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Week Ending: December 15th, 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
December 8th, 2007
Ligand Presents Positive LGD-4665 Phase I Clinical Trial Results at the American Society of Hematology Annual Meeting (ASH)
http://www.redorbit.com
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced positive results from a Phase I clinical trial with LGD-4665 in a poster titled "Single and Multiple Oral Doses of LGD-4665, a Small Molecule Thrombopoeitin Receptor Agonist, Increase Platelet Counts in Healthy Male Subjects," at the American Society of Hematology (ASH) 49th Annual Meeting, being held at the Georgia World Congress Center in Atlanta December 8-11, 2007.
The poster presentation highlighted LGD-4665 as an oral, small-molecule drug that mimics the activity of thrombopoietin (TPO), a growth factor that promotes growth and production of blood platelets. The poster presentation can be viewed by visiting the Investor Relations section of Ligand's website at www.ligand.com.
Ligand's Phase I clinical trial evaluated three dosing regimens of LGD-4665, including single doses, multiple daily doses for 14 days, and Day 1 loading doses followed by daily doses for 13 days. The drug was safe and well tolerated, and statistically significant platelet increases were observed in both single and multiple daily dose regimens.
"These efficacy results demonstrate potential use of this new molecule in thrombocytopenic patients that in the future could reduce the need for platelet transfusions, and ultimately improve patient outcomes," said James B. Bussel, M.D., Director of the Platelet Disorders Center, Children's Blood Foundation Division at the New York-Presbyterian Hospital/Weill Cornell Medical Center.
Summary Phase I Clinical Trial Results
LGD-4665 showed impressive activity following single and multiple doses with an increase in mean maximum platelet counts of 58% with a single dose administration of 120 mg and 83% with 10 mg dosed daily for 14 days.
Results demonstrated that with a Day 1 loading dose, the increase in mean maximum platelet counts was 27% with 2.5 mg, 43% with 5.0 mg and 79% with 7.5 mg daily for 13 days.
A gradual decline in platelet levels was observed post-treatment.
The pharmacokinetic properties showed reliable absorption with a dose-proportional increase of systemic exposure in both single doses and multiple doses. The half-life of LGD-4665 was approximately 90 hours.
LGD-4665 was well-tolerated and demonstrated an encouraging safety profile at all dose levels and all dosing regimens. There were no serious adverse events. The majority of adverse events observed were mild-to-moderate with no apparent direct relationship to LGD-4665 exposure. There were no clinically significant or LGD-4665 related vital signs or laboratory abnormalities.
In clinical studies of 14-day dosing, LGD-4665 is 10 times more potent than eltrombopag, based on published data with 10-day dosing.
Pre-clinical Highlights
LGD-4665 is a highly selective full agonist mimetic of TPO.
LGD-4665 demonstrated an additive effect with TPO in the stimulation of thrombopoiesis by human bone-marrow hematopoietic stem cells.
"We are very encouraged by the promising activity and safety profile demonstrated with LGD-4665 in this Phase I study," said Zofia E. Dziewanowska, M.D., Ph.D., Ligand's Vice President of Clinical Research. "In addition, a pharmacokinetic profile of LGD-4665 allows not only for a once-a-day dosing but, due to its long half-life, potentially for a weekly dosing regimen, as well. Based on its strong potency, convenience and potential for dosing flexibility, we believe that LGD-4665 could be used as treatment for a wide variety of diseases associated with thrombocytopenia, including hepatitis C, chemotherapy-induced thrombocytopenia (CIT), myelodysplastic syndromes (MDS), idiopathic thrombocytopenic purpura (ITP) and several other cancers and liver diseases."
LGD-4665 Study Design
The placebo-controlled, double-blind, dose-escalating Phase I clinical trial was conducted at a single center in 106 healthy male subjects. In the single dose portion of the trial, six subjects were randomized in the several dose cohorts to receive either a single dose of LGD-4665 or placebo (in a 2:1 ratio). Dose levels ranged from 1 mg to 120 mg, and were escalated sequentially based on the review of safety and activity (increase in platelet levels) according to predefined criteria. In the multiple dose portion of the trial, at doses of 2.5 mg to 10 mg daily, 14 subjects at each dose level were randomized to placebo or LGD-4665 for 14 days, either with or without a one-time loading dose. Similar to the single dose study, dose escalation was determined following safety and activity evaluations conducted at the conclusion of each dose cohorts.
Eltrombopag and GlaxoSmithKline
In 1997, Ligand formed a research and development alliance with GlaxoSmithKline (GSK), which led to the discovery of eltrombopag (Promacta), a first generation TPO mimetic. Since then, GlaxoSmithKline has announced that it expects to submit an NDA for eltrombopag by year-end for the treatment of short-term ITP. In addition, two Phase III trials were initiated by GSK in the fourth quarter of 2007 for hepatitis C, and GSK is studying the drug for CIT. GSK has made significant progress advancing its program, and eltrombopag may be the first oral TPO mimetic to be approved. Ligand will receive a royalty from eltrombopag sales.
Ligand's Next Generation TPO Program
The Ligand thrombopoietin program commenced after the conclusion of the GSK partnership and has focused on developing novel proprietary drug candidates that mimic the activity of thrombopoietin. LGD-4665 is the lead, small-molecule TPO mimetic under development at Ligand Pharmaceuticals. LGD-4665 binds to the thrombopoeitin receptor in a manner similar to TPO and activates the production of platelets by the bone marrow. In addition, several next generation molecules from a chemical series distinct from LGD-4665, are in the research phase with promising TPO mimetic activities.
Thrombocytopenia Market Opportunity
Thrombocytopenia is seen in 5-10% of all patients hospitalized for any cause. Several key indications for thrombocytopenia include ITP, hepatitis C and MDS/chemotherapy.
ITP - According to the Platelet Disorder Support Association (PDSA), approximately 200,000 patients are affected by ITP in the U.S. In the current U.S. ITP population, half of the patients have thrombocytopenia and require drug interventions and/or platelet transfusions. A similar patient population exists in the European Union (EU).
Hepatitis C - The Centers for Disease Control and Prevention (CDC) estimates that 2.7 million patients in the U.S. are chronically infected with HCV. Thrombocytopenia is a frequently reported complication of HCV and antiviral therapy. An estimated 10% of hepatitis C patients have clinically significant thrombocytopenia associated with cirrhosis.
Chemotherapy - The American Cancer Society estimates 1.5 million new cases of non-skin cancers with the majority of patients expected to receive chemotherapy regimens. Thrombocytopenia is a frequently reported complication in approximately 10% of patients receiving chemotherapy
Myelodysplastic Syndromes (MDS) - According to the Cleveland Clinic Foundation, 35,000 to 40,000 patients in the U.S. have MDS. In addition, 50% of patients with certain hematological malignancies such as MDS suffer from disease-induced thrombocytopenia.
LGD-4665 holds potential for additional medical applications including bone-marrow transplants, cirrhosis, lupus, intensive-care and peri-operative patients, HIV and for pre-treatment before a platelet donation. The worldwide market for innovative TPO drugs has the potential to generate billions of dollars of sales annually.
Business Outlook
Ligand expects to advance the development of LGD-4665 for multiple indications. In 2008, the Company currently expects to initiate clinical trials for ITP, MDS and hepatitis C. In addition, the Company plans to conduct further studies evaluating drug pharmacology including the potential for weekly dosing with LGD-4665.
The Company anticipates that its total 2008 expenses for G&A and R&D costs to operate the Company, excluding stock-based compensation, to be approximately $35 million.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical unmet medical needs of patients in the areas of thrombocytopenia, hepatitis C, cancer, hormone-related diseases, osteoporosis and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to intracellular receptors.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties and reflect Ligand's judgment as of the date of this press release. For example, we may spend more or less than the anticipated operational expense set forth herein, and operating expenses do not include any one-time charges. These statements also include those regarding data analysis and evaluation of LGD-4665, utility or potential benefits to patients, plans for continued development and further studies of LGD-4665 for the treatment of diseases associated with thrombocytopenia. Actual events or results may differ from our expectations. For example, there can be no assurance that other trials or evaluations of LGD-4665 or other TPO-related product candidates will be favorable or that they will confirm results of previous studies, that data evaluation will be completed or demonstrate any hypothesis or endpoint, that LGD-4665 or other TPO-related product candidates will provide utility or benefits to certain patients, that any presentations will be favorably received, that LGD-4665 or other TPO-related product candidates will be useful as a single agent or in combination with other drugs, that marketing applications will be filed or, if filed, approved, or that clinical or commercial development of these product candidates will be initiated, completed or successful or that our rights to LGD-4665 and other TPO-related product candidates will not be successfully challenged. Our stock price may suffer as a result of the failure of any trials to be completed or meet their endpoints or if any actual events differ from our expectations. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases as well as in public periodic filings with the Securities and Exchange Commission, available via www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Source: Business Wire
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December 10th, 2007
SciGen Enters Agreement With Nasvax Regarding Hepatitis B Vaccine
http://au.biz.yahoo.com
Original Announcement: SciGen Enters Into Agreement With NasVax
SciGen announced that it has executed a Joint Development & Commercialization Agreement with NasVax Ltd. to jointly develop and commercialise a prophylactic intranasal Hepatitis B vaccine. The product subject of the collaboration is under development, and will combine antigens for immunisation against Hepatitis B produced by SciGen with Nasvax adjuvant technology, and will be directed towards intranasal delivery.
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Hepatitis C victims may reject settlement talks
http://www.japantimes.co.jp/
Kyodo News
Patients infected with hepatitis C and their lawyers decided Sunday to reject an upcoming out-of-court settlement plan for their damages suit if the Osaka High Court presents a compromise settlement that only holds the state and drug makers accountable in some cases.
Such a plan would not provide full redress to all of the victims suffering from hepatitis C, the lawyers said after their meeting in Tokyo.
According to an outline of the settlement proposal already presented by the high court, it will hold the defendants liable only for those cases in which plaintiffs were administered with tainted blood products after certain dates, depending on the products they received.
While the court will urge the defendants to provide financial aid to plaintiffs who were administered with such blood products earlier than the baselines, the plaintiffs and lawyers believe that the amount of compensation received by victims will vary and several victims could be excluded from the settlement plan.
The high court is scheduled to issue the settlement proposal on Thursday.
A total of around 200 plaintiffs have filed damages suits at five district courts since October 2002.
Last Tuesday, Health, Labor and Welfare Minister Yoichi Masuzoe apologized to the victims for the government's inaction over the infections. It was the first time that such an apology had been offered.
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XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International Scientific Conference on Viral Hepatitis
http://biz.yahoo.com
VALLEY COTTAGE, N.Y., Dec. 10 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB, TASE: XTL) announced today that it will make two scientific presentations related to its pre-clinical Hepatitis C virus (HCV) small molecule program at HEP DART 2007, an international scientific conference on viral hepatitis being held this week in Lahaina, Hawaii.
A poster presentation entitled "Mechanistic Characterization of Potent Small Molecule HCV Inhibitors that Target NS5A" describes a family of small molecule inhibitors of HCV that target the NS5A viral protein. Potency of these compounds was evaluated in a replicon assay, which is known to have good correlation with clinical efficacy and is the current gold standard for pre- clinical testing of inhibitors of HCV. In the replicon assay, the compounds had single-digit nM (nanomolar) and low double-digit nM potencies against genotypes 1b and 1a, respectively. These genotypes constitute the majority of HCV infections in the U.S.
New data presented further substantiate NS5A as the target of these compounds. The new data includes results from in vitro binding to NS5A, resistance selection, molecular genetic and molecular modeling studies.
NS5A is a viral protein that is essential for RNA production and is distinct from the protease and polymerase - the viral targets of the more advanced HCV inhibitors in clinical development. As such, inhibitors of NS5A are considered promising candidates for the treatment of HCV. As a relatively new target, only one NS5A inhibitor has entered clinical trials to date - A831 - which is presently in a Phase 1 clinical trial. A831 was developed by Arrow Therapeutics, which was recently acquired by AstraZeneca. The Company's compounds presented appear to be significantly more potent than A831 in the replicon assay.
A second poster presentation entitled "Pharmacologic Evaluation of Novel Small Molecule HCV Inhibitors Affecting NS5A-dependent Functions" describes the results of studies on the potency, specificity, toxicology and pharmacokinetics of the Company's lead HCV molecules. In these studies, when administered orally to rodents, the compounds demonstrated preferential accumulation in the liver in concentrations that were orders of magnitude above those required to block viral replication as predicted by the replicon assay, with half-lives consistent with a twice a day dosing regimen. Toxicology studies showed that the activity of these molecules was selective for HCV, with no apparent adverse effects on a range of human cell types or on rodents exposed to repeated high doses.
The small molecules being presented by the Company at the conference emerged from the Company's DOS program, aimed at discovering novel HCV inhibitors by applying a unique chemistry technology called Diversity Oriented Synthesis.
ABOUT HEPATITIS C VIRUS
There are approximately 3 million people infected with HCV in the U.S. alone. HCV infection significantly increases the infected person's risk of developing chronic liver disease, cirrhosis and liver cancer, and is the leading cause of liver transplantation in the Western World. HCV infection remains a major unmet medical need as the current standard of care (interferon-based therapy) achieves success in only 50% of patients infected with genotype 1 of the virus (genotype 1 affects 75% patients in the U.S.), and has significant side affects associated with it.
ABOUT XTL BIOPHARMACEUTICALS LTD.
XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the development of therapeutics for the treatment of neuropathic pain and HCV. XTL is developing Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of diabetic neuropathic pain, which is currently in a Phase 2b study. XTL is also developing novel pre-clinical HCV small molecule inhibitors. XTL also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. XTL is publicly traded on the NASDAQ and Tel-Aviv Stock Exchanges (Nasdaq: XTLB; TASE: XTL).
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future performance and prospects of our pre-clinical compounds for HCV from our XTL-DOS program, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete the pre-clinical development DOS program; our ability to clinically develop candidates from the DOS program; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, including our annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2007. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.xtlbio.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
Source: XTL Biopharmaceuticals Ltd.
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Greater need for education regarding blood borne viruses
http://www.news-medical.net
A new cohort study could facilitate targeted interventions for adolescent offenders who are at a high risk of hepatitis C (HCV) infection and obesity related liver disease.
Researchers Dr David van der Poorten, Professor Dianna Kenny and Professor Jacob George sought to create a new definition for the normal upper limit of liver biochemistry to define the associations and implications of raised alanine aminotransferase (ALT).
ALT is measured to see if the liver is damaged or diseased. Low levels of ALT are normally found in the blood. However, when the liver is damaged or diseased, it releases ALT into the bloodstream, which makes ALT levels go up. Most increases in ALT levels are caused by liver damage.
The study, which is published in the December issue of Hepatology, examined the liver health of at risk adolescents examining data from a large cohort of young male offenders under supervision by the New South Wales Department of Juvenile Justice.
They examined the results of liver tests and lipid studies from blood samples of 439 young male offenders who agreed to participate in the health survey between October 2003 and December 2007. They also considered clinical, demographic, and lifestyle data and performed statistical analysis to determine relevant associations.
They determined that upper limit of normal for liver enzymes using the liver test of participants at low risk of liver disease (young men with normal BMI, cholesterol, triglycerides, and blood pressure; and no hepatitis B or C or high alcohol consumption). Those upper limits of normal were determined as being significantly lower than current upper limits for these tests.
Applying these cut offs to all participants, they found that 17 per cent had raised ALT, and compared to those with normal ALT, "there was a strong association for overweight and obesity," said Professor Kenny. "To prevent further hepatic damage and to minimise cardiovascular and diabetes risk, targeted interventions in adolescents at the earliest stages of metabolic dysfunction are a particularly high priority"
The new upper limit also detected 80 per cent of the HCV infected patients, who were significantly more likely to have injected drugs in the last 12 months.
"The study has provided a wealth of clinical and health related data relevant to adolescents," said Professor Kenny. "The new definition of normal adolescent ALT allows greater sensitivity in diagnosing early liver disease. By identifying those with hepatitis B, C and obesity related liver disease; targeted intervention can and should be implemented to minimise future health-related morbidity," she said.
http://www.usyd.edu.au
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December 11th, 2007
Bile acid may improve hepatitis C therapy response
http://news.yahoo.com
By David Douglas
NEW YORK (Reuters Health) - A bile acid - called ursodeoxycholic acid -- may improve response to treatment in patients with chronic hepatitis C virus (HCV) who don't respond to standard therapy with interferon and ribavirin, Japanese researchers report in the medical journal Gut.
Ursodeoxycholic acid is a secondary bile acid that breaks down fat, and reduces the amount of cholesterol produced by the liver and absorbed by the intestines. It also helps break down cholesterol that has formed into gall stones and increases bile flow in patients with primary biliary cirrhosis.
Ursodeoxycholic acid therapy, which reduces levels of a type of enzyme (aminotransferase), may slow the progression of liver fibrosis and prevent the development of liver cancer, Dr. Masao Omata told Reuters Health.
Omata, of the University of Tokyo Graduate School of Medicine, and colleagues note that 1b is the most common HCV strain in Japan and can be resistant even to combination therapy. Only about 50 percent of patients with this HCV type have a sustained response to treatment.
To investigate whether the addition of ursodeoxycholic acid can improve treatment results, the researchers studied 596 patients who had elevated levels of the liver enzyme alanine aminotransferase (ALT). The patients were randomly assigned to receive one of three daily doses of ursodeoxycholic acid for 24 weeks.
ALT, as well as two additional liver enzymes, aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT), decreased at week 4 and then remained constant during drug administration.
Changes in ALT and AST did not differ in the patients who received the two higher doses -- 600 milligrams (mg) or 900 mg -- but GCT was significantly lower in the 900 mg group. In patients with initial GCT levels exceeding 80 IU/L who received 900 mg, ALT also showed a significant decrease.
However, there was no change in blood levels of HCV in any of the groups. Overall, 19.1 percent of patients reported adverse effects, but there were no differences in adverse effects among three groups.
Based on the findings, "there is not sufficient data to advise ursodeoxycholic acid treatment in hepatitis C," co-author of an accompanying editorial Dr. Raoul Poupon of Universite Pierre and Marie Curie, Paris told Reuters Health.
SOURCE: Gut, December 2007.
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Two on hepatitis panel were paid by maker of fibrinogen
http://www.japantimes.co.jp/
Kyodo News
Two people on a government panel investigating the plight of hepatitis C patients infected by the blood product fibrinogen have each received about ¥200,000 from its maker, the government disclosed Tuesday.
The money was paid over a span of three years by what was then known as Mitsubishi Pharma Corp. as fees for lectures and written contributions, the government said in a written answer to a memorandum of question submitted by Lower House member Kazunori Yamanoi of the Democratic Party of Japan.
Mitsubishi Pharma, the successor to scandal-tainted Green Cross Corp., is now part of Mitsubishi Tanabe Pharma Corp.
The government has been accused of failing to take action after being told that 418 people were infected with hepatitis C through fibrinogen.
The hepatitis C panel was set up in November by the Health, Labor and Welfare Ministry. It has five members, including hepatitis experts. The names of the two members who got the money have not been disclosed.
"The amount of the money is not large, and will not affect panel discussions," the ministry said.
Under a ministry rule concerning donations and fees to council members who assess and screen medical products, members can take part in both deliberations and voting if the amount received is ¥500,000 or less a year.
The panel on hepatitis C patients is not subject to the regulation, and the ministry said the amount of money involved wouldn't present a problem even if it were.
In a related move, plaintiffs in damages suits against the government and drugmakers over hepatitis C infections following the administration of tainted blood products asked the government Monday to provide uniform redress for all of the victims.
Prime Minister Yasuo Fukuda said he intends to "deal promptly" with the matter after the Osaka High Court presents a settlement plan later this week, and will determine what action to take after looking at the court's proposal.
Deputy Chief Cabinet Secretary Matsushige Ono, who met with four plaintiffs and their lawyers on behalf of Fukuda, said they sought the prime minister's decision on providing uniform redress.
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GENimmune Receives Orphan Medicinal Product Designation from European Commission for its hepatitis C Monoclonal Antibody
http://www.pharmalive.com
GHENT (Belgium), December 11, 2007 - GENimmune, the newly created biopharmaceutical subsidiary of Innogenetics, today announced that its candidate hepatitis C monoclonal antibody has been granted Orphan Medicinal Product Designation by the European Commission. The product is under development for the prevention of hepatitis C virus re-infection after liver transplantation.
It is estimated that over 3% of the world’s population, some 175 million persons worldwide, are chronically infected with the hepatitis C virus (HCV). Three to four million new infections occur each year.
A substantial number of chronically infected HCV patients develop progressive liver disease, which can lead to liver cirrhosis or liver cancer. When liver failure occurs, liver transplantation remains the sole life-saving option. However, following transplantation, hepatitis C liver disease re-occurs in almost 100% of patients, and is characterized by an accelerated disease course.
In the US and Europe combined, approximately 13,000 liver transplantations are carried out annually. Some 40% of these liver transplants are due to complications from HCV infection. The risk for re-infection, the high cost of liver transplantation, and the limitations of current drugs justify the development of new treatments.
As an outcome of its E1 research program, GENimmune has identified a series of HCV monoclonal antibodies that show potent neutralizing properties by blocking the infection of liver cells in vitro. The neutralizing properties were studied in collaboration with Dr. Robert Purcell’s team at the Laboratory for Infectious Diseases, Hepatitis Viruses and Molecular Hepatitis Sections (NIAID, NIH, Bethesda, MD). These monoclonal antibodies provide a possible additional means to counter HCV infection after liver transplantation. Based on the solid preclinical data, GENimmune is developing these antibodies to prevent recurrent HCV-induced liver disease in liver transplant recipients. One antibody has been selected for the Orphan Medicinal Product Designation application.
The validity of GENimmune’s different treatment approach for hepatitis C liver disease has also been recognized by the scientific community. An article describing the new monoclonals co-authored with NIH scientists has been accepted by the peer-reviewed Journal of Virology, and is scheduled for publication January 2008. Posters describing the properties of the monoclonals were also being presented at the annual International HCV Meeting in Glasgow, UK (Sept. 9-13) and at the Liver Meeting of the American Association for the Study of Liver Disease (AASLD) held in Boston, MA (Nov. 2-6).
Based on the criteria laid down in Regulation (EC) N° 141/2000, the European Commission has granted Orphan Medicinal Product Designation for GENimmune’s lead recombinant human hepatitis C monoclonal antibody. The designation resulted from the positive opinion by the Committee for Orphan Medicinal Products (COMP)*.
Orphan Medicinal Products benefit from various advantages, including a 10-year market exclusivity period following Marketing Authorization in the European Community.
Furthermore, GENimmune will be entitled to benefit from free Protocol Assistance to help in product development, which will maximize the chances of success upon Marketing Authorization Application. Orphan Drug designation also results in important fee reductions.
Guy Buyens, CEO of GENimmune commented: "The Orphan Medicinal Product Designation for our neutralizing human monoclonal antibody is an important milestone for GENimmune. It is a clear confirmation that this product offers a innovative solution to meet an urgent medical need. Furthermore, it fully valorizes our previous investment in the HCV E1 program. The decision by the European Medicines Agency (EMEA) provides GENimmune with either an exciting opportunity for streamlined development of this product by ourselves, or as a means to work on this program with an interested partner. In either case, this antibody now becomes an important asset of our expanding pipeline of innovative products that will make us a key player in the field of immune therapeutics.”
*http://www.emea.europa.eu/pdfs/human
/comp/45843807en.pdf ;
EU designation number: EU/3/07/503
About GENimmune
GENimmune is a biopharmaceutical company developing immune therapeutics to cure and prevent human disease by optimizing the immune response. The new company intends to become a key player in the treatment of major, intractable diseases by the creation of a broad and effective pipeline of modern immune therapeutics and vaccines. It will do so by synergizing its technical and clinical expertise for in-house product development, co-development projects, and biomanufacturing partnerships.
GENimmune is currently developing novel therapeutic vaccines and monoclonal antibodies against chronic diseases caused by the hepatitis B and hepatitis C viruses, as well as against human papillomavirus, the cause of cervical cancer.
GENimmune is a wholly owned subsidiary of Innogenetics NV, which is listed on Euronext Brussels [INNX].
For further information, please contact:
Guy Buyens
Chief Executive Officer GENimmune
Tel.: +32 (0)9 329 1639
E-mail: contact@genimmune.be
Web: www.genimmune-nv.com
BTW BE 0474.140.651 RPR Gent
About Innogenetics
Innogenetics NV is an international biotechnological company that develops and markets diagnostic products and develops immune therapeutics to improve therapy management and patient health.
Innogenetics’ diagnostics business unit develops and markets a wide range of diagnostic assays with a focus on molecular diagnostics and multiparameter testing. Its products are sold in over 90 countries through its 6 subsidiaries and a large number of distributors. In 2006, diagnostics sales totalled €45.8 million, more than 95% of which were achieved outside Belgium.
As of October 1, 2007, Innogenetics grouped its therapeutics activities into the wholly owned subsidiary called GENimmune. GENimmune focuses on developing innovative immune therapeutics and therapeutic vaccines and is supported by a world-class biomanufacturing unit providing third-party services as well.
Founded in 1985, Innogenetics is listed on Euronext Brussels [Ticker: INNX].
For further information, please contact:
Innogenetics
Filip Goossens
Investor Relations Manager
Phone + 32 9 329 1639
Fax + 32 9 245 7625
investor_relations@innogenetics.com
www.innogenetics.com
TVA BE 0427.550.660 RPR Gent
Forward looking statement
This press release contains forward-looking statements that involve risks and uncertainties, including but not limited to projections of future revenues, operating income, and other risks. Prospective investors should be aware that these statements are estimates, reflecting only the judgments and projections of Innogenetics’ management, and no undue reliance should be placed on such forward-looking statements.
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Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
http://www.finanznachrichten.de
PRINCETON, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Pharmasset, (Nachrichten) Inc. announces that interim results of physician-sponsored studies of clevudine for the treatment of chronic hepatitis B virus (HBV) and both preclinical and clinical results of R7128 for the treatment of chronic hepatitis C virus (HCV) will be presented at the Frontiers in Drug Development in Viral Hepatitis (HEP-DART) conference being held in Lahaina, Hawaii from December 9 - 13, 2007. The abstract titles and abbreviated study summaries are described below. The full conference abstracts are currently available for download in PDF format in the "Events&Presentations" section of Pharmasset's website at http://investor.pharmasset.com/events.cfm. The full scientific presentations will be available for download in PDF format following the conference in the "Product Pipeline" section of Pharmasset's website at http://www.pharmasset.com/pipeline.
- Clevudine was Superior to Lamivudine in the Patients with HBeAg(+) Chronic Hepatitis B. GK Lau, et al.
Abstract Summary: The aim of this study is to compare the efficacy and safety of clevudine versus lamivudine for 48 weeks in chronic hepatitis B (CHB) e-antigen positive (HBeAg(+)) patients in a randomized and blinded manner. Based on the preliminary results from 22 patients (11 clevudine, 11 lamivudine), 48-weeks of dosing with clevudine 30mg showed superior viral suppression to lamivudine 100mg without the emergence of viral breakthrough in HBeAg(+) CHB patients. At week 48, serum HBV DNA levels were below the level of detection (<300 copies/mL) in 82% of patients in the clevudine group and 36% of patients in the lamivudine group. In the lamivudine group, viral breakthrough occurred in 3 patients during weeks 32-48, but no patient had viral breakthrough during the 48 week treatment period in the clevudine group.
- Early biochemical and virological response of clevudine therapy in patients with HBV associated liver cirrhosis. KW Chung, et al.
Abstract Summary: This analysis was performed to evaluate the early biochemical and virological response of clevudine in chronic hepatitis B patients with cirrhosis. Data from 13 patients with chronic hepatitis B and cirrhosis were collected. Preliminary results for patients who have been treated for at least 1 month are presented. Clevudine 30 mg administered once daily demonstrated early viral suppression and significant biochemical improvement in patients with liver cirrhosis.
- Clevudine monotherapy showed rapid viral and biochemical response in chronic hepatitis B patients with cirrhosis. CH Lee, et al.
Abstract Summary: This analysis was performed to evaluate the efficacy of clevudine in chronic hepatitis B patients with cirrhosis. Data from 23 patients with chronic hepatitis B and cirrhosis were collected. Among them, 5 patients were diagnosed with decompensated liver cirrhosis or hepatocellular carcinoma (HCC). For patients who received clevudine for at least 12 weeks, preliminary data indicated that 20 patients (87%) had HBV DNA less than 1,000 copies/mL and 17 patients (74%) had normal alanine transferase (ALT). Clevudine 30 mg administered once daily demonstrated potent viral suppression and significant biochemical improvement in patients with cirrhosis.
- Novel Mechanism of Action of Clevudine Triphosphate: Evidence for Non- competitive Inhibition of Hepatitis B Virus DNA Polymerase. E Murakami, et al.
Abstract Summary: The unique mechanism of action of clevudine was examined using an endogenous HBV polymerase assay. The mode of inhibition for clevudine triphosphate was determined to be non-competitive. Since several active site mutations are known to confer resistance to clevudine in vitro, clevudine triphosphate may be binding at or near the active site of the HBV polymerase without being utilized as a substrate. To the best of our knowledge, this is the first example of a nucleoside analog triphosphate showing non-competitive inhibition.
- Potent Antiviral Activity of the Nucleoside HCV Inhibitor, R7128, in Prior IFN Non-Responders. JG McHutchison, et al.
Abstract Summary: R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog polymerase inhibitor, for treatment of HCV. A 14-day monotherapy study demonstrated that R7128, a direct antiviral, can deliver sufficient antiviral potency via monotherapy to suppress HCV below the level of detection (<15 IU/mL) in an interferon failure population. The mean reduction in HCV RNA with the 1500 mg BID dose was -2.7 log10 IU/mL and ranged from -1.2 to -4.2 log10 (below the limit of detection) at Day 15. Twice-daily (BID) administration was superior to once-daily (QD) administration for antiviral suppression. The pharmacokinetic profile following single and multiple doses indicated good exposure to PSI-6130 with no dose-related adverse events or laboratory abnormalities. The lack of virologic rebound also provides early evidence of high genetic barrier for nucleoside inhibitors of NS5B polymerase. The safety and efficacy of this monotherapy study support further development of R7128 in combination with pegylated interferon and ribavirin.
- High Genetic Barrier to HCV Resistance Presented by PSI-6130. A Uzgiris, et al.
Abstract Summary: PSI-6130 is the parent molecule of the prodrug R7128, an orally active inhibitor of the hepatitis C virus NS5B polymerase currently in clinical development. Proprietary and public database containing HCV NS5B sequences representing six HCV genotypes were analyzed for the presence of the S282T substitution. S282T results in a small loss in the antiviral activity of PSI-6130 and is not highly polymorphic in the wild-type HCV population. These in vitro data indicate that there is a high genetic barrier to resistance to PSI-6130. Since PSI-6130 is metabolized to two active triphosphate forms, it is enticing to speculate that the two structurally different active metabolites would further increase the genetic barrier of PSI-6130.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an orally administered treatment for chronic HCV infection, is enrolling a 4-week Phase 1 clinical trial in combination with Pegasys(R) and Copegus(R) through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.
About Hepatitis B
Hepatitis B viruses can cause liver disease leading to significant morbidity and death. HBV can cause either acute or chronic (lifelong) infection. The World Health Organization (WHO) has reported that approximately 350 million people worldwide have chronic HBV infection. According to the Centers for Disease Control and Prevention (CDC), approximately 1.25 million people in the United States are chronically infected with HBV, and the Hepatitis B Foundation reports that 100,000 people will become infected with HBV this year.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations&Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that adverse events could cause the cessation of the Phase 3 registration studies and/or our development of clevudine, the risk that adverse events could cause the cessation of the Phase 1 combination study and/or our development of R7128, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
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December 12th, 2007
Cancer Surveillance Futile in Advanced Cirrhosis
http://www.medscape.com
NEW YORK (Reuters Health) Dec 03 - Surveillance for the early diagnosis of hepatocellular carcinoma (HCC) in cirrhosis patients appears to be useful only for those in earlier stages of the disease, Italian researchers report in the November issue of the American Journal of Gastroenterology.
"This study clearly shows that surveillance becomes pointless if applied to patients who have reached an advanced stage of cirrhosis -- Child-Pugh class C -- and are not candidates for liver transplantation," lead investigator Dr. Franco Trevisani told Reuters Health.
In patients with advanced cirrhosis, hepatic failure usually makes cancer treatment too dangerous and treatment outcomes are poor. In addition, these patients also have a high rate of cirrhosis-related mortality.
To help refine surveillance selection criteria, Dr. Trevisani of the University of Bologna and colleagues studied data on 468 Child-Pugh class B and 140 class C patients.
HCC was diagnosed during annual or semiannual surveillance in 252 patients and was detected outside of routine surveillance in 356.
The team found that surveillance significantly improved the prognosis in class B patients, increasing survival by 5.1 months. Compared with controls, the number of radical treatments was doubled (35% versus 18%) and the number of patients considered untreatable was almost halved (29% versus 51%).
In the class C patients who were not candidates for liver transplantation, surveillance resulted in almost twice the rate of radical therapies. This figure is low, the investigators note. "Poor liver function likely worsened the treatment results and increased cirrhosis-related mortality."
The researchers conclude that surveillance is worthwhile in class B patients and should be maintained in class A patients migrating to class B. However, surveillance proves useful only for class C patients who are awaiting surgery.
Am J Gastroenterol 2007;102:2448-2457.
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ZymoGenetics Presents PEG-Interferon Lambda Phase 1a Data
http://www.therapeuticsdaily.com/
SEATTLE--(BUSINESS WIRE)--Dec 11, 2007 - ZymoGenetics, Inc. (NASDAQ:ZGEN), today presented data from a Phase 1a clinical trial with PEG-Interferon lambda (also known as IL-29) in healthy volunteers showing that administration of single doses of PEG-Interferon lambda was well tolerated at doses that produced anticipated pharmacologic activity, including up-regulation of interferon response markers associated with antiviral effects. No fever or hematologic effects, which are typically seen with interferon alpha, were observed at any of the dose levels tested.
"Results from this single dose Phase 1a study in healthy volunteers support moving forward into a repeat dose Phase 1b study in patients with hepatitis C," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer. "The biologically active dose levels observed in the Phase 1a study have been used to design a Phase 1b study to evaluate the safety and antiviral effects of repeat dosing in patients with relapsed hepatitis C infection. "We're hopeful this study will confirm preclinical findings indicating PEG-Interferon lambda has antiviral activity with greater tolerability for patients."
About the Phase 1a Study
The primary objectives of this randomized, placebo-controlled, dose-escalation Phase 1a study were to characterize the safety, tolerability and pharmacokinetics of a single dose of PEG-Interferon lambda administered subcutaneously. Twenty subjects were treated with PEG-Interferon lambda at dose levels up to 7.5 mcg/kg (n=17) or placebo (n=3). Administration of a single dose of PEG-Interferon lambda was associated with dose-related pharmacokinetic and pharmacodynamic effects and was well tolerated at biologically active doses. Evidence of biological activity, including up-regulation of interferon response markers, was seen starting at doses of 1.5 mcg/kg. These results suggest that antiviral activity against hepatitis C virus (HCV) might also be seen at these dose levels.
Overall, administration of PEG-Interferon lambda was well tolerated at doses up to 5 mcg/kg. No fever or hematologic effects were observed at any of the dose levels tested. The primary safety observations consisted of dose-related increases in liver transaminases without associated increases in bilirubin in a subset of patients treated at doses of 5 mcg/kg and higher, and minor decreases in fibrinogen not associated with bleeding or changes in platelet counts, all of which were reversible.
Results of the Phase 1a study with PEG-Interferon lambda were presented at the HEP DART 2007 meeting.
About PEG-Interferon Lambda
The native human protein interferon lambda is generated by the immune system in response to viral infection. It mediates antiviral activity through a receptor that is distinct from that used by interferon alpha and is generally present on fewer cell types within the tissues of the body. Receptors for interferon lambda are present on several important sites of viral infection, most notably cells of the lung and liver. ZymoGenetics' product candidate recombinant PEG-Interferon lambda has shown in vitro anti-viral activity against several viruses, including hepatitis C.
About Hepatitis C
Chronic infection with HCV is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma worldwide. In the United States, it is estimated that HCV is associated with up to 20,000 deaths per year, and is the main indication for liver transplantation. An estimated 4.1 million people in the United States have been exposed to HCV, and approximately 3.2 million have chronic HCV infection. Without effective intervention, the National Institutes of Health project that the number of deaths from chronic HCV infection may triple in the next 10-20 years.
Current Standard of Care for Hepatitis C
The current standard of care for chronic HCV infection involves treatment with interferon alpha and ribavirin. This form of HCV therapy has been associated with a number of significant side effects, including flu-like symptoms, anorexia, depression, hemolytic anemia and myelosuppression. This side-effect profile often necessitates additional medications to manage the side effects, and can lead to early discontinuation of treatment and poor adherence to prescribed therapy, leading to worsened treatment outcomes. Currently, the response rates for the most common form of HCV in the United States to standard treatment are only approximately 50%. There remains a need for better tolerated and more effective therapy for HCV infection. The development of PEG-Interferon lambda is intended to provide an alternative to interferon alpha.
About ZymoGenetics
ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The Company is developing a diverse pipeline of product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com .
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2006. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
Contact
ZymoGenetics, Inc.
Investor and Media Relations:
Susan W. Specht, MBA
Director, Corporate Communications
206-442-6592
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Study shows Hep C virus can be passed along by sharing crack pipe
http://ca.news.yahoo.com
By The Canadian Press
VICTORIA - There's new evidence that Hepatitis C virus can be passed among people sharing crack pipes.
The data comes from a new study of drug paraphernalia used by more than 50 crack users in Toronto which found evidence of the virus on the stems of crack pipes. Dr. Benedikt Fischer, director of the University of Victoria's Centre for Addictions Research, says the study affirms the risk that oral crack users can pass on Hepatitis C though risky methods.
B.C. Health Officer Dr. Perry Kendall says the study adds weight to the argument that Hepatitis C can be transmitted between crack smokers.
Kendall says it's unfortunate that the distribution of safer crack pipe kits has become controversial in some areas of the country, including Ottawa where one program was scrapped, and Nanaimo, B.C., where a similar program was put on hold this summer.
He said just like needle exchange programs, the pipe kits can help reduce the spread of infectious disease while reaching out to people to try to bring them back into the addictions treatment system.
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Common children's vaccine recalled
http://www.kentucky.com
By LINDA A. JOHNSON
AP Business Writer
TRENTON, N.J. --The recall of a routine vaccine for babies due to contamination risks could trigger a shortage and likely will alarm parents, but officials said there is no known health threat.
The recall announced Wednesday covers roughly 1.2 million doses of the vaccine against Hib, which causes meningitis, pneumonia and other serious infections [PedvaxHIB], and a combination vaccine for Hib and hepatitis B [Comvax]. The Hib vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.
Drugmaker Merck & Co. produces about half of the nation's annual supply of 14 million doses of Hib vaccine.
Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots.
"The potential for contamination of any individual vaccine is low," said Kelley Dougherty, a spokeswoman for the Whitehouse Station-based company.
Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.
"This is not a health threat in the short run, but it is an inconvenience," she said.
Barbara Kuter, Merck's head of pediatric medical affairs, told The Associated Press that the company will not be able to supply any vaccine for at least nine months.
"Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production next fall, she said.
"It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear.
Donna Cary, spokeswoman for Sanofi Pasteur, the only other company making the vaccine for the U.S., said it was too soon to say whether it can boost production. The company, a unit of Paris-based drugmaker Sanofi-Aventis SA, makes an Hib vaccine in France that is distributed both to the U.S. and other countries.
"We're looking at what we can add and we're working closely with the CDC on this," to see whether some vaccine could be shifted to the U.S. from other countries, Cary said.
Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.
It was unclear how many of the 1.2 million doses were administered to children.
The recalled doses, distributed beginning in April, are considered potent, so revaccinations won't be needed, Schuchat said.
Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, skin irritation around the shot site. Problems could be worse for children with weakened immune systems.
Any problems would have appeared within a week of vaccination, Schuchat said, and there have been no such reports.
The contamination was on unspecified equipment used in making the vaccine. Kuter said a sterility test during a routine evaluation of Merck's West Point, Pa., vaccine plant determined that the equipment was contaminated with a common bacterium called Bacillus cereus, or B. cereus.
It is a spore-making microorganism commonly associated with food poisoning and causes diarrhea and vomiting in people who eat contaminated foods.
The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection.
This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from some worried parents.
Merck is one of the few drugmakers that make vaccines. Company representatives could not immediately say how much revenue the Hib vaccine produces.
While the company took a black eye with its September 2004 withdrawal of painkiller Vioxx due to increased heart attack risk, it has been performing well recently. It gave an upbeat assessment Tuesday in its annual briefing for analysts.
Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.
Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well, and profits are up. Merck posted a 62 percent increase in its third-quarter profit as revenues jumped 12 percent.
The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines.
Merck shares fell 68 cents Wednesday to close at $59.72 before the recall announcement. The shares fell 12 cents in after-hours trading.
AP Medical Writer Mike Stobbe in Atlanta contributed to this report.
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December 13th, 2007
Novelos Therapeutics Concludes Nov-205 Hepatitis C Trial Based on Favorable Safety Profile
http://biz.yahoo.com
Plans to Initiate a Longer Proof-of-Concept Trial in 2nd Half of 2008
NEWTON, Mass.--(BUSINESS WIRE)--Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has concluded the initial U.S.-based double-blind, placebo-controlled Phase 1b trial evaluating NOV-205 as monotherapy in chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin. Based on favorable safety data in this 14-dose trial with 18 subjects (12 treated with NOV-205 and 6 with placebo), Novelos plans to initiate a longer proof-of-concept trial in hepatitis C non-responders in the second half of 2008.
NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties and, as such, likely requires dosing longer than 14 days to observe a clinical response. Its regulatory approval in the Russian Federation was based on a longer duration of dosing in treatment naïve hepatitis B and C patients (48 daily doses in the case of chronic disease) in which serum viral RNA levels were greatly reduced and serum biochemical markers of liver damage were significantly improved or normalized. NOV-205 was also well-tolerated in those studies. The next U.S.-based trial will aim to expand the safety database for NOV-205 and begin to assess its effects on similar efficacy-related endpoints that showed improvement in the Russian studies, although the trial will be conducted in a more difficult to treat hepatitis C non-responder population.
“We believe that the safety data from the Phase 1b trial support the initiation of a treatment regimen with NOV-205 that is more likely to result in demonstrable clinical activity as NOV-205 is not a direct anti-viral agent,” said Dr. Raymond Koff, Novelos’ expert Medical Advisor for hepatitis. “We look forward to evaluating NOV-205’s single agent activity in an extended dosing setting in chronic hepatitis C non-responders – a large patient population for which there is no established, beneficial therapy.”
The World Health Organization estimates that chronic hepatitis C affects 170 million people worldwide and up to four million people are newly infected each year. Chronic infection can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma. While there are varying estimates about the size of the global market for hepatitis C drugs, according to Nature Reviews Drug Discovery the current global market is believed to be in excess of $3 billion per year, growing to more than $8 billion by 2010. In the U.S., according to the Centers for Disease Control and Prevention, an estimated 3.9 million persons are infected with hepatitis C, and 2.7 million persons in the U.S. are chronically infected. Hepatitis C accounts for approximately 30,000 new infections and 8,000-10,000 deaths each year in the U.S.
The current standard-of-care drugs for chronic hepatitis C – the combination of pegylated interferon and ribavirin – are expensive, have significant toxicities, are difficult to tolerate for many patients and have limited long-term efficacy in genotype 1 patients (the most common HCV genotype seen in the U.S. and much of the world). Approximately 50% of the genotype 1 patients do not benefit from treatment with pegylated interferon plus ribavirin, and currently there is no approved standard of care to treat these non-responding chronic hepatitis C patients.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound currently in Phase 3 development for lung cancer under a SPA and Fast Track, acts together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is in addition being developed for acute radiation injury. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed. For additional information about Novelos please visit www.novelos.com
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
Contact:
Novelos Therapeutics, Inc.
Company
Harry S. Palmin, 617-244-1616 x11
President and CEO
hpalmin@novelos.com
or
Investor Relations
Stephen Lichaw, 201-240-3200
slichaw@novelos.com
Source: Novelos Therapeutics, Inc.
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Condoms proposed for Victorian prisoners
http://www.nzherald.co.nz
In a major policy reform, the Victorian government is considering giving the state's prisoners access to condoms.
The move comes after studies showed more than half of male prisoners in Victoria had hepatitis C, the Herald Sun reported, and would end an eight-year ban on condoms in jails.
Mr Brumby would not confirm the initiative, but a spokesman for Corrections Minister Bob Cameron said the government was exploring ways to introduce condoms to prisons.
"There are a number of practical and security issues that would need to be resolved before condoms could be introduced into the prisons," spokesman Alex Twomey said.
A working group led by Corrections Victoria and the Human Services Department was examining the spread of communicable diseases in prisons, he said.
"The government will consider any recommendations," he said.
Issues to be considered include how to provide condoms - vending machines failed in NSW when prison guards refused to stock them - and whether prisoners would have to pay for condoms.
Former premier Steve Bracks was opposed to providing condoms to prisoners, despite an election promise from the opposition and pressure from ombudsman George Brouwer to do so.
A 2002 study of Victorian prisoners found 55 per cent of male prisoners and 67 per cent of females tested positive for hepatitis C, compared to 1 per cent in the general population.
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Hepatitis C patients reject settlement
http://www.asahi.com
THE ASAHI SHIMBUN
OSAKA--Plaintiffs infected with hepatitis C through tainted blood products rejected the outline of a proposed court-mediated settlement for their group lawsuit Thursday.
In the settlement proposals, the Osaka High Court limited the legal responsibilities of the central government and the drug makers based on a Tokyo District Court ruling in March. In addition, not all of the plaintiffs would receive compensation under the proposal.
The plaintiffs are calling for compensation for all hepatitis C patients infected through tainted blood products.
According to the Tokyo court ruling, the government is responsible for infections through fibrinogen blood products between April 1987 and June 1988, while the makers, Mitsubishi Tanabe Pharma Corp. and its subsidiary, assume liability for patients given the contaminated products from August 1985 until June 1988.
The Osaka High Court on Thursday proposed paying settlement money to plaintiffs who were given tainted fibrinogen products between 1985 and 1988.
The court also proposed paying, in the form of legal expenses, plaintiffs not eligible for settlement money.
According to the proposed outline, patients who file suits in the future will be paid settlement money if they were administered risky blood products between 1985 and 1988.
The government will admit responsibility for the specified period and offer an apology.
The plaintiffs immediately refused the proposal, which narrows the scope of relief benefits more in line with the government's argument.
Quoting the Tokyo District Court ruling, the government had argued that almost all the hepatitis C infections before the specified period should be attributed to transfusion of contaminated blood.
The government had also insisted that a line should be drawn on patients eligible for the benefits out of fear that the number would grow endlessly.
The plaintiffs had argued that all the victims, including those who file suits in the future, should be eligible, regardless of the time they were administered risky blood products and the types of products they were administered.
The plaintiffs had said they would make concessions on the amount of compensation per patient if all the victims are included.
Since October 2002, a combined 204 plaintiffs filed suits at five district courts in Osaka, Tokyo, Fukuoka, Sendai and Nagoya.
The plaintiffs had expressed readiness to settle the court battles in the same terms as a possible court-mediated settlement at the Osaka High Court.
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Big jump in hepatitis C sufferers
http://www.channel4.com
The number of people newly diagnosed with hepatitis C jumped 10% in 2006, figures show.
There were 8,346 new cases in England in 2006, up from 7,580 in 2005, according to the Health Protection Agency (HPA).
Its report said increased awareness and testing of hepatitis C had contributed to the rise.
An NHS campaign resulted in the doubling of the number of visits to an NHS website (www.hepc.nhs.uk) and a dedicated hepatitis C information line, it added.
Dame Anita Roddick, who died in September aged 64, also raised awareness of the infection, the HPA said. She announced in February that she had contracted hepatitis C from a blood transfusion in 1971.
Hepatitis C is passed on through contact with infected blood and less commonly through other body fluids.
Symptoms can be mild or even non-existent for many years, meaning it can be decades before people are diagnosed. This has earned it the name the "silent epidemic".
Professor Pete Borriello, director of the HPA's Centre for Infections, said: "The improved public awareness we are seeing for hepatitis C represents a marked change to the position we were in just a few years ago.
"This is good news. The increase in testing and diagnosis of infection will enable more people to gain access to the appropriate treatment and help reduce some of the severe complications of hepatitis that can occur, such as liver cancer.
"However, there is no room for complacency. Despite the increase in awareness and diagnosis of hepatitis C, there is still some considerable way to go if the burden of this infection is to be reduced in the future."
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Ottawa mayor against crack pipe program despite hep C study
http://www.cbc.ca
CBC News
Research that found traces of the hepatitis C virus on a used crack pipe has not changed Ottawa Mayor Larry O'Brien's opposition to the city's former crack pipe program.
The study released this week by Dr. Benedikt Fischer of the University of Victoria showed it may be possible to pass hepatitis C from one crack smoker to another.
That was one situation that the Ottawa program tried to prevent by providing clean, rubber-tipped crack pipes to addicts until it was cancelled by city council in July
O'Brien said Friday he is "very open-minded in terms of scientific evidence," but would have to see data that suggest the city program caused addicts to avoid sharing crack pipes before he would change his mind.
"Based on what I've seen, based on what the police have told me, based on what I've been told by the crack addicts themselves, it isn't even in their mindset," he said while at a staff Christmas party at city hall.
However, he added there's no question in his mind that sharing crack pipes is dangerous.
Incidents of crack pipe sharing did fall after the Ottawa program began, according to a study by University of Ottawa researcher Lynne Leonard that was available online as a corrected proof in the International Journal of Drug Policy in May.
However, the mayor and some councillors dispute the study's findings.
The mayor has expressed his opposition to the program since he started running for office in the 2006 election campaign, saying that addicts need help, not supplies.
When council cancelled the program, at least one councillor argued there's no evidence the program did reduce the spread of disease and the program sent mixed messages, since people could be arrested for possessing crack.
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