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June 27, 2008
Good News for Non-Responders to HCV Combination Therapy
A Phase 3 trial evaluating ZADAXIN® (thymalfasin) as a potential third component for Hepatitis C traditional combination therapy has just been completed. Although the data is currently being analyzed and won't be available until later in the year, the lead investigator anticipates good news for previous non-responders.
SciClone and Sigma-Tau Provide Update on Phase 3 Hepatitis C Study
June 26, 2008
http://money.cnn.com/news/newsfeeds/articles/marketwire/0410557.htm
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A. today announced that all 553 enrolled patients successfully completed a Phase 3 trial. After 48 weeks of therapy, all patients responding to treatment have now completed their 24-week follow-up. The unblinded data from the trial are expected to be available in the fourth quarter of 2008. The Phase 3 trial is evaluating ZADAXIN® (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin. In February 2008, SciClone and Sigma-Tau S.p.A. announced promising blinded interim data from this trial.
"The completion of the study is an important step toward unblinding the data. Previously reported data from this Phase 3 hepatitis C trial have been promising," said Mario Rizzetto, M.D., Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. "The standard data review and analysis is underway with an unblinding of the data expected in late 2008."
"We continue to believe that thymalfasin could represent an important advance in the treatment of non-responder hepatitis C patients and address a growing and acute need," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc.
The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the United States and Europe until 2021. Details of the thymalfasin triple therapy for HCV, the hepatitis C virus, and thymalfasin may be found in the press release from SciClone Pharmaceuticals dated February 11, 2008, at www.sciclone.com.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in a late-stage clinical trial for the treatment of hepatitis C, and successfully completed a phase 2 clinical trial in malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead(TM). For the U.S. market, SciClone's other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit www.sciclone.com.
About sigma-tau Group
Sigma-tau Group is a leading research-based Italian pharmaceutical company with a consolidated 2007 turnover of approximately EUR 665 million (US$ 920 million) and over 2500 employees worldwide. The therapeutic areas in which sigma-tau Group focuses its Research and Development include cardiovascular disease, metabolism, neurology, oncology and immunology, totalling 48 projects. Over 30 indications are explored in clinical trials with 24 molecules of which 17 are proprietary and the majority of them (14) are NCEs. Sigma-tau Group has operating subsidiaries throughout Europe and the U.S. and is active in every major pharmaceutical market. For additional information about sigma-tau Group, please visit www.sigma-tau.it.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding future sales and financial results for 2008, and progress, timing and results of our clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including changes in demand for ZADAXIN, the progress or failure of clinical trials, our actual experience in executing on our objectives, the performance of our partners, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, the performance and future actions of our strategic partners, unexpected delays in clinical trial enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. Further, although our financial guidance is based on our current estimates, factors such as the actual timeline and design of the phase 3 melanoma clinical trial and final decisions regarding expense sharing arrangements for the trial could alter the estimates of our research and development expenses, net loss and year-end cash balance for 2008.
Corporate Contact:
Ana Kapor
SciClone Pharmaceuticals, Inc.
650.358.3437
Posted by Editors at 10:35 AM --- Printer-friendly version
June 23, 2008
Purer, Less Costly Interferon for Hepatitis C and B Treatment
The Taiwan-based biopharmaceutical company PharmaEssentia Corp. is testing P1101, its third-generation PEG-interferon-alpha drug candidate. Because it is a longer-lasting, purer interferon that is less costly to produce, P1101 could enhance the treatment options for Hepatitis C and B.
(Taiwan) PharmaEssentia announces milestone in development of new third-generation interferon hepatitis B and C drug candidate
www.biotecheast.com
(Press release, PharmaEssentia Corp.)
18 June, 2008
Drug development company PharmaEssentia Corp. today announced that new PK/PD data on P1101, its third-generation PEG-interferon-alpha drug candidate for hepatitis B and C, showed the drug is particularly long-lasting compared to the two other pegylated-interferon drugs currently on the market. This indicates that PharmaEssentia's drug may only need to be injected once every two or more weeks by the patient, compared to the usual once-a-week administration.
Reducing dosage frequency is considered desirable for minimizing side effects and increasing the efficacy; and is more convenient for the patient as such biopharmaceutical drugs must usually be administered by injection.
Additionally, the modified structure of PharmaEssentia's PEG-INF-alpha makes for a purer drug, leading to a simpler manufacturing process and better quality control over the end product, particularly when produced at higher doses. P1101 has only a predominant single positional isomer connecting the PEG molecule on the protein, compared with 8 to 14 isomers found in the two other pegylated-interferon drugs, respectively.
Less frequent dosage should also mean a lower end cost and better compliance for the patient.
Assuming that upcoming clinical trails are all completed successfully, Dr. KC Lin, founder and CEO of PharmaEssentia, sees the drug gaining rapid acceptance and market share upon launch.
"Our drug will be purer, easier to manufacture, and more importantly, a more convenient and cheaper interferon option for doctors and patients. It's set to transform the whole picture of HCV/HBV treatment," explained Lin.
Summary of pharmacokinetics (PK) and pharmacodyamics (PD) studies:
PK results: Mean serum concentrations of PEG-IFN after a single subcutaneous dose of 30ug/kg of one of the two other pegylated-interferon drugs currently on the market, or P1101 (PharmaEssentia) were measured. PEG-IFN was detectable in all four animals through 14 days after P1101 administration, while PEG-IFN was only detectable in two out of four monkeys for the 14 days duration after administration of the two other pegylated-interferon drugs.
PD results: A single subcutaneous dose of 30 ug/kg of one of the two other pegylated-interferon drugs currently on the market, or P1101, resulted in significant increase in serum 2’,5’-OAS (biomarker of IFN-alpha exposure) concentration. Serum 2’,5’-OAS concentration reached its Cmax 72 hours after dosing and gradually declined for the animals treated with the other two pegylated-interferon drugs. For animals receiving the P1101 dose, serum 2’,5’-OAS concentration also reached Cmax 72 hours after dosing. However, 2’,5’-OAS concentration only decreased slightly throughout the 14 days of the study period.
About PharmaEssentia Corp.:
PharmaEssentia Corp., a Taiwan-based biopharmaceutical company, is focusing its efforts on making improvements to the biologics family of drugs using a combination of its own proprietary novel site-specific PEGylation, a medicinal chemistry approach, and protein engineering technologies to create new "PEGylated" biologics.
Through its novel technology platform, PharmaEssentia Corp. has a series of PEGylated biologics called the "PEG-5 biologics": PEG-IFN-alpha-2b, IFN-beta, GCSF, EPO, GH, undergoing various stages of research and development. The current market for the diseases targeted by these drugs is estimated at around US$25 billion with an annual growth rate of 9 percent.
PharmaEssentia’s PEG-IFN-alpha-2b a third-generation long-acting interferon for the treatment of hepatitis B and C, is currently in preparation for US FDA IND filing in the 3rd quarter of 2008. PEG-IFN-alpha-2b has only a single form compared to 14 and 8 with the two other pegylated-interferon drugs currently on the market, thus requiring a potentially less frequent administration regime. Through a unique refolding process, PEG-IFN-alpha-2b has a better yield (up to as high as 40 percent compared to wild type INF) and longer half-life (administration every two weeks or more) at a competitive CMC (Chemical Manufacturing Control).
PharmaEssentia at BIO 2008, San Diego:
We are currently seeking qualified co-development or out-licensing partners for our PEG-Interferon-alpha drug candidate (HBV, HCV). Please contact us to arrange a meeting during the partnering sessions at BIO 2008, 17-18 June, in San Diego, or feel free to visit us at booth 2501 at the Taiwan Pavilion.
PharmaEssentia CEO Dr. KC Lin will also be giving a presentation at the BIO 2008, Business Forum, Room 5B, 3:00pm, 18 June, 2008. You are very welcome to attend.
Contact:
PharmaEssentia Corp.
13F, No. 3 YuanQu St., Nankang District
Taipei 115, Taiwan
Tel: 886 2 2655 7688
Fax: 886 2 2655 7626
www.pharmaessentia.com
Ms. Shu-Fen Li, MBA
Director of Business Development and Strategic Planning
Ph: +886-2-2655-7688 ext. 7812
shufen_li@pharmaessentia.com
For editors:
PEG-IFN-alpha-2b = PEG-IFN-α-2b
IFN-beta = IFNβ
Posted by Editors at 02:35 PM --- Printer-friendly version
New Technology May Help Treat Hepatitis
While pharmaceutical companies are racing to find safer, more effective treatments for viral Hepatitis C and B, physicists from Arizona have a unique perspective on accomplishing the same goal. Learn how these scientists believe the virus could be rendered harmless with this non-traditional, non-invasive procedure.
by Nicole Cutler, L.Ac.
As one of the leading causes of liver disease, both the Hepatitis B and C viruses remain difficult to eliminate. Although medical technology has produced some potent medicines to battle these liver-invading viruses, they are ineffective for a significant percentage of those infected. However, scientists from Arizona have stepped into an entirely new field of medicine that proposes a completely different approach to dismantling a virus. By mathematically determining the frequency by which viruses can be shaken to death, physics may trump the biological sciences in the quest to safely eliminate viral pathogens.
Although this innovative technology’s potential for fighting Hepatitis B or C is currently in a conceptual stage, the logic behind it is intriguing and hopeful. All objects have resonant frequencies at which they naturally vibrate; however, too much vibration can destroy an object. A good example of this phenomenon is the destruction of the Tacoma Narrows Bridge, which warped and finally collapsed in 1940 due to a wind that rocked the bridge back and forth at one of its resonant frequencies. Similar to how opera singers can hit notes that shatter glass, recent experimental evidence has shown that laser pulses tuned to the right frequency can kill certain viruses.
An idea that runs parallel to the marvel of resonant frequency is a breakthrough explained by Bruce Lipton in his book, The Biology of Belief. In this archetype, Lipton believes that the key to life does not lie within a person’s DNA – but, rather, within the mechanisms of the cell membrane. In contrast to conventional medical science, proponents of Lipton’s work advocate that the cell’s membrane operates in response to its environment and controls how the genes inside the cell are interpreted.
In Lipton’s biological model, the cell dies when the membrane is destroyed, just as a person would die if their brain were removed. Applying this theory to the work of physicist Otto Sankey of Arizona State University, using resonant frequencies that stress the outer shell of the virus to its breaking point would theoretically kill the virus residing inside. According to Sankey, “The capsid of a virus is something like the shell of a turtle. If the shell can be compromised [by mechanical vibrations], the virus can be inactivated.”
Consisting of small units of protein, the capsid is the outer shell of a virus. The three primary purposes of a capsid include:
1. protecting the virus’s genetic material
2. detecting cells suitable for infection
3. initiating infection by “opening” the target cell to inject DNA into the cytoplasm
As a result of Sankey’s initial discovery, researchers are hard at work developing methods to calculate the vibrational motion of every atom of a capsid. Armed with knowing the vibrational motion of a capsid’s atoms, the lowest resonant frequencies can be determined. Even though determining any particular capsid’s lowest resonant frequency may be within arms reach, this technology is still a long way from being used to neutralize viruses in infected people.
One of the biggest challenges of using lasers to break open a capsid is that a laser’s light cannot penetrate the skin very deeply. However, Sankey suggests that there may be ways to circumvent this limitation such as:
· Hooking a person up to a dialysis-like machine that cycles blood through a tube where it can be zapped with a laser.
· Due to its penetrative ability, applying a resonant frequency with ultrasound equipment instead of a laser.
Adding to the task of using lasers to kill a hepatitis virus is the apparent complexity of the Hepatitis B and Hepatitis C capsids.
Hepatitis B Capsid – As published in the June 2006 edition of the journal Molecular Cell, Scripps researchers examined the capsid of the Hepatitis B virus. According to Professor Mark Yeager, MD, PhD, the Hepatitis B virus is enormous, nearly 10 times larger than a hemoglobin molecule. The Hepatitis B capsid has icosahedral symmetry, resembling the geometric structure of a geodesic dome. The capsid itself is contained within an outer envelope formed by a lipid bilayer, similar to the membranes that enclose all human cells. The membrane of the Hepatitis B virus is studded with glycoprotein spikes, which bind to receptors on liver cells to mediate infection.
Hepatitis C Capsid – The Hepatitis C capsid also has the twenty-sided icosahedral crystalline form. This structure forms an efficient sphere that can be built from the smallest building blocks, conserving host cell energy for the production of viruses. Additionally, Hepatitis C also surrounds their capsids with an additional envelope of lipids to further insulate the virus from damage.
Once the frequency is established for dismantling a viral capsid, and a safe and effective way to administer that frequency is determined, then the hepatitis viruses will no longer be a threat to liver health. The Arizona scientists assure us that normal cells will not be affected by virus-killing lasers or sound waves because they have resonant frequencies much lower than those of viruses. Another promising characteristic of this technology is that viruses are unlikely to develop a resistance to mechanical shaking like they do with drugs.
Applying vibrational physics to therapeutic virology is a fascinating concept. With enough time, experimentation and successful trials, scientists are hopeful they will find the right resonant frequencies for each virus. Although this technology has a long way to go, a zap of light could change the way we treat viral hepatitis in the future.
References:
Dryden, Kelly A, Mark Yeager et al., Native Hepatitis B virions and capsids Visualized by Electron Cryomicroscopy, Molecular Cell, June 2006.
Lipton, Bruce, PhD, The Biology of Belief: Unleashing the Power of Consciousness, Matter and Miracles, Mountain of Love/Elite Books, Santa Rosa, CA, 2005.
www.epidemic.org, Anatomy of the Virus, Trustees of Dartmouth College, 2008.
www.iscid.org, Capsid, International Society for Complexity, Information and Design, 2008.
www.livescience.com, New Way to Kill Viruses: Shake them to Death, Michael Schirber, Imaginova Corp., February 2008.
www.mercola.com, A New Way to Kill Viruses: Shake them to Death, Dr. Joseph Mercola, 2008.
www.sciencedaily.com, Researchers Map Infectious Hepatitis B Virus, ScienceDaily LLC, 2008.
Posted by Editors at 02:12 PM --- Printer-friendly version
Alcoholism and Viral Hepatitis
Conquering viral hepatitis is hard enough without the added challenge of alcoholism. The drug gabapentin as a treatment for alcohol dependence is currently being evaluated in human trials.
by Nicole Cutler, L.Ac.
Since drinking alcohol can rapidly accelerate the liver damage caused by chronic viral hepatitis, a diagnosis of Hepatitis B or C always demands immediate cessation of consuming anything with alcohol. For some individuals, abandoning an occasional drink is easy. However, those with an addiction to alcohol will likely find giving up booze to be the hardest part of being diagnosed with chronic liver disease. To put the task of abstinence within an alcoholic’s reach, researchers are currently looking into the use of gabapentin to help people overcome alcohol addiction.
What is Gabapentin?
Originally approved by the U.S. Food and Drug Administration in 1994, gabapentin was originally developed for the treatment of epilepsy. In a class of medications called anticonvulsants, gabapentin treats seizures by decreasing abnormal excitement in the brain. Also widely known by its brand name Neurontin, more recent applications include its ability to reduce several types of chronic pain.
Gabapentin is a structural analog of the neurotransmitter GABA (gamma-aminobutyric acid). Although GABA has anticonvulsant properties, gabapentin’s molecular and cellular mechanisms of action are unclear. Despite this uncertainty, scientists who investigate alcoholism know that the GABAergic system in the brain plays an important role in regulating voluntary ethanol intake.
Gabapentin for Alcohol Dependence
Scientists have known for several years that alcohol produces many of its intoxicating actions through GABA receptor activation. Pre-clinical studies of alcohol dependence have shown that GABAergic activity decreases during alcohol withdrawal and protracted abstinence – the periods in which a recovering alcoholic is vulnerable to relapse.
Researchers at Scripps Research Institute believe that these GABAergic changes are probably a major cause of relapse in individuals undergoing treatment for alcoholism. By activating GABA receptors, these published studies support the use of gabapentin to help overcome alcohol addiction:
· A randomized, double-blind, placebo-controlled trial published in the November 2007 edition of Journal of Clinical Psychiatry evaluated the use of gabapentin in alcoholics being treated in a Brazilian public outpatient drug treatment center. The researchers found that gabapentin reduced alcohol consumption and craving, which they concluded might help patients maintain abstinence.
· As published in the May 2008 edition of the Journal of Neuroscience, investigators evaluated the effect of gabapentin on ethanol dependence. Although this was not a human study, the researchers did find that gabapentin reversed the behavioral measures of alcohol dependence. Their conclusion suggests that this drug represents a potential medication for the treatment of alcoholism.
Can Gabapentin Hurt the Liver?
Especially important for people living with a chronic viral hepatitis infection, any medications taken must be evaluated in terms of their potential to injure the liver. Although gabapentin is not metabolized by the liver, only future studies will confirm its safety for people with chronic hepatitis.
According to Yale University School of Medicine lecturer Orly Avitzur, MD, MBA, gabapentin is a water-soluble amino acid, which is eliminated unchanged by the kidneys without any appreciable metabolism by the liver. However, she does cite several cases of gabapentin-related liver toxicity in the medical literature.
Gabapentin’s manufacturer Pfizer reports an incidence of less than one percent of abnormal liver function in clinical trials of patients taking gabapentin with epilepsy or postherpetic neuralgia – the two most common uses for the drug. However, Pfizer has also collected an undisclosed number of spontaneous reports of hepatic events in its post-marketing safety surveillance database.
Before gabapentin is confirmed safe for those with viral hepatitis, it must first be proven as an effective treatment for alcoholism. Sponsored by the National Institute on Alcohol Abuse and Alcoholism, a study at The Scripps Research Institute is currently recruiting participants to evaluate this possibility.
Due to alcohol’s acceleration of liver damage in those with viral hepatitis, getting help abandoning booze is critical for people with Hepatitis B or C. While not yet a feasible option, gabapentin’s potential to help transition from alcohol dependence into abstinence signifies hope for those dually afflicted with alcoholism and chronic hepatitis.
References:
Furieri, FA, et al., Gabapentin reduces alcohol consumption and craving: a randomized, double-blind, placebo-controlled trial, Journal of Clinical Psychiatry, November 2007.
http://en.wikipedia.org, Gabapentin, Wikimedia Foundation Inc., 2008.
Roberto M, et al., Cellular and behavioral interactions of gabapentin with alcohol dependence, Journal of Neuroscience, May 2008.
www.clinicaltrials.gov, Gabapentin Treatment of Alcohol Dependence, US National Library of Medicine, 2008.
www.epilepsy.com, How Does the Body Digest Gabapentin?, epilepsy.com, 2008.
www.medscape.com, Gabapentin and Hepatotoxicity, Orly Avitzur, MD, MBA, Medscape Neurology and Neurosurgery, 2008.
www.newsrx.com, Gabapentin does not alter effects of alcohol, NewsRx, 2008.
www.nlm.nih.gov, Gabapentin, US National Library of Medicine, 2008.
www.scripps.edu, Scientists Describe Dangerous Cocktail of Alcohol, Brain Peptides, and Neurotransmitters, Jason Socrates Bardi, The Scripps Research Institute, 2008.
Posted by Editors at 02:04 PM --- Printer-friendly version
June 11, 2008
HCV Treatment Success: Early Response vs. Genotype
As presented at the April 2008 meeting of the European Association for the Study of the Liver, a rapid virological response can help clinicians customize the length of treatment for Hepatitis C – regardless of genotype.
by Nicole Cutler, L.Ac.
There is much debate among experts about the duration of treatment required for treating the Hepatitis C virus (HCV). As prescribed by physicians worldwide, the standard duration of a prescription for pegylated interferon (Pegasys or PegIntron) plus weight-based ribavirin differs depending on the patient’s genotype. However, recently announced research suggests that duration of treatment is best based on the individual’s virological response at specific intervals rather than their genotype.
The standard course of treatment is established by analyzing the results of large clinical trials. As determined by computational averages, these trials provide analysts with an ideal regimen for the population as a whole. In general, the standard duration of treatment is 24 weeks for HCV genotypes 2 and 3, and 48 weeks for HCV genotype 1. Despite this traditionally used model for determining treatment length, researchers have been finding that the best approach for Hepatitis C may veer away from this standardization and lean towards individual customization.
Historically, HCV genotype is the single most important predictor of a person’s outcome from treatment with pegylated interferon and ribavirin. Defined as a sustained viral response, a successful outcome is when the virus is undetectable in the blood six months after treatment ends.
The statistics consistently demonstrate that while about 50 percent of those with genotype 1 will achieve a sustained virologic response (SVR), between 70 and 90 percent of patients with genotype 2 or 3 will achieve SVR. Regardless of HCV genotype, experts have observed that patients who respond quickly to drug treatment are also more likely to be cured by them. Because pegylated interferon and ribavirin therapy is costly and carries the risk of serious side effects, scientists are continuously exploring new ways of predicting SVR so that the length of treatment can be customized for each patient.
The week of April 23-27, 2008, the 43rd annual meeting of the European Association for the Study of the Liver was held in Milan, Italy. Along with the myriad of revelations at this meeting, researchers presented a retrospective analysis of three randomized trials that demonstrated a rapid virologic response (RVR) to be superior to HCV genotype at predicting sustained virologic response.
Upon studying the outcomes of three trials, which, collectively, followed nearly 1,400 people receiving treatment for HCV, analysts compared these two factors for predicting SVR:
1. HCV genotype
2. RVR – defined as undetectable viral load after only four weeks of treatment
Among those achieving RVR in just four weeks of treatment, most (over 86 percent) achieved SVR independent of their HCV genotype. The value of this information applies to the scientists who calculate treatment time and to the physicians administering pegylated interferon and ribavirin treatment for HCV. The researchers recommended including RVR into the computations for treatment duration. In addition, they advise using an individual’s response to treatment after just one month to customize drug regimens regardless of genotype.
The debate over exactly how much medication for how long continues to churn in the Hepatitis C scientific community. By varying the treatment duration based on an individual’s early response, unnecessary side effects and costs of interferon and ribavirin can be spared. As factors other than genotype emerge as predictive of future treatment success, clinicians gain more insight into guiding their patients toward a customized, best possible outcome.
References:
Dalgard, Olav, et al., A Randomized Controlled Trial of Pegylated Interferon Alfa and Ribavirin for 14 vs. 24 Weeks in Patients with HCV Genotype 2 or 3 and Rapid Virological Response, Hepatology, January 2008.
Fried MW, et al., Rapid virological response is a more important predictor of sustained virological response (SVR) than genotype in patients with chronic hepatitis C virus infection, Program and abstracts of the 43rd Annual Meeting of the European Association for the Study of the Liver, Journal of Hepatology, April 2008.
http://clinicaloptions.com, RVR a Better Predictor of SVR Than HCV Genotype in HCV-Infected Patients With Peginterferon alfa-2a Plus Ribavirin, Clinical Care Options LLC, 2008.
Mangia, Alessandra, et al., Individualized Treatment Duration for Hepatitis C Genotype 1 Patients: A Randomized Controlled Trial, Hepatology, January 2008.
www.hcvadvocate.org, Adjustment of Treatment Duration Based on Early Response, Liz Highleyman, HCV Advocate, The Hepatitis C Support Project, March 2008.
www.hivandhepatitis.com, Duration of Pegylated Interferon plus Ribavirin May Be Tailored Based on Early Patient Response, Liz Highleyman, hivandhepatitis.com, 2008.
www.hivandhepatitis.com, HCV Genotype Is the Strongest Predictor of Sustained Virological Response after Retreatment of Hepatitis C Patients: Final Results of EPIC 3, hivandhepatitis.com, 2008.
www.natap.org, Virological response at 4 and 12 weeks predict high rates of sustained virological response in genotype 1 patients treated with peginterferon alfa-2a (40KD) plus ribavirin, Jules Levin, EASL, April 2007.
Posted by Editors at 12:26 PM --- Printer-friendly version
June 10, 2008
Fatty Liver Disease is a Major Health Concern
This liver disorder is incredibly common and its progression to a serious disease is usually preventable.
Health Watch: Fatty Liver Disease is a growing concern
By Brent D. Lemberg, MD • Special to The Journal • June 5, 2008
www.theithacajournal.com
Most Americans are aware that alcoholism and hepatitis C can lead to cirrhosis of the liver, but few people understand the risk of cirrhosis from fatty liver disease. An estimated 20 to 30 percent of all Americans have some degree of fatty liver disease, making it the most prevalent liver disease in this country.
Who is at risk?
Fatty liver disease is most common in people who are obese or who have the metabolic syndrome, which comprises a group of conditions including obesity, diabetes and high cholesterol. Ninety percent of all obese patients have fatty liver disease, as do 50 percent of all diabetics.
What causes this disease?
Normally, the liver helps to break down, process and remove fat, cholesterol and lipids from the body. However, when a person becomes overweight and/or develops insulin resistance, the liver becomes less efficient and begins to store fat rather than breaking it down. Stored fat in the liver can lead to inflammation, which in turn can cause permanent scarring and cirrhosis.
How serious is this problem?
While the majority of cases of fatty liver disease are fairly benign, about 30 percent of the time, fatty liver disease advances to a more serious condition known as nonalcoholic steatohepatitis (NASH). Of those, 10 percent develop cirrhosis. The number of people facing the risk of cirrhosis is increasing as the incidence of obesity rises in this country. The Centers for Disease Control (CDC) predict that by the year 2025, nearly 40 percent of Americans will be obese, including 20-30 percent of American children. This poses a very significant health problem in this country.
Cirrhosis of the liver
Cirrhosis is one of the top ten causes of death by disease in this country. It results from permanent scarring of the liver, caused by chronic disease or damage. A scarred liver cannot function properly and is no longer able to filter toxins from the blood or produce important enzymes and clotting factors. Cirrhosis puts you at risk for liver failure and may require a liver transplant.
How is it detected?
Because there are often no specific symptoms, fatty liver disease is usually detected when a routine blood chemistry profile shows elevated liver enzymes. In determining the cause of a person's elevated liver function, we check for risk factors for other reasons for liver disease such as viral hepatitis, autoimmune diseases, and medication-induced liver disease. A person in the latter stages of fatty liver disease may have pain in the right upper quadrant of his or her abdomen, and may experience fatigue. After ruling out other causes of liver disease, the doctor may order an ultrasound, CT scan, or MRI to look for signs of fat in the liver. A liver biopsy is rarely necessary to diagnose fatty liver disease, as long as other causes have been ruled out.
Recommended treatment
There is no quick fix. The optimal treatment is to lose weight, control diabetes, and lower your cholesterol. Losing 10 percent of your body weight is often enough to return liver function back to normal. There is ongoing research for medications to treat fatty liver disease, and there is some interest in the role of antioxidants, such as vitamins A and C.
However, at this time, the best treatment is weight loss. We have seen dramatic improvement of fatty liver disease in severely obese patients who have successfully undergone weight-loss (bariatric) surgery, such as gastric bypass.
People can and do live for a long time with fatty liver disease if it does not progress to a serious condition. The very best strategy is prevention, which starts by setting a healthy example for our children.
Dr. Lemberg is board-certified in gastroenterology/hepatology and internal medicine. He is on the medical staff of Cayuga Medical Center and in practice with Gastroenterology Associates of Ithaca, where he can be reached at 272-5011.
Posted by Editors at 02:29 PM --- Printer-friendly version
HCV Viral Load Reduced in Phase I/II Trial
Given to those already infected with Hepatitis C, ChronVac-C® is designed to boost the immune response against the virus. Preliminary trial results report a decrease in viral load of over 95 percent in the first patient to complete ChronVac-C® therapy.
Reduced Hepatitis C Viral Level Achieved with DNA Vaccine Delivered by Inovio Biomedical's Electroporation Delivery System in Phase I/II Clinical Study
June 4, 2008
www.businesswire.com
SAN DIEGO--(BUSINESS WIRE)--Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB, reported preliminary results indicating a dramatic reduction in hepatitis C viral load in its ongoing phase I/II clinical study of its ChronVac-C® therapeutic DNA vaccine, which is delivered using Inovio’s electroporation-based DNA delivery system. This result is from the first patient in the middle dose group to complete treatment against hepatitis C virus infection. Samples taken before, during and after treatment show that the viral levels in blood successively decreased by more than 95% during treatment. Inovio's electroporation delivery technology is intended to enhance the potency of DNA vaccines against cancers and infectious diseases.
ChronVac-C® is a therapeutic vaccine given to individuals already infected with the hepatitis C virus with the aim to clear the infection by boosting the immune response against the virus. This clinical study is being conducted at the Infectious Disease Clinic and Center for Gastroenterology at the Karolinska University Hospital in Huddinge and Solna, respectively, in Sweden. The intended enrollment of 12 patients will be divided into three dose groups with increasing doses of ChronVac-C(R). Each patient receives four vaccinations one month apart. After the last vaccination, patients are followed for another six months. The study's main purpose is to assess safety. It is also testing whether the treatment boosts the immune response to HCV (immunogenicity) and its effect on virus replication in the liver. If the patient is completely virus-free six months after completing treatment, he/she will be considered cured.
In the lowest dose group, two patients who completed treatment developed a T-cell response to hepatitis C. The preliminary result from this first patient to complete treatment in the intermediate dose group is the first to indicate a significant reduction in viral load. There have been no severe adverse events.
“The benefit we would hope to see from a successful hepatitis C virus DNA vaccine would be a dramatic reduction in viral levels,” stated Avtar Dhillon, MD, Inovio's president and CEO. “We look forward to seeing the longer term results of this DNA vaccine and its potential to address this multi-billion dollar market.”
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple DNA-based immunotherapies and DNA vaccines. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio’s electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio’s technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio’s technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio 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 Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2007, our 10-Q for the three months ended March 31, 2008 and other regulatory filings from time to time. There can be no assurance that any product in our product 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 proved accurate.
Contacts
Investors:
Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101
or
Media:
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005, x108
Posted by Editors at 02:24 PM --- Printer-friendly version
June 06, 2008
New Breakthrough Could Prevent Hepatitis C Replication
Inspired by a pharmaceutical prototype to stop bovine viral diarrhea virus, Immtech reveals that one of their compounds may inhibit Hepatitis C's entry into human cells.
Immtech Announces Results From Hepatitis C Discovery Program
http://sev.prnewswire.com
NEW YORK, June 3 /PRNewswire-FirstCall/ -- Immtech Pharmaceuticals, Inc. AMEX: IMM announced today positive results against the hepatitis C virus (HCV) of a compound from its drug discovery portfolio. The prototype compound belongs to an expanding class of compounds that has previously demonstrated activity against a related surrogate virus, bovine viral diarrhea virus (BVDV). The compound was found to have significant activity against HCV under assay conditions designed to demonstrate inhibition of the virus entry process, using a newly available in vitro cell culture system that employs infectious and replicating virus.
Norman Abood, Ph.D., Sr. Vice President, Discovery Programs, stated, "We aim to develop a compound with a novel mechanism of action that is complementary to the currently recognized treatments of HCV. It appears that Immtech's class of compounds inhibits an early, non-replicative step in the virus life cycle, based upon our earlier work in BVDV. The majority of the industry's efforts have focused on programs to identify drug candidates, such as protease and polymerase inhibitors, which inhibit HCV virus replication. Our latest findings provide an approach that will allow us to potentially identify a drug candidate with a new and complementary mechanism of action."
As of 2005 there were more than 11 million people living with hepatitis C in major markets around the world, and the sale of drugs to treat the disease, including treatments that are prescribed after a first course of treatment fails, was $3 billion. The HCV drug market is expected to expand to $9 billion in 2012 and to more than $10 billion annually by 2014.
About Immtech Pharmaceuticals, Inc.
Immtech is a pharmaceutical company focused on the development and commercialization of new drugs to treat infectious diseases. Immtech has a well defined, expanding library of compounds targeting Hepatitis C, drug-resistant Gram-positive bacteria, fungal infections and other serious diseases. It is expanding its targeted markets by applying its proprietary pharmaceutical platform to treat a range of disorders. Immtech holds exclusive worldwide licenses to certain patents, patent applications and technology for products derived from its proprietary pharmaceutical platform. For additional information, please visit the Company's website at http://www.immtechpharma.com
This press release contains "forward-looking statements" regarding Immtech Pharmaceuticals, Inc.'s business. Except for historical information, the matters discussed in this press release are "forward-looking statements" and are subject to risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: (i) Immtech's ability to develop commercially viable products; (ii) Immtech's ability to achieve profitability; (iii) Immtech's ability to retain key personnel; (iv) the ability of Immtech's scientists and collaborators to discover new compounds; (v) the availability of additional research grants; (vi) Immtech's ability to obtain regulatory approval of its drug candidates; (vii) the success of Immtech's clinical trials; (viii) dependence upon and contractual relationship with partners; (ix) Immtech's ability to manufacture or to contract with a third party to manufacture its drug candidates at a reasonable cost; (x) Immtech's ability to protect its intellectual property; (xi) competition and alternative technologies; (xii) Immtech's ability to obtain reimbursement from third party payers for any product it commercializes; and (xiii) potential exposure to significant product liability.
Additional risks are discussed in the Company's current filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. The forward-looking statements are made as of the date of this press release, and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Website: http://www.immtechpharma.com/
Posted by Editors at 05:24 PM --- Printer-friendly version
June 02, 2008
Marijuana Use Sparks Liver Transplant Controversy
Despite its legality in 12 states, learn why medical marijuana use may render a person with Hepatitis C ineligible for a liver transplant.
by Nicole Cutler, L.Ac.
Hepatitis C is not only the leading cause of chronic liver disease in the United States, it is also the most common reason for liver transplants in this country. Unfortunately, some with Hepatitis C are being denied access to liver transplants because of their use of a controversial type of symptom relief.
Although transplantation is considered a last resort for liver disease, the number of people waiting for a new organ far outnumbers the supply. Since donated livers are in such high demand, a complex system of prioritizing who gets transplant surgery has evolved. Obviously, great deliberation is involved in deciphering transplant eligibility and recipient ranking. However, the ethics of this process has been called into question for those using medical marijuana. Occasionally used to ease Hepatitis C symptoms, patients legally using medical marijuana are at high risk of being denied a spot on the liver transplant recipient queue.
UNOS
The United Network for Organ Sharing (UNOS) is a non-profit, scientific and educational organization that administers the nation's only Organ Procurement and Transplantation Network. UNOS is responsible for organ matching and placement throughout the United States. According to the UNOS website, over 98,000 people are currently on an organ transplant waiting list. Many people wait for years for a new liver, often not surviving the wait. According to the Scientific Registry of Transplant Recipients, less than a third of those waiting for a liver actually receive one.
The UNOS entrusts individual hospitals and transplant centers to develop their own criteria for transplant candidates. Some of these institutions automatically reject people who use "illicit substances" — including those legally prescribed medical marijuana. "Most transplant centers struggle with issues of how to deal with people who are known to use marijuana, whether or not it's with a doctor's prescription," said Dr. Robert Sade, director of the Institute of Human Values in Health Care at the Medical University of South Carolina. "Marijuana, unlike alcohol, has no direct effect on the liver. It is, however, a concern ... in that it's a potential indicator of an addictive personality."
Medical Marijuana
Marijuana has been used for medicinal purposes for approximately 4,000 years. Surviving texts from ancient India confirm that its psychoactive properties were recognized, and doctors used it for a variety of illnesses and ailments. These included a whole host of gastrointestinal disorders, nausea, low appetite, insomnia, headaches and as a pain reliever.
People with Hepatitis C have reported using marijuana (cannabis) to treat both symptoms of the disease as well as the nausea associated with antiviral therapy. An observational study by investigators at the University of California at San Francisco (UCSF) found that Hepatitis C patients who used cannabis were significantly more likely to adhere to their treatment regimen than patients who didn't use it. Despite this support for medical marijuana, several trials reported an association between daily cannabis use and the development of liver fibrosis in Hepatitis C. Aside from the question of legality, experts disagree on the therapeutic use of cannabinoids for Hepatitis C treatment.
The medical use of cannabis has been legalized in several countries including Canada, Belgium, Australia, the Netherlands, the United Kingdom, New Zealand and Spain. Since 1996, twelve U.S. states have legalized medical marijuana use: Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington. Doctors in these states can write a prescription for marijuana for a legitimate medical issue. However, the United States Supreme Court ruled that the federal government has the right to regulate and criminalize marijuana in these states, even for medical purposes.
Sad Outcome in Washington
The debate about medical marijuana’s impact on liver transplant eligibility jumped to center stage in May of 2008 when Washington state resident Timothy Garon passed away. To combat his Hepatitis C symptoms, Garon’s physician had authorized medical marijuana for alleviating his nausea and stomach pain and to stimulate his appetite. Legally authorized in Washington state since 1998, Garon’s attorney believes that his client’s medical marijuana use kept him off of the liver transplant list, a decision that ultimately cost Garon a chance for survival.
No one tracks how many patients are denied transplants over medical marijuana use. Pro-marijuana groups have cited a handful of cases, including at least two patient deaths, in Oregon and California, since the mid- to late 1990s, when states began adopting medical marijuana laws.
With the nation’s shortage of transplantable livers, some administrators may be using their moral judgment to decide who gets on an eligibility list. Thus, using medical marijuana to ease advanced Hepatitis C symptoms may put some people at a disadvantage. Until our nation’s lawmakers, physicians and administrators are all in agreement about the use of cannabis for certain illnesses, those in need of a liver transplant may wish to think ahead – and either choose a different medicine for symptom relief or consult with their chosen hospital about their view on medical marijuana as a factor in transplant eligibility.
References:
http://en.wikipedia.org, Medical Cannabis, Wikimedia Foundation Inc., 2008.
http://norml.org, Hepatitis C, The National Organization for the Reform of Marijuana Laws, 2008.
http://seattletimes.newsource.com, Is medical-marijuana use reason to deny someone an organ transplant?, Seattle Times Staff and Associated Press, The Seattle Times Company, May 2008.
http://stopthedrugwar.com, Marinol Death Sentence: Oregon Man Denied Liver Transplant Because of Prescription -- He's Not the Only One, stopthedrugwar.com, 2008.
Sylvestre, et al, Cannabis use improves retention and virological outcomes in patients treated for hepatitis C, European Journal of Gastroenterology & Hepatology, 2006.
www.cbhd.org, Liver Transplants: How Do We Choose Who Should Live When Not All Can?, Gregory W. Rutecki, The Center for Bioethics and Human Dignity, 2008.
www.drugwarfacts.org, Medical Marijuana, Common Sense for Drug Policy, 2008.
www.unos.org, Who We Are, United Network for Organ Sharing, 2008.
www.usatoday.com, Playing field for liver transplants is not level, studies find, Robert Davis, USA Today, 2008.
Posted by Editors at 11:28 AM --- Printer-friendly version