July 26, 2010

Idenix Pharmaceuticals Reports Second Quarter 2010 Financial Results and Provides Research and Development Update on HCV Programs

CAMBRIDGE, Mass., July 26 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

Research and Development Highlights

Phase IIa: IDX184, a liver-targeted hepatitis C virus (HCV) nucleotide prodrug

•All patients have recently completed dosing in the 14-day Phase IIa clinical trial evaluating 50 to 200 mg doses of IDX184 in combination with pegylated interferon and ribavirin in treatment-naive HCV genotype 1-infected patients. Data from this study have been submitted to the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held at the end of October in Boston.

Phase I/II: IDX320, an HCV protease inhibitor

•In the second quarter of 2010, Idenix initiated a three-day proof-of-concept study in 38 treatment-naive HCV genotype 1-infected patients. This trial is a Phase I/II randomized, parallel-arm, double-blind, placebo-controlled study evaluating the safety and antiviral activity of IDX320. The study is evaluating four doses of IDX320, ranging from 50 to 400 mg once-per-day, and one 200 mg twice-daily dose. Data from this study will be submitted as a late-breaker to the upcoming AASLD meeting.

Phase I: IDX184/IDX320 Combination

•In July 2010, Idenix conducted a two-week Phase I, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic drug-drug interaction between IDX320 and IDX184 in healthy volunteers. Two cohorts were evaluated in the study with 10 subjects in each cohort randomized eight to active drug and two to placebo. Subjects in the first cohort received 400 mg once-daily of IDX320 plus placebo for the first week, subsequently adding 100 mg once-daily of IDX184 for the second week. Subjects in the second cohort received 100 mg once-daily of IDX184 plus placebo for the first week, subsequently adding 400 mg once-daily of IDX320 for the second week. Data analysis is ongoing.

Phase I: IDX375, an HCV non-nucleoside polymerase inhibitor

•In the second quarter of 2010, Idenix continued the Phase I clinical trial in healthy volunteers evaluating single and multiple doses, ranging from 200 to 1200 mg per day, of the free acid form of IDX375. Assuming favorable data in this study, the company expects that a three-day proof-of-concept study in treatment-naive genotype 1-infected patients will be initiated in the second half of 2010. An abstract from this program has been submitted to the upcoming AASLD meeting.

"I am pleased to report that our three hepatitis C clinical programs continue to advance and we are also on track to select a clinical candidate with pan-genotypic properties from our preclinical NS5A program later this year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "Assuming favorable clinical results, we will submit data to regulatory agencies from the IDX184 Phase IIa study, the IDX320 proof-of-concept study and the IDX184/IDX320 drug-drug interaction study to support discussions related to the potential initiation of a combination study of IDX184 and IDX320 in HCV-infected patients in the second half of the year."

Second Quarter 2010 Financial Results

For the second quarter ended June 30, 2010, Idenix reported total revenues of $1.3 million, compared to total revenues of $2.4 million in the second quarter of 2009. The company reported a net loss of $16.3 million, or a loss of $0.23 per basic and diluted share, for the second quarter ended June 30, 2010, compared to a net loss of $16.3 million, or a loss of $0.28 per basic and diluted share for the second quarter ended June 30, 2009.

For the six months ended June 30, 2010, Idenix reported total revenues of $4.0 million, compared to total revenues of $6.5 million for the six months ended June 30, 2009. The company reported a net loss of $32.5 million, or a loss of $0.47 per basic and diluted share, for the six months ended June 30, 2010, compared to a net loss of $29.2 million, or a loss of $0.50 per basic and diluted share, for the six months ended June 30, 2009.

2010 Financial Guidance

The company expects that its current cash and cash equivalents, together with the anticipated royalty payments associated with product sales of Tyzeka®/Sebivo® (telbivudine), can fund operations into mid-2011. This guidance assumes no additional milestone payments, license fees, reimbursement for development programs and no financing activities.

Conference Call and Webcast Information

Idenix will hold a conference call today at 4:30 p.m. ET. To access the call please dial (800) 471-3635 U.S./Canada or (706) 758-9475 International and enter passcode 87241600. To listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection. A replay of the conference call and webcast will be available until August 9, 2010. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 87241600.

Recent Scientific Presentations

Scientists from Idenix presented data at the following two clinical workshops in Boston: The 5th International Workshop on Clinical Pharmacology of Hepatitis Therapy on June 23rd-24th and the 5th International Workshop on Hepatitis C - Resistance and New Compounds on June 24th-25th. The presentations are available on the company's website at http://www.idenix.com/hepc/publications/.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with chronic hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

Forward-looking Statements

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements regarding the company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "plans," "anticipates," "will," "expects," "goal," "estimates," "projects," "would," "could," "targets," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the company's clinical development programs or commercialization activities in HIV or hepatitis C including any expressed or implied statements regarding the efficacy and safety of our drug candidates, the likelihood and success of any future clinical trials involving our drug candidates or successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C, or any potential pipeline candidates and expectations with respect to additional milestone payments, future royalty payments and cash balances at the end of 2010. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that historical sales of Tyzeka®/Sebivo® (telbivudine) will in any way suggest future royalty payments or royalty rates owed to the company, or that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaborations with Novartis Pharma AG and GlaxoSmithKline; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in each of the company's annual report on Form 10-K for the year ended December 31, 2009 and quarterly report on Form 10-Q for the quarter ended March 31, 2010 as filed with the Securities and Exchange Commission (SEC), and in any subsequent periodic or current report that the company files with the SEC.

All forward-looking statements reflect the company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the company's estimates change.

SOURCE Idenix Pharmaceuticals, Inc.



Battle Brews Over Future For Research Chimps

Chimpanzees Moving Back Into Active Research

POSTED: 9:28 am MDT July 26, 2010
UPDATED: 10:16 am MDT July 26, 2010

ALBUQUERQUE, N.M. -- A controversy is brewing over the future of Alamogordo's research chimpanzees.

The federal government's plan is to move the chimps out of New Mexico and back into invasive research. That has some saying the animals deserve better, especially after the contributions they have made.

In the 1950s, astronaut teams were training in New Mexico, hoping to reach new heights. But before Mercury 7 and the moon walk, came some pioneering primates. Only a small number made it to space, and some died in the process. But astrochimps Ham and Enos, who underwent extensive testing at Holloman Air Force Base in New Mexico, saw success, making it back to Earth safely and paving the way for the humans.

The descendants of the space chimps faced their own missions, which involved experiments exposing them to illnesses such as HIV and hepatitis C as part of biomedical research.

But 2001 brought an agreement to halt the research and just house the chimps at the Alamogordo primate facility.

Now, the chimps' time may be up.

The National Institutes of Health plans to move the chimps to a Texas lab where they will again face invasive research. The NIH cited space, cost and resources as motives for the move.

Fifteen chimps have already made the trip. By early next year, the remaining chimps -- about 187 -- will move to that same site.

"Bad idea," said Gov. Bill Richardson. "I am going to fight to keep the chimpanzees in Alamogordo. That is a primary research facility. I think saying that they are doing it to save costs, to save money, is not sufficient. It will be cruel to the chimpanzees."

Richardson and other supporters want the Alamogordo facility to be turned into a chimpanzee sanctuary.

Calls to the NIH by Action 7 News have not been returned.

A spokesperson for Sen.Tom Udall said Udall is not in favor of the plan and he will be meeting with the NIH to discuss the issue.

More than 40 jobs and federal money will also be lost with this move. The contract that keeps the chimps in Alamogordo expires in May 2011.


Anti-Aging Strategy May Help HCV Liver Transplant Recipients

July 20, 2010

Find out about a molecular biology discovery that has led to a new understanding about the general health decline that can follow a liver transplant.

by Nicole Cutler, L.Ac.

By evaluating one of the cellular components of senescence (the period of decline in health and function associated with aging), British researchers have identified a reason that liver transplant recipients are particularly susceptible to degenerating health. Since the Hepatitis C virus (HCV) is the most likely reason for a liver transplant in the United States, those with advanced HCV are more vulnerable to this characteristic of aging. Although the medical community is just beginning to unravel some of the biological factors involved in senescence, those with HCV who need a liver transplant can capitalize on the knowledge garnered thus far.


Three American scientists were awarded the 2009 Nobel Prize for Physiology and Medicine for their discovery about aging. Involving how chromosomes are copied during cellular division, these scientists identified telomere length as a predictor of health and longevity.

Crucial for cellular division, telomeres are protective DNA-protein complexes positioned at the tips of chromosomes:

· When cells divide, the exact sequence of DNA must be transcribed from the chromosomes of the parent cell to create chromosomes for the new cell.

· A piece of the telomere is clipped off and donated to the DNA sequence at the end of the chromosome so that the copying is complete and accurate.

· Most cells normally divide about 50-70 times, their telomeres getting progressively shorter until the cells lose their ability to divide, sustain genetic damage (which can cause cancer) or die.

Telomeres and Liver Transplant Recipients

On the heels of recognizing shortened telomere length as a hindrance to health and longevity, William Gelson from the University of Cambridge and colleagues investigated whether liver transplant recipients demonstrated this unwanted feature of senescence in immune cells.

As published in the May 2010 issue of Liver Transplantation, the British researchers found this marker of senescence to be accelerated in those with Hepatitis C who undergo liver transplants. Gelson and colleagues found that the telomeres of an important immune cell (lymphocytes) were significantly shorter in liver transplant recipients compared with control subjects. These findings suggest that besides immunosuppressive drugs used to prevent organ rejection, weakened immunity leading to complications (infections and cancers) in transplant patients may be attributable to senescence of the immune system - as identified by lymphocytes with shortened telomeres.

These findings suggest that liver transplant recipients may experience faster immune cell aging, which could help explain their increased rates of infections, cancer and other serious conditions.

Keeping Telomeres Long

While modern science is still a long time away from discovering the fountain of youth that prevents senescence, many experts believe that antioxidants represent the best defense against aging and illness.

As published in the July 2002 edition of the journal, Trends in Biochemical Sciences, researchers from the University of Newcastle found that oxidative damage is repaired less well in the DNA of the telomere than elsewhere in the chromosome. Additionally, it was determined that oxidative stress accelerates telomere loss, whereas antioxidants decelerate it.

For decades, increasing the dietary consumption of antioxidants has been considered to be a superior strategy for retaining one's youth and healthfulness. However, our new understanding of telomere length in liver transplant recipients gives those with late stage HCV infection more incentive than ever to indulge in antioxidants. Because shortened telomeres are more abundant following a liver transplant - and they foretell of a shorter life span - strategies to preserve telomere length (such as antioxidant consumption) will emerge as paramount to delay senescence in HCV liver transplant recipients.


http://nobelprize.org/nobel_prizes/medicine/laureates/2009/press.html, The Nobel Prize in Physiology or Medicine 2009, Retrieved July 11, 2010, Nobel Web AB, 2010.

http://www.all-things-aging.com/2010/06/telomeres-aging-and-cancer.html, Telomeres, Aging and Cancer, Constance McCloy, PT, EdD, Retrieved July 11, 2010, All Things Aging, 2010.

http://longevity.about.com/od/whyweage/a/senescence.htm, Senescence, Healthy Aging and Longevity, Mark Stibich, PhD, Retrieved July 11, 2010, About.com, 2010.

http://www.hivandhepatitis.com/hep_c/news/2010/0709_2010_c.html, Immune Cells Show Signs of Senescence after Liver Transplantation, Liz Highleyman, Retrieved July 10, 2010 hivandhepatitis.com, 2010.

http://www.ncbi.nlm.nih.gov/pubmed/12114022, Oxidative stress shortens telomeres, von Zglinicki T, Retrieved July 11, 2010, Trends in Biochemical Sciences, July 2002.

http://www.ncbi.nlm.nih.gov/pubmed/20440767, Features of immune senescence in liver transplant recipients with established grafts, Gelson W., et al, Retrieved July 11, 2010, Liver Transplantation, May 2010.

http://www.springerlink.com/content/jw847g541l435103/, Cellular senescence, ageing and disease, D.G.A. Burton, Retrieved July 11, 2010, Age, March 2009.


Why Whey for Hepatitis?

July 23, 2010

The number of reasons whey protein can help someone with chronic, viral hepatitis may surprise you.

by Nicole Cutler, L.Ac.

Often added to milkshakes or blended drinks, whey protein can usually be found on store shelves in sections dedicated to building muscle mass. As such, whey protein has long been an ingredient consumed by bodybuilders and serious athletes. Despite whey protein's popularity with the muscle-pumping crowd, it has several characteristics that also make it an ideal staple for those living with chronic, viral hepatitis.

About Chronic, Viral Hepatitis

Chronic, viral hepatitis describes liver disease that is usually caused by the Hepatitis B virus or Hepatitis C virus. Hepatitis A usually does not progress to a chronic problem, and the other hepatitis viruses are much less common. Hepatitis B and C have the potential to be cured with modern medicine. However, a significant portion of those infected are unable to clear the virus from their liver with the currently available medications. These individuals are advised to make an array of lifestyle changes to protect their liver from damage and prevent this disease from progressing to a more advanced stage.

About Whey

The protein in milk is whey protein. Whey is the liquid that separates from curd during the production of cheese. When the liquid dries into powdered whey, the nutrients become concentrated, and it can be packaged and used in that form.

While predominantly composed of protein, whey is a complex substance that also contains lactose, fat and minerals. Each with its own unique properties, whey's protein content is a conglomeration of smaller components (called sub-fractions). A handful of whey's sub-fractions include:

· Beta-lactoglobulin - Provides an excellent source of essential and branched chain amino acids (BCAAs). While BCAAs help prevent muscle breakdown and spare glycogen during exercise, they also are helpful for those with advanced liver disease. Although the reason is unclear, experts understand that people with cirrhosis of the liver may live longer, improve their liver function, have fewer hospital admissions and have an increased quality of life by taking supplemental BCAAs.

· Alpha-lactalbumin - The primary protein found in human breast milk, alpha-lactalbumin is high in tryptophan, an essential amino acid. Potential benefits of this protein include sleep regulation and mood improvement under stress.

· Immunoglobulins (IgGs) - Provides immunity-enhancing benefits, a coveted function for those with chronic hepatitis.

· Glycomacropeptides - Helps control and inhibit the formation of dental plaque and dental cavities - a common problem in those with chronic hepatitis.

· Lysozyme - Contains immunity-enhancing properties, a coveted function for those with chronic hepatitis.

· Lactoferrin - May help to reduce inflammation, an invaluable characteristic for those whose liver easily becomes inflamed.

Whey and Glutathione

While some of whey protein's sub-fractions can help someone with hepatitis remain healthy, whey's promotion of glutathione delivers a specific benefit to those with liver disease. Whey protein contains high levels of the amino acid cysteine, which is needed for the body to produce glutathione.

Glutathione is an antioxidant found in all tissues protecting against potential damage from wastes and toxins. Clinical studies have demonstrated that the level of glutathione is significantly depressed in many people with Hepatitis C. Experts also recognize that glutathione deficiency is an important factor contributing to liver damage. Thus, supplements that boost the body's production of glutathione indirectly benefit people with chronic hepatitis.

Japanese Study

A Japanese animal study published in the May 2006 edition of Bioscience, Biotechnology and Biochemistry, investigated the effect of whey protein on the liver. Although their subjects were not human, the researchers found that rats on a whey-containing diet demonstrated the following:

· Lower liver enzyme levels indicating liver damage (ALT and AST)

· Lower indicators of liver fibrosis (hyaluronic acid)

· Lower levels of traditional hepatitis markers (lactate dehydrogenase and bilirubin)

Based on the results, the authors concluded that supplementing with whey protein can help prevent the development of hepatitis and portal fibrosis.

Too Much Whey

As a dietary supplement, whey protein is generally considered to be safe. However, the sentiment that you can have too much of a good thing applies to whey protein. Extremely high doses of whey protein supplements could overload the liver and cause damage. To avoid this possibility, experts suggest restricting intake of whey protein to less than 30 grams at one time.

While whey protein is certainly no cure, it does show great potential as a dietary supplement for those with liver disease. Because it supports the immune system, helps the body handle stress, eases inflammation and promotes glutathione production, whey protein should be considered by anyone who is managing chronic, viral hepatitis.


http://articles.mercola.com/sites/articles/archive/2009/12/08/Top-12-Foods-for-Healthy-Immune-Response.aspx, Top 12 Foods for Healthy Immune Response, Dr. Mercola, Retrieved December 11, 2009, Dr. Joseph Mercola, 2009.

http://bastyrcenter.org/content/view/787/, Branched-Chain Amino Acids Treat Cirrhosis, Retrieved December 13, 2009, Bastyr Center for Natural Health, 2009.

http://health.learninginfo.org/liver-health.htm, Liver Health: How to Care for Your Liver, Retrieved December 13, 2009, learninginfo.org, 2009.

http://www.fitfaq.com/whey-protein.html, The Whey It Is, William D. Brink, Retrieved December 12, 2009, fitFAQ.com, 2009.

http://www.hepatitis-central.com/mt/archives/2007/07/hcv_and_the_bod.html, HCV and the Body's Most Important Antioxidant, Nicole Cutler, L.Ac., Natural Wellness, 2009.

http://www.jstage.jst.go.jp/article/bbb/70/5/70_1281/_article, Hepatoprotective Effects of Whey Protein on D-Galactosamine-Induced Hepatitis and Liver Fibrosis in Rats, Hisae Kume, et al, Bioscience, Biotechnology and Biochemistry, May 2006.

http://www.wheyoflife.org/articles/Aug_ARA_Article.pdf, Nourish Your Body The Healthy "Whey", Retrieved December 13, 2009, Whey Protein Institute, 2009.

http://www.wheyoflife.org/faq.cfm#1, Whey Protein FAQ's, Retrieved December 13, 2009, Whey Protein Institute, 2009.


How to Better Understand Your HCV Viral Load Tests

July 22, 2010

Although they have very similar sounding names, learn why qualitative Hepatitis C tests and quantitative Hepatitis C tests have some important differences.

by Nicole Cutler, L.Ac.

To everyone except physicians who treat hepatitis and fastidious researchers, the range of tests that someone with the Hepatitis C virus (HCV) endures can be dizzying. Unless you are lucky enough to have a hepatologist sit down and explain the differences and implications of each blood draw, it is easy to be misled by the barrage of lab test results. Especially important for individuals who are currently enrolled in or who have finished HCV antiviral therapy, understanding viral load tests can bring clarification to an otherwise confusing lab result.

Hepatitis C RNA tests are tools clinicians use to confirm a diagnosis and guide treatment. The challenge in discerning between the kinds of HCV tests likely lies in the similar sounding words to describe the tests: qualitative and quantitative. Even the most seasoned healthcare practitioners frequently flub these categories. Below you will find a brief description of the two HCV RNA (the genetic material for Hepatitis C) tests and a helpful mnemonic technique to differentiate between the two:

· Qualitative Test - This kind of test detects the presence or absence of HCV RNA. It is reported as either detected (positive) or not detected (negative). The qualitative test is useful to confirm an active HCV infection. The L in qualitative can be equated to a label - as in it is used to label someone as having or not having the virus.

· Quantitative Test - The quantitative test measures the actual number of copies of HCV RNA in the blood. Commonly referred to as the viral load, a quantitative test is typically used to monitor how a person is responding to HCV treatment. The N in quantitative can be equated to a number - as in it is used to report the number of HCV viral particles present.

More About Qualitative Testing

To report whether or not HCV is present in the blood, the qualitative HCV RNA tests use either a process called polymerase chain reaction (PCR) or a process called transcription-mediated amplification (TMA). If such a test is positive, or detected, then chronic Hepatitis C infection is confirmed. Although it does not compute a number, the qualitative test is more accurate than the quantitative test because it can detect very low levels of the virus.

More About Quantitative Testing

Quantitative tests that measure the actual level of Hepatitis C virus in the blood may use the processes of PCR, TMA or signal amplification (branched DNA). These viral load tests compute the number of HCV RNA particles present, and are expressed in either international units per liter (IU/L) or copies per milliliter (mL). The quantitative HCV RNA test is used to monitor individuals who undergo antiviral treatment - prior to beginning therapy, during therapy and upon its completion.

Additional Viral Load Test Facts

The following seven facts about Hepatitis C viral load tests help deepen our understanding of the testing process.

1. If someone has a positive qualitative test but a quantitative test showing no detectable virus, then that person has a very low level of the virus in his or her blood.

2. If someone has a negative qualitative test following antiviral treatment, they are clear of the Hepatitis C virus.

3. In order to obtain a sustained viral response (considered a successful conclusion to HCV treatment), a qualitative test should be negative following the completion of treatment and then again six months later. Most physicians will use a qualitative test (as opposed to a quantitative test) to confirm a sustained viral response.

4. Viral load as measured by a quantitative test does not correlate with the severity of Hepatitis C.

5. The viral load measurement does not correlate with the severity of liver disease. Only a liver biopsy (or equivalent method) can determine the health of the liver.

6. Because HCV viral load will normally fluctuate, repeated viral load tests are only indicated for those on or considering antiviral treatment.

7. If a quantitative HCV RNA result is reported as <615 IU/L, then the test is unable to measure any of the virus. Thus, such a result should be followed by a qualitative test.

Upon reviewing the differences between quantitative and qualitative Hepatitis C tests, there will be a little less mystery in deciphering lab results. Although HCV RNA quantitative tests are mostly used to gauge how someone progresses with antiviral therapy, the qualitative test is the only way to know for sure if the Hepatitis C virus is still taking up residence in your body.


http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/#c, Chronic Hepatitis C: Current Disease Management, Retrieved July 14, 2010, National Digestive Diseases Information Clearinghouse, 2010.

http://hepatitis.about.com/od/diagnosis/f/HCVRNATest.htm, What are HCV RNA Tests?, Charles Daniel, Retrieved July 15, 2010, about.com, 2010.

http://www.hcvadvocate.org/hcsp/articles/Bernstein-1.html, The Importance of Laboratory Test Results in Hepatitis C Infection, David Bernstein, MD, FACP, FACG, Retrieved July 15, 2010, Hepatitis C Support Project, 2010.

http://www.hepatitis.va.gov/vahep?page=diag-tests-03-02, Hepatitis C RNA Qualitative Testing, Retrieved July 15, 2010, US Department of Veteran Affairs, 2010.

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TG_HCV_MolecularTesting.htm, Molecular Testing in the Management of Hepatitis C Virus Infection, Retrieved July 15, 2010, Quest Diagnostics, 2010.


V.A. Easing Rules for Users of Medical Marijuana

July 23, 2010


DENVER — The Department of Veterans Affairs will formally allow patients treated at its hospitals and clinics to use medical marijuana in states where it is legal, a policy clarification that veterans have sought for several years.

A department directive, expected to take effect next week, resolves the conflict in veterans facilities between federal law, which outlaws marijuana, and the 14 states that allow medicinal use of the drug, effectively deferring to the states.

The policy will not permit department doctors to prescribe marijuana. But it will address the concern of many patients who use the drug that they could lose access to their prescription pain medication if caught.

Under department rules, veterans can be denied pain medications if they are found to be using illegal drugs. Until now, the department had no written exception for medical marijuana.

This has led many patients to distrust their doctors, veterans say. With doctors and patients pressing the veterans department for formal guidance, agency officials began drafting a policy last fall.

“When states start legalizing marijuana we are put in a bit of a unique position because as a federal agency, we are beholden to federal law,” said Dr. Robert Jesse, the principal deputy under secretary for health in the veterans department.

At the same time, Dr. Jesse said, “We didn’t want patients who were legally using marijuana to be administratively denied access to pain management programs.”

The new, written policy applies only to veterans using medical marijuana in states where it is legal. Doctors may still modify a veteran’s treatment plan if the veteran is using marijuana, or decide not to prescribe pain medicine altogether if there is a risk of a drug interaction. But that decision will be made on a case-by-case basis, not as blanket policy, Dr. Jesse said.

Though veterans of the Vietnam War were the first group to use marijuana widely for medical purposes, the population of veterans using it now spans generations, said Michael Krawitz, executive director of Veterans for Medical Marijuana Access, which worked with the department on formulating a policy.

Veterans, some of whom have been at the forefront of the medical marijuana movement, praised the department’s decision. They say cannabis helps soothe physical and psychological pain and can alleviate the side effects of some treatments.

“By creating a directive on medical marijuana, the V.A. ensures that throughout its vast hospital network, it will be well understood that legal medical marijuana use will not be the basis for the denial of services,” Mr. Krawitz said.

Although the Obama administration has not embraced medical marijuana, last October, in a policy shift, the Justice Department announced that it would not prosecute people who used or distributed it in states where it was legal.

Laura Sweeney, a spokeswoman for the Justice Department, would not comment spefically on the veterans department policy. “What we have said in the past, and what we have said for a while, is that we are going to focus our federal resources on large scale drug traffickers,” she said. “We are not going to focus on individual cancer patients or something of the like.”

Many clinicians already prescribe pain medication to veterans who use medical marijuana, as there was no rule explicitly prohibiting them from doing so, despite the federal marijuana laws.

Advocates of medical marijuana use say that in the past, the patchwork of veterans hospitals and clinics around the country were sometimes unclear how to deal with veterans who needed pain medications and were legally using medical marijuana. The department’s emphasis on keeping patients off illegal drugs and from abusing their medication “gave many practitioners the feeling that they are supposed to police marijuana out of the system,” Mr. Krawitz said.

“Many medical-marijuana-using veterans have just abandoned the V.A. hospital system completely for this reason,” he said, “and others that stay in the system feel that they are not able to trust that their doctor will be working in their best interests.”

In rare cases, veterans have been told that they need to stop using marijuana, even if it is legal, or risk losing their prescription medicine, Mr. Krawitz said.

David Fox, 58, an Army veteran from Pompey’s Pillar, Mont., uses medical marijuana legally to help quiet the pain he experiences from neuropathy, a nerve disorder. But he said he was told this year by a doctor at a veterans’ clinic in Billings that if he did not stop using marijuana, he would no longer get the pain medication he was also prescribed.

A letter written to Mr. Fox in April from Robin Korogi, the director of the veterans health care system in Montana, explained that the department did not want to prescribe pain medicine in combination with marijuana because there was no evidence that marijuana worked for noncancer patients and because the combination was unsafe.

“In those states where medical marijuana is legal, the patient will need to make a choice as to which medication they choose to use for their chronic pain,” Ms. Korogi wrote. “However, it is not medically appropriate to expect that a V.A. physician will prescribe narcotics while the patient is taking marijuana.”

Mr. Fox was shocked by the decision, he said.

“I felt literally abandoned,” he said. “I still needed my pain meds. I thought they were supposed to treat you. It was devastating for me.”

Mr. Fox, who said that at one point he was weaning himself off his pain medication for fear of running out, has held one-man protests in front of the clinic, carrying signs that read “Abandoned by V.A., Refused Treatment.”

Veterans officials would not comment on specific cases, citing medical privacy laws.

This month, Dr. Robert A. Petzel, the under secretary for health for the veterans department, sent a letter to Mr. Krawitz laying out the department’s policy. If a veteran obtains and uses medical marijuana in accordance with state law, Dr. Petzel wrote, he should not be precluded from receiving opioids for pain management at a veterans facility.

Dr. Petzel also said that pain management agreements between clinicians and patients, which are used as guidelines for courses of treatment, “should draw a clear distinction between the use of illegal drugs, and legal medical marijuana.”

Dr. Jesse, the veterans department official, said that formalizing rules on medical marijuana would eliminate any future confusion and keep patients from being squeezed between state and federal law.

Steve Fox, director of government relations for the Marijuana Policy Project, which favors the legal regulation of the drug, called the decision historic. “We now have a branch of the federal government accepting marijuana as a legal medicine,” he said.

But Mr. Fox said he wished the policy had been extended to veterans who lived in states where medical marijuana was not legal.

He said it was critical that the veterans department make its guidelines clear to patients and medical staff members, something officials said they planned on doing in coming weeks.

Said Dr. Jesse, “The whole goal of issuing a national policy is to make sure we have uniformity across the system.”

James Dao contributed reporting.


Meta-analysis of radiofrequency ablation versus hepatic resection for small hepatocellular carcinoma

BMC Gastroenterol. 2010 Jul 9;10(1):78. [Epub ahead of print]

Zhou Y, Zhao Y, Li B, Xu D, Yin Z, Xie F, Yang J.


ABSTRACT: BACKGROUND: There is no clear consensus on the better therapy [radiofrequency ablation (RFA) versus hepatic resection (HR)] for small hepatocellular carcinoma (HCC) eligible for surgical treatments. This study is a meta-analysis of the available evidence. METHODS: Systematic review and meta-analysis of trials comparing RFA with HR for small HCC published from 1997 to 2009 in PubMed and Medline. Pooled odds ratios (OR) with 95% confidence intervals (95% CI) were calculated using either the fixed effects model or random effects model. RESULTS: One randomized controlled trial, and 9 nonrandomized controlled trials studies were included in this analysis. These studies included a total of 1411 patients: 744 treated with RFA and 667 treated with HR. The overall survival was significantly higher in patients treated with HR than in those treated with RFA at 3 years (OR: 0.56, 95% CI: 0.44-0.71), and at 5 year (OR: 0.60, 95% CI: 0.36-1.01). RFA has a higher rates of local intrahepatic recurrence compared to HR (OR: 4.50, 95% CI: 2.45-8.27). In the HR group the 1, 3, and 5 years disease -free survival rates were significantly better than in the HR-treated patients (respectively: OR: 0.54, 95% CI: 0.35-0.84; OR: 0.44, 95% CI: 0.28-0.68; OR: 0.64, 95% CI: 0.42-0.99). The postoperative morbidity was higher with HR (OR: 0.29, 95% CI: 0.13-0.65), but no significant differences were found concerning mortality. For tumors [less than or equal to] 3 cm HR did not differ significantly from RFA for survival, as reported in three NRCTs . CONCLUSIONS: HR was superior to RFA in the treatment of patients with small HCC eligible for surgical treatments, particularly for tumors > 3 cm. However, the findings have to be carefully interpreted due to the lower level of evidence.

PMID: 20618937 [PubMed - as supplied by publisher]


Hepatitis C rate may be down in the U.S.: study

Thursday, July 22, 2010 Last Updated: 2010-07-22 13:00:30 -0400 (Reuters Health)

By Amy Norton

NEW YORK (Reuters Health) - A new study finds that the percentage of U.S. blood donors with evidence of hepatitis C infection is substantially lower now than in the early 1990s -- in what researchers say probably reflects an overall decline in the infection rate among Americans.

The findings also hint at a link between multiple pregnancies and the virus, and of a protective effect of obesity, although it's too soon to tell whether these associations will hold up.

Hepatitis C is a viral infection passed through contact with infected blood -- most often by sharing tainted needles -- though a small number of cases are sexually transmitted or passed from mother to baby during childbirth.

In a minority of people, the body is able to clear the virus soon after infection. However, the infection becomes chronic 75 percent to 85 percent of the time, often leading to liver damage such as chronic inflammation, scarring of the liver tissue (cirrhosis) and, in some cases, liver cancer. The U.S. Centers for Disease Control and Prevention estimate that between 1 and 5 percent of people infected with hepatitis C eventually die of cirrhosis or liver cancer.

Since 1992, the U.S. donor-blood supply has been screened for hepatitis C, and the risk of receiving a donation carrying the virus is now estimated at one in 2 million, according to the National Heart, Lung, and Blood Institute.

Based on studies from the early 1990s, about a half a percent of U.S. blood donors between 1992 and 1993 harbored antibodies to hepatitis C -- which indicates either a chronic infection or a past infection that cleared.

The rate in more recent years had been unclear, however.

In the new study, published in the Journal of Infectious Diseases, researchers analyzed samples from nearly 960,000 donors who gave blood at six U.S. blood banks between 2006 and 2007.

They found that less than a tenth of a percent of donors tested positive for antibodies to hepatitis C.

"It's a strikingly lower prevalence" compared with 1992-1993, said lead researcher Dr. Edward L. Murphy, of the University of California, San Francisco.

The decrease, Murphy told Reuters Health, likely reflects, in part, an overall decline of hepatitis C infection among relatively younger Americans. The "Baby Boomers" born between the late 1940s and early 1960s had higher rates of injection-drug use than subsequent generations, and therefore a higher risk of carrying hepatitis C.

In support of such a "birth cohort effect," Murphy's team found that in 2006-2007, donors in their 40s and 50s had the highest rate of hepatitis C compared with other age groups. In the early 1990s, the highest rates had been seen among donors in their 30s and 40s.

The findings, according to Murphy, suggest that the Baby Boomer generation is likely to have the highest rate of hepatitis-C- related liver disease, and that the rate will decline among younger Americans.

"I think the message here is a positive one," he said.

Of course, Murphy added, the rate of hepatitis C among blood donors would not be reflective of that among injection-drug users, who continue to have the highest risk of hepatitis C infection among Americans.

The study also found two "novel" factors associated with a higher risk of hepatitis C infection among blood donors.

Among women, the odds of having antibodies to the virus climbed along with the number of children they'd had. Of women who had never given birth, only about one in 3,300 had antibodies to hepatitis C, compared to one in 1,600 among women who'd had one child. The highest rate - about one in 1,000 -- was seen among women who'd had five or more children.

Murphy cautioned that "you don't want to put too much into one finding," and said that further studies are needed to confirm the association between childbirth and hepatitis C. But the finding, he said, raises the possibility that some women acquire the infection during childbirth -- via contaminated instruments or during C-section, for example.

The other new finding was that obese adults were less likely than their normal-weight counterparts to have hepatitis C antibodies. And among people with antibodies, obese individuals were less likely to have genetic material that signals the ongoing presence of the virus; the implication is that obese people may be more likely than thinner ones to clear the infection.

Murphy called that finding "surprising," and said that, as with the findings on pregnancy, more research is needed to confirm the association.

As for why obesity would potentially protect against hepatitis C, Murphy noted that obesity is believed to involve a chronic state of low-level inflammation in the body.

That inflammation is usually considered a negative thing, as it may contribute to diseases like diabetes and heart disease. But, according to Murphy, it's possible that when it comes to hepatitis C infection, inflammation involving increased production of certain immune-system substances is protective.

If further studies confirm the link between body weight and hepatitis C infection, he said, it will be important to weed out why.

SOURCE: http://link.reuters.com/muk98m Journal of Infectious Diseases, online July 9, 2010.


Achillion Pharma nominates NS5A inhibitor as lead clinical candidate for treatment of HCV

Monday, July 26, 2010 13:00 IST New Haven, Conn

Achillion Pharmaceuticals, Inc, a leader in the discovery and development of treatments for the most challenging infectious diseases, has nominated a lead clinical candidate for its its fourth proprietary programme against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.

"The overall profile of ACH-2928 demonstrates that it is highly active and retains potency against HCV genotypes 1a and 1b, as well as across other genotypes. The compound's high potency, in the picomolar range, and its favourable pharmacokinetic properties strongly suggest once-daily dosing," said Milind S Deshpande, executive vice president and chief scientific officer of Achillion. "Importantly, we believe ACH-2928 is highly effective in combination with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin."

Michael D Kishbauch, Achillion's president and CEO, stated, "The nomination of this novel NS5A clinical candidate is both exciting and significant. The treatment paradigm for HCV is moving toward combination therapies, and we are now poised to pursue our own combination therapies, putting ACH-2928 together with our highly potent protease inhibitors, ACH-1625 and ACH-2684. The development of our fourth proprietary HCV programme underscores the depth of our robust drug discovery expertise in this important therapeutic area. We have initiated IND-enabling testing of ACH-2928, and plan to initiate combination treatment in 2011."

"The nomination of ACH-2928 is further evidence of our expertise in HCV drug discovery and structure-based design. We continue to build discrete intellectual property estates to which we retain all commercial rights," concluded Kishbauch.

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease.


Also See:

DHS Tests Women against Hep C Infection

Submitted by Seher Dhillon on Mon, 07/26/2010 - 11:19

Following the detection of the alleged purposeful infusion of hepatitis C infection in Melbourne women by an anesthetist, about 14 more women have been tested positive.

The probe triggered by Victoria's Department of Human Services examined as many as 1,800 women in the region. With yesterday’s figures, the number of infected women has reached 58.

In a similar test series held in May, the department found more than 44 women testing positive with the disease.

The Department has now approached another 400 women in the region for the tests, in addition to the 30 from New Zealand.

As many as 55 New Zealand women taking part in Croydon Day Surgery in east Melbourne have been found to be infected with Hepatitis C.

In the beginning of this year, around 12 women were spotted to have picked up the infection. It was here, when DHS initiated further drives to test the rest of the women in the area.

Dr. Peters, alleged anesthetist to have infused the infection in his patients, has now been sacked.

"We have a team of public health doctors and nurses making calls, explaining why the call is being made and organizing a blood test”, Victoria’s Chief Health Officer, John Carnie.


Also See:

Can-Fite Drug Candidate CF102 Significantly Decreased Viral Load of HCV in 3 Patients with Liver Cancer

© Business Wire 2010
2010-07-26 17:17:04 -

Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange reported today that a significant decrease in HCV viral load was detected in 3 patients with liver cancer who are treated daily orally with CF102. The company is studying CF102 as a treatment for liver cancer (hepatocellular carcinoma, or HCC). The results announced today relate to data which came out of a Phase 1/2 clinical trial of CF102 in the treatment of patients with advanced HCC.

This protocol is enrolling patients with advanced or treatment-refractory hepatocellular carcinoma (HCC), or liver cancer.

Because one of the most important risk factors for HCC is chronic viral hepatitis, patients in this trial are tested at entry for infection with hepatitis C virus (HCV). Although not part of the primary trial objectives, those patients who are HCV-positive are retested periodically to gauge the effect of CF102 on HCV infection in this population.

Till now 4 patients with HCC are also HCV-positive with a circulating viral load of >10 6 IU/mL at entry and in 3 out of the 4 patients, the viral load significantly decreased in the absence of any other intervention, strongly indicating an effect of CF102 in suppressing viral replication in the liver.

According to Can-Fite CEO Dr Pnina Fishman, “These results are especially encouraging for 2 reasons. First, they validate our extensive pre-clinical data indicating CF102’s effectiveness in treating liver disease in general, and hepatitis C in specific. Second, they provide encouragement in light of Can-Fite’s other ongoing CF102 trial, a Phase 1/2 study in patients with HCV infection. Based on the current new data we were approved to extend the current HCV clinical study to a treatment period of couple of months. We are optimistic that CF102 can become part of the treatment regimen for the millions of people worldwide who suffer from hepatitis C.”

HCV is predominantly transmitted through body fluids and less frequently by sexual intercourse, and no vaccines are currently available. About 50% to 85% of HCV infected patients develop a chronic form of the disease, of whom 25% to 76% develop active chronic disease and cirrhosis, which is the leading cause of liver transplantation in Europe and the US and greatly increases the risk of liver cancer. Patients are currently offered drug therapy that generally consists of oral Ribavirin in combination with interferon injections. These drugs have severe adverse events and most patients rapidly become refractory to them. The market size today is more than $3 Billion and is estimated to grow to around $8.3 Billion on 2012.

The Company previously reported that preclinical studies have suggested that the drug is active against HCV via inhibition of NS5, RNA dependent RNA polymerase. CF102 was also found to trigger programmed cell death (apoptosis) of liver cancer cells. The Company recently announced the successful completion of a Phase I clinical study with CF102 under an IND in the US, showing a safety profile and a linear pharmacokinetic behavior of the drug.

CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, an investigator from Rabin Medical Center, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Pnina Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Pnina Fishman and focuses on the development of molecule-based drugs that bind to receptors on and inhibit the development of cancer or inflammatory cells.

Can-Fite's development pipeline currently has two drugs, CF101 and CF102. The company is simultaneously conducting clinical trials with the two drugs for various indications. CF101 is being studied for the treatment of inflammatory and Ophthalmic diseases and CF102 is studied for the treatment of Liver Diseases.

Can-Fite BioPharmaPnina Fishman, Ph.D.Chief Executive OfficerTel:
+972-3-9241114Fax: +972-3-9249378 pnina@canfite.co.il
Also See: Can-Fite reports CF102 success against hepatitis