
HCV
Advocate easl 2007 News Review
Week Ending:
In This Issue:
Hepatitis C
·
Firm's Future Hinges
on New Hepatitis Drug
·
Bullish Views on Vertex
ahead of Liver Meeting
·
Analysis: Total
Hepatitis C Cure Possible
·
Idenix Midstage
Study Results Mixed
·
Viropharma:
Hepatitis-C Treatment More Effective in Combination
·
Higher Doses of Ribavirin
Are Effective in Hepatitis C Virus Genotype 1 Patients: Presented at EASL
Hepatitis B
·
ANA380 Exhibits Activity In Vitro
Against Multiple Clinically Relevant Hepatitis B Virus Mutants
Download PDF version of
this News Review:
April 9th, 2007
By Stephen Heuser, Globe Staff
For one of Boston's biggest
biotechnology companies, the future hinges on a potential billion-dollar drug
and a liver-research conference about to kick off 3,700 miles away in Spain.
At the annual meeting of the
European Association for the Study of the Liver , starting this week in
Barcelona, perhaps the most hotly anticipated presentation will be Vertex
Pharmaceuticals Inc.'s unveiling of new data from human trials of its pill for
hepatitis C.
Between 3 million and 4
million Americans are thought to be infected with hepatitis C, a virus that can
lead to cancer and liver failure. It spread through the blood supply before
broad screening began in the early 1990s. Infected people can harbor the
disease without symptoms for over a decade.
Vertex's pill, which mounts a
new type of attack on the virus, has achieved dramatic results in early tests on
a handful of infected patients. In most, it appeared to eradicate the virus in
a matter of weeks. On Saturday evening the company plans to unveil details of a
bigger trial on 250 patients, comparing those on standard therapy with others
who got therapy plus Vertex's drug.
Dr. Raymond Chung , a liver
specialist at Massachusetts General Hospital , said Saturday's results won't
tell the whole story, but he called them an important indicator of how well the
drug might work. Along with a handful of similar drugs in development, he said,
"You're seeing the leading edge of a real shift in treatment."
Currently, patients are
prescribed a year's worth of interferon injections plus pills, an $18,000
course of therapy that causes symptoms like a severe flu, and cures half of
those who endure it.
Chung said he was particularly
interested in one "shoot-the-moon" strategy that Vertex was
employing. In a multipart trial of the drug, one group was taken off treatment
after just three months -- far less time than the current standard of a year.
On Saturday, Vertex expects to reveal whether the virus bounced back in those
short-term patients, or whether they managed to stay virus-free long enough to
be considered cured.
Even if Vertex's pill can't
eradicate the virus in 12 weeks, Chung said, it could still be important if it
boosts longer-term interferon treatment.
In a reflection of how crucial
the drug is for the company, Vertex's stock has risen and fallen sharply in the
past year with disclosures of even tiny pieces of medical data. It jumped
nearly 20 percent one day last fall when some early positive news came out on a
trial; it slid in December when the company revealed that 9 percent of
clinical-trial patients had to discontinue treatment because of a serious rash
and other side effects. Last week, the stock rose 10 percent, simply on
anticipation that this weekend's results would be positive.
With 700 local employees and
an 18-year history in Cambridge, Vertex is a pillar of the local biotechnology
landscape. But its ups and downs suggest how important a single disease, and a
single product, can be to even a well-established biotech company.
Vertex has only one product on
the market, a minor AIDS drug sold by GlaxoSmithKline PLC. The company loses
money every year, paying far more for research than it books in revenue, but
one big success could change that equation. Although its hepatitis C drug is
unlikely to reach the market before 2009, analysts estimate it could rack up
sales of $1 billion a year.
Attracted by that potential
market, a number of other firms are taking aim at hepatitis C, many in Boston.
Enanta Pharmaceuticals Inc. , a private company in Watertown, recently signed a
deal with Abbott Laboratories of Illinois to develop drugs similar to the one Vertex
is testing.
Idenix Pharmaceuticals Inc.,
which is majority-owned by Swiss drug giant Novartis AG, is testing a drug with
a slightly different mechanism, as is the New Haven company Achillion
Pharmaceuticals Inc.
The promise of a fast-acting
new treatment for hepatitis C has already paid off for Vertex, which signed an
international sales deal with Johnson & Johnson last summer. But it also
carries risks. A hepatitis C drug being developed by a European company caused
toxic side effects in animals. And after unsuccessful trials, Coley
Pharmaceutical Group of Wellesley suspended tests of its experimental hepatitis
C drug in January, laying off 33 of its 150 employees.
This week's presentation is
only the first in a series of findings expected from Vertex. Still in the
wings: a larger trial involving 320 patients, and a third trial with 440
patients who weren't cured by standard therapy.
If the company succeeds, it
will also face another question: What to do about the tens of millions of
people with hepatitis C in developing nations who can't afford the steep price
of therapy.
Vertex said it has a deal with
Johnson & Johnson to start an international foundation dedicated to
hepatitis C treatment.
"It's something that we've
talked about extensively, and having a partner that shared our view of the
importance of that was key," said Vertex spokesman Michael Partridge ,
although he said it was too early to discuss details of the program.
Stephen Heuser can be reached
at sheuser@globe.com.
April 10th,
2007
By Bill Berkrot - Analysis
NEW YORK (Reuters) - Vertex
Pharmaceuticals Inc. (VRTX.O: Quote, Profile, Research) will present data on
its closely watched experimental hepatitis C treatment this week and many
analysts are saying this is a good time to buy the company's beaten down shares
despite the risk that the data could disappoint.
Investors appear to be
listening, as Vertex shares have recovered about 14 percent in recent days
ahead of the European liver disease meeting in Barcelona at which the data will
be unveiled on Saturday.
The shares had shed about a
third of their value from late November through March as enthusiasm for the
drug, VX-950 or telaprevir, was tempered by safety concerns.
The shares broke back through
the $30 barrier late last week and climbed another 2 percent on Tuesday to
$32.16 after trading at around $45 back in November.
Sanford Bernstein analyst
Geoffrey Porges thinks the data coming out of the meeting will calm investor
nerves substantially and is encouraging clients to buy Vertex shares.
"I believe that we'll
come away from this meeting believing that VX-950 is still the leading and most
likely candidate to transform the treatment of hepatitis C virus," Porges
said.
"We'll see a lot of
preclinical data about other compounds and other combinations of compounds (at
the meeting) but I don't think we'll see anything that is anywhere near where
Vertex is in terms of having significant clinical data," added Porges, who
has a price target of $52 on Vertex shares.
Merrill Lynch analyst Hari
Sambasivam wrote in a research note last month: "While we cannot rule out
further declines, current levels represent an opportunity for patient
investors."
VX-950 is being tested in
combination with two medicines considered to be the gold standard of treatment
-- a long-acting interferon and the antiviral drug ribavirin.
Analysts, investors and liver
specialists will pore over the mid-stage clinical trial data with particular
interest in the sustained virologic response (SVR) of the drug -- the percentage
of patients in whom the virus stayed below detectable levels -- and the number
of patients who dropped out due to adverse side effects.
DROPOUT RATE
Concern over the dropout rate
seen in previous data put considerable pressure on the shares and raised
tolerability concerns, although much of the dropout seen earlier was due to a
rash rather than more serious side effects.
"We view the home run
scenario of 75 percent SVR rate for telaprevir for only 12 weeks of therapy as
possible but a long shot," Piper Jaffray analyst Rachel McMinn wrote in a
research note. "We view an SVR rate in the 40 percent to 50 percent range
as more probable."
Cowen and Co. analyst Phil
Nadeau said investors are likely looking for at least a 40 percent sustained
response. "If you see over 40 to 50 percent, people will be happy; less
than 40 and people will be somewhat disappointed," he said.
"If it's very potent,
people might be more tolerant on the side effects," Nadeau noted. "If
it's thought to be less potent, the side effects become more important."
Much of the focus before the
meeting appears to be on three-month follow-up data from a small subset of
about 20 patients who had treatment stopped after just 12 weeks in an effort to
glean further efficacy and tolerability clues, several analysts said.
However, Bernstein's Porges
believes that group to be far too small to draw meaningful conclusions. He
instead will be looking at the full complement of 175 patients that had started
taking the medicine during the Phase IIb trial.
"When you've got nearly
200 patients treated, and probably you'll see no more than 5 to 10 incidents of
side effects including rash, I think that will calm peoples' fears and
anxieties a lot," Porges predicted.
Options and equities analysts
are expecting near-term volatility, but most are predicting a long-term winner
with sales of the drug eventually exceeding $1 billion a year.
Cowen's Nadeau, who is
forecasting global sales for the drug of $1.5 billion by as early as 2010,
agreed that near-term volatility is likely, but he remains bullish on Vertex.
"This drug is a front
runner in the hepatitis C space," Nadeau said, "and no matter what
happens over the weekend there's still many other ways this can become a very
large, very successful product."
(Additional reporting by Doris
Frankel in Chicago)
April 11th,
2007
Highlights key data at the 42nd annual meeting of the European
Association for the Study of the Liver (EASL)
KENILWORTH, N.J., April 11
/PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News)
reaffirms its commitment to advancing the science and treatment of chronic
hepatitis C virus (HCV) infection with several key data presentations at the
European Association for the Study of the Liver (EASL) 42nd annual meeting in
Barcelona, Spain, April 11-15. A total of 38 data presentations highlighting
Schering-Plough hepatitis medications will be presented at EASL 2007.
Among these are several
studies with PEGINTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin)
combination therapy, a current standard of care in the treatment of chronic
hepatitis C, evaluating how results at important treatment milestones can help
physicians make informed treatment decisions.
Schering-Plough also is
exploring novel therapeutic approaches, both through targeted internal research
programs and strategic collaborations. Chief among these efforts is boceprevir
(SCH 503034), Schering-Plough's investigational oral HCV protease inhibitor
currently in Phase II clinical development for treating chronic hepatitis C.
Individual in vitro studies of boceprevir in combination with investigational
oral HCV polymerase inhibitors from Wyeth/ViroPharma and Idenix/Novartis have
been completed and will be presented at EASL.
"Schering-Plough is proud
of its long-term role in introducing innovative treatments to the field of
hepatitis," said Robert J. Spiegel, M.D., chief medical officer and senior
vice president, Schering-Plough Research Institute. "Our vision with
PEGINTRON, our cornerstone HCV therapy, and ongoing work with boceprevir, our
investigational oral HCV protease inhibitor, is to continue to advance the
science and deliver additional treatment options for patients with hepatitis C
infection."
PEGINTRON
Numerous studies with
PEGINTRON will be presented at EASL evaluating patient response to therapy at
certain treatment milestones, an approach that is aimed at individualising
treatment for patients.
Schering-Plough also is
exploring novel therapeutic approaches with PEGINTRON in combination with
investigational antiviral agents to optimize treatment for patients with more difficult-to-treat
forms of the disease, such as those with HCV genotype 1 and nonresponders to
previous therapy.
Boceprevir (SCH 503034)
Schering-Plough is undertaking
a large, fully integrated clinical development program for its oral HCV
protease inhibitor boceprevir (SCH 503034), with the goal of developing new
strategies for improving treatment outcomes for patients with hepatitis C.
As part of this effort,
Schering-Plough has collaborated with Wyeth/ViroPharma and Idenix/Novartis to
conduct separate in vitro studies of boceprevir in combination with their
respective investigational HCV polymerase inhibitors, HCV-796, a non-nucleoside
polymerase inhibitor, and NM107 (the active moiety of NM283, valopicitabine), a
nucleoside polymerase inhibitor. These in vitro experiments suggest that the
combination of boceprevir and either one of these polymerase inhibitors
achieves additive antiviral activity and a complementary resistance profile;
the combination of two agents increases the barrier for developing resistance
to either drug alone.
In addition, Schering-Plough
has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1),
a large Phase II study that is currently enrolling 400 HCV genotype 1,
treatment-naļve patients in sites across the United States, Canada and Europe.
The primary objective of the study is to evaluate the safety and efficacy of
boceprevir 800 mg TID in combination with PEGINTRON and REBETOL in the
treatment-naļve patient population.
Schering-Plough also is
conducting a large Phase II study evaluating the safety and efficacy of
boceprevir 800 mg TID in combination with PEGINTRON and REBETOL in patients
chronically infected with HCV genotype 1 who were nonresponders to previous
peginterferon and ribavirin combination therapy. The study involves
approximately 350 patients at centers in the United States and Europe. All
study participants have completed treatment and are in the follow-up phase.
Sustained virological response data from this study will be available later in
2007, and will help guide future clinical development of boceprevir.
Key Data Presentations at EASL
PEGINTRON
·
Peginterferon Alfa-2b and Ribavirin for 14 or 24 Weeks in Patients with HCV
Genotype 2 or 3 and Rapid Virological Response, The North-C Trial. Dalgard, O.
et al. Oral presentation, Sunday, April 15, at 13:15, General Session 4.
·
A Pegylated Interferon Alfa-2b Dose Reduction in HCV 1B Patients with
Rapid Viral Response Does Not Affect Sustained Virological Response. Napoli, N.
et al. Poster presentation, Thursday, April 12.
·
Comparison of Early Virologic Response Among Patients with Chronic
Hepatitis C Infected with Genotype Non 2/3 Treated with Pegylated Interferon
Alfa-2b and Ribavirin in Dependence with Hepatic Fibrosis Stages. Berak, H. et
al. Poster presentation, Thursday, April 12.
Bocepevir (SCH 503034)
·
Combination of Two Hepatitis C Virus Inhibitors, SCH 503034 (Boceprevir)
and NM107 (the active moiety of NM283, valopicitabine), Provides Enhanced
Anti-Replicon Activity and Suppresses Emergence of Resistant Replicons.
Ralston, R. et al. Late-breaker poster presentation, Thursday, April 12.
·
Favorable Cross-Resistance Profile of Two Novel Hepatitis C Virus
Inhibitors, SCH 503034 (Boceprevir) and HCV-796, and Enhanced Anti-Replicon
Activity Mediated by the Combined Use of Both Compounds. Howe, A.Y. et al.
Poster presentation Thursday, April 12.
·
SCH 503034 (Boceprevir), an Oral HCV Protease Inhibitor, is Well
Tolerated in Patients with Varying Degrees of Hepatic Impairment. Preston,
R.A., et al. Poster presentation Thursday, April 12.
About PEGINTRON and REBETOL Combination Therapy
PEGINTRON is approved in the
United States for use alone or with ribavirin (800 mg/day) for the treatment of
chronic hepatitis C in patients with compensated liver disease who have not
been previously treated with interferon alpha and who are at least 18 years of
age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and
REBETOL
WARNING
Alpha interferons, including
PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric,
autoimmune, ischemic, and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations. Patients with
persistently severe or worsening signs or symptoms of these conditions should
be withdrawn from therapy. In many but not all cases these disorders resolve
after stopping PEGINTRON therapy.
Ribavirin causes hemolytic
anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease
that has led to fatal and nonfatal myocardial infarctions. Patients with a
history of significant or unstable cardiac disease should not be treated with
REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline
and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination
REBETOL/PEGINTRON therapy must not be used by women, or male partners of women,
who are or may become pregnant during therapy and during the 6 months after
stopping therapy. REBETOL and combination REBETOL/PEGINTRON therapy should not
be initiated until a report of a negative pregnancy test has been obtained
immediately prior to initiation of therapy. Women of childbearing potential and
men must use effective contraception (at least two reliable forms) during
treatment and during the 6- month post-treatment follow-up period. Significant
teratogenic and/or embryocidal effects have been demonstrated for ribavirin in
all animal species in which adequate studies have been conducted. These effects
occurred at doses as low as one twentieth of the recommended human dose of
REBETOL. If pregnancy occurs in a patient or partner of a patient during
treatment or during the 6 months after treatment stops, physicians are
encouraged to report such cases by calling (800) 727-7064.
PEGINTRON
There are no new adverse
events specific to PEGINTRON as compared to INTRON® A (Interferon alfa-2b,
recombinant) for Injection; however, the incidence of some (e.g., injection
site reactions, fever, rigors, nausea) were higher. The most common adverse
events associated with PEGINTRON were "flu- like" symptoms, occurring
in approximately 50 percent of patients, which may decrease in severity as
treatment continues. Application site disorders were common (47 percent), but
all were mild (44 percent) or moderate (4 percent) and no patient discontinued,
and included injection site inflammation and reaction (i.e., bruise, itchiness,
irritation). Injection site pain was reported in 2 percent of patients
receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated
with alpha interferons including PEGINTRON.
Psychiatric adverse events,
which include insomnia, were common (57 percent) with PEGINTRON but similar to
INTRON A (58 percent). Depression was most common at 29 percent. Suicidal
behavior including ideation, suicidal attempts, and completed suicides occurred
in 1 percent of patients during or shortly after completing treatment with
PEGINTRON.
PEGINTRON/REBETOL is
contraindicated in patients with autoimmune hepatitis, decompensated liver
disease, and in patients with hemoglobinopathies (e.g., thalassemia major,
sickle-cell anemia).
The following serious or
clinically significant adverse events have been reported at a frequency less
than 1 percent with PEGINTRON or interferon alpha: severe decreases in
neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension,
arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of
autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus,
psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and
pneumonia, some resulting in patient deaths), urticaria, angioedema,
bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL
combination trial the incidence of serious adverse events was 17 percent in the
PEGINTRON/REBETOL groups compared to 14 percent in the INTRON A/REBETOL group.
The incidence of severe adverse events in the PEGINTRON/REBETOL combination
therapy trial was 23 percent in the INTRON A/REBETOL group and 31-34 percent in
the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred
in 42 percent of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34
percent of those receiving INTRON A/REBETOL.
REBETOL should not be used in
patients with creatinine clearance less than 50 mL/min.
Schering-Plough is a global
science-based health care company with leading prescription, consumer and
animal health products. Through internal research and collaborations with
partners, Schering-Plough discovers, develops, manufactures and markets
advanced drug therapies to meet important medical needs. Schering-Plough's
vision is to earn the trust of the physicians, patients and customers served by
its approximately 33,500 people around the world. The company is based in
Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE
NOTICE: The information in this press release includes certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements relating to the
company's strategy regarding and the potential of PEGINTRON, REBETOL and
boceprevir (SCH 503034). Forward-looking statements relate to expectations or
forecasts of future events. Schering-Plough does not assume the obligation to
update any forward-looking statement. Many factors could cause actual results
to differ materially from Schering-Plough's forward- looking statements,
including market forces, economic factors, product availability, patent and
other intellectual property protection, current and future branded, generic or
over-the-counter competition, the regulatory process, and any developments
following regulatory approval, among other uncertainties. For further details
of these and other risks and uncertainties that may impact forward-looking
statements, see Schering-Plough's Securities and Exchange Commission filings,
including Part I, Item 1A, "Risk Factors" in the company's 2006 10-K.
Source: Schering-Plough Corporation
April 12th,
2007
Data to be Presented April 15th at EASL Conference in Barcelona, Spain
VANCOUVER and SAN DIEGO, CA, April 11 /CNW/ -
MIGENIX Inc. (TSX: MGI, OTC: MGIFF), a clinical-stage developer of drugs for infectious
diseases, has received new top-line results confirming the previously announced
clinical results (November 6, 2006) indicating evidence of clinical benefit,
safety and tolerability in a Phase II study using the oral alpha-glucosidase
inhibitor, celgosivir (MX-3253), in combination with pegylated interferon and
ribavirin.
In addition to confirming the
overall conclusions of the original study analysis, retesting resulted in a
larger percentage of patients achieving an Early Virologic Response(*)
("EVR") rate with celgosivir plus peginterferon alfa-2b and ribavirin
(the "triple combination") as compared to treatment with
peginterferon alfa-2b and ribavirin alone (the "control treatment")
in patients with chronic hepatitis C virus genotype 1 infections who were
characterized as non-responders to prior therapy with optimized pegylated
interferon plus ribavirin, achieving:
·
42% (5/12) EVR with the celgosivir triple combination arm compared to
10% (1/10) EVR in the control treatment arm. This compares with 33% (4/12) EVR (triple combination) vs 10% (1/10)
(control treatment) in the original study results. (*) EVR = 2 log(10) or
greater HCV viral load reduction at 12 weeks.
·
1.63 log(10) (triple combination) mean HCV viral load reduction
("VLR") compared to a 0.92 log(10) VLR (control treatment). This
compares with a 1.2 log(10) VLR (triple combination) vs a 0.4 log(10) VLR
(control treatment) in the original study results.
·
a more rapid onset of treatment effect as measured by VLR within the
first 2 weeks of therapy in the triple combination as compared to the control
treatment.
These new top-line results
complete the retesting announced February 6, 2007 as a result of
Schering-Plough Corporation ("Schering") having informed MIGENIX that
approximately 50% of the original viral load samples from the study, which
Schering tested under a Material Transfer and License Option Agreement between
the companies, required retesting.
AnnKatrin Petersen, M.D., Vice
President, Clinical Development of MIGENIX stated, "the increase in EVR to
42% after retesting (33% previously) for the celgosivir triple combination
group in these very difficult to treat patients, along with the clear evidence
of rapid reduction in viral load give us increased confidence in the potential
of celgosivir to contribute in the treatment of HCV patients."
Jim DeMesa, M.D., President
and CEO of MIGENIX added, "This confirmation of our previously announced
results allows us to now focus on providing a data package to Schering-Plough
over the next few weeks for their limited period of exclusive review under our
License Option Agreement. The better EVR results seen upon retesting,
especially in these very difficult-to-treat non-responder patients, reinforces
our optimism in celgosivir's potential to improve treatment outcomes for these
HCV patients with few therapeutic options."
EASL Presentation
The results from this study
will be presented on April 15, 2007 at the 42nd Annual Meeting of the European
Association for the Study of the Liver (EASL) being held in Barcelona, Spain
April 11-15, 2007. The presentation entitled: "Phase II Proof of Concept
Study of Celgosivir in Combination with Peginterferon Alfa-2b and Ribavirin in
Chronic Hepatitis C Genotype-1 Non-responder Patients" will be made in the
General Session 4 on Sunday, April 15th from 1:00pm-1:15pm in Hall F of the
CCIB Conference Center. Dr. Kelly Kaita, the Director of the Viral Hepatitis
Investigative Unit (VHIU) at the Health Sciences Centre, University of Manitoba
and a lead investigator in the MIGENIX Phase II study will make the
presentation on behalf of MIGENIX.
Additional Information About the Clinical Study
The Phase II non-responder
combination study was designed to determine, over 12 weeks of treatment, the
efficacy, safety, and tolerability of celgosivir in combination with
peginterferon alfa-2b, with or without ribavirin, in HCV-positive (genotype 1)
patients who were non-responders or partial responders to prior therapy with
optimized pegylated interferon and ribavirin.
A total of 57 patients were
enrolled into this Phase II study (36 were non-responders and 21 were partial
responders). Patients were randomized into three treatment arms: (i) celgosivir
(400mg once daily) plus peginterferon alfa-2b plus ribavirin ("triple
combination"); (ii) celgosivir (400mg once daily) plus peginterferon
alfa-2b ("double combination"); and (iii) celgosivir placebo plus
peginterferon alfa-2b plus ribavirin ("control treatment"). Of the 36
non-responders, 30 patients completed the 12-weeks of treatment: 12 in the
triple combination arm, 8 in the double combination arm, and 10 in the control
treatment arm. Beyond the triple combination and control treatment results
reported above the following results were also consistent with the originally
reported results: (a) the double combination did not show a meaningful
difference in mean viral load reduction and EVR when compared to the control
treatment in non-responder patients; and (b) in the partial responder patient
population, there were insufficient patients (n=3) in the triple combination
arm for any conclusions to be drawn and the double combination showed less
effect than the control treatment.
Celgosivir combination therapy
was well tolerated and resulted in no significant adverse events. As expected
from previous experience, the most frequent side effects related to celgosivir
were gastrointestinal in nature and were generally mild. Other frequently
observed side effects were fatigue and flu-like symptoms - which are side
effects usually associated with pegylated interferon and ribavirin. Only 7 of
the 57 patients entering the study dropped out prior to week 12.
Material Transfer and License Option Agreement
Under the terms of the
Agreement, Schering supplied PEGETRON(TM) (peginterferon alfa-2b powder for
solution plus ribavirin 200 mg capsules) as well as certain technical and
laboratory support and other services for MIGENIX's celgosivir Phase II
combination study in chronic HCV patients and a related extension protocol. In
addition, the Agreement granted Schering limited periods of exclusivity for
data review of clinical trial results and for the negotiation of a license
agreement. With the new top-line results, we will be working to provide a data
package to Schering over the next few weeks, after which Schering's limited
period of exclusivity for data review under the Agreement will commence. No
license terms have been negotiated with Schering to date.
About Celgosivir (MX-3253)
Celgosivir is an alpha-glucosidase
I inhibitor and is currently the only anti-HCV drug in clinical development
that acts on host-directed glycosylation. In preclinical studies, celgosivir
has shown excellent in vitro synergy with various interferons in the clinic or
in development including Pegasys, PEG-Intron, Infergen, Alferon and IFN-omega
(with or without ribavirin) and other drugs in development for the treatment of
HCV (e.g. polymerase inhibitors) and therefore has the potential to be included
as part of many combination therapeutic approaches to improve efficacy in
anti-HCV therapy.
About HCV
HCV, the most common chronic
blood-borne infection in the United States, causes inflammation of the liver
and may progress to more serious complications such as cirrhosis of the liver,
liver cancer and death. Approximately 2.7 million people in the United States
are chronically infected with HCV, and the Centers for Disease Control and
Prevention (CDC) estimates that by the year 2010, the number of deaths
attributed annually to HCV could surpass that due to HIV/AIDS in the US.
Worldwide, the World Health Organization estimates that 170 million individuals
have chronic HCV infection, with 3 to 4 million new infections each year.
Therapy for HCV currently
employs a drug combination approach, which is anticipated to continue in the
future. The current standard of care for treatment-naive chronic hepatitis C is
pegylated interferon combined with ribavirin, which fails to provide a
satisfactory outcome for approximately 50% of patients infected with HCV
genotype 1 (the most prevalent genotype in North America). In addition, these
drugs can cause significant side effects that limit tolerance to therapy, or a
frequent lack of sustained treatment response.
About MIGENIX
MIGENIX is committed to
advancing therapy, improving health, and enriching life by developing and
commercializing drugs primarily in the area of infectious diseases. The
Company's clinical programs include drug candidates for the treatment of
chronic hepatitis C infections (Phase II and preclinical), the prevention of
catheter-related infections (Phase III) and the treatment of dermatological
diseases (Phase II). MIGENIX is headquartered in Vancouver, British Columbia,
Canada with US operations in San Diego, California. Additional information can
be found at www.migenix.com.
"Signed"
James M. DeMesa, M.D.
President & CEO
FORWARD-LOOKING STATEMENTS
This news release contains
forward-looking statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995, and forward looking information
within the meaning of applicable securities laws in Canada, (collectively
referred to as "forward-looking statements"). Statements, other than
statements of historical fact, are forward-looking statements and include,
without limitation, statements regarding our strategy, future operations,
timing and completion of clinical trials, prospects, plans and objectives of
management. The words "anticipates", "believes",
"budgets", "could", "estimates",
"expects", "forecasts", "intends",
"may", "might", "plans", "projects",
"schedule", "should", "will", "would"
and similar expressions are often intended to identify forward-looking
statements, which include underlying assumptions, although not all
forward-looking statements contain these identifying words. By their nature,
forward-looking statements involve numerous assumptions, known and unknown
risks and uncertainties, both general and specific, that contribute to the
possibility that the predictions, forecasts, projections and other things
contemplated by the forward-looking statements will not occur.
Although our management
believes that the expectations represented by such forward-looking statements
are reasonable, there is significant risk that the forward-looking statements
may not be achieved, and the underlying assumptions thereto will not prove to
be accurate. Forward-looking statements in this news release include, but are
not limited to, statements concerning: our expectations regarding the time
required to complete and provide a data package of the celgosivir Phase II
study results to Schering; our expectations for the celgosivir Phase II study
results being presented on April 15, 2007 at the EASL conference; and celgosivir
having the potential to be included as part of many combination therapeutic
approaches to improve efficacy in anti-HCV therapy.
With respect to the
forward-looking statements contained in this news release, we have made
numerous assumptions regarding, among other things, our ability to successfully
complete the celgosivir Phase II data package for Schering within our expected
timelines, EASL accepting the new celgosivir Phase II results, the
competitiveness of the celgosivir study results to date and future results
supporting its potential in the treatment of HCV.
Actual results or events could
differ materially from the plans, intentions and expectations expressed or
implied in any forward-looking statements, including the underlying assumptions
thereto, as a result of numerous risks, uncertainties and other factors
including: uncertainties related to early stage of technology and product
development; uncertainties as to the requirement that a drug be found to be
safe and effective after extensive clinical trials and the possibility that the
results of such trials, if completed, will not establish the safety or efficacy
of our products; dependence on corporate collaborations; uncertainties as to
future expense levels and the possibility of unanticipated costs or expenses or
cost overruns; the possibility that opportunities will arise that require more
cash than presently anticipated and other uncertainties related to predictions
of future cash requirements; and other risks and uncertainties which may not be
described herein. Certain of these factors and other factors are described in
detail in the Company's Final Prospectus dated November 29, 2006, Annual
Information Form and Annual Report on Form 20-F for the year ended April 30,
2006 and other filings with the Canadian securities regulatory authorities and
the U.S. Securities & Exchange Commission.
Forward-looking statements are
based on our current expectations and MIGENIX assumes no obligations to update
such information to reflect later events or developments.
The Toronto Stock Exchange has
not reviewed and does not accept responsibility for the adequacy or accuracy of
this release.
For further information: Art
Ayres, MIGENIX Inc., Tel: (604) 221-9666
Ext. 233, aayres@migenix.com ; Dian Griesel
BARCELONA, Spain--(BUSINESS
WIRE)--Apr 11, 2007 - New data supporting the clinical development of
telaprevir (VX-950), one of the most advanced investigational oral protease
inhibitors for the treatment of hepatitis C virus (HCV) infection, will be
presented at the 42nd Annual Meeting of the European Association for the Study
of the Liver (EASL) in Barcelona this week. In total, nine abstracts related to
telaprevir have been accepted for presentation at the EASL conference,
including an abstract that describes telaprevir activity against genotypes 2, 3
and 4 in vitro. A late-breaker oral presentation will take place on Saturday,
April 14 at 5:45 p.m. Central European Summer Time (11:45 a.m. Eastern Daylight
Time). Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) is developing
telaprevir in collaboration with Tibotec.
"Hepatitis C is a major
global health problem with a significant unmet medical need. Despite treatment
advancements in the last 10 years, there is an urgent need for new therapeutic
options that can offer patients shorter course therapy and better
efficacy," said John Alam, M.D., Executive Vice President, Medicines
Development, and Chief Medical Officer of Vertex. "The data to be presented
at EASL demonstrate the recent progress made in our clinical evaluation and
understanding of telaprevir as a novel treatment for hepatitis C, underscoring
our commitment to evaluate telaprevir's potential in important sub-populations,
such as those with genotype non-1 hepatitis C."
Telaprevir is one of the most
advanced specifically targeted antiviral therapies for HCV (STAT-C). STAT-Cs
represent a new approach to hepatitis C treatment by directly targeting the
enzymes the virus uses to replicate.
Oral Presentation: Telaprevir Demonstrates Potency Against Genotype 2, 3
and 4 in vitro
Chao Lin, Ph.D., of Vertex,
will present an abstract titled, "Telaprevir (VX-950) is a Potent
Inhibitor of HCV-NS3 Proteases Derived from Genotype Non-1 HCV-Infected
Patients" at 6:15 p.m. CEST (12:15 p.m. EDT) on Thursday, April 12.
"While genotype 1
accounts for the majority of hepatitis C cases, the proportion of those living
with genotypes 2, 3 and 4 is significant," continued Dr. Alam. "In
this in vitro study, telaprevir demonstrated similar potency against the NS3-4A
protease derived from those patients with genotype 2, 3 and 4 to the in vitro
results demonstrated with telaprevir in genotype 1. These results support our
plans to begin to study telaprevir in genotypes 2, 3 and 4 in 2007."
Late-Breaker Presentation
A late-breaker presentation
titled, "Results of an Interim Analysis of a Phase 2 Study of Telaprevir
(VX-950) with Peginterferon alfa-2a and Ribavirin in Previously Untreated
Subjects with Hepatitis C," will be presented by John McHutchison, M.D.,
Principal Investigator for the PROVE 1 study and Director of Gastroenterology
and Hepatology Research at Duke Clinical Research Institute, on Saturday, April
14 at 5:45 p.m. CEST (11:45 a.m. EDT).
In accordance with EASL
embargo policy, these data remain under embargo until conclusion of the
late-breaker session on Saturday, April 14 at 6:00 p.m. CEST (12:00 p.m. EDT).
Additional Telaprevir Presentations