Phase II hepatitis C clinical trial starts
Ribozyme Pharmaceuticals has begun a multicenter Phase II clinical trial using Heptazyme for treating patients with chronic hepatitis C.
Heptazyme, a direct anti-viral therapeutic engineered to target the hepatitis C virus, has shown potent anti-viral activity in pre-clinical models. The study will evaluate Heptazyme’s safety and efficacy when administered alone and in combination with interferon.
"Whether as monotherapy or in combination with interferon, Heptazyme offers significant promise for the four million Americans we believe to be infected with this deadly disease,” said principal investigator Myron Tong, M.D., Ph.D, chief of the Liver Center at Huntington Medical Research Institute in Pasadena, Calif., and professor of medicine at the University of Southern California. “It offers a potentially exciting treatment advance over presently available therapies due to the drug’s high degree of specificity and anticipated low side effect profile."
Additional investigators include Dr. Gregory T. Everson at the University of Colorado Health Sciences Center, Dr. Ira Jacobson at Cornell University Medical Center, New York Presbyterian Hospital, Dr. Donald Jensen at Rush-Presbyterian-St. Luke’s Medical Center, Dr. John McHutchison at Scripps Clinic and Dr. Eugene Schiff at the University of Miami School of Medicine.
The World Health Organization estimates that approximately 125 million people worldwide are infected with the hepatitis C. Currently treatments are effective in up to 50 percent of patients, leaving a significant number with no therapy. Current therapies often are associated with serious side effects.
|Vaccine may fight cervical cancer
A genetically engineered vaccine appears to direct the immune system to kill tumors caused by human papillomavirus 16 (HPV-16) report researchers from the University of Pennsylvania and Johns Hopkins University. Their research appears in the October 2001 issue of the Journal of Virology.
HPV-16, one of the most common sexually transmitted diseases, is associated with most cervical cancers. A protein known as E7 is believed to be required for tumor formation.
The researchers developed a vaccinia virus genetically altered to express E7 as a potential treatment. Using the genetically altered virus as a vaccine, they believed they could stimulate the immune system to attack and kill tumor cells.
In the study, half the mice treated with the vaccinia virus were tumor-free two months after inoculation.
Bacteria test for platelets may make blood safer
Doctors at University Hospitals in Cleveland released the results of an investigation of a new method to detect bacterial contamination in blood platelets at the annual meeting of the American Association of Blood Banks in San Antonio, Texas in October. They found that the Pall BDS, a detection device in development, was able to detect all the bacteria studied.
Roslyn Yomtovian, M.D., director of University Hospitals’ Blood Bank and Transfusion Medicine Service and lead investigator, said that bacteria are the most common infectious agents transmitted by blood and are a far greater threat to public health than viruses such as HIV and hepatitis. The transfusion risk for acquiring such viruses has greatly diminished due to improvements in blood donor screening technology.
“With 9 million platelet units and 12 million red blood cell units transfused in the United States every year, at least 3,000 transfusions, primarily platelets, are contaminated with bacteria and cause severe illness or death for hundreds of patients across the country,” said Yomtovian. Platelets are particularly vulnerable to bacterial contamination because they must be stored at room temperature.
Yomtovian and pathologists Michael R. Jacobs, M.D., and Elizabeth Palavecino, M.D., studied the Pall BDS. The system measures oxygen in a sample obtained from a platelet unit. Because bacteria consume oxygen, abnormally low levels of oxygen in the platelet sample indicate the presence of bacteria, resulting in contaminated platelets being detected and discarded.
The investigators evaluated the bacterial species (both gram positive and gram negative) that represent over 98 percent of the deaths resulting from bacterially contaminated platelets. In all cases, the Pall BDS detected bacterial contamination of the platelets (100% sensitivity) after 30 hours of incubation. No false positives were reported.
“Bacteria can be present in platelets in very low number and different strains can multiply at different rates, thereby making detection difficult,” Jacob said. “That is why this method holds so much promise. If blood banks have the technology to detect bacteria before platelets are used for transfusion, it follows that fewer patients will receive contaminated blood and develop an illness.”
Transfused platelets can be contaminated from a variety of sources including the donor’s own blood and the equipment used. The contamination most often occurs during the collection process. Yomtovian said that bacteria present on the skin of most healthy people may enter the blood during the donation process. No matter how much disinfectant is applied to the skin, it cannot be completely sterilized and some bacteria remain.
|Lupus gene discovered
Researchers at the University of Colorado Health Sciences Center have made the first identification and description of a gene that increases the risk of systemic lupus erythematosus (lupus). In an article published in the September issue of Immunity, the researchers discuss their generation of a specially bred mouse model to map and study genes that may predispose people to develop lupus.
New Zealand mice show features identical to patients with lupus and are considered by many researchers to be an excellent model of the human disease. The CU team isolated chromosome regions from these mice that cause lupus. Molecular studies then implicated interferon-inducible gene, Ifi202, as a likely candidate for a genetic factor that increases the risk of disease.
"Although heredity is key to the development of lupus, many genes are involved and it is a complex process. We believe that this is one piece of the puzzle," said Brian Kotzin, MD, chief of the Division of Clinical Immunology and director of the Autoimmunity Center
of Excellence at the CU-Health Sciences Center.
Kotzin, principal investigator of this study, worked closely with Stephen Rozzo, PhD, assistant professor of immunology at CU, to implicate Ifi202 as the disease gene.
Lupus is an autoimmune disease, where the body’s immune system, instead of fighting off infection, begins to attack the body itself. Its name comes from the skin rash that can occur on the face of afflicted individuals. Arthritis also is common with the disease, but lupus frequently attacks internal organs, especially the kidneys, which makes it extremely dangerous.
|Gentra Systems is Tekne award finalist
Minneapolis-based Gentra Systems has been named a finalist for the 2001 Tekne Award for Innovation – Life Sciences presented by the Minnesota High Tech Association and Minnesota Technology, Inc.
Gentra is a privately held company that develops nucleic acid purification kits and instrumentation. Its products include purification chemistries PureGene, PureScript and Generation as well as the AutoPure, the only instrument capable of purifying DNA from large clinical samples up to 10 mL in size.
The Tekne Awards are presented to technology innovators who have made lasting contributions to enhancing the quality of life and competitiveness of Minnesota. Companies, individuals, city officials, associations and organizations were asked to suggest innovative technologies, leaders, products and processes and identify the individuals behind them.