From HIV and Hepatitis
Vertex Ends Clinical Trial of Dual Telaprevir plus VX-222 Regimen SUMMARY: Vertex Pharmaceuticals announced last month that it is discontinuing a clinical trial arm that was testing a 2-drug regimen of the hepatitis C virus (HCV) protease inhibitor telaprevir plus the HCV polymerase inhibitor VX-222, after preliminary results showed that people taking the dual combination were more likely to experience viral breakthrough. The company will continue to test telaprevir plus VX-222 in combination with pegyalted interferon/ribavirin and ribavirin alone.
No Tenofovir Resistance after 3 Years among Chronic Hepatitis B Patients SUMMARY: Tenofovir (Viread) remains active against hepatitis B virus (HBV) and is not prone to drug-resistance mutations even after 3 years of treatment, according to study results published in the December 22, 2010 advance online edition of Hepatology. Further data presented at a recent liver disease conference indicate that this still remains the case after 4 years.
Experts Devise Roadmap for Development of Direct-acting Hepatitis C Drugs SUMMARY: A group of medical experts, government regulatory officials, pharmaceutical company representatives, and patient advocates met in early December to discuss a promising new approach to hepatitis C treatment and produce a "roadmap" for development and implementation of direct-acting antiviral agents -- including how best to test and use these new drugs in combination regimens, and their use in children. The first agents of this type are expected to be approved in 2011.
From Medscape
Steady Hep C Mortality Rates Disappoint in Australia
Reuters Health Information, January 4, 2011
HCV -4 Spreads From Egypt and Africa Into Europe
Reuters Health Information, January 4, 2011
Nigeria: What to Know About Hepatitis B
Before blood transfusion is carried out on people, screening tests are done for the presence of certain diseases. Aside the Human immune-deficiency virus (HIV), the second most sought disease is hepatitis B. Some Health Experts say the risk of getting hepatitis from a blood transfusion is currently about 1 in 500,000 for hepatitis B and 1 in 30 million for hepatitis C. The chance of getting HIV or HTLV infection is about 1 in 5 million.
Ligand Licenses Liver Drug Candidates Bruce V. Bigelow
1/6/11 San Diego’s Ligand Pharmaceuticals said today it has licensed two liver drug candidates to Chiva Pharmaceuticals, a Los Altos Hills, CA, affiliate of Hainan Kaihua Pharmaceutical. Ligand says the deal, which gives Chiva rights to develop and market the drugs in China, could be worth more than $100 million in milestone payments and royalties. Ligand also has the potential to get a 10 percent stake in Chiva as well as sublicensing revenue. Ligand acquired drugs a year ago through its acquisition of Metabasis Therapeutics. One drug is a potential treatment for hepatitis B and the other is being tested as a treatment for hepatocellular carcinoma, the most common type of liver cancer.
Liver Cancer
Abnormal Cancer Rates at Fort Detrick Tied to Monsanto's Agent Orange
Tim King Salem-News.com
Monsanto's Agent Orange; the gift of death that keeps on killing... To learn more about Fort Detrick, visit: VeteransToday.com (BALTIMORE, Md.) - Deadly poisons at Fort Detrick in Frederick tied to Agent Orange and the Vietnam War period, have prompted public health officials in Maryland to warn that certain cancers are appearing to occur among younger people who live near the Army Base than in people statewide. Clifford Mitchell of Maryland's Department of Health and Mental Hygiene, told The AP Monday that investigators will probe deeper into the discrepancies involving liver, bone and endocrine cancers. Marked differences in liver cancer have been noted, and health experts in Maryland as well as the EPA, say the matter needs substantial further investigation.
Alnylam presents ALN-VSP phase I liver cancer trial results
Friday, January 07, 2011 16:00 IST Cambridge, MassachusettsAlnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, presented new clinical data from its ALN-VSP phase I liver cancer trial in a presentation at the Dana-Farber Cancer Institute in Boston. Results from molecular analysis of human biopsy samples showed achievement of pharmacologically relevant siRNA drug levels in tissues. In addition, using a highly precise polymerase chain reaction (PCR)-based technique known as 5'- rapid amplification of cDNA ends (5'-RACE), analysis of human tissue samples showed proof of RNAi-mediated target mRNA cleavage, and thus RNAi in man with the systemically delivered RNAi therapeutic. These results provide significant human proof of concept for Alnylam's efforts in advancing RNAi therapeutics to patients."These data provide conclusive evidence that RNAi can be harnessed in man and, as such, represent a notable and important milestone in the advancement of RNAi therapeutics as a potential new class of medicines," said Phillip Sharp, Ph.D., Institute Professor, The Koch Institute for Integrative Cancer Research, MIT, and Chairman of Alnylam Scientific Advisory Board and Alnylam Director. "I applaud Alnylam scientists, clinicians, and their collaborators for reaching this important achievement and I look forward to the results of their continued efforts."
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HIV
From HIV and Hepatitis
Does Nevirapine Lower Viral Load More than Efavirenz? SUMMARY: Among the non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs, nevirapine (Viramune) may be able to reduce plasma HIV viral load to a lower level than efavirenz (Sustiva, also in the Truvada and Atripla combination pills), according to a French study described in the December 13, 2010 advance online edition of AIDS. Both drugs suppress virus to undetectable levels using standard tests, but people taking nevirapine were more likely to reach a level below 1 copy/mL.
SUMMARY: A novel type of HIV entry inhibitor dubbed VIR-576, which blocks HIV's ability to insert its gp41 fusion peptide into the outer membrane of a host cell, demonstrated promising safety and efficacy in a small clinical study published in the December 20, 2010 issue of Science Translational Medicine. VIR-576 did not show cross-resistance with other antiretroviral drugs -- including other entry inhibitors -- and is unlikely to promote resistance itself, according to study investigators
Risk Factors for Cancer Mortality among People with HIV SUMMARY: HIV positive people on antiretroviral therapy are more likely to die after cancer diagnosed if they have poor immune function as indicated by a low CD4 T-cell count or are unable to achieve undetectable viral load, according to a study published in the December 14, 2010 advance online edition of AIDS. Regular cancer screening starting at a younger age and prompt treatment could help improve survival in this population, investigators advised.
SUMMARY: The U.S. Food and Drug Administration (FDA) recently approved new dose regimens for 2 widely used antiretroviral drugs. The protease inhibitor darunavir (Prezista), boosted with ritonavir, is now approved for once-daily dosing for treatment-experienced adults with HIV who have no known pre-existing darunavir-associated resistance mutations. The agency also approved a 200 mg formulation of the NNRTI etravirine (Intelence), allowing patients to take fewer pills at a time.
SUMMARY: ViiV Healthcare -- the HIV specialty company formed by GlaxoSmithKline and Pfizer -- announced this week that it will now participate in the Welvista program, a collaborative initiative to provide antiretroviral medications to low-income people on AIDS Drug Assistance Program (ADAP) waiting lists, which are growing in several states in the wake of the ongoing financial crisis.
From NATAP
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OraSureTechnologies A Pennsylvania biotech company is currently awaiting FDA approval for the first ever over-the-counter HIV test. In just 20 minutes, the test will reveal whether a person has contracted the virus. No health clinics or hospitals. No agonizing waiting for lab results. Today, the product is only used in medical labs. But OraSure is working with the FDA to gain approval for use in the field by minimally trained staff. An application for over-the-counter sale could be next. Continue reading.... Transplants LifeCycle Pharma Announces Positive Results Of Phase 2 Clinical Trial For LCP-Tacro™ In De Novo Liver Transplant Patients 07 January 2011LifeCycle Pharma A/S (OMX: LCP) has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules...
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Protect yourself against hepatitis A By DR. DAN BRENNAN -- JAN. 7, 2011 The virus known as hepatitis A has been in the news this week after several hundred parishioners were exposed to the germ at a religious service in New York State. Hepatitis A, often contracted through eating or drinking contaminated food or water, is a vaccine preventable disease often confused with other types of hepatitis viruses.
Healthy You If I Had....... Friday Previously on the blog we posted a weekly video in a series deemed "If I Had." These videos cover numerous disorders and diseases. Physicians share what they would do "IF they Had..." the disease in the topic video.
Today the topic is:
If I Had - A Recurring Cough - Dr. Jennifer Temel, MD
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Visit Insider Medicine
Hospital Rankings Stumble on Data Reliability
2 hours ago Hospital quality-of-care score cards are only as reliable as the data that go into them, researchers cautioned in a study pointing to substantial statistical "noise" disrupting comparisons in vascular surgery.
FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies
January 2011 09:48 GA_googleFillSlot("NewsMedicalSquares"); Bristol-Myers Squibb Company (NYSE: BMY), and AstraZeneca (NYSE: AZN) today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States. KOMBIGLYZE XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).
Recalled Antibiotic Maker Recalls Underweight Tablets
Teva Pharmaceuticals has issued a recall for a single lot of 250 mg metronidazole tablets because some of the pills may not contain the proper amount of the active ingredient.
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January 06, 2011
January 05, 2011 -
January 05, 2011 -
Of Interest
Facts Cancer Nanotechnology
December 3, 2010
BY WILLIAM G. GILROY (PhysOrg.com) -- Research directed by Basar Bilgicer, assistant professor of chemical and biomolecular engineering and a member of the Advanced Diagnostics and Therapeutics initiative at the University of Notre Dame, could one day enable clinicians to deliver powerful chemotherapy drugs to tumors without deleterious side effects.
Although chemotherapeutic agents are poisonous to tumors, they also can kill healthy cells, leading to toxic side effects. Bilgicer’s research involves developing drug- loaded nanoparticles to target the tumor tissue, so that the chemotherapeutic agents can be delivered specifically to the tumors rather than healthy tissue..
Chimerix Commences CMX001 Open-Label Clinical Study for the Treatment of Patients With Life-Threatening or Serious dsDNA Viral Infections
New Expanded Access Study Builds on CMX001 Emergency IND and Clinical Experience Chimerix, Inc. January 7, 2011 8:37am EST
RESEARCH TRIANGLE PARK, N.C., Jan. 7, 2011 — /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that patient enrollment has begun in a multicenter, open-label clinical study of CMX001 (the CMX001-350 study) for the treatment of life-threatening or serious conditions caused by double-stranded DNA (dsDNA) viruses.
Under the expanded-access protocol developed in conjunction with the U.S. Food and Drug Administration (FDA), patients will receive treatment with CMX001 for any of 12 different dsDNA viral infections, including adenovirus (AdV), herpes viruses (cytomegalovirus (CMV), herpes simplex virus (HSV) and Epstein Barr virus), polyoma viruses (BK virus and JC virus), and pox viruses. The CMX001-350 study will enroll 200 patients at major medical centers primarily in the United States.
MX001 is being developed by Chimerix for dual-use as a broad-spectrum antiviral for the treatment of life-threatening viral infections in immunocompromised patients and as a medical countermeasure in the event of a smallpox outbreak. Chimerix is currently conducting a Phase 2 dose-defining clinical study of CMX001 in immunocompromised hematopoietic stem cell transplant patients at risk of life-threatening infection with CMV, which has enrolled over 130 patients. Additionally, the Company is initiating a Phase 2 clinical study in immunocompromised pediatric and adult hematopoietic stem cell transplant patients with AdV infections. "Data from this open-label clinical study will be a critical component of our strategy to develop CMX001 as a broad-spectrum antiviral agent," said Kenneth I. Moch, President and CEO of Chimerix. "We anticipate that the CMX001-350 study will provide important supportive data for our overall clinical development program."
"CMX001 is exhibiting a favorable tolerability profile and signs of potent antiviral activity across our clinical studies, including the more than 130 Emergency INDs requested by leading investigators," said Wendy Painter, M.D., M.P.H., Chief Medical Officer of Chimerix. "The demand for CMX001 to treat life-threatening infections continues to grow among the clinical community, and we are extremely proud to provide CMX001 under this open-label study."
CMX001-350 Open-Label Study Design
he primary objective of the multicenter open-label study of CMX001 is to provide CMX001 to patients with immediately life-threatening or serious disease caused by any of 12 different viral infections resulting from dsDNA viruses. The open-label study is expected to enroll 200 infected adult and pediatric patients. Critically-ill patients expected to enroll in this study in the highest numbers include immunocompromised patients suffering from a variety of dsDNA infections, particularly patients undergoing solid organ transplant or hematopoietic stem cell transplant. However, the study is intended for any patient with a serious dsDNA viral disease for whom no satisfactory alternate therapy is available and who does not qualify for other CMX001 clinical studies.(1)
The study will evaluate the safety, tolerability and antiviral activity of CMX001. Researchers will also evaluate the activity of CMX001 through changes in clinical signs and symptoms of infection. Patients will receive CMX001 orally twice weekly for up to three months, and treatment may be extended for up to six months depending on the patient's clinical response. Antiviral activity will be measured by changes in viral burden from baseline in an individual patient's condition and across all patients with a given dsDNA virus. Drug pharmacokinetics and any potential signs of drug resistance will also be assessed.
The clinical design parameters of the CMX001-350 study were based in large part on Chimerix's experiences providing CMX001 to patients under investigator-held Emergency Investigational New Drug applications (EINDs). At the request of leading physicians, Chimerix has to date provided CMX001 to more than 130 patients under EINDs or foreign equivalent at over 45 medical centers in the United States, Canada, Europe and Israel. CMX001 has been used for the treatment of life-threatening dsDNA infections where either there are no FDA-approved treatments or the patients have failed the available treatments. Patients treated with CMX001 have had infections from all five classes of dsDNA viruses that infect humans, including AdV, herpes viruses such as CMV, HSV and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses. Data from these EIND experiences have been recently reported in a number of publications and medical conferences, and are available on the Chimerix website at http://www.chimerix.com/.
Additional information on study objectives, enrollment criteria and patient eligibility for the CMX001-350 study is available at http://www.clinicaltrials.gov/.
About Chimerix Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. The company's lead candidate, CMX001, is being developed as a potential broad-spectrum antiviral agent for the treatment of life-threatening dsDNA viral diseases. Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of cytomegalovirus (CMV) in hematopoietic stem cell transplant patients (CMX001-201), a Phase 2 study being initiated for the treatment of adenovirus (AdV) infection in pediatric and adult hematopoietic stem cell transplant patients (CMX001-202), and an Open-Label Study (CMX001-305) for the treatment of any of 12 different dsDNA viral infections, including AdV, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses. Over 325 people have received CMX001 to date, including over 130 patients treated under Emergency INDs. CMX001 has been well tolerated in all studies, with a growing body of evidence of the compound's antiviral activity in humans. CMX001 is also being developed as a medical countermeasure in the event of a smallpox outbreak. Chimerix has received significant funding from the National Institute of Allergy and Infectious Disease to develop CMX001 for smallpox. Chimerix's second clinical-stage antiviral compound CMX157, a potent nucleoside analogue with activity against HIV and hepatitis B, is in development for the treatment of HIV infection including those caused by multi-drug resistant viruses. CMX157 has completed Phase 1 clinical studies demonstrating that the compound is well tolerated and that the active antiviral, TFV-PP, was measurable in peripheral blood mononuclear cells (PBMCs) after a single dose and remained detectable for six days, suggesting the possibility of a convenient, once-weekly dosing regimen. CMX157's promising safety profile and efficient conversion to the active drug in PBMCs, coupled with the potent in vitro antiviral activity across diverse drug-resistant strains of HIV, indicate that this compound may directly address several limitations of current HIV therapies. Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com/.
(1) Code of Federal Regulations, Title 21, Revised April 2010 SOURCE Chimerix, Inc.
Read more: http://www.centredaily.com/
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