(Press-News.org) Early results of a trial to treat leukaemia with a WT1 DNA vaccine, has shown robust vaccine-specific antibody responses in all vaccinated patients evaluated to date.
Furthermore, T cell immune responses, including those of the "killer T cells," were detected. Antibody and T cell responses are strong signals of the DNA vaccine's potential to treat the disease.
Presented at the DNA Vaccines 2012 conference in California by Christian Ottensmeier, the trial's principal investigator and Professor of Experimental Cancer Research at the University of Southampton, these interim results, from eight patients, are part of a phase II trial that will enroll 31 patients in its chronic myelogenous leukaemia (CML) arm.
To date, 14 CML patients have been enrolled while another 13 unvaccinated CML patients have been enrolled to serve as a control group. The vaccine has been shown to be safe overall and well-tolerated in the trial subjects. A detailed analysis of T cell immune responses as well as the impact of the vaccination on the molecular marker, BCR-ABL, which is a specific chromosomal abnormality that is associated with CML disease, will be performed during the trial.
As a result of the favourable safety and immunogenicity profiles observed in the CML vaccinated group, the trial is now open to enroll the acute myeloid leukaemia (AML) clinical trial arm, with a total target of 37 subjects in each of the vaccinated and control groups.
Professor Ottensmeier comments: "These preliminary data show strong vaccine-induced immune responses in vaccinated subjects in the CML arm. We are looking forward to enrolling and testing the vaccine's impact in AML patients, who currently have limited treatment options and a low rate of progression free survival."
This open-label, multi-center phase II clinical trial is evaluating a DNA vaccine-based immune therapy to treat these two types of leukaemia. The DNA vaccine, developed by the University of Southampton, is delivered using Inovio Pharmaceuticals, Inc proprietary electroporation technology. The trial is funded by research charity Leukaemia and Lymphoma Research (LLR) and the National Institute for Health Research Efficacy and Mechanism Evaluation Programme.
Leukemia is a cancer of the bone marrow and blood that accounts for at least 300,000 new cases and 222,000 deaths worldwide each year - a very high death rate. Wilms' Tumor gene 1 (WT1) is highly associated with these types of cancer. Preclinical data from mice showed strong induction of antigen-specific CD8+ T cells and the ability to kill human tumor cells expressing WT1. This is the first study to combine DNA vaccination with electroporation delivery of WT1 antigens with the goal of stimulating high and durable levels of immune responses, in particular T cells, which are considered critical for improving clinical outcomes for this disease.
In this ongoing phase II trial, all participants initially receive six doses of two DNA vaccines (called p.DOM-WT1-37 and p.DOM-WT1-126) delivered at four week intervals. Vaccine responders may continue with booster vaccinations every three months out to 24 months. An additional 60 to 75 AML/CML patients are being enrolled across the two arms as non-vaccinated controls for comparison. The primary endpoints are molecular response to a disease marker called BCR-ABL in CML patients and time to disease progression in AML patients. The study is also monitoring WT1 transcript levels, immune responses to the WT1 antigen, time to progression and overall survival, and two-year survival in the AML group. The trial is taking place at hospitals in Southampton, London and Exeter.
Inovio's CEO, Dr. J. Joseph Kim, adds: "We are encouraged by preliminary phase II data showing a WT1 DNA vaccine's potential, administered with our novel delivery technology, to generate T cells and robust antibodies to treat leukemia. These results follow on our recent scientific breakthrough represented by our human data showing the powerful killing effect of T cells generated by our cervical dysplasia therapeutic vaccine."
### END
Winning the battle against leukaemia: Positive early results in clinical trial for DNA vaccine
2012-12-07
ELSE PRESS RELEASES FROM THIS DATE:
Rilpivirine for HIV: Added benefit for single agent proven
2012-12-07
Since the start of 2012, a new drug called rilpivirine has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1). It is marketed by two different pharmaceutical companies, by one as a single agent (trade name Edurant®) and by the other as a fixed combination with other HIV drugs (trade name Eviplera®). In two early benefit assessments pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has investigated whether the two new drugs have advantages ...
High hormone levels put young black males at risk for cardiovascular disease
2012-12-07
AUGUSTA, Ga. – Increased levels of the hormone aldosterone in young black males correlate with an unhealthy chain of events that starts with retaining too much salt and results in an enlarged heart muscle, researchers say.
The findings indicate physicians may want to reach for aldosterone inhibitors early in their effort to control blood pressure and reduce cardiovascular risk in young black males.
Their studies of a cohort of 191 healthy black and white 15- to 19-year-olds showed that only in the black males was higher aldosterone associated with impaired sodium excretion, ...
A pattern given by nature
2012-12-07
A new plant-parasitic nematode worm (Meloidoderita salina) was found in a tidal salt marsh at Mont Saint Michel Bay (MSMB) in France, where its abbey is a world-famous historical heritage. The species name 'salina' refers to salty soil and is derived from the Latin word 'sal' or 'salis' meaning 'salt'. The study was published in the peer-reviewed, open source scientific journal ZooKeys.
The female nematode worm of Meloidoderita salina deposits its eggs in two different structures. One of them is called egg mass which is an external gelatinous matrix, the other one is ...
Monkey business: What howler monkeys can tell us about the role of interbreeding in human evolution
2012-12-07
ANN ARBOR—Did different species of early humans interbreed and produce offspring of mixed ancestry?
Recent genetic studies suggest that Neanderthals may have bred with anatomically modern humans tens of thousands of years ago in the Middle East, contributing to the modern human gene pool. But the findings are not universally accepted, and the fossil record has not helped to clarify the role of interbreeding, which is also known as hybridization.
Now a University of Michigan-led study of interbreeding between two species of modern-day howler monkeys in Mexico is shedding ...
Vanderbilt study finds diverse genetic alterations in triple-negative breast cancers
2012-12-07
Most triple-negative breast cancer patients who were treated with chemotherapy to shrink the tumor prior to surgery still had multiple genetic mutations in their tumor cells, according to a study by Vanderbilt-Ingram Cancer Center (VICC) investigators.
Finding multiple mutations instead of just one primary mutation that can be targeted for therapy sheds more light on the challenges of treating triple-negative breast cancer.
The study, led by Justin Balko, Pharm.D., Ph.D., and research faculty in the laboratory of Carlos Arteaga, M.D., director of the Breast Cancer Program ...
Abuse during childhood linked to adult-onset asthma in African-American women
2012-12-07
(Boston) – According to a new study from the Slone Epidemiology Center (SEC) at Boston University, African-American women who reported suffering abuse before age 11 had a greater likelihood of adult-onset asthma compared to women whose childhood and adolescence were free of abuse.
The study, which is published online in the Journal of Allergy and Clinical Immunology, was led by Patricia Coogan, DSc, senior epidemiologist at SEC and associate professor of epidemiology at the Boston University School of Public Health.
This study followed 28,456 African-American women, ...
Can compressed fluids increase enzyme activity in industrial bioprocesses?
2012-12-07
New Rochelle, NY, December 6, 2012—Enzymes play a crucial role as biocatalysts, increasing the speed and efficiency and decreasing the energy consumption of biochemical reactions in many industrial processes. The advantages of using compressed propane to enhance the biocatalytic activity of an industrial enzyme are described in an article published in Industrial Biotechnology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com). The article is available free on the Industrial Biotechnology website (http://www.liebertpub.com/ind). ...
Penn-led research suggests a new strategy to prevent or halt periodontal disease
2012-12-07
PHILADELPHIA — Periodontitis, a form of chronic gum disease that affects nearly half of the U.S. adult population, results when the bacterial community in the mouth becomes unbalanced, leading to inflammation and eventually bone loss. In its most severe form, which affects 8.5 percent of U.S. adults, periodontitis can impact systemic health.
By blocking a molecular receptor that bacteria normally target to cause the disease, scientists from the University of Pennsylvania have now demonstrated an ability in a mouse model to both prevent periodontitis from developing and ...
Serious acute kidney injury: More common than ever
2012-12-07
Highlights
The incidence of the most severe form of acute kidney injury has increased 10% per year on average over the past decade.
Deaths associated with the condition have doubled during that time.
Washington, DC (December 6, 2012) — Acute kidney injury (AKI), an abrupt or rapid decline in kidney function, is a serious and increasingly prevalent condition that can occur after major infections, major surgery, or exposure to certain medications. The incidence rates of the most serious form of AKI—which requires dialysis—increased rapidly in all patient subgroups ...
Drought in the Horn of Africa delays migrating birds
2012-12-07
The catastrophic drought last year in the Horn of Africa affected millions of people but also caused the extremely late arrival into northern Europe of several migratory songbird species, a study from University of Copenhagen published today in Science shows. Details of the migration route was revealed by data collected from small back-packs fitted on birds showing that the delay resulted from an extended stay in the Horn of Africa.
The extensive 2011 drought in the Horn of Africa had significant consequences for European songbirds such as thrush nightingale and red-backed ...