MAX SCHOLZ PAINTING; MAN READING PAPER
Pharmasset Further Expands Trials Of Hepatitis C Drug
Oct 10
Pharmasset Inc. (VRUS) is further expanding a trial of its hepatitis C treatment, citing the oral drug's rapid and consistent antiviral effects.
The clinical-stage pharmaceutical company is adding a new study arm that will evaluate the treatment, PSI-7977, when used without other chemotherapies, for a 12-week period. Another arm will look at PSI-7977 in combination with ribavirin to treat two hepatitis C subtypes. An earlier study planned to assess the treatment along with ribavirin and interferon will be revised to remove the interferon.
Pharmasset said the study results will be presented Nov. 6 at the annual meeting of the American Association for the Study of Liver Diseases.
In September, Pharmasett reported that PSI-7977 showed positive results at a higher dose when combined with other treatments after 12 weeks. The company also had expanded its study of PSI-7977 in June, to look at it as a standalone treatment, as well as shorter treatment programs.
Pharmasset Announces Further Expansion of ELECTRON Trial in Hepatitis C
--**Added PSI-7977 monotherapy arm in treatment-naive patients with HCV GT1 --**Added PSI-7977/RBV arm in treatment experienced patients with HCV GT2/3 --**Modified previously-announced treatment regimen in HCV GT1 prior null responders to explore IFN-free regimen of PSI-7977/RBV
PRINCETON, N.J., Oct. 10, 2011 /PRNewswire via COMTEX/ -- Pharmasset, Inc. /quotes/zigman/101019/quotes/nls/vrus VRUS +6.59% announced today the addition of two treatment arms to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The rapid and consistent antiviral effects and high barrier to resistance demonstrated with PSI-7977 to date provided the rationale for additional exploratory regimens in this setting. The protocol amendment adds one arm exploring 12 weeks of PSI-7977 monotherapy in treatment naive patients with HCV genotype 1 (GT1), and one arm of PSI-7977 and ribavirin (RBV) in treatment-experienced patients with HCV genotype 2 (GT2) or genotype 3 (GT3). In addition, the previously announced arm in HCV GT1 patients with a prior "null" response to an interferon (IFN) containing regimen, which was planned to assess PSI-7977/IFN/RBV, has been modified to an IFN-free 12-week regimen of PSI-7977/RBV.
"We look forward to reporting SVR12 results from Part 1 and interim data from the PSI-7977 monotherapy arm of ELECTRON on Sunday, November 6th, 2011 at the upcoming 2011 American Association for the Study of Liver Diseases (AASLD) annual meeting. The preliminary results to be discussed at AASLD led us to expand the study to add an arm of PSI-7977 monotherapy for HCV GT1," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We and others continue to explore the potential of PSI-7977 for IFN-free and monotherapy treatment regimens in a broader group of individuals living with HCV of all genotypes and regardless of their response to prior treatment."
In addition to previously announced interferon-free studies of PSI-7977 by Bristol Myers Squibb and Tibotec, The National Institute of Health (NIH) recently initiated an interferon-free 24 week study of PSI-7977 400mg QD with and without ribavirin, in 60 treatment naive patients with HCV genotype 1 (GT1) in the US.
About ELECTRON
ELECTRON is an exploratory study of PSI-7977 for the treatment of chronic HCV infection. Part 1 of the trial is evaluating 12-week regimens of interferon-free PSI-7977 400mg QD with ribavirin (RBV), and three abbreviated duration peginterferon (Peg-IFN) regimens of 4, 8, or 12 weeks in treatment-naive patients with HCV GT2 or GT3. The primary endpoint of the trial is the safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without Peg-IFN. On May 11, 2011, Pharmasset announced the completed enrollment of Part 1 of ELECTRON:
PSI-7977 400 mg with Peg-IFN and RBV for 12 weeks (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks, Peg-IFN weeks 1-8 only (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks; Peg-IFN weeks 1-4 only (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks (GT2/3)
In Part 2 of ELECTRON, a 5th cohort was added to explore PSI-7977 monotherapy in treatment naive patients with HCV GT2 or GT3:
PSI-7977 400 mg monotherapy for 12 weeks (n=10 GT2/3)
Following on the previously reported 100% SVR12 in treatment-naive subjects with HCV GT2/3 (PROTON), a 6th cohort was added to ELECTRON to explore an 8-week duration of PSI-7977Peg-IFN/RBV. The previously announced 7th cohort in HCV GT1 patients with a prior "null" response to Peg-IFN, has been modified to an interferon-free 12-week regimen of PSI-7977/RBV.
PSI-7977 400 mg with Peg-IFN/RBV for 8 weeks (n=10 GT2/3 treatment-naive)
PSI-7977 400 mg with RBV for 12 weeks (n=10 GT1 null)
In Part 3 of ELECTRON, two additional IFN-free regimens will be explored in treatment-naive patients with HCV GT1 and in treatment-experienced patients with HCV GT2 or GT3.
PSI-7977 400 mg monotherapy for 12 weeks (n=25 GT1 treatment-naive)
PSI-7977 400 mg with RBV for 12 weeks (n=25 GT2/3 treatment-experienced)
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in five Phase 2b trials, including abbreviated duration interferon and interferon-free regimens, in subjects with all HCV genotypes. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, is in QUANTUM, a Phase 2b interferon-free trial of PSI-7977 and PSI-938 in subjects with all HCV genotypes. Mericitabine (RG7128) continues in three Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
ContactRichard E. T. Smith, Ph.D.VP, Investor Relations and Corporate CommunicationsOffice: +1 (609) 865-0693
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
SOURCE Pharmasset, Inc.
Trials show that adding Incivo clears the virus in almost twice as many previously untreated patients (79% vs. 46%) and almost four times as many who had previously relapsed following treatment (84% vs. 22%). The drug also halved the current total treatment duration to six months in many (58%) previously untreated patients in trials.
Treatment with peginterferon alfa and ribavirin is successful in only about 50% of patients with genotype 1, leaving half of patients without successful treatment.
But Incivo does not have the market all to itself – a rival treatment, Merck and Roche’s Victrelis (boceprevir), was launched in the UK in August.
Both drugs are oral protease inhibitors, but many analysts predict Incivo will prove to be more favoured because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen. But Janssen and its US marketing partner Vertex (which discovered the drug) will face stiff competition from Victrelis.
Commenting on the launch of Incivo, Professor Graham Foster, Queen Mary's University Hospital of London said: "This is an exciting time for people living with chronic genotype-1 hep C. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus."
Professor Foster added: "For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment."
Speaking on behalf of patients living with hep C, Charles Gore, chief executive of the Hepatitis C Trust said: "Hepatitis C can be a devastating disease; however, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer. The arrival of protease inhibitors is the first major treatment advance in more than 10 years and a significant step forward for the hep C community."
Chronic hep C is the most common reason for liver transplants in Europe. An estimated 216,000 to 466,000 people in the UK are chronically infected with hep C, yet only 80,000 have been diagnosed. Of those who develop chronic hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation.
The most frequently reported moderate adverse reactions were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence greater than or equal to 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.
Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients.
UK Hepatitis C Map
Janssen has also launched the first ever online "UK Hepatitis C Map," an interactive map for hep C, available at HelpEveryPersonC.co.uk which provides data on prevalence of hep C by area. It also details of local support groups, treatment centres and stories from people living with hep C and their friends, family and carers. In addition the website offers downloadable questionnaires about hep C which people who have any questions may take to their healthcare professional to aid their discussion about hep C.
Incivo’s launch coincides with news that the Scottish Medicines Consortium has approved Victrelis for use in the NHS in Scotland. NICE is expected to issue its guidance on Incivo and Victrelis in May 2012.
New treatment helps clear the virus in significantly more patients compared to current standard of care alone1A
LONDON, [10th October 2011] – The Scottish Medicines Consortium (SMC), which advises NHS Scotland on prescribing new treatments, announced today that 'Victrelis'® (boceprevir), the first licensed direct acting treatment for chronic hepatitis C (CHC) genotype 1 infection, is accepted for use within NHS Scotland. Boceprevir was reviewed for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who have failed previous therapy or who are previously untreated.
In the pivotal phase III randomised studies, addition of boceprevir to current standard of care in patients with CHC genotype 1 infection, who had failed previous therapy or who were previously untreated, increased the proportion of patients who achieved a sustained virologic response.1A
Professor Clifford Leen, Consultant Physician Infectious Diseases, Western General Hospital, Edinburgh commented "The SMC's positive advice on the efficacy and cost-effectiveness of boceprevir in Scotland is very important for patients with chronic hepatitis C genotype 1. It supports the use of a more effective treatment compared to standard therapy alone (peginterferon and ribavirin), which improves SVR1A and will allow some patients to have a 6 month course of treatment rather than the current 12 months.1B Improved SVR has been shown to reduce mortality in patients with hepatitis C."2A
Around 39,000 people in Scotland are chronically infected with hepatitis C.3A Many of those who are infected do not show symptoms for a long period and consequently diagnosis is often delayed.4A,5A As a result, hepatitis C is often described as the ‘silent epidemic’.4A,5A Scotland has made significant progress in the diagnosis and treatment of patients with hepatitis C since 2006, 3B and leads the UK in terms of established government strategies. However, the latest Health Protection Agency report estimates that by the end of 2010, more than half of people with chronic hepatitis C in Scotland were still not diagnosed (55%).3A
Hepatitis C, caused by a blood-borne virus, can result in inflammation of the liver and subsequent fibrosis (scarring) of the liver tissue. Ultimately, the hepatitis C virus can cause significant liver damage including cirrhosis and liver cancer.4B The virus exists in different strains called genotypes. Genotype 1 is the most common in the UK, affecting 40-50% of patients,6A and is also the most difficult to clear with 40% SVR rates on current treatment versus around 80% for genotypes 2 and 3.7A
Notes to Editor
More Information on boceprevir
Please refer to the Summary of Product Characteristics (SPC) attached with this press release.
‘Victrelis’ is a Trademark of Merck and Co., Inc., Whitehouse Station, New Jersey, USA.
MSD's global commitment to advancing hepatitis therapy
MSD is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with boceprevir, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About MSD
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd-uk.co.uk
Biotron Soars on Results for Hepatitis C Drug
MELBOURNE—Australian drug developer Biotron Ltd. said on Monday it has received good results from trials of a new treatment for hepatitis C.
Shares in Biotron soared as much as 49% after the company said preliminary analysis of data from its latest clinical trial confirmed that orally administered small molecule drug BIT225 had a good antiviral impact against the disease.
"This highly encouraging result is the culmination of 10 years of research and development of Biotron's antiviral program," said Biotron Managing Director Michelle Miller in a statement, adding that the trial data "validates Biotron's approach to treatment of this virus."
The company said patients receiving BIT225 in combination with interferon and ribavirin—the current standard of care for treating hepatitis C—had greater reductions in hepatitis C virus levels than patients receiving standard of care treatment alone.
Hepatitis C is a virus that causes liver inflammation and liver disease. It is estimated to infect 170 million people worldwide and is spread by blood to blood contact, the Hepatitis Australia website says.
Chris Burrell, professor of virology at the University of Adelaide, said there is a "tremendous need" to improve on the current drugs used to treat hepatitis C because of toxicity issues and side effects such as anemia, rashes, flu-like symptoms and psychological issues.
"It's a gruelling kind of process," he said of the current treatments.
Mr. Burrell said that the benefit of the new Biotron drug could be that if it is used in conjunction with the existing therapies, the dosages of the existing therapies might be able to be reduced, therefore minimizing side effects.
Australia's biotech industry has benefited from a share of the 60 billion Australian dollars (US$58.9 billion) of government support for universities, research institutes and industry over the last nine years, in terms of grants and tax offsets. The surge follows warnings by Australia's leaders in recent years that the country is falling behind on research and development spending.
Biotron said BIT225 is the first in a new class of direct-acting antiviral drugs for hepatitis C, targeting a specific virus protein essential to virus production and replication. The current therapy for hepatitis C sees interferon used to stimulate a patient's own immune system to fight the virus and ribavirin, which does not act in a targeted way, work against replication of the virus. BIT225 is also in development for the treatment of human immunodeficiency virus.
Biotron's Ms. Miller told Dow Jones Newswires the company plans to seek U.S. Food and Drug Administration approval for the drug in the long term. "At this point in time we're still working out the plan going forward," she said.
She said the company had been in discussion with potential partners to develop the drug, either through a licence agreement with a major pharmaceutical company or a "co-development pathway."
"We know there's a lot of interest in this space," she said.
The data analyzed was from a Phase 2a trial, which assesses dosing requirements, and Ms. Miller said the company is now exploring the design of further trials for the drug.
The shares closed up 29% at 12.5 Australian cents.
Write to Gavin Lower at gavin.lower@dowjones.com
WONDER PILL WAGES WAR ON HEPATITIS C
The drug, called INCIVO, or telaprevir, treats those with the most common form of the illness, genotype 1, which is also hardest to tackle.
The new treatment has been found to be more effective than the current standard of care and, when added to the standard treatment, can clear the virus in twice as many previously untreated patients and almost four times as many who had previously relapsed following treatment.
This means Incivo will clear the virus in around four out of five patients compared with the old standard of care which will only clear it in two or three out of five.
The standard treatment for Hep C is peginterferon alfa and ribavirin, which is successful in only about half of patients with genotype 1, leaving the other 50 per cent without a successful treatment.
Hepatitis C is an infectious disease, with often no symptoms, known as the silent killer The treatment is a one off, 12 week course, which costs £22,398, and must be taken in combination with peginterferon alfa and ribavirin.
Peginterferon alpha breaks down slowly and maintains a consistent amont of drug in the patient’s system for a longer period of time and rabavirin works with the interferon to stop the virus from replicating.
The new drug is a protease inhibitor which blocks an important sagtege of the virus replication and can enhance the effectiveness of the other two drugs.
Hepatitis C is an infectious disease, with often no symptoms, known as “the silent killer”.
In the UK it is thought 216,000 have the virus, but charities believe the figure is actually closer to 466,000.
Yet only 80,000 have been formally diagnosed.
At least 45 per cent of people with hepatitis C have genotype 1, which means as many as 210,000 could be helped by the new drug.
The blood-borne infection attacks the liver, causing cirrhosis and in some cases cancer.
The virus can be spread by something as simple as sharing a razor or toothbrush and blood transfusions before 1991 also put people at risk.
This new drug breakthrough is hailing a new era of treatment for the disease with some 29 new drugs set to be available in the next four to five years.
Charles Gore, chief executive of the Hepatitis C Trust said: “Hepatitis C can be a devastating disease. However, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer.
“The arrival of protease inhibitors is the first major treatment advance in more than 10 years and a significant step forward for the hep C community.”
Professor Graham Foster, Queen Mary’s University Hospital of London, said: “This is an exciting time for people living with chronic genotype 1 hep C.
“Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50 per cent of chronic genotype-1 hep C patients got rid of the virus.
“For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”
Incivo, which is a protease inhibitor made by Janssen Pharmaceutical, is a three-times-a-day pill replaces the current treatment which is administered via injection.
It is available from today after receiving its European license last month, but will only be available if prescribed by an NHS doctor which will depend on the individual PCT, or privately.
It is scheduled to be reviewed by NICE for use in England and Wales and by SMC for use in Scotland and it is hoped a decision will be made by next year whether it will be approved for widespread use on the NHS.
Drug that cured Wibsey woman of hepatitis C is rolled out across the UK
7:10am Monday 10th October 2011
A Bradford mother-of-two has hailed a new hepatitis C drug for “saving her life” after she was cured of the illness during a trial for the new treatment.
Lesley Jenkins, 51, of Wibsey, took part in the trial after living with the life-threatening illness which she contracted when she had a blood transfusion after the birth of her son in 1985.
As the Telegraph & Argus has previously reported, she was diagnosed with the illness, which estimates suggest 2,207 individuals are infected with in Bradford, in 2007 and following standard chemotherapy she embarked on the trial for the drug Telaprevir in February, 2009.
Mrs Jenkins now works part-time for the Hepatitis C Trust, as well as running her own training consultancy business, after being cleared of the illness after 18 months.
She credits the drug, which was being rolled out across the UK today, with saving her life after normal treatments were not found to work.
She said: “I had it for half my life and I feel I’m living a normal life again now.
“I feel born again at 52, I feel like my life has started again.
“I am so pleased I was part of the trial because I feel as if I have done my bit to pay back. I have made a contribution going forward for the people who are waiting for this drug.”
Clinical trials have suggested a Telaprevir-based regimen is more effective than standard treatment in all genotype-1 patient types, including those with advanced liver disease such as cirrhosis.
Using Telaprevir cleared the virus in almost twice as many previously untreated patients and almost four times as many who had previously relapsed following treatment.
It can also halve the period of treatment to just six months in 58 per cent of previously untreated patients.
Professor Graham Foster, of Queen Mary’s University Hospital of London, said: “For many adults with chronic genotype-1 hepatitis C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”
For more information and help for those with hepatitis C visit HelpEveryPersonC.co.uk .
Scripps Florida scientist to study Hepatitis C
JUPITER — The Scripps Research Institute has been awarded a $2.2 million grant by the National Institutes of Health (NIH) to determine how the hepatitis C virus (HCV) induces liver cancer. The research could lead to potentially new therapeutic targets for treating those chronically infected with the virus.
Timothy Tellinghuisen, an assistant professor on the Florida campus of Scripps Research, is the principal investigator for the project.
Hepatitis C virus infection is a major public health problem worldwide. Estimates place the number of HCV infected individuals at approximately 170 to 200 million, representing nearly three percent of the world's population, according to the World Health Organization. HCV infection and its assorted pathologies are responsible for an estimated 250,000 deaths a year worldwide.
A majority of patients remain chronically infected, which can lead to progressive liver damage, cirrhosis, and often the development of hepatocellular carcinoma—liver cancer. An estimated 60 to 70 percent of all those infected develop chronic infections and most progress to major liver damage. Each year, as many as five percent of these chronically infected patients will develop liver cancer.
While the mechanisms by which HCV induces liver cancer are largely unknown, Tellinghuisen's ongoing research points to host cell signaling pathways that are likely altered by the virus, creating a replication niche for the virus that avoids the body's innate immune system.
"We have identified a host protein—called CARD14—as an important factor for HCV RNA replication," he said. "We believe that a pathway regulated by this protein gets manipulated by the virus to maintain chronic infections and that this contributes, in part, to liver cancer development. The new grant will help us explore the extensive role of CARD14 in HCV replication and, quite possibly, identify new ways to attack chronic HCV infection."
Overall, the new grant will enable Tellinghuisen and his colleagues to characterize how the virus manipulates this host cell pathway, identify the genes regulated by this pathway and determine their effect on viral infection and persistence, and define the function of this protein in normal liver physiology.
For more information, please go to http://www.scripps.edu/florida.
Preventing recurrence in hepatocellular carcinoma
The latest issue of the American Journal of Transplantation investigates strategies to decrease the risk of recurrence, and extend access to liver transplantation for hepatocellular carcinoma.
Liver transplantation is the best treatment of patients with unresectable early hepatocellular carcinoma, allowing disease-free survival rates of 60–80% at 5 years.
Despite these good results, some 10% of recipients experience a posttransplant hepatocellular carcinoma recurrence, which leads to death in almost all patients.
Recurrence is either due to the growth of occult metastases or to the engraftment of circulating tumor cells.
Dr Christian Toso and colleagues from Switzerland hypothesized that strategies to decrease the engraftment of circulating tumor cells could decrease the risk of recurrence and, in addition, extend access to transplantation to patients with more advanced hepatocellular carcinoma.
The research team report that these potential strategies can be schematized into 5 steps.
These potential strategies can be schematized into 5 steps
American Journal of Transplantation
The first step includes selecting recipients with low baseline levels of circulating hepatocellular carcinoma cells, by adding biological markers to the accepted combination of morphological criteria.
The second included decreasing the perioperative release of hepatocellular carcinoma cells, with careful perioperative handling of the tumors.
Preventing the engraftment of circulating hepatocellular carcinoma cells by decreasing liver graft ischemia-reperfusion injury, which has been shown to promote cancer cell engraftment and growth, and using anticancer drugs, including mammalian target of rapamycin inhibitors.
The final step included tuning immunity toward hepatocellular carcinoma clearance.
Dr Toso's team concluded, "We report on strategies to decrease the risk of recurrence and, in addition, extend access to transplantation to patients with more advanced hepatocellular carcinoma."
Am J Transplant 2011: 11(10): 2031–203510 October 2011
Media
Deliberations continue Monday inHep C trial
Deliberations will resume Monday morning in the punishment phase of southern Nevada's second civil trial of three drug companies found liable in the 2007 Hepatitis C outbreak.
Jurors recessed Friday without reaching a decision on punitive damages against Baxter Healthcare Corp., SICOR I
nc. and Teva Parenteral Medicines, Inc..
The companies were found liable for the infections of three former patients and two spouses linked to the outbreak.
Prosecutors claimed the companies purposely sold large containers of an anesthetic to clinics as a means of saving money and in order to improve sales. Further, they claim the drug companies did so despite knowing nurses would re-use them. The lead attorney for the plaintiffs announced about $20 million were being handed to those five individuals. According to Attorney Robert Eglet, Robert Sacks will receive $6 million; Anne Arnold and her husband will receive $10 million and $2.5 million, respectively; and Anthony Devito and his wife
will receive $5 million and $1.5 million, respectively.
Plaintiffs are asking for $600 million in punitive damages.
At least one company plans to appeal the decision.
Therapeutic vaccines for hepatitis B and C infections.
BLUE BELL, Pa., Oct. 10, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of synthetic vaccines against cancers and infectious diseases, announced today that it has entered into a product development collaboration agreement with its affiliate, VGX International Inc. (KSE:011000), to co-develop Inovio's SynCon® therapeutic vaccines for hepatitis B and C infections.
Under the terms of the agreement, VGX International will receive marketing rights for these vaccines in Asia, excluding Japan, and in return will fully fund IND-enabling and initial phase I and II clinical studies. Inovio will receive payments based on the achievement of clinical milestones and royalties based on sales in the licensed territories and retains all commercial rights in all other territories.
The first product to enter clinical testing will be a synthetic multi-antigen hepatitis C virus (HCV) vaccine covering genotypes 1a and 1b and targeting the antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A (NS4A), as well as NS4B and NS5A proteins. The vaccine will be delivered with Inovio's CELLECTRA® delivery device. IND-enabling toxicology tests will be conducted in 1H 2012, with the intent being to initiate a phase I clinical study in late 2012. The target population for the vaccine clinical trials will be HCV infected individuals.
Supporting this product development advancement are positive preclinical results from Inovio's novel SynCon® vaccine targeting NS3/4A, which were published in the journal Molecular Therapy in the paper, "Hepatitis C Virus NS3/NS4A DNA Vaccine Induces Multi-epitope T Cell Responses in Rhesus Macaques Mimicking Human Immune Responses." Following immunization, rhesus macaques mounted strong HCV-specific T cell immune responses strikingly similar to those reported in patients who have cleared the virus on their own. The responses included strong NS3-specific interferon-γ (IFN-γ) induction, robust CD4 and CD8 T cell proliferation, and induction of polyfunctional T cells. The study was funded in part by a $2.8 million PA CURE grant received by Inovio and its collaborators in 2010 to develop this multi-antigen synthetic HCV vaccine.
"Hepatitis B and C are a major global health problem, with about 470 million people infected worldwide. As a development leader of synthetic vaccines, we are pleased to collaborate with our affiliate VGX International to advance our global, multi-antigen HCV vaccine into the clinic. This latest development is an integral part of Inovio's multi-pronged approach to develop our therapeutic hepatitis vaccine pipeline," stated Dr. J. Joseph Kim, President and CEO.
Inovio has an ongoing open label Phase II clinical study with ChronTech Pharma AB to test the effect of a DNA vaccine (ChronVac-C®) encoding for NS3/4A protein (genotype 1a) administered by Inovio's MedPulser® electroporation delivery device followed by the standard of care (SOC) drug treatment using interferon and ribavirin. In an earlier phase I study, 5 of 6 participants (83%) who received the vaccine along with SOC cleared the virus. SOC drug treatment alone in patients infected with HCV genotype 1 results in clearance of the virus in 40-50% of patients. Interim results from this phase II study are expected in 2012.
Inovio previously announced a research collaboration with ChronTech Pharma AB and Transgene S.A. to test the immunogenicity of a DNA/electroporation prime - MVA boost approach against HCV by combining two promising, previously studied clinical candidates. A Phase I clinical study is anticipated to start in Q4 2011.
Under the same agreement, Inovio and VGX International will also co-develop Inovio's SynCon® therapeutic vaccine for hepatitis B virus.
About Hepatitis B and Hepatitis C Virus Infections
HBV and HCV infections pose a major global public-health problem and are major causes of chronic liver disease. Three to five times more people are living with chronic viral hepatitis infections than with HIV infection. In the next 10 years, about 150,000 people in the United States are expected to die from liver cancer and end-stage liver disease associated with chronic hepatitis B virus (HBV) and hepatitis C virus (HCV). It is estimated that as many as 5.3 million people—or about 2% of the US population—are living with chronic HBV or HCV infections. Of those, 800,000 to 1.4 million have HBV and 2.7–3.9 million have HCV. Worldwide there are about 300 million people infected with chronic HBV and 170 million people with chronic HCV.
The direct medical costs associated with HBV and HCV infections in the U.S. are estimated to reach nearly $8 billion annually. Almost half the liver transplantations in the United States are necessitated by end-stage liver disease associated with HBV or HCV infection. Because of the aging of people now infected (including some people with asymptomatic infections who will become symptomatic), HBV- and HCV-related illnesses, deaths, and costs are all expected to rise substantially during the next two decades.
About Inovio Pharmaceuticals, Inc.
Inovio is developing its revolutionary synthetic consensus immunogen technologies to extend the profound medical benefits of the 20th century's immune-system-stimulating vaccines by preventing and treating today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery method, have been shown in humans to be safe and generate best-in-class immune responses. Inovio's clinical programs include Phase II studies for cervical dysplasia/cancer, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2010, our Form 10-Q for the quarter ended June 30, 2011, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
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