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HepC Newsletter
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Dema-@aol.com
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Oct 28, 2009 10:46 PST
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NATAP _http://natap.org/_ (http://natap.org/)
_______________________________________________
Inhibitex Announces Data Presentation at the 60th Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD)
Mon Oct 26, 2009 11:29am EDT
INX-189 Exhibits Favorable Pharmacology Profile in Preclinical Studies
ATLANTA--(Business Wire)--
Inhibitex, Inc. (NASDAQ: INHX) announced today that a poster presentation
describing preclinical data on INX-189, the lead compound from its HCV
nucleotide polymerase inhibitor program, will be presented by Dr. Joseph M.
Patti, Chief Scientific Officer and Senior Vice President of R&D, at the
60th
Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD) in Boston, MA. The full abstract can be viewed at the AASLD
website at
_www.aasld.org_ (http://www.aasld.org) .
The poster (#1611 Patti, et al), entitled "Pharmacological Properties and
In
Vitro Characterization of INX-189, a Liver Targeted Phosphoramidate
Nucleoside
Analogue Inhibitor of NS5b" will be presented in the HCV Therapy:
Preclinical
and Early Clinical Development session from 8:00 am - 1:00 pm on Tuesday,
November 3rd, 2009.
About HCV and Protides
Hepatitis C is a disease of the liver caused by the hepatitis C virus
(HCV). It
is estimated that approximately 4 million Americans and 170 million
individuals
worldwide are infected with HCV. HCV can cause chronic liver disease,
cirrhosis
and cancer, and is the leading cause of liver transplant in the United
States.
Inhibitex is developing a series of proprietary phosphoramidates, or
protide
nucleoside inhibitors, that target the RNA-dependent RNA polymerase (NS5b)
of
HCV. Protides are designed to by-pass the rate limiting first step in the
formation of the active nucleoside triphosphate. INX-189 is a protide of a
2`-C-methyl guanosine analogue. The Company believes that its protides po
ssess
several pharmacological advantages over nucleosides alone and potentially
other
nucleotide prodrugs. These advantages include greater potency, a rapid
conversion of the protide into its active form in the liver, and
potentially
less toxicity due to reduced systemic exposure of the nucleoside.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical
company focused on developing products to treat serious infectious
diseases. In
addition to INX-189, the Company`s pipeline includes FV-100, its
clinical-stage
nucleoside analogue in Phase II development for the treatment of herpes
zoster
(shingles). The Company has also licensed the use of its proprietary
MSCRAMM®
protein technology to Wyeth for the development of staphylococcal
vaccines.
For additional information about the Company, please visit
_www.inhibitex.com_ (http://www.inhibitex.com) .
Safe Harbor Statement
This press release contains forward-looking statements within the meaning
of the
Private Securities Litigation Reform Act of 1995 that involve substantial
risks
and uncertainties. All statements, other than historical facts included in
this
press release, including statements regarding the Company`s belief that its
protides possess several pharmacological advantages over nucleosides alone
and
potentially other nucleoside prodrugs, are forward looking statements.
These
results and expectations may not be achieved in the future and various
important
factors could cause actual results or events to differ materially from the
forward-looking statements that the Company makes, including the risk of:
the
Company not obtaining regulatory approval on a timely basis, or at all, to
advance the development of INX-189 into clinical trials; the results of
ongoing
or future preclinical studies of INX-189 not supporting its further
development;
obtaining, maintaining and protecting the intellectual property
incorporated
into and supporting the commercial viability of the Company`s product
candidates; and other cautionary statements contained elsewhere herein and
in
its Annual Report on Form 10-K for the year ended December 31, 2008, as
filed
with the Securities and Exchange Commission, or SEC, on March 23, 2009 and
its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 as filed
with
the SEC on August 12, 2009. Given these uncertainties, you should not place
undue reliance on these forward-looking statements, which apply only as of
the
date of this press release.
There may be events in the future that the Company is unable to predict
accurately, or over which it has no control. The Company's business,
financial
condition, results of operations and prospects may change. The Company may
not
update these forward-looking statements, even though its situation may
change in
the future, unless it has obligations under the Federal securities laws to
update and disclose material developments related to previously disclosed
information. The Company qualifies all of the information contained in this
press release, and particularly its forward-looking statements, by these
cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.
Inhibitex, Inc.
Russell H. Plumb, 678-746-1136
Chief Executive Officer
_rpl-@inhibitex.com_ (mailto:rpl-@inhibitex.com)
***********************
NATAP _http://natap.org/_ (http://natap.org/)
_______________________________________________
ZymoGenetics Initiates Phase 2 Clinical Trial of PEG-Interferon lambda in
Hepatitis C with Bristol-Myers Squibb
Tue Oct 27
PEG-Interferon lambda is a Targeted Type 3 interferon in development for
Hepatitis C
SEATTLE--
ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a
Phase 2
clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in
treatment-naïve
patients with chronic hepatitis C virus (HCV) infection (the "EMERGE"
study).
The first patient has been dosed in the study, triggering a $70 million
milestone payment to ZymoGenetics from Bristol-Myers Squibb Company
(NYSE:BMY),
pursuant to the terms of a previously announced collaboration agreement.
"In the Phase 1b clinical trial, PEG-Interferon lambda demonstrated robust
antiviral activity and was well tolerated in patients with genotype 1
hepatitis
C," said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical
Officer
of ZymoGenetics. "Because PEG-Interferon lambda binds to a unique
receptor, it
has the potential to treat HCV without many of the treatment-limiting side
effects associated with current interferons."
The EMERGE study is an international, randomized multi-center clinical
trial
that will enroll approximately 50 patients in the first, open label
portion that
will explore a wide range of doses to be tested in the second part of the
study.
The second part of the study is designed to enroll approximately 500
patients.
Weekly subcutaneous doses of PEG-Interferon lambda will be administered
for up
to 48 weeks. The study will assess the safety and antiviral efficacy of
PEG-Interferon lambda compared to PEGASYS®. All patients will also receive
daily
ribavirin. The primary endpoint of the trial is the proportion of patients
who
achieve undetectable levels of HCV RNA after 12 weeks of therapy (cEVR).
Sustained virological response (SVR) defined as undetectable levels of HCV
24
weeks after treatment will also be assessed.
PEG-Interferon lambda
PEG-Interferon lambda (IL-29) is a novel type 3 interferon in development
for
hepatitis C. The native human protein Interferon lambda is generated by the
immune system in response to viral infection. In a Phase 1b clinical trial
in
patients with relapsed HCV, administration of PEG-Interferon lambda over
four
weeks in combination with ribavirin was shown to be well-tolerated and
resulted
in significant antiviral activity.
About ZymoGenetics
ZymoGenetics is focused on the creation of novel protein drugs to improve
patient care and address unmet medical needs. The company`s strategy is to
discover, develop and commercialize its products independently, in
collaboration
with partner companies or through out-licensing. ZymoGenetics developed and
markets RECOTHROM® Thrombin, topical (Recombinant), a synthetic version of
a
human blood-clotting enzyme used to stop bleeding during surgery. The
company is
developing a proprietary portfolio of immune-based product candidates.
PEG-Interferon lambda is a novel type-3 interferon in clinical development
for
the treatment of chronic hepatitis C infection. Interleukin-21 is a novel
cytokine in clinical development for the treatment of metastatic melanoma
and
renal cell carcinoma. Several other proprietary product candidates are in
preclinical development. In addition, ZymoGenetics has licensed rights to
multiple clinical and preclinical drug candidates being developed by other
companies. For further information, visit _www.zymogenetics.com_
(http://www.zymogenetics.com) .
ZymoGenetics Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning
of
the Private Securities Litigation Reform Act of 1995.These forward-looking
statements are based on the current intent and expectations of the
management of
ZymoGenetics.These statements are not guarantees of future performance and
involve risks and uncertainties that are difficult to predict. ZymoGenetics
actual results and the timing and outcome of events may differ materially
from
those expressed in or implied by the forward-looking statements because of
risks
and uncertainties associated with clinical development.For example, the
results
of preliminary studies do not predict clinical success, and larger and
later-stage clinical trials may not produce the same results as
earlier-stage
trials.In addition, the forward-looking statements in this press release
are
subject to the other risks detailed in the company's public filings with
the
Securities and Exchange Commission, including the company's Annual Report
on
Form 10-K for the year ended December 31, 2008 and Quarterly Report on
Form 10-Q
for the quarter ended June 30, 2009. Except as required by law,
ZymoGenetics
undertakes no obligation to update any forward-looking or other statements
in
this press release, whether as a result of new information, future events
or
otherwise.
PEGASYS® (Peginterferon alfa-2a) is a registered trademark of Hoffman La
Roche.
Media and Investors
ZymoGenetics, Inc.
Susan W. Specht, 206-442-6592
_spe-@zymogenetics.com_ (mailto:spec-@zymogenetics.com)
**********************
HCV Trial Begins for New Immune Drug
_http://www.hepatitis-central.com/mt/archives/2009/10/hcv_trial_begin.html?e
ml=hepcen92_
(http://www.hepatitis-central.com/mt/archives/2009/10/hcv_trial_begin.html?eml=hepcen92)
Hepatitis, Liver Enzymes and Fibrosis Progression
_http://www.hepatitis-central.com/mt/archives/2009/10/does_alt_correl.html?e
ml=hepcen92_
(http://www.hepatitis-central.com/mt/archives/2009/10/does_alt_correl.html?eml=hepcen92)
The Relationship Between Hepatitis C and Vascular Disease
_http://www.hepatitis-central.com/mt/archives/2009/10/the_relationshi.html?e
ml=hepcen92_
(http://www.hepatitis-central.com/mt/archives/2009/10/the_relationshi.html?eml=hepcen92)
Medivir AB and Tibotec Partner Up To Develop Hepatitis C Polymerase Drug
_http://www.hepatitis-central.com/mt/archives/2009/10/medivir_ab_and.html?em
l=hepcen92_
(http://www.hepatitis-central.com/mt/archives/2009/10/medivir_ab_and.html?eml=hepcen92)
Weight-Loss Shortcut Can Cause or Worsen Liver Disease
Even though losing weight is the best way to reduce the risk of fatty
liver disease, how you shed the pounds is crucial to your liver’s health.
by Nicole Cutler, L.Ac.
_http://www.liversupport.com/wordpress/2009/10/weight-loss-shortcut-can-caus
e-or-worsen-liver-disease/?eml=lshn46_
(http://www.liversupport.com/wordpress/2009/10/weight-loss-shortcut-can-cause-or-worsen-liver-disease/?eml=lshn46
)
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