HCV Advocate easl 2007 News Review

 

EASL 2007 Index

 

 

Week Ending: April 14th 2007

Hepatitis C

·        Firm's Future Hinges on New Hepatitis Drug

·        Bullish Views on Vertex ahead of Liver Meeting

·        Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C

·        New Clinical Study Results Indicate Higher Early Virologic Response with Celgosivir Combination Therapy in HCV Non-Responders

·        Vertex Pharmaceuticals Announces New Data for Investigational HCV Protease Inhibitor Telaprevir to be Presented at 42nd Annual Meeting of the European Association for the Study of the Liver (EASL)

·        Intarcia Therapeutics Announces Final Results from a Phase 2 Study of Injectable Omega Interferon plus Ribavirin for the Treatment of Hepatitis C Genotype-1

·        Analysis: Total Hepatitis C Cure Possible

·        Idenix Midstage Study Results Mixed

·        Viropharma: Hepatitis-C Treatment More Effective in Combination

·        Treatment Optimisation with PEGASYS plus COPEGUS Offers Patients with Hepatitis C an Excellent Chance for a Cure

·        Idenix Reports Results from Two Phase IIb Studies of the Combination of Valopicitabine and Pegylated Interferon in Hepatitis C Genotype-1 Patients at the 42nd Annual Meeting of the European Association for the Study of the Liver

·        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

 

 

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April 9th, 2007

Firm's Future Hinges on New Hepatitis Drug

http://www.boston.com

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

Bullish Views on Vertex ahead of Liver Meeting

http://www.reuters.com

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

Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C

http://biz.yahoo.com/

 

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

New Clinical Study Results Indicate Higher Early Virologic Response with Celgosivir Combination Therapy in HCV Non-Responders

 

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

 

Vertex Pharmaceuticals Announces New Data for Investigational HCV Protease Inhibitor Telaprevir to be Presented at 42nd Annual Meeting of the European Association for the Study of the Liver (EASL)

http://www.pharmalive.com

 

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