery company
focused on the goal of developing safer, more efficacious
formulations of drugs that address unmet medical needs. Its product
development pipeline includes biological and chemical drugs
formulated with the Medusa® and Micropump® proprietary platforms.
Several Medusa-based products are at various clinical stages of
development; Medusa's lead internal product candidate IFN-alpha XL
(long-acting interferon alpha-2b) is being evaluated a Phase 2a
trial in HCV patients. The Company has developed approved products
and manufactures Micropump-based microparticles under FDA-audited
GMP guidelines. Flamel Technologies has collaborations with a
number of leading pharmaceutical and biotechnology companies,
including GlaxoSmithKline (Coreg CR®, carvedilol phosphate) and
Merck Serono (long-acting interferon beta-1a). Flamel recently
acquired Éclat Pharmaceuticals, a St. Louis, Missouri-based
specialty pharmaceutical company focused on developing and
commercializing niche brands and generic products. Additional
information can be found at www.flamel.com
This document contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including certain plans, expectations, goals and projections
regarding financial results, product developments and technology
platforms. All statements that are not clearly historical in nature
are forward-looking, and the words "anticipate," "assume,"
"believe," "expect," "estimate," "plan," "will," and similar
expressions are generally intended to identify forward-looking
statements. All forward-looking statements involve risks,
uncertainties and contingencies, many of which are beyond our
control that could cause actual results to differ materially from
those contemplated in such forward-looking statements. These risks
include risks that the acquisition of Éclat Pharmaceuticals will
not be successful, the expected timing of the filing of our first
New Drug Application (NDA) with the FDA may be delayed, the
identified opportunities will not result in shorter-term, high
value results, clinical trial results will not be positive or that
our partners may decide not to move forward, management transition
to a new chief executive officer may be disruptive or not succeed
as planned, products in the development stage may not achieve
scientific objectives or milestones or meet stringent regulatory
requirements, products in development may not achieve market
acceptance, competitive products and pricing may hinder our
commercial opportunities we may not be successful in identifying
and pursuing opportunities to develop our own product portfolio
using Flamel's technology, and the risks associated with our
reliance on outside parties and key strategic alliances. These and
other risks are described more fully in Flamel's Annual Report on
Form 20-F for the year ended December 31, 2011 that has been filed
with the Securities and Exchange Commission (SEC). All
forward-looking statements included in this release are based on
information available at the time of the release. We undertake no
obligation to update or alter our forward-looking statements as a
result of new information, future events or otherwise.
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