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Week Ending: July 21st , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
July 14th, 2007
Idenix's HCV Drug On Hold; 'Not Optimistic,' CEO Says
http://www.bioworld.com/
By Randall Osborne
West Coast Editor
FDA Cites GI Side Effects
Idenix Pharmaceuticals Inc.'s FDA-ordered clinical hold on the nucleoside inhibitor valopicitabine for hepatitis C virus comes just a month after encouraging Phase II data, and probably means death for the drug also known as NM283, thanks to gastrointestinal side effects that the agency found serious enough to stop development.
"I have to tell you that we were very surprised - Idenix and Novartis - by their perspective," Jean-Pierre Sommadossi, chairman and chief executive officer of Cambridge, Mass.-based Idenix, told investors during a conference call.
Wall Street didn't like it, either. Shares of Idenix (NASDAQ:IDIX) closed Friday at $3.57, down $2.22, or 38.3 percent.
"We're evaluating our options for the program, but I want to tell you up front that I am not optimistic" about valopicitabine's viability, Sommadossi said.
Douglas Mayers, chief scientific officer for Idenix, noted that the company recognized the GI problems.
"I think we reached the same quantitative conclusions," he said, but Idenix believed valopicitabine was worth another test to find the right dose. The FDA disagreed.
In spring 2006, Idenix reduced dosing in a Phase IIb trial in a bid to dodge the GI side effects, and the firm's stock fell 28 percent on the news. Basel, Switzerland-based Novartis exercised its option to license the product anyway, in a deal valued as high as $525 million. Under a collaboration begun in 2003, Novartis holds the right of first refusal on Idenix's entire pipeline. (See BioWorld Today, March 30, 2006.)
An increasingly crowded HCV space has led the FDA to consider tweaking its clinical requirements for compounds designed to treat the disease, and the Antiviral Drugs Advisory Committee convened late last year specifically to discuss the issue. (See BioWorld Today, Nov. 1, 2006.)
The FDA cleared Idenix/Novartis' nucleoside analogue for hepatitis B virus, Tyzeka (telbivudine), in October, and the drug is called Sebivo outside the U.S.
Last month, Foster City, Calif.-based Gilead Sciences said Study 103, its second Phase III trial of the anti-HIV drug Viread (tenofovir disoproxil fumarate) in treating HBV, met its primary efficacy endpoint. The data showed that Viread is non-inferior to the company's once-daily antiviral drug Hepsera (adefovir dipivoxil) among patients with "e" antigen (HBeAg)-positive chronic disease.
"We will have to wait and see" what Viread's progress means for Tyzeka, Sommadossi said, adding that not all the data have been presented in a scientific forum. "Let's not forget in our Phase IIIb/Phase IV program [with Tyzeka] we initiate combination therapy actually with tenofovir. We believe that the future of treatment for hepatitis B is going to be a combination of a nucleoside and a nucleotide," so a combination of Tyzeka and Viread could be "ideal," he said.
Mayers said HBV therapy will become a "many-year proposition" in which blocking resistance and getting response that lasts will be critical, and a combo therapy could provide "durable responses for a decade or more."
In the works by Idenix are a non-nucleoside reverse transcriptase inhibitor being evaluated in Phase I for HIV. The HCV discovery push goes on, and includes a preclinical, second-generation nucleoside polymerase inhibitor, and programs with an HCV non-nucleoside polymerase inhibitor and an HCV protease inhibitor.
As of June 30, 2007, Idenix had approximately $160 million of cash, cash equivalents and marketable securities. Ronald Renaud, Idenix's recently appointed chief financial officer, said guidance remains unchanged, and the firm expects to end 2007 with $100 million to $110 million.
Asked about in-licensing possibilities, Renaud said the firm is "very comfortable with what we have here and what we're investing in, in terms of our internal pipeline, and I think that's going to be our primary focus on a going-forward basis. In terms of the guidance for Tyzeka, we still stand behind [an estimate of] total worldwide sales of $20 million" for the year, he said.
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Lotus reports on its hepatitis B drug development
http://www.pharmaceutical-business-review.com
By Staff Writer
Lotus Pharmaceuticals has reported new developments in the formulation of its hepatitis B drug that could add an additional $6 million annually in net profits for the Beijing company.
Dr Liu Zhongyi, Lotus CEO and founder, said, "in April 2007, our company invested about $750,000 to develop injectable Ganbifu, which is primarily used for the treatment of chronic viral type B Hepatitis or HBV.
"We are now starting the required animal experimentation. It is expected to reach the market in 2009, and its annual sales revenues are forecast up to $20 million annually, with profits approaching $6 million."
According to the Chinese Academy of Medical Sciences, about 170 million Chinese are infected chronically with HBV and 10% suffer from chronic hepatitis. Around half a million Chinese die from hepatitis B caused hepatocellular carcinoma and endstage cirrhosis each year.
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July 16th, 2007
Celebrity Health - Anita Roddick
http://news.bbc.co.uk
In a series on celebrities and their health, the BBC News website talks to The Body Shop founder Anita Roddick about life with Hepatitis C and cirrhosis of the liver.
Dame Anita Roddick first set up The Body Shop in Brighton in 1976 to create a livelihood for herself and her two daughters while her husband was away trekking on horseback from Buenos Aires to New York.
Her environmentally friendly ideas were ahead of their time and her "green" cosmetics store soon took off.
Now the brand, which she no longer runs, is sold in more than 50 countries.
Anita is also known for her campaigning zeal, adding her voice to human rights injustices, to ending animal testing and to anti-war campaigns.
HOW DID YOU FIRST REALISE SOMETHING WAS WRONG?
I did not even realise that I had it.
HOW DID YOU GET DIAGNOSED?
It was at a routine insurance blood test.
They found something was wrong, something a bit bizarre.
So they did another test and another test and they found I had Hepatitis C.
WHAT WAS YOUR REACTION TO THE DIAGNOSIS?
I knew nothing about the disease. I did not know the difference between Hepatitis A, B and C.
When I was first diagnosed we did not know how long I had had it. Eventually I found out I had been infected from a blood transfusion following the birth of my youngest daughter, Sam, in 1971.
That was the only blood transfusion I have ever had and thank God the surgery had kept my medical notes.
Most of the people my age with Hepatitis C have it following some sort of medical intervention.
Hepatitis C works very slowly. I lived for 35 years with this silent killer and had boundless energy.
Then we realised it had moved to cirrhosis of the liver.
I realised then that what I had been putting down to age had been the symptoms of Hepatitis C.
I got more tired and started forgetting things. I have read everything I can about the disease and I got a lot of help from the Hepatitis C Trust.
WHAT WAS YOUR TREATMENT?
I can't really have any treatment because I have both cirrhosis and a particular strain of the virus that makes me unlikely to respond.
Also I have had some tiny heart attacks that I put down to getting in and out of aeroplanes so often. They have not affected me, but mean my doctor has counselled against treatment.
But when I got the diagnosis I started to take control of my health.
I couldn't just sit back and say I am just waiting to die.
HOW DID YOU FEEL DURING TREATMENT?
I used alternative therapies such as going to a detox spa in Sri Lanka, which was fantastic.
And I have taken a course in macrobiotics.
You absolutely shouldn't drink alcohol, which has never been a problem for me.
Everything with alcohol had to go, even mouthwash. And so did fatty foods because they made me nauseous.
I do a lot of stretching exercise and listen to people when they say what has worked for them.
You don't expect to get cured, but you do get a healthier body.
HOW DO YOU FEEL NOW?
I have regular check-ups with a blood test and MRI scan.
Before these appointments I always think "oh my God" as I wonder whether the cirrhosis will have moved into a tumour.
I visit Addenbrooke' s Hospital, Cambridge for this because this would be where I would have my liver transplant, if and when the time came.
Although having said that, there are not many livers around for transplant.
People in Britain would rather be buried or cremated with their organs, but my view is that when you are dead, you are dead.
I am constantly itchy and have to use topical creams to help with that. The itching is caused by the body trying to get rid of excess bile.
But I do not want to be defined by my illness.
I am just waiting and seeing - by nature I am an optimist.
People say to me: "Why don't you sue the NHS over this." But you can't blame an organisation over something they did not, at that time, even know existed.
And for the last six months my condition has been stable and that does give you a real uplift.
WHAT IS YOUR MESSAGE TO OTHER PEOPLE WITH THE SAME CONDITION?
You may be at risk if you had a blood transfusion before September 1991 (since then donated blood in the UK has been checked for the virus) or if you have been injected with a contaminated needle - through body piercing, tattoos, poorly sterilised equipment and sharing needles.
Dame Anita Roddick spoke to promote the work of The Hepatitis C trust.
Hepatitis C
- It can seriously damage the liver and its ability to function, mainly spread through infected blood or other bodily fluids
- In England the number of people infected with chronic Hepatitis C is estimated to be up to 500,000
- It can take decades for the symptoms to appear
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/6225638.stm
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D-G: Liver tonics not sure guard against liver diseases
http://thestar.com.my
By AUDREY EDWARDS
PETALING JAYA: Those who take liver tonics regularly should not think it is a passport to continue living unhealthily, says Health Ministry director-general Tan Sri Dr Ismail Merican.
“They must be very sure of what they are doing. If they consume excessive alcohol, no amount of preventive agents is going to prevent the liver from becoming cirrhotic or diseased,” he said in an interview with The Star.
“It does not give you the passport to go on a spree and practice an unhealthy lifestyle.”
Dr Ismail, who is also Malaysian Liver Foundation (MLF) president, emphasised that having a healthy lifestyle, including regular exercise to prevent obesity, was still important in preventing liver disease that can cause fatty liver.
Such tonics are supposed to protect the liver by ridding the body of toxins.
He added that there was also an interest in herbal therapy to produce similar agents but cautioned the public to “not get carried away with every herb in town”.
The MLF estimates that 2.5 million Malaysians have hepatitis and most are unaware that they have the disease until they are informed too late that they are suffering from complications.
About 25% of individuals are at risk of serious infections and eventual death from cirrhosis and liver cancer.
In 67 cases of hepatocellular cancer at Selayang Hospital between 2003 and 2004, it was found that 63% was due to chronic Hepatitis B infection and 15% because of chronic Hepatitis C infection.
Only 8.9% of the cases were suitable for curative treatment, which is liver resection.
Dr Ismail also reminded the public that vaccinations against Hepatitis A and Hepatitis B were disease-specific, as there were instances of patients thinking that one type of vaccine covered both strains of the virus.
He added that the younger generation was at risk of contracting Hepatitis A if they had not been vaccinated because they did not have the antibodies.
“There is a danger that you will get more serious diseases if you get it when you are older compared to when you are younger,” he said.
“Get vaccination against Hepatitis A and B. That is the best thing to do.”
There is no vaccination against Hepatitis C.
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July 17th, 2007
Mathematical Model Identifies Genes which Battle Hepatitis C
http://www.newswise.com
A cooperative research project between the University of Haifa and Indiana University yielded the discovery of a mathematical model which identifies genes which battle viruses. Using the method, researchers successfully identified 37 out of 22,000 genes which are active in the battle against the virus hepatitis C, which attacks the liver.
Newswise — Joint research by Dr. Leonid Brodsky, of the Institute of Evolution of the University of Haifa, and Dr. Milton Taylor, of Indiana University, led to the discovery of a mathematical method which can identify which genes in our bodies conduct the battle against the various viruses that attack us. In their research, they identified 37 genes out of 22,000 possible genes which fight the hepatitis C virus.
"When we know which genes are responsible for fighting the viruses which attack our liver, we will be able to look for the medications which will activate these genes most favorably," said Dr. Brodsky. The team conducted clinical trials, supported by the Health National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the US National Institutes of Health (NIH), which included 400 patients at eight different centers in the United States. The results will be published in the prestigious journal PLOS ONE.
The hepatitis C virus, found mostly among many patients who have had a blood transfusion or who share needles, attacks the liver and in extreme cases can cause cancer of the liver. At present, there is one well know medication, interferon, used to treat the virus; however, while some patients respond to the treatment with interferon, others do not. In this research, the clinical study was combined with the mathematical model developed by Dr. Brodsky. The study identified 37 genes which are key for patient response to treatment.
"In the specific case of hepatitis C, we have now isolated the genes that show which patients will respond to treatment. Until now, all patients received treatment for an extended period of time without knowing whether or not they would respond. In the future, we hope to find other medications that will be more effective in activating all of the 37 genes." summarized Dr. Brodsky.
He further explained that this mathematical model is not limited to identifying the genes which fight viruses that attack the liver. It can also be applied further in the fields of medicine, biology and agriculture.
Source: University of Haifa
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Schering Ends Metabasis Drug Deal
http://biz.yahoo.com
Metabasis Therapeutics Says Schering-Plough Plans to End Deal to Commercialize Hepatitis Drug
SAN DIEGO (AP) -- Metabasis Therapeutics Inc. said Tuesday that Schering-Plough Corp. plans to end its deal to commercialize the biopharmaceutical company's experimental hepatitis B treatment pradefovir after tests indicated a heightened cancer risk.
In 2000, Metabasis licensed the compound to Valeant Pharmaceuticals International, which sold worldwide rights to Schering-Plough last December. The drug maker paid $19.2 million upfront to Valeant and $1.8 million to Metabasis for the experimental drug.
Metabasis said Tuesday that Schering-Plough now plans to end its agreements with the companies and return all rights to the product back to Metabasis.
The move comes after two-year-long tests in mice and rats found a higher risk of cancer at higher doses.
The company said it was disappointed but not surprised by Schering-Plough's decision.
Metabasis also announced Tuesday that a diabetes drug candidate failed to significantly lower blood sugar in a mid-stage trial.
Shares of Metabasis lost more than half their value, dropping $3.85, or 55.8 percent, to $3.05.
Questions or comments about this story should be directed to reporter Adam Schreck at 212-621-7190.
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Hepatitis C virus impairs brain function in HIV-positive people
http://www.aidsmap.com
Adam Legge
Hepatitis C virus (HCV) can travel into the brain and replicate there causing significant cognitive impairment in people with HIV co-infection, say researchers at the San Diego HIV Neurobehavioral Research Center in a study published in the July edition of the Journal of Infectious Diseases.
There has recently been a surge of research interest in a possible link between HCV infection and cognitive impairment after HCV DNA was discovered in brain tissue and cerebrospinal fluid.
HCV levels in the blood are known to be linked with the severity of memory impairment in HCV-infected individuals but it has been difficult to study virus levels in the central nervous system (CNS).
This study looks specifically at people with both HIV and HCV infection, as the immune suppression associated with HIV infection can make it easier for HCV to replicate.
Researchers studied post-mortem brain tissue from 12 people who had HCV/HIV coinfection and 13 HIV-infected people who were HCV-negative.
They looked for HCV ribonucleic acid (RNA) - which is the template for HCV DNA and therefore evidence that the virus has been actively replicating.
They found HCV RNA in the brain tissue of all the HIV/HVC-coinfected individuals but none of the HCV-negative individuals.
Antibodies to HCV were also found in the CNS of people with the coinfection.
The researchers then looked back at the cognitive abilities of the individuals, assessed before death, and found that presence of HCV RNA was significantly associated with considerable cognitive impairment as well as the presence of brain issue inflammation, or encephalitis.
The researchers conclude that their results support the idea that replicating HCV is capable of causing neurological damage is present in people also infected with HIV.
Exactly how the virus causes this damage is unclear but this study has also found evidence that HCV virus may be found in a specific type of brain cell called the astroglia.
These cells are involved in a huge range of activities in the brain, including the transportation of a neurotransmitter called glutamate.
Previous studies have suggested that glutamate transport is defective in people with HCV infection and HIV is also known to impair glutamate transport.
This suggests that HCV and HIV might be working together to block clearance of glutamate from the synapses of people with the coinfection, possibly leading to structural damage in the brain and therefore cognitive impairment, the authors conclude.
Reference
Letendre S. Pathogenesis of hepatitis C virus coinfection in the brains of patients infected with HIV. Journal of Infectious Diseases 196: 361-370, 2007
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NICE issues new guidance on Hepatitis C treatments
http://www.imt.ie
Irish Medical Times
By Greg Baxter
The prescribing watchdog in the UK has issued new guidance recommending the use of two drugs for National Health Service patients with mild chronic hepatitis C. The National Institute for Health and Clinical Excellence (NICE) recommends that peginterferon alpha and ribavirin be prescribed for asymptomatic infection, before measurable damage takes place in a patient’s liver.
NICE guidelines previously recommended treatment of hepatitis C in patients with moderate to severe symptoms.
Under the new guidance:
- People with mild chronic hepatitis should also be offered combination therapy with peginterferon alfa and ribavirin within the licensed indications of these drugs;
- People with mild chronic hepatitis who are unable to tolerate ribavirin, or for whom ribavirin is contraindicated, should be offered peginterferon alfa monotherapy;
- The decision as to whether a person with mild chronic hepatitis C should be treated immediately or should wait until the disease has reached a moderate stage (‘watchful waiting’) should be made by the patient after fully informed consultation with the responsible clinician; and
- There is insufficient evidence to recommend combination therapy or monotherapy with peginterferon alfa for people with mild chronic hepatitis C who are under the age of 18 years, or those who have had a liver transplant.
The maker of pegylated interferon alpha (Pegasys), Roche, has welcomed the decision. According to the company, the recommendation could potentially result in an early cure and avoid the potential progression of the virus to liver cirrhosis, liver cancer or death.
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July 18th, 2007
Protecting HIV Patients from Hepatitis B Virus
www.newswise.com
Newswise — Since the transmission of HIV and Hepatitis B virus (HBV) are so similar, individuals infected with one of these viruses are at a significantly increased risk for contracting the other. As it is not quite clear how patients that don’t respond to the HBV vaccine should be managed, new research from the University of Alberta has evaluated the immune response of HBV vaccine given intradermally (into the skin) in HIV-infected individuals who failed to respond to two cycles of HBV vaccine given intramuscularly (into the muscle).
“Because those infected with HIV are at a greater risk for contracting HBV, it is crucial we promote HBV immunizations and continue to put our research efforts into why some HIV patients fail to respond to the vaccine,” said Dr. Stephen Shafran, Professor and Director, Division of Infectious Diseases, at the University of Alberta.
Protecting persons with HIV from contracting the HBV is an important goal. However, people with HIV have a substantially lower success rate with the HBV vaccine compared to the general population.
For this study, researchers were particularly interested in measuring the levels of antibody to hepatitis B produced (called anti-HBs) because the presence of anti-HBs is considered the marker of immunity to HBV infection. Of the patients tested in the cohort, when given the HBV vaccine intradermally rather than intramuscularly, 50 per cent of the subjects successfully produced protective levels of anti-HBs after four doses of vaccine. Conversely, the remaining 50 per cent of patients still did not produce anti-HBs even after given additional doses of HBV vaccine.
“Based on our study we can conclude that administering HBV vaccine intradermally cannot be recommended for HIV-infected adults who did not respond initially to intramuscular administered vaccine,” said Shafran. “Other vaccine strategies, perhaps involving multiple antigens or adjuvants, will need to be investigated.”
This research appears in HIV Medicine, July 2007.
Source: University of Alberta
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Fighting drug resistance in hepatitis C virus
http://www.webwire.com
Researchers at McGill University have found a clue in developing new drug candidates to fight the hepatitis C virus (HCV) by identifying a defence mechanism in the virus similar to resistance found in HIV.
“If you understand the biochemical mechanisms of drug resistance, you may be able to develop drugs in the test tube that are more capable of doing their job in the clinic,” says Dr. Matthias Götte, an associate professor in the Department of Microbiology & Immunology at McGill and a recipient of a national career award from the Canadian Institutes of Health Research (CIHR). Antiviral therapies commonly employ inhibitors, compounds that block enzymes from reproducing the virus. The infection eventually subsides as a result. However, a defence mechanism previously identified in HIV works when the virus enzyme “excises” inhibitors, removing them and allowing the virus to continue multiplying.
In their study, to be published in the August issue of the journal Antimicrobial Agents and Chemotherapy (AAC) but already available online, Götte and colleagues experimented with a promising class of inhibitors, called nucleoside analogues, to see whether hepatitis C uses a similar defence mechanism. They found that some of these inhibitors are efficiently excised, while others remain attached and block a crucial virus enzyme. Understanding how some nucleoside analogues counteract excision may enhance their function as drugs.
Since hepatitis C infection is a major cause of severe liver damage and liver cancer, further research is needed urgently, says Götte. There are an estimated 200 million hepatitis C-positive people worldwide. Approximately 1 per cent of Canadians are infected with the virus, some 250,000 people.
Several factors have held back the development of better treatment to fight HCV. People often carry the infection unknowingly because symptoms arise much later as compared with HIV. Tests for patient infection were only made comprehensive in the early nineties, and the tools required for advanced drug design were not available until recent years.
“Treatment success depends largely on the strain of virus causing infection, and the current hepatitis C therapy is often thwarted by the most common strain. The success rate is much lower than seen in HIV drug treatment,” says co-author Megan Powdrill, a graduate student who worked on the study. Dr. Claudia D’Abramo, a former graduate student, and Dr. Jérôme Deval, a former postdoctoral fellow, are also co-authors of the paper.
Götte’s group is taking lessons from HIV therapy and drug development to boost research on HCV. His group and colleagues from Gilead Sciences, a biopharmaceutical company in California, recently experimented with a drug called tenofovir. Unlike AZT, another major anti-HIV drug, tenofovir counteracts excision in HIV by forming an inactive complex with the enzyme. This paper will also be published in the August issue of AAC. “Although the formation of a similar complex with hepatitis C inhibitors is not evident,” said Götte, “this adds to our understanding of how viral resistance can be overcome.”
This research was funded by the Canadian Cancer Research Society, the Canadian Institutes of Health Research (CIHR), the National Canadian Training Program in Hepatitis C (NCRTP-HepC) and the Fonds de la Recherche en Santé du Québec (FRSQ).
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July 19th, 2007
OraSure Technologies Announces Pre-Clinical Study Results for Prototype Rapid HCV Antibody Test at AACC Annual Meeting
http://biz.yahoo.com
- Prototype Test Performance Equivalent to Lab-Based Testing in Pre-clinical Trials of Human Subjects -
BETHLEHEM, Pa.--(BUSINESS WIRE)--OraSure Technologies, Inc. (NASDAQ:OSUR - News), the market leader in oral fluid diagnostics, today announced pre-clinical study results for a prototype rapid Hepatitis C ("HCV") antibody test on the Company's OraQuick® test platform, using oral fluid, finger-stick whole blood, venous whole blood, serum and plasma samples. These results were reported by OraSure at the 2007 Annual Meeting of the American Association of Clinical Chemistry held in San Diego, California.
In pre-clinical studies conducted by the Company, performance of the prototype HCV test for all specimen types was shown to be equivalent to or better than results obtained from currently available, state of the art laboratory-based enzyme immunoassay tests using serum and plasma specimens. Additional information regarding the preclinical study results presented by OraSure at the ACC Annual Meeting can be found at www.orasure.com/aacc.
"We are very pleased with the pre-clinical results generated by our prototype OraQuick® rapid HCV antibody test," said Douglas A. Michels, President and CEO of OraSure Technologies. "Our development efforts are proceeding on schedule, and we intend to begin the final clinical studies required to obtain FDA approval during the next several months. Our plan is to complete these studies as soon as possible and file an application for FDA approval in early 2008. Assuming we are successful, we expect that our test will be the first rapid HCV antibody test approved by the FDA for use in the United States."
Prospective pre-clinical testing of 419 low-risk human subjects using oral fluid, finger stick and venous whole blood, serum and plasma, generated concordant results across all specimen types for each individual. Specificity, which is the percentage of tests that correctly show a negative result when an individual is not infected, was 99.8% in all specimen types. Three individuals in this group were newly identified as having been infected with HCV. In testing of 92 individuals known to be infected with HCV, pre-clinical results indicated sensitivity in venous whole blood and oral fluid of 100%. In addition, 639 archived HCV-positive plasma samples were tested and similarly resulted in 100% sensitivity. Sensitivity is a measure of the percentage of tests that correctly show a positive result when an individual is infected with HCV.
The pre-clinical studies also evaluated the test's sensitivity during seroconversion. Seroconversion refers to the period of time immediately after infection during which an individual's body generates detectable antibodies to HCV. Out of 22 seroconversion panels tested, the prototype HCV test detected HCV antibody on average three days earlier than a laboratory-based assay and in no case did the prototype test detect HCV antibody later than the laboratory assay.
Hepatitis C is the most common blood-borne infection in America, affecting approximately four million people or about one in every 50 adults, according to the Centers for Disease Control and Prevention. Most people who contract the disease will develop chronic hepatitis C infection and more than half of infected persons are not aware that they have the disease. Chronic Hepatitis C can cause cirrhosis, liver failure and liver cancer. About half of all cases of primary liver cancer in the developed world are caused by Hepatitis C, and Hepatitis C related liver disease is now the leading cause for liver transplants. Without increased therapeutic treatment, the number of deaths from HCV infection is expected to increase substantially over the next 10 to 20 years due to the progression of liver disease in the infected population.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. For more information on the Company, please go to www.orasure.com .
Important Information
This press release contains certain forward-looking statements, including with respect to products, product performance, clinical studies, regulatory filings and the effects of HCV infection. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; changes in relationships, including disputes or disagreements, with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for the Company's products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties or products required for use of our products; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to product liability, patent infringement, and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to complete consolidation or restructuring activities; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission ("SEC") filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2006, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
Contact:
OraSure Technologies, Inc.
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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July 20th, 2007
Novel Hydrogels Invented For Repairing, Regenerating Human Tissue
http://www.sciencedaily.com
Science Daily — University of Delaware scientists have invented a novel biomaterial with surprising antibacterial properties that can be injected as a low-viscosity gel into a wound where it rigidifies nearly on contact--opening the door to the possibility of delivering a targeted payload of cells and antibiotics to repair the damaged tissue.
Regenerating healthy tissue in a cancer-ridden liver, healing a biopsy site and providing wounded soldiers in battle with pain-killing, infection-fighting medical treatment are among the myriad uses the scientists foresee for the new technology.
The patented invention by Joel Schneider, UD associate professor of chemistry and biochemistry, and Darrin Pochan, associate professor of materials science, and their research groups marks a major step forward in the development of hydrogels for medical applications.
Formulating hydrogels as delivery vehicles for cells extends the uses of these biopolymers far beyond soft-contact lenses into an intriguing realm once viewed as the domain of science fiction, including growing bones and organs to replace those that are diseased or injured.
“This is an area that will be exploding over the next decade,” Pochan said.
Hydrogels are formed from networks of super-absorbent, chain-like polymers. Although they are not soluble in water, they soak up large amounts of it, and their porous structure allows nutrients and cell wastes to pass right through them.
Schneider and Pochan and their research teams have been focusing on developing peptide-based hydrogels that, once implanted in the human body, will become scaffolds for cells to hold onto and grow--cells such as fibroblasts, which form connective tissue, and osteoblasts, which form bone.
“They're like rebar when you're building something with concrete,” Schneider said. “They give the cement something to hang onto.”
The basis of UD's hydrogels is “MAX1,” a self-assembling peptide that the scientists designed six years ago and named after Pochan's son, Max.
Peptides are short chains of amino acids, the building blocks of proteins. Different amino acids are bonded together to form chains, which then fold up into more compact shapes with specific functions.
The peptide that Schneider and Pochan and their research teams designed undergoes triggered “self-assembly,” meaning that the peptide will fold automatically into a specific shape in response to a particular trigger, or environmental stimulus, such as exposure to light. After folding, it self-assembles, affording the hydrogel.
Using “MAX8,” the eighth iteration of their original peptide, Lisa Haines-Butterick, a doctoral student in Schneider's group, figured out how to encapsulate living cells in the hydrogel and then inject the gel into secondary sites without harming the cells.
“Although we have currently only demonstrated this capacity of our gels using simple models, we envision that when injected into the body, the cells encapsulated in the gel can go about their business in restructuring the tissue,” Schneider explained.
UD's peptide-based hydrogels display several novel features. Not only are they cytocompatible, meaning that they are not toxic to the living cells they are enlisted to deliver, but some of the gels are inherently antimicrobial, killing certain gram-negative and gram-positive bacteria, a characteristic the research team currently is exploring.
The UD hydrogels also can be freeze-dried into a powder and reconstituted into a solution for use. They can be injected from a syringe, offering a minimally invasive approach to medical treatment, as well as a targeted, “leak-proof' way of potentially delivering cells and drugs to a wound or diseased organ.
Collaborations with physicians at Christiana Care Health System in Newark, Del., may lead to future developments for the hydrogels. Schneider recently began working with Dr. Joseph Bennett, a surgeon at the Helen F. Graham Cancer Center who resects liver tumors.
Both Schneider and Pochan attribute this new collaboration to the Center for Translational Cancer Research, a collaboration of Christiana Care Health System, A. I. duPont Hospital for Children and UD, including the University's Delaware Biotechnology Institute. The center is under the direction of Mary C. Farach-Carson a professor of both biological sciences and material sciences at UD.
“You know, the liver is an amazing organ,” Schneider said. “It has the ability to regenerate itself quite easily. If almost 70 percent of it is lost to disease and removed, that remaining 30 percent can grow back, affording a functional liver. We want to use the hydrogels to deliver hepatocytes to the liver,” he noted. “These could be used to beef up the liver's function prior to surgery if, for example, someone had hepatitis, or drank a lot, factors that would normally limit the amount of cancerous liver that can be removed.”
While Schneider and Pochan aren't Felix and Oscar in The Odd Couple, they do work in very different scientific disciplines, and they have an easy banter. Both scientists joined the UD faculty in 1999. They met during new faculty orientation at the president's house, seated at the same table. “Serendipity can really be your friend,” Pochan said.
Besides learning about each other's research, Pochan and Schneider also found out they lived in the same neighborhood in Philadelphia, although at different times (Schneider during postgraduate research at the University of Pennsylvania, and Pochan during his first years at UD), and even had some of the same mutual friends there.
“The thing is, he used to throw these things away,” Pochan said, referring to the hydrogels and pointing his thumb at Schneider.
“For the research I was working on when I was a graduate student a long time ago, the last thing I wanted to make was hydrogels,” Schneider explained, “so when that's what I ended up with, I'd throw them out. Then Darrin said to me, 'You know, these things are really pretty interesting....'
Schneider and Pochan's most recent hydrogel study is reported in the May 8 (print) edition of the Proceedings of the National Academy of Sciences. Their research is funded by the National Science Foundation and the National Institutes of Health.
The University of Delaware is pursuing commercialization opportunities for the research. Patents have been filed in the United States, Canada, Europe and Japan. For more information, contact Bradley Yops, assistant director of intellectual property and technology transfer, Office of the Vice Provost for Research and Graduate Studies, at (302) 831-0147.
Note: This story has been adapted from a news release issued by University of Delaware.
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From the twilight world of death row to a new life filled with hope and promise
http://www.yorkshirepost.co.uk
By Sarah Freeman
Nick Yarris spent 22 years on death row for a crime he didn't commit. While inside, his parents were spat at, his brother overdosed and he contracted hepatitis C, so how does he manage to be so laid back?
Nick Yarris rarely has a moment to himself.
In between looking after his young daughter Lara, filming a documentary and writing book, he has a packed diary of public appearances, but after spending 8,075 days – the bulk of his adult life – on Pennsylvania's death row, he has had more than enough time for quiet reflection.
By the time he was stopped by the police for a traffic offence in December 1981, his life, fuelled by drink and drugs, was already spiralling out of control. However, even the most pessimistic evaluations could not have predicted what would happen next.
"It all happened in a split second," says Nick, now 46, who will be one of the guests at this weekend's Festival of Ideas in Sedbergh.
"As I got out of the car the officer grabbed my arm, there was a scuffle and his gun accidentally went off.
"The incident was blown way out of proportion and before I knew it I has been thrown in prison charged with attempted murder and kidnapping."
It's impossible to know the exact truth of what happened that winter's morning, but Nick's desperation to avoid a lengthy prison sentence led him to a decision which would land him on Death Row and his family in a two-decade long nightmare.
While flicking through a newspaper Nick read about the ongoing investigation into the rape and murder of Linda Mae Craig and in the hope of securing bail, he told police he knew who was responsible, giving the name of a man he thought was already dead.
When the accused turned up alive, well and with a cast-iron alibi, Nick's testimony was proved to be little more than a tissue of lies and with the police convinced he must be, in fact, the murderer, they set about building the case against him.
The prosecution witnesses amounted to a well-known burglar and drug addict who claimed Nick had confessed to the crimes, and a woman who placed him at the murder scene.
It was enough to convince the jury, and at the end of one of the fastest capital murder trials of recent times, he was sentenced to death, joining inmates of Huntington Prison, high in the mountains of Pennsylvania.
"It's the endless silence that gets you," says Nick, who began his battle to prove his innocence in 1988 after learning of the research being carried out into DNA testing in the UK.
"Unfortunately, I ended up being assigned to lawyers who refused to believe I was innocent, and time and again I was betrayed, let down and ignored."
Worse was to come. Following botched dental treatment while in prison he contracted hepatitis C and as the disease attacked his liver, already ravaged from years of drink, Nick lost the will to fight.
By 2002, 20 years after he first put on his prison uniform, Nick was begging the authorities to execute him, a plea he now believes represents the starkest argument against the death penalty.
"The thought of being executed is actually a relief," he says. "There are some people who think it's the ultimate punishment, but actually it's the ultimate escape from the horrors of growing old inside four small walls. I had been unable to grieve properly for my brother who overdosed while I was in prison, and there were times when I would repeatedly bang my head against the wall. I felt numb and feeling pain was better than feeling nothing at all.
"For me, pleading for death actually saved my life as it made my attorney try one last time to get the results of DNA evidence which had lain untested in a lab for so many years."
The results, which showed Nick matched neither of the profiles found at the scene, finally cast doubt on the conviction. After a year of stalling, he finally walked out of prison in January 2004 with little more than the shirt on his back and the knowledge in his own mind at least that his name had been cleared.
Compensation has not yet been offered, but if he is angry at the way he was treated on being released from prison he refuses to be bitter about those who put him there in the first place.
"When I came out I had $5 of my own money in my pocket and I have never received a penny from the state," he says. "It's insulting, we are so quick to punish, but so blind to the aftermath of prison. Someone has to stand up and take responsibility.
"I had no health insurance so couldn't get treatment for the hepatitis. I wanted to stand on my own two feet, but I had no money and ended up homeless.
"After eight months, I went to visit my parents and they gave me a letter which was inviting me to come to Britain to speak in front of Parliament. For the first time I felt like my story was being recognised, that someone wanted to hear what I have to say.
"That was the day my life changed."
When he arrived in Britain, Nick, whose hope is to see the death penalty in America outlawed, didn't know what to expect, but as he talked to his many supporters, one of whom would become his wife and mother to his daughter, Lara, he began to feel a sense of purpose.
"Even before I was sent to death row, my life wasn't exactly heading in a good direction," he says. "My drug taking and drinking was in response to being abused as a child, but what I did was incredibly stupid and I can't just lay the blame for what happened completely on someone else.
"It took a while, but there came a point when I had reached the lowest point I could and decided that the only way I was going to have any sort of future was if I began to educate myself and look for the positives. I took inspiration from the likes of Nelson Mandela and when I began to tell my own story, suddenly I felt like I had a future, but I didn't expect to find a wife.
"Karen had read about my story and came to hear me speak. We hit it off and she said she would look me up when she was next in America because she had friends who lived in the same area. She kept her promise and we're now married, living in London with a beautiful daughter. Life is pretty perfect."
Nick now works with Reprieve, the campaigning organisation set up to represent Death Row prisoners, but the psychological scars of the endless years he shouldn't have spent behind bars understandably mean he is reluctant to meet those who have found themselves in a similar situation.
"For 20 years I was in a completely different world and when I was released I had to leave that world behind," he says. "I know what other prisoners are going through, but I don't think I could ever visit them.
"What I can hope is that my story gives them hope. The last few years have been incredibly cathartic and I'm currently writing a book and making a documentary which is a wonderful opportunity.
"To deal with what happened I had to leave America, but my parents, who endured all sorts of abuse when I was inside, still live in the same place. It's funny, the same press which vilified my family has now been responsible for setting the record straight and now instead of spitting at them, people stop them in the street to tell them how much they admire them. Finally people can really appreciate what they went through."
While Nick's story is remarkable in so many ways, one of the biggest shocks came just two days after the birth of his daughter when he got a call from his doctor.
"The hepatitis hadn't just gone into remission, but they could not longer find any trace of it," he says with the exact same incomprehension he felt at the time.
"I spent a lot of time in prison sat in myself and hating God, but now I think maybe it was all part of some bigger plan.
"A few years ago, I honestly thought that I would be dead, but now I have everything to live for and who could want anything more than that?"
Sedbergh Festival Of Ideas
This event includes various lectures, discussions, photographic exhibitions on science, philosophy, history, culture, ethics and current affairs. Speakers include author Gervase Phinn, Demos think tank researcher Samuel Jones, historian and crime writer Ruth Dudley Edwards, Gisela Stuart MP for Birmingham Edgbaston and a member of the Foreign Relations Committee, and Greg Rosen, chair of the policy and research committee of the Fabian Society and chair of the Labour History Group. The festival runs from today to Sunday.
For full details, visit www.sedbergh.org.uk/ideasfestival/2007/
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