World J Gastroenterol. 2010 Dec 21;16(47):6016-9.
Yang XW, Tan WF, Yu WL, Shi S, Wang Y, Zhang YL, Zhang YJ, Wu MC.
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Road 225, Shanghai 200438, China. yang16jing@163.com
Abstract
AIM: To assess the benefits and limits of surgery for primary hepatic lymphoma (PHL), and probability of survival after postoperative chemotherapy.
METHODS: A retrospective analysis was undertaken to determine the results of surgical treatment of PHL over the past 8 years. Only nine patients underwent such treatment. The detailed data of diagnosis, treatment, and prognosis were carefully studied.
RESULTS: All patients were mistaken as having α-fetoprotein-negative hepatic cancer before pathological diagnosis. The mean delay time between initial symptoms and final diagnosis was 26.8 d (range: 14-47 d). Hepatitis B virus infection was noted in 33.3% of these patients. Most of the lesions were found to be restricted to a solitary hepatic mass. The surgical procedure performed was left hepatectomy in five cases, including left lateral segmentectomy in three. Right hepatectomy was performed in three cases and combined procedures in one. One patient died on the eighth day after surgery, secondary to hepatic insufficiency. The cumulative 6-mo, 1-year, and 2-year survival rates after hepatic surgery were, respectively, 85.7%, 71.4%, and 47.6%. One patient survived for > 5 years after surgery without any signs of recurrence until latest follow-up, who received routine postoperative chemotherapy every month for 2 years and then regular follow-up. By univariate analysis, postoperative chemotherapy was a significant prognostic factor that influenced survival (P = 0.006).
CONCLUSION: PHL is a rare entity that is often misdiagnosed, and has a potential association with chronic hepatitis B infection. The prognosis is variable, with good response to early surgery combined with postoperative chemotherapy in strictly selected patients.
PMID: 21157979 [PubMed - in process]
Source
January 11, 2011
Evaluation of Current Treatment Recommendations for Chronic Hepatitis B: A 2011 Update
Journal of Gastroenterology and Hepatology
Accepted Article (Accepted, unedited articles published online for future issues)
Myron John Tong Ph.D., M.D.1,2,*, Leeyen Hsu B.S.2, Patrick W. Chang 2, Lawrence Mitchell Blatt Ph.D. 2
DOI: 10.1111/j.1440-1746.2011.06623.x
© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd
Author Information
1 From the Pfleger Liver Institute and the Division of Digestive Diseases, David Geffen School of Medicine at the University of California in Los Angeles, California, and the
2 Liver Center, Huntington Medical Research Institutes, Pasadena, California, USA.
* Correspondence: Myron John Tong Ph.D., M.D.,
* Correspondence: Myron J. Tong, Ph.D., M.D., Liver Center, Huntington Medical Research Institutes 660 South Fair Oaks Avenue Pasadena, CA 91105 Phone: (626) 397-5820 Email: myrontong@hmri.org Fax: (626) 297-5827
Keywords:Anti-viral therapy;hepatocellular carcinoma;liver-related deaths;albumin;platelets;basal core promoter mutants;precore mutants
Abstract
Background/Aims: Guidelines for the treatment of chronic hepatitis B have been recently updated in the 2009 EASL consensus statement, the 2008 United States Panel, the 2008 Asian-Pacific consensus statement, and the 2009 AASLD practice guidelines. We sought to determine whether these guidelines identified patients who developed hepatocellular carcinoma (HCC) or who died of non-HCC liver-related deaths for anti-viral therapy.
Methods: The criteria described in the new treatment guidelines were matched to the database of 369 HBsAg-positive patients in whom 30 developed HCC and 37 died of non-HCC liver-related deaths during a mean follow-up of 84 months.
Results: Using criteria for anti-viral therapy as stated by the four current guidelines, 19-30% of patients who died of non-HCC liver-related complications and 23-53% of patients who developed HCC would have been excluded for anti-viral therapy. If baseline serum albumin levels of ≤3.5g/dl or platelet counts of ≤130,000mm3 were included into the treatment criteria, then 85% to 94% of patients who developed liver-related complications would have been recommended for anti-viral therapy. Also, the addition of precore A1896 mutants and basal core promoter T1762/A1764 mutants would have identified 98.5% to 100% of these patients.
Conclusion: The updated treatment guidelines for hepatitis B still excluded patients who developed serious liver-related complications. The inclusion of baseline serum albumin and platelet counts to current criteria would have identified a majority of these patients for anti-viral therapy. These tests should be included into hepatitis B treatment strategies.
Source
Accepted Article (Accepted, unedited articles published online for future issues)
Myron John Tong Ph.D., M.D.1,2,*, Leeyen Hsu B.S.2, Patrick W. Chang 2, Lawrence Mitchell Blatt Ph.D. 2
DOI: 10.1111/j.1440-1746.2011.06623.x
© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd
Author Information
1 From the Pfleger Liver Institute and the Division of Digestive Diseases, David Geffen School of Medicine at the University of California in Los Angeles, California, and the
2 Liver Center, Huntington Medical Research Institutes, Pasadena, California, USA.
* Correspondence: Myron John Tong Ph.D., M.D.,
* Correspondence: Myron J. Tong, Ph.D., M.D., Liver Center, Huntington Medical Research Institutes 660 South Fair Oaks Avenue Pasadena, CA 91105 Phone: (626) 397-5820 Email: myrontong@hmri.org Fax: (626) 297-5827
Keywords:Anti-viral therapy;hepatocellular carcinoma;liver-related deaths;albumin;platelets;basal core promoter mutants;precore mutants
Abstract
Background/Aims: Guidelines for the treatment of chronic hepatitis B have been recently updated in the 2009 EASL consensus statement, the 2008 United States Panel, the 2008 Asian-Pacific consensus statement, and the 2009 AASLD practice guidelines. We sought to determine whether these guidelines identified patients who developed hepatocellular carcinoma (HCC) or who died of non-HCC liver-related deaths for anti-viral therapy.
Methods: The criteria described in the new treatment guidelines were matched to the database of 369 HBsAg-positive patients in whom 30 developed HCC and 37 died of non-HCC liver-related deaths during a mean follow-up of 84 months.
Results: Using criteria for anti-viral therapy as stated by the four current guidelines, 19-30% of patients who died of non-HCC liver-related complications and 23-53% of patients who developed HCC would have been excluded for anti-viral therapy. If baseline serum albumin levels of ≤3.5g/dl or platelet counts of ≤130,000mm3 were included into the treatment criteria, then 85% to 94% of patients who developed liver-related complications would have been recommended for anti-viral therapy. Also, the addition of precore A1896 mutants and basal core promoter T1762/A1764 mutants would have identified 98.5% to 100% of these patients.
Conclusion: The updated treatment guidelines for hepatitis B still excluded patients who developed serious liver-related complications. The inclusion of baseline serum albumin and platelet counts to current criteria would have identified a majority of these patients for anti-viral therapy. These tests should be included into hepatitis B treatment strategies.
Source
How Bananas and Herbs May Prevent the Transmission of HIV
By Chris Kilham
Published January 11, 2011
FoxNews.com
There has been some buzz lately in the medical/science community about an article published in last year's issue of the Journal of Biological Chemistry, which announced findings that novel lectins found in bananas may help to prevent the transmission and spread of HIV.
The study, originating from the University of Michigan, suggests that eventually many lives may be saved as a result of the development of Ban Lec, a concentrated extract of banana lectins. Lectins are proteins that bind to sugars. The HIV virus is contained in an “envelope” containing the sugar mannose. In laboratory studies, Ban Lec attached itself to the envelope of HIV, prohibiting its replication. Does this mean that eating bananas can help to prevent the transmission of HIV? Absolutely not. There is no evidence of any kind to suggest that eating bananas is any sort of a preventive factor in HIV infection. What this suggests is that Ban Lec, a highly concentrated lectin agent, may eventually prove beneficial in inhibiting HIV transmission.
According to UN AIDS Epidemic Update statistics, approximately 2.6 million people became infected with HIV in 2009. Among them, approximately 375,000 were children. HIV spreads through sexual transmission and through the use of shared needles, as well as by being born to infected parents, and is controlled by avoiding IV needle use, engaging in sex with partners tested free of HIV and wearing a condom. Even then, there is risk. HIV is considered a pandemic, claiming millions of lives globally. Sub-Saharan Africa has been especially hard hit by HIV, with an estimated 22.5 million people infected. In 2009 alone, an estimated 1.3 million Africans died of AIDS-related illnesses. The end of this is nowhere in sight.
Against this backdrop of horror and fatality, many thousands of researchers are investigating possible anti-HIV agents. Some of these are herbal. In one reported HIV study, a polysaccharide from the common herb hyssop inhibited the replication of the virus. The same compound also demonstrated significant protective activity on infected cells. While these findings are encouraging, they do not mean that hyssop prevents HIV.
In another study, a high lignin extract of pine cone seeds demonstrated anti-HIV activity, and helped to reverse the cellular destruction caused by HIV-infected white blood cells. Still other research shows that plant sterols, which are similar to cholesterol, may help to inhibit the invasion of cells by HIV. In mice and monkeys, an extract of pokeweed inhibited HIV significantly. At least three North American prairie plants have demonstrated significant enough anti-HIV activity that they are being studied further.
Does this science mean that a cure for HIV is close at hand? No, it does not. Does this mean that herbs can prevent or cure HIV? At this point we have no reason to believe that this is so. HIV remains a scourge that is ripping its way through the human population with no end in sight.
Of the various botanicals used in cases of HIV, cannabis appears to be the most beneficial. Though cannabis does not inhibit HIV infection or stop the virus from replicating, it does prove highly valuable in cases of HIV wasting syndrome and in cases of HIV-related neuropathy. In HIV wasting syndrome, infected people can experience tremendous difficulty eating or maintaining weight. The use of cannabis stimulates appetite in this population, enabling HIV infected people to eat, and to maintain weight. In cases of HIV-related neuropathy, infected persons experience pain in the longer nerves of the body, especially pain in the soles of the feet. But by smoking or eating cannabis, this pain can be managed enough to greatly reduce or even eliminate this pain. The virus remains, but the pain is managed.
Additionally, HIV infected people often use extracts of immune-enhancing mushrooms, especially the mushroom Reishi (Ganoderma lucidum) to bolster overall immune function. Many mushrooms contain polysacchardies that enhance immune function, and some of these funguses may prove helpful in long-term strategies to maintain better health in case of HIV infection. This form of treatment is popular among proponents of Traditional Chinese Medicine.
Despite encouraging science and the occasional positive news story, there is no known cure for HIV. And even though various studies of herbs suggest that some may eventually prove useful as complementary therapies for managing HIV, that day is down the road. And bananas? Don’t hold out too much hope there. Bananas are good foods, and their lectins may demonstrate anti-HIV properties, but there is a great deal of science yet to be performed to determine the actual worth of this approach in a human population.
While nature often holds a cure for life-threatening diseases, in the case of HIV, we have yet to find such a cure. In the meantime, all the basics apply. Be responsible in your sexual activity, avoid high-risk behaviors such as having sex with strangers and prostitutes and sharing needles, use a condom to reduce the risk of infection, and do not assume that eating any particular thing gives you protection against the virus. It doesn’t.
Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com
Source
Published January 11, 2011
FoxNews.com
There has been some buzz lately in the medical/science community about an article published in last year's issue of the Journal of Biological Chemistry, which announced findings that novel lectins found in bananas may help to prevent the transmission and spread of HIV.
The study, originating from the University of Michigan, suggests that eventually many lives may be saved as a result of the development of Ban Lec, a concentrated extract of banana lectins. Lectins are proteins that bind to sugars. The HIV virus is contained in an “envelope” containing the sugar mannose. In laboratory studies, Ban Lec attached itself to the envelope of HIV, prohibiting its replication. Does this mean that eating bananas can help to prevent the transmission of HIV? Absolutely not. There is no evidence of any kind to suggest that eating bananas is any sort of a preventive factor in HIV infection. What this suggests is that Ban Lec, a highly concentrated lectin agent, may eventually prove beneficial in inhibiting HIV transmission.
According to UN AIDS Epidemic Update statistics, approximately 2.6 million people became infected with HIV in 2009. Among them, approximately 375,000 were children. HIV spreads through sexual transmission and through the use of shared needles, as well as by being born to infected parents, and is controlled by avoiding IV needle use, engaging in sex with partners tested free of HIV and wearing a condom. Even then, there is risk. HIV is considered a pandemic, claiming millions of lives globally. Sub-Saharan Africa has been especially hard hit by HIV, with an estimated 22.5 million people infected. In 2009 alone, an estimated 1.3 million Africans died of AIDS-related illnesses. The end of this is nowhere in sight.
Against this backdrop of horror and fatality, many thousands of researchers are investigating possible anti-HIV agents. Some of these are herbal. In one reported HIV study, a polysaccharide from the common herb hyssop inhibited the replication of the virus. The same compound also demonstrated significant protective activity on infected cells. While these findings are encouraging, they do not mean that hyssop prevents HIV.
In another study, a high lignin extract of pine cone seeds demonstrated anti-HIV activity, and helped to reverse the cellular destruction caused by HIV-infected white blood cells. Still other research shows that plant sterols, which are similar to cholesterol, may help to inhibit the invasion of cells by HIV. In mice and monkeys, an extract of pokeweed inhibited HIV significantly. At least three North American prairie plants have demonstrated significant enough anti-HIV activity that they are being studied further.
Does this science mean that a cure for HIV is close at hand? No, it does not. Does this mean that herbs can prevent or cure HIV? At this point we have no reason to believe that this is so. HIV remains a scourge that is ripping its way through the human population with no end in sight.
Of the various botanicals used in cases of HIV, cannabis appears to be the most beneficial. Though cannabis does not inhibit HIV infection or stop the virus from replicating, it does prove highly valuable in cases of HIV wasting syndrome and in cases of HIV-related neuropathy. In HIV wasting syndrome, infected people can experience tremendous difficulty eating or maintaining weight. The use of cannabis stimulates appetite in this population, enabling HIV infected people to eat, and to maintain weight. In cases of HIV-related neuropathy, infected persons experience pain in the longer nerves of the body, especially pain in the soles of the feet. But by smoking or eating cannabis, this pain can be managed enough to greatly reduce or even eliminate this pain. The virus remains, but the pain is managed.
Additionally, HIV infected people often use extracts of immune-enhancing mushrooms, especially the mushroom Reishi (Ganoderma lucidum) to bolster overall immune function. Many mushrooms contain polysacchardies that enhance immune function, and some of these funguses may prove helpful in long-term strategies to maintain better health in case of HIV infection. This form of treatment is popular among proponents of Traditional Chinese Medicine.
Despite encouraging science and the occasional positive news story, there is no known cure for HIV. And even though various studies of herbs suggest that some may eventually prove useful as complementary therapies for managing HIV, that day is down the road. And bananas? Don’t hold out too much hope there. Bananas are good foods, and their lectins may demonstrate anti-HIV properties, but there is a great deal of science yet to be performed to determine the actual worth of this approach in a human population.
While nature often holds a cure for life-threatening diseases, in the case of HIV, we have yet to find such a cure. In the meantime, all the basics apply. Be responsible in your sexual activity, avoid high-risk behaviors such as having sex with strangers and prostitutes and sharing needles, use a condom to reduce the risk of infection, and do not assume that eating any particular thing gives you protection against the virus. It doesn’t.
Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com
Source
Hepatitis B and C virus hepatocarcinogenesis: Lessons learned and future challenges
Articles in Press
Michael J. Boucharda, Sonia Navas-Martinb 1
Received 12 August 2010; received in revised form 15 November 2010; accepted 25 November 2010. published online 20 December 2010.
Corrected Proof
Abstract
Worldwide, hepatocellular carcinoma (HCC) is one of the most common cancers. It is thought that 80% of hepatocellular carcinomas are linked to chronic infections with the hepatitis B (HBV) or hepatitis C (HCV) viruses. Chronic HBV and HCV infections can alter hepatocyte physiology in similar ways and may utilize similar mechanisms to influence the development of HCC. There has been significant progress towards understanding the molecular biology of HBV and HCV and identifying the cellular signal transduction pathways that are altered by HBV and HCV infections. Although the precise molecular mechanisms that link HBV and HCV infections to the development of HCC are not entirely understood, there is considerable evidence that both inflammatory responses to infections with these viruses, and associated destruction and regeneration of hepatocytes, as well as activities of HBV- or HCV-encoded proteins, contribute to hepatocyte transformation. In this review, we summarize progress in defining mechanisms that may link HBV and HCV infections to the development of HCC, discuss the challenges of directly defining the processes that underlie HBV- and HCV-associated HCC, and describe areas that remain to be explored.
Keywords: Hepatitis B virus, Hepatitis C virus, Hepatocellular carcinoma, Hepatocarcinogenesis, Liver
a Department of Biochemistry and Molecular Biology, Drexel University College of Medicine, Philadelphia, PA 19102, USA
b Department of Microbiology and Immunology, Center for Molecular Virology and Translational Neuroscience, Institute for Molecular Medicine and Infectious Disease, Drexel University College of Medicine, Philadelphia, PA 19102, USA
Corresponding author. Address: Department of Biochemistry and Molecular Biology, Drexel University College of Medicine, 245N. 15th Street, MS 497, Philadelphia, PA 19102, USA. Tel.: +1 215 762 1898; fax: +1 215 762 4452.
1 Address: Department of Microbiology and Immunology, Drexel University College of Medicine, 245N. 15th Street, MS1013A, Philadelphia, PA 19102, USA. Tel.: +1 215 762 7284; fax: +1 215 762 8284.
PII: S0304-3835(10)00549-5
doi:10.1016/j.canlet.2010.11.014
© 2010 Published by Elsevier Inc
Source
Michael J. Boucharda, Sonia Navas-Martinb 1
Received 12 August 2010; received in revised form 15 November 2010; accepted 25 November 2010. published online 20 December 2010.
Corrected Proof
Abstract
Worldwide, hepatocellular carcinoma (HCC) is one of the most common cancers. It is thought that 80% of hepatocellular carcinomas are linked to chronic infections with the hepatitis B (HBV) or hepatitis C (HCV) viruses. Chronic HBV and HCV infections can alter hepatocyte physiology in similar ways and may utilize similar mechanisms to influence the development of HCC. There has been significant progress towards understanding the molecular biology of HBV and HCV and identifying the cellular signal transduction pathways that are altered by HBV and HCV infections. Although the precise molecular mechanisms that link HBV and HCV infections to the development of HCC are not entirely understood, there is considerable evidence that both inflammatory responses to infections with these viruses, and associated destruction and regeneration of hepatocytes, as well as activities of HBV- or HCV-encoded proteins, contribute to hepatocyte transformation. In this review, we summarize progress in defining mechanisms that may link HBV and HCV infections to the development of HCC, discuss the challenges of directly defining the processes that underlie HBV- and HCV-associated HCC, and describe areas that remain to be explored.
Keywords: Hepatitis B virus, Hepatitis C virus, Hepatocellular carcinoma, Hepatocarcinogenesis, Liver
a Department of Biochemistry and Molecular Biology, Drexel University College of Medicine, Philadelphia, PA 19102, USA
b Department of Microbiology and Immunology, Center for Molecular Virology and Translational Neuroscience, Institute for Molecular Medicine and Infectious Disease, Drexel University College of Medicine, Philadelphia, PA 19102, USA
Corresponding author. Address: Department of Biochemistry and Molecular Biology, Drexel University College of Medicine, 245N. 15th Street, MS 497, Philadelphia, PA 19102, USA. Tel.: +1 215 762 1898; fax: +1 215 762 4452.
1 Address: Department of Microbiology and Immunology, Drexel University College of Medicine, 245N. 15th Street, MS1013A, Philadelphia, PA 19102, USA. Tel.: +1 215 762 7284; fax: +1 215 762 8284.
PII: S0304-3835(10)00549-5
doi:10.1016/j.canlet.2010.11.014
© 2010 Published by Elsevier Inc
Source
Keep on livin': Racing series entertains and educates about hepatitis C
By MATT GLEASON World Scene Writer
Published: 1/10/2011 2:21 AM
Last Modified: 1/10/2011 5:25 AM
For online information about hepatitis C from the Centers for Disease Control and Pevention
Tulsa comedian Susan Dale likes to say that her family is "biracial: They're half white-trash, half red-neck," or, for short: "Red-trash."
The adventures of Dale's Kansas-based family, and its national road-racing team, are chronicled in the TV pilot of the reality series "Livin' 4 Racin' Time."
The pilot stars, among others, Susan and her parents, along with her brothers: Allen Dale, who is head driver, and Don Dale, head mechanic.
The pilot will air at 2 p.m. Saturday on KTUL, channel 8.
A four-part version of the pilot is available on YouTube.
On the side of the team's various vehicles, including a 1987 Camaro and an Indy-style racecar, these words are painted in orange: "Get Tested. Hepatitus C." Of course, Allen Duke misspelled hepatitis, which is a running joke in the family. But hepatitis C isn't funny.
"There are approximately 35,000 new cases of hepatitis C in the United States every year," according to information on the Tulsa Health Department website. "About 85 percent of those infected develop chronic liver disease, while approximately 25 percent eventually develop scarring in the liver (cirrhosis). An estimated 10,000-15,000 people die from hepatitis C each year.
"On average, there are 300 cases of acute and chronic hepatitis C each year in Tulsa County."
People at risk of hepatitis C include:
"Anyone who had a transplant, blood transfusion, or received blood products prior to July 1992," according to the health department, "intravenous (IV) drug users, even if drug use only occurred once, and patients with kidney disease who are required to undergo blood filtration (hemodialysis)."
No one in Susan Dale's family has hepatitis C, but a former classmate inspired Allen Duke to use the team's racecars as fast-moving billboards, even if that meant sacrificing precious advertising space. Soon after, Susan Dale's production company Lynn-Baxter Studios - Lynn is her middle name - aimed to film the series and public service announcements about the importance of getting tested for hepatitis C.
A documentary about hepatitis C is also in the works.
Dale, who works three jobs these days, helms the series, which is produced with help from several thousand dollars donated by the Muscogee (Creek) Nation. The pilot was partially filmed at Hallett Motor Racing Circuit in Jennings.
The pilot has aired on the Florida-based River Broadcasting Network, Dale said. And five other cable networks have contacted her about airing the series once it has a handful of professional-quality shows ready to air.
Dale said of the new reality series: "We know this is changing people's lives."
Source
Published: 1/10/2011 2:21 AM
Last Modified: 1/10/2011 5:25 AM
For online information about hepatitis C from the Centers for Disease Control and Pevention
Tulsa comedian Susan Dale likes to say that her family is "biracial: They're half white-trash, half red-neck," or, for short: "Red-trash."
The adventures of Dale's Kansas-based family, and its national road-racing team, are chronicled in the TV pilot of the reality series "Livin' 4 Racin' Time."
The pilot stars, among others, Susan and her parents, along with her brothers: Allen Dale, who is head driver, and Don Dale, head mechanic.
The pilot will air at 2 p.m. Saturday on KTUL, channel 8.
A four-part version of the pilot is available on YouTube.
On the side of the team's various vehicles, including a 1987 Camaro and an Indy-style racecar, these words are painted in orange: "Get Tested. Hepatitus C." Of course, Allen Duke misspelled hepatitis, which is a running joke in the family. But hepatitis C isn't funny.
"There are approximately 35,000 new cases of hepatitis C in the United States every year," according to information on the Tulsa Health Department website. "About 85 percent of those infected develop chronic liver disease, while approximately 25 percent eventually develop scarring in the liver (cirrhosis). An estimated 10,000-15,000 people die from hepatitis C each year.
"On average, there are 300 cases of acute and chronic hepatitis C each year in Tulsa County."
People at risk of hepatitis C include:
"Anyone who had a transplant, blood transfusion, or received blood products prior to July 1992," according to the health department, "intravenous (IV) drug users, even if drug use only occurred once, and patients with kidney disease who are required to undergo blood filtration (hemodialysis)."
No one in Susan Dale's family has hepatitis C, but a former classmate inspired Allen Duke to use the team's racecars as fast-moving billboards, even if that meant sacrificing precious advertising space. Soon after, Susan Dale's production company Lynn-Baxter Studios - Lynn is her middle name - aimed to film the series and public service announcements about the importance of getting tested for hepatitis C.
A documentary about hepatitis C is also in the works.
Dale, who works three jobs these days, helms the series, which is produced with help from several thousand dollars donated by the Muscogee (Creek) Nation. The pilot was partially filmed at Hallett Motor Racing Circuit in Jennings.
The pilot has aired on the Florida-based River Broadcasting Network, Dale said. And five other cable networks have contacted her about airing the series once it has a handful of professional-quality shows ready to air.
Dale said of the new reality series: "We know this is changing people's lives."
Source
Peregrine Initiates Randomized Phase II Trial of Bavituximab in Chronic Hepatitis C
Open-Label Trial Evaluating 12 Weeks of Therapy With Novel Targeted Antibody Bavituximab in Combination With Ribavirin Versus Standard of Care
TUSTIN, CA--(Marketwire - January 10, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it has initiated a randomized Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. This open-label trial will determine the early virologic response (EVR) rate of patients after 12 weeks of therapy with Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating potential, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin. Peregrine expects to complete enrollment shortly in an ongoing Phase Ib HCV trial and report data by mid-year.
"Our fourth randomized Phase II trial evaluating bavituximab for oncology and viral infections is designed to build on our three prior Phase I HCV trials, which have demonstrated our antibody's acceptable safety and promising signs of antiviral activity," said Steven W. King, president and chief executive officer of Peregrine. "Although there are several targeted antiviral drug candidates in development against HCV, immune stimulation with interferon remains a cornerstone of the standard HCV regimen, but unfortunately causes serious side effects and unacceptable toxicity for many patients. With bavituximab's immune reactivation mechanisms and safety profile to date, we are eager to assess this new combination as a potential alternative to interferon-based regimens for patients infected with HCV."
Bavituximab may address a fundamental "immune evasion" mechanism exploited by many infectious pathogens. A growing body of published data from researchers worldwide shows that bavituximab's PS target, exposed on the surface of cells infected by viruses and protozoan parasites, suppresses the immune system's ability to fight disease. PS-targeting antibodies such as bavituximab bind to PS and block the immunosuppressive signals created by the target, thereby allowing the immune system to mount a robust immune response against the pathogen. In prior HCV clinical trials, bavituximab administered as monotherapy in single and multiple doses demonstrated a positive safety profile with no dose-limiting toxicities or serious adverse events. Bavituximab as a monotherapy also showed promising on therapy antiviral activity of up to 1.5 log viral load reduction.
About the Phase II HCV Trial
In this multicenter Phase II randomized, open-label trial, up to 66 patients with previously untreated genotype-1 chronic HCV infection will be randomly assigned to one of three treatment arms. Patients will receive daily oral ribavirin (1000 mg) with either weekly bavituximab (0.3 mg/kg or 3 mg/kg) or PEG-IFN alpha-2a (180 µg) for up to 12 weeks and will be tested for safety parameters and antiviral activity.
The primary endpoint of the study is the proportion of patients achieving early virologic response (EVR), an early predictor of which patients are likely to clear virus with continued treatment. EVR is defined as a greater than or equal to 2 log reduction in HCV RNA after 12 weeks of treatment. Secondary endpoints include safety, tolerability and HCV viral kinetics. For further information about this trial, please visit http://www.peregrinetrials.com/ or http://www.clinicaltrials.gov/ct2/results?term=bavituximab.
About HCV
According to the U.S. Centers for Disease Control and Prevention, an estimated 3.2 million individuals in the United States have chronic hepatitis C virus (HCV) infection. Chronic HCV infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or death. It is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplant in the United States. Approximately 8,000 to 10,000 people die every year from HCV-related liver disease.
About Bavituximab's Antiviral Approach
Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body's immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.
Researchers have found that PS is exposed on the outer membrane of cells infected with HCV, HIV, influenza, herpes viruses, hemorrhagic fever viruses, respiratory syncytial virus, measles as well as other viruses. A growing body of scientific publications, including Nature Medicine and The Journal of Experimental Medicine, has highlighted data on the role of PS and Peregrine's PS-targeting therapies in infectious diseases.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from the Phase II HCV trial will not be consistent with results experienced in earlier HCV clinical trials and preclinical studies, the risk that investigators may experience delays in patient enrollment, risk that results may not support registration filings with the U.S. Food and Drug Administration, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. Factors that could cause actual results to differ materially or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2010 and the quarterly report on Form 10-Q for the quarter ended October 31, 2010. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contact:
Amy Figueroa
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
Source
TUSTIN, CA--(Marketwire - January 10, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it has initiated a randomized Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. This open-label trial will determine the early virologic response (EVR) rate of patients after 12 weeks of therapy with Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating potential, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin. Peregrine expects to complete enrollment shortly in an ongoing Phase Ib HCV trial and report data by mid-year.
"Our fourth randomized Phase II trial evaluating bavituximab for oncology and viral infections is designed to build on our three prior Phase I HCV trials, which have demonstrated our antibody's acceptable safety and promising signs of antiviral activity," said Steven W. King, president and chief executive officer of Peregrine. "Although there are several targeted antiviral drug candidates in development against HCV, immune stimulation with interferon remains a cornerstone of the standard HCV regimen, but unfortunately causes serious side effects and unacceptable toxicity for many patients. With bavituximab's immune reactivation mechanisms and safety profile to date, we are eager to assess this new combination as a potential alternative to interferon-based regimens for patients infected with HCV."
Bavituximab may address a fundamental "immune evasion" mechanism exploited by many infectious pathogens. A growing body of published data from researchers worldwide shows that bavituximab's PS target, exposed on the surface of cells infected by viruses and protozoan parasites, suppresses the immune system's ability to fight disease. PS-targeting antibodies such as bavituximab bind to PS and block the immunosuppressive signals created by the target, thereby allowing the immune system to mount a robust immune response against the pathogen. In prior HCV clinical trials, bavituximab administered as monotherapy in single and multiple doses demonstrated a positive safety profile with no dose-limiting toxicities or serious adverse events. Bavituximab as a monotherapy also showed promising on therapy antiviral activity of up to 1.5 log viral load reduction.
About the Phase II HCV Trial
In this multicenter Phase II randomized, open-label trial, up to 66 patients with previously untreated genotype-1 chronic HCV infection will be randomly assigned to one of three treatment arms. Patients will receive daily oral ribavirin (1000 mg) with either weekly bavituximab (0.3 mg/kg or 3 mg/kg) or PEG-IFN alpha-2a (180 µg) for up to 12 weeks and will be tested for safety parameters and antiviral activity.
The primary endpoint of the study is the proportion of patients achieving early virologic response (EVR), an early predictor of which patients are likely to clear virus with continued treatment. EVR is defined as a greater than or equal to 2 log reduction in HCV RNA after 12 weeks of treatment. Secondary endpoints include safety, tolerability and HCV viral kinetics. For further information about this trial, please visit http://www.peregrinetrials.com/ or http://www.clinicaltrials.gov/ct2/results?term=bavituximab.
About HCV
According to the U.S. Centers for Disease Control and Prevention, an estimated 3.2 million individuals in the United States have chronic hepatitis C virus (HCV) infection. Chronic HCV infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or death. It is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplant in the United States. Approximately 8,000 to 10,000 people die every year from HCV-related liver disease.
About Bavituximab's Antiviral Approach
Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body's immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.
Researchers have found that PS is exposed on the outer membrane of cells infected with HCV, HIV, influenza, herpes viruses, hemorrhagic fever viruses, respiratory syncytial virus, measles as well as other viruses. A growing body of scientific publications, including Nature Medicine and The Journal of Experimental Medicine, has highlighted data on the role of PS and Peregrine's PS-targeting therapies in infectious diseases.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from the Phase II HCV trial will not be consistent with results experienced in earlier HCV clinical trials and preclinical studies, the risk that investigators may experience delays in patient enrollment, risk that results may not support registration filings with the U.S. Food and Drug Administration, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. Factors that could cause actual results to differ materially or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2010 and the quarterly report on Form 10-Q for the quarter ended October 31, 2010. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contact:
Amy Figueroa
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
Source
Inhibitex Reports Positive Interim Safety and Antiviral Data from Ongoing Phase 1b Study of HCV Nucleotide Inhibitor INX-189
January 09, 2011 06:00 PM Eastern Time
-9mg and 25mg QD Doses Demonstrate Significant Reductions in HCV RNA Levels-
ATLANTA--(BUSINESS WIRE)--Inhibitex, Inc. (Nasdaq: INHX) today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV).
The trial, which is being conducted under an IND in the United States, is a double-blind, placebo-controlled, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of INX-189, administered orally once-daily for seven days, for the treatment of HCV genotype 1 treatment naïve patients. Each treatment cohort in the study is comprised of 10 patients, eight that receive INX-189 and two that receive placebo. In addition to the 9 mg and 25 mg dose cohorts, the Company plans to enroll up to three more INX-189 monotherapy cohorts in the study, as well as two cohorts that will receive different doses of INX-189 once daily for seven days in combination with ribavirin.
INX-189, dosed once-daily at 9mg and 25mg for seven days, demonstrated potent antiviral activity with a mean HCV RNA reduction from baseline levels of -0.71 and -1.03 log10 IU/mL, respectively. The mean HCV RNA decline from baseline levels observed in patients that received placebo was -0.06 log10 IU/mL. The HCV RNA declines from baseline were statistically significant from placebo, with p-values of 0.0156 and 0.0006 in the 9 mg and 25 mg cohorts, respectively. In addition to the mean reductions in viral load, clinically meaningful decreases in alanine transaminase (ALT) levels were observed for patients receiving INX-189 at both dose levels and no patients experienced viral breakthrough.
See Table
Preliminary assessments of the data available from the first two cohorts in the Phase 1b study indicate that INX-189 was well tolerated. There were no serious adverse events reported, no discontinuations due to an adverse event, and no adverse events related to changes in clinical laboratory evaluations. All reported adverse events were mild or moderate and were not dose dependent. In addition, the pharmacokinetics of the 9mg and 25mg doses in HCV-infected patients were comparable to those observed in healthy volunteers, and continue to support the evaluation of INX-189 as a once-daily therapy.
“We are pleased with the interim results of the trial to-date and the rapid and potent antiviral activity demonstrated at these low doses of INX-189,” commented Joseph M. Patti, Ph.D., Inhibitex’s CSO and Senior Vice-President of Research. “We look forward to completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in this ongoing study, and anticipate reporting additional safety, antiviral and pharmacokinetic data from the study upon its completion later this quarter.”
About HCV and INX-189
Hepatitis C is a disease of the liver caused by HCV. It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methylguanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
In a Phase 1a study, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial demonstrated the following:
• INX-189 was well tolerated at all dose levels;
• No drug-related serious adverse events;
• No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache, nasal congestion, ecchymosis, and presyncope;
• No grade II or higher laboratory abnormality adverse events; and
• Pharmacokinetic data supported INX-189’s potential for once-daily dosing.
About Inhibitex
Inhibitex, Inc. is a clinical stage biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. In addition to INX-189, the Company’s clinical stage pipeline includes FV-100, a bicyclic nucleoside inhibitor in Phase II development for the treatment of shingles. The Company also has additional HCV nucleotide polymerase inhibitors in various stages of preclinical development, and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of active staphylococcal vaccines.
For additional information about the Company, please visit http://www.inhibitex.com/.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding: the Company completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in the ongoing Phase 1b study; the Company reporting additional safety, antiviral and pharmacokinetic data later this quarter; and the potential of INX-189 as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of ongoing or future preclinical or clinical studies of INX-189 not supporting its further development for lack of safety, tolerability, antiviral activity, or any other reason; INX-189 not demonstrating sufficient anti-viral activity as monotherapy or any anti-viral synergies with ribavirin in the Phase 1b trial as a once-daily dose; either the Company, the FDA, a safety review board or an investigational review board suspending or terminating the clinical development of INX-189 at any time for lack of safety, tolerability, anti-viral activity, or any other reason; obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of the Company’s product candidates; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, as filed with the SEC on November 15, 2010. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.
Contacts
Inhibitex, Inc.
Russell H. Plumb, 646-378-2922
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, CFA, 678-746-1136
lstern@troutgroup.com
Source
-9mg and 25mg QD Doses Demonstrate Significant Reductions in HCV RNA Levels-
ATLANTA--(BUSINESS WIRE)--Inhibitex, Inc. (Nasdaq: INHX) today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV).
The trial, which is being conducted under an IND in the United States, is a double-blind, placebo-controlled, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of INX-189, administered orally once-daily for seven days, for the treatment of HCV genotype 1 treatment naïve patients. Each treatment cohort in the study is comprised of 10 patients, eight that receive INX-189 and two that receive placebo. In addition to the 9 mg and 25 mg dose cohorts, the Company plans to enroll up to three more INX-189 monotherapy cohorts in the study, as well as two cohorts that will receive different doses of INX-189 once daily for seven days in combination with ribavirin.
INX-189, dosed once-daily at 9mg and 25mg for seven days, demonstrated potent antiviral activity with a mean HCV RNA reduction from baseline levels of -0.71 and -1.03 log10 IU/mL, respectively. The mean HCV RNA decline from baseline levels observed in patients that received placebo was -0.06 log10 IU/mL. The HCV RNA declines from baseline were statistically significant from placebo, with p-values of 0.0156 and 0.0006 in the 9 mg and 25 mg cohorts, respectively. In addition to the mean reductions in viral load, clinically meaningful decreases in alanine transaminase (ALT) levels were observed for patients receiving INX-189 at both dose levels and no patients experienced viral breakthrough.
See Table
Preliminary assessments of the data available from the first two cohorts in the Phase 1b study indicate that INX-189 was well tolerated. There were no serious adverse events reported, no discontinuations due to an adverse event, and no adverse events related to changes in clinical laboratory evaluations. All reported adverse events were mild or moderate and were not dose dependent. In addition, the pharmacokinetics of the 9mg and 25mg doses in HCV-infected patients were comparable to those observed in healthy volunteers, and continue to support the evaluation of INX-189 as a once-daily therapy.
“We are pleased with the interim results of the trial to-date and the rapid and potent antiviral activity demonstrated at these low doses of INX-189,” commented Joseph M. Patti, Ph.D., Inhibitex’s CSO and Senior Vice-President of Research. “We look forward to completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in this ongoing study, and anticipate reporting additional safety, antiviral and pharmacokinetic data from the study upon its completion later this quarter.”
About HCV and INX-189
Hepatitis C is a disease of the liver caused by HCV. It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methylguanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
In a Phase 1a study, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial demonstrated the following:
• INX-189 was well tolerated at all dose levels;
• No drug-related serious adverse events;
• No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache, nasal congestion, ecchymosis, and presyncope;
• No grade II or higher laboratory abnormality adverse events; and
• Pharmacokinetic data supported INX-189’s potential for once-daily dosing.
About Inhibitex
Inhibitex, Inc. is a clinical stage biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. In addition to INX-189, the Company’s clinical stage pipeline includes FV-100, a bicyclic nucleoside inhibitor in Phase II development for the treatment of shingles. The Company also has additional HCV nucleotide polymerase inhibitors in various stages of preclinical development, and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of active staphylococcal vaccines.
For additional information about the Company, please visit http://www.inhibitex.com/.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding: the Company completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in the ongoing Phase 1b study; the Company reporting additional safety, antiviral and pharmacokinetic data later this quarter; and the potential of INX-189 as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of ongoing or future preclinical or clinical studies of INX-189 not supporting its further development for lack of safety, tolerability, antiviral activity, or any other reason; INX-189 not demonstrating sufficient anti-viral activity as monotherapy or any anti-viral synergies with ribavirin in the Phase 1b trial as a once-daily dose; either the Company, the FDA, a safety review board or an investigational review board suspending or terminating the clinical development of INX-189 at any time for lack of safety, tolerability, anti-viral activity, or any other reason; obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of the Company’s product candidates; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, as filed with the SEC on November 15, 2010. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.
Contacts
Inhibitex, Inc.
Russell H. Plumb, 646-378-2922
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, CFA, 678-746-1136
lstern@troutgroup.com
Source
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