Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate
Lyon (France), December 9, 2016 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines, today announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).
Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection that can cause serious health problems and disabilities. Each year, an estimated 300,000 Americans and 85,000 Europeans develop Lyme disease and according to the CDC (Centers for Disease Control and Prevention), it is the fastest growing vector-borne infectious disease in the United States.
Read the rest of the story:
https://www.ncbi.nlm.nih.gov/pubmed/9829450
Clin Ther. 1998 Sep-Oct;20(5):993-1008; discussion 992.
A cost-of-illness study of Lyme disease in the United States.
Erratum in
Clin Ther 1999 Feb;21(2):430.
Abstract
Lyme disease produces a diverse clinical picture that can include serious and potentially debilitating cardiac, neurologic, joint, and skin involvement. It is characterized in three stages--early localized (stage I), early disseminated (stage II), and late disseminated (stage III)--and medical management is highly dependent on the stage at which the patient presents and the physician's awareness of available treatment options. This study was conducted to establish the medical and economic burden of Lyme disease in the overall US population, which included determining its endemicity in high-risk states and counties, describing current treatment patterns, measuring direct and indirect costs, and defining the cost burden by age group (<18 years and > or =18 years of age). Medical, epidemiologic, and economic data were collected, and an algorithm was developed representing the natural course of Lyme disease and the progress of health states over time following medical intervention. Using an annual mean incidence of 4.73 cases of Lyme disease per 100,000 population in the decision analysis model yielded an expected national expenditure of $2.5 billion (1996 dollars) over 5 years for therapeutic interventions to prevent 55,626 cases of Lyme disease sequelae. This estimate included both direct medical and indirect costs. However, there is evidence of considerable variation in incidence within states. Our findings support development of vaccination strategies for specific target groups.
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I found some additional data from the study…these costs were based on 1996 values
The treatment costs for early disseminated disease accounted for 36% of the total direct costs and 64% spent of antibiotic treatments as well as treatment of side effects.
With the costs of late disseminated disease, the values were reversed,
roughly 2/3rds spent on treatment of the manifestations.
Early disseminated disease cost from:
$731/per patient/per year for arthritis to
$3,445/patient/year for cardiac sequelae
Costs for late disseminated:
Musculoskeletal complications $2740/patient/year and
cardiac complications came to $8270/patient/year
The Bacillus Subtilis Story:
Excerpt:
"For many years afterwards, cultures of Bacillus subtilis were sold worldwide as a medicinal product (sold in the U.S. and Mexico, for example, under the brand name Bacti-Subtil) rapidly becoming the world's leading treatment for dysentery and other intestinal problems. Unfortunately for Americans, this popular bacterial supplement that cures intestinal infections began losing favor in the late 1950's and 1960's, upon the advent of synthetic antibiotics which were heavily touted by the giant pharmaceutical companies as "wonder drugs," even though they cost five times as much as Bacti-Subtil, and took three times longer to accomplish the same results."
Read more:
http://morrigandunn.blogspot.com/2010/04/bacillus-subtilis-story-when-arabs-ate.html
Probiotic containing Bacillus subtilis: Bio-Identical SBO Probiotics Cosortia
Lyme disease is exceedingly difficult to treat, due to its well-known shape-shifting (pleomorphic) abilities, with conventional antibiotics often failing to produce a long-term cure. Could the commonly used natural plant Stevia provide a safer, and more effective means to combat this increasingly prevalent infection?
A promising new preclinical study has revealed that whole stevia leaf extract possesses exceptional antibiotic activity against the exceedingly difficult to treat pathogen Borrelia Burgdorferi known to cause Lyme disease. The study found...
The discovery of the size and complexity of the human microbiome has resulted in an ongoing reevaluation of many concepts of health and disease, including diseases affecting the CNS. A growing body of preclinical literature has demonstrated bidirectional signaling between the brain and the gut microbiome, involving multiple neurocrine and endocrine signaling mechanisms. While psychological and physical stressors can affect the composition and metabolic activity of the gut microbiota, experimental changes to the gut microbiome can affect emotional behavior and related brain systems. These findings have resulted in speculation that alterations in the gut microbiome may play a pathophysiological role in human brain diseases, including autism spectrum disorder, anxiety, depression, and chronic pain. Ongoing large-scale population-based studies of the gut….
Because of CDC policy failures, mismanagement and violations of federal law, hundreds of thousands of Lyme patients experience a greatly diminished quality of life—a tragedy compounded by financial hardships from out-of-pocket costs and lost income. The burden on individuals as well as on our economy is enormous, the suffering is widespread and much of this is preventable.
A D.C. based citizens action group wants the Centers for Disease Control (CDC) in Atlanta to change its stance on the treatment of Lyme disease in the United States.
The Patient Centered Care Advocacy Group filed a "citizen petition" with the Centers for Disease and Control Prevention calling on it to end the preferential treatment it extends to the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of Lyme disease. The petition was filed in accordance with the Administrative Procedure Act (APA), which governs the conduct of the federal government.
According to the petition, the CDC....
Here is an example of ongoing work on stem cell transplants for the treatment of Parkinson's disease, in which the proximate cause of the condition is an accelerated age-related loss of a small but vital population of dopamine-generating neurons in the brain. Similar transplant therapies have been tested in a number of species, and in human patients over the past decade, but there is a great variety of possible cell sources and methodologies of treatment. Progress towards a standardized therapy emerging from all of this has been frustratingly slow.
Human parthenogenetic stem cells, derived from unfertilized oocytes, can be used to generate unlimited supply of neural stem cells for transplantation. Researchers testing the potential of cell therapy for treating Parkinson's disease (PD) has found that grafting human parthenogenetic stem cell-derived neural stem cells (hpNSCs) into non-human primates modeled with PD promoted behavioral recovery, increased dopamine concentrations in the brain, and induced the expression of beneficial genes and pathways when compared to control animals not transplanted with stem cells.
The researchers also reported that the intracerebral injection and transplantation of hpNSCs was "safe and well-tolerated" for the two transplantation test animal groups with moderate to severe PD symptoms. "Previous clinical studies have shown that grafted fetal neural tissue can achieve considerable biochemical and clinical improvements in PD, however the source of fetal tissue is limited and may sometimes be ethically controversial. Human parthenogenetic stem cells offer a good alternative because they can be derived without destroying potentially viable human embryos and can be used to generate an unlimited supply of neural cells for transplantation."
PD is characterized by a profound loss of function of the brain's basal ganglia, resulting in a loss of dopamine neurons. Experiments using stem cells have offered benefits in pre-clinical studies, but have also provided "a wide variety of patient outcomes." This study used hpNSCs because the cells demonstrate characteristics of human embryonic stem cells, but are not sourced from viable embryos, which may be destroyed in the process. Previous studies with hpNSCs had shown that the cells could also be "chemically directed" to differentiate into multipotent neural stem cells and were able to be frozen for future use. While the study was designed to determine whether the test animals showed greater improvement than the control group, researchers added that a longer outcome period than 12 months may have demonstrated continued improvement and divergence from controls.
Can genetically engineered mice save Nantucket from the scourge of Lyme disease?
If the 10,000 residents of the island off Massachusetts didn't have such a soft spot for deer, they might not be entertaining the prospect, which could provide the groundwork for an even more exotic approach to controlling tick-borne diseases on the mainland.
But popular opinion has long opposed public health officials' recommendation of radically reducing the population of deer serving both as a food source for tickscarrying the Lyme pathogen and a convenient place for adult females to lay their eggs.
"The people who get sick yell and scream at me for not doing anything about it,'' said Malcolm MacNab, chairman of the Nantucket Board of Health, "and the others yell and scream at me because I want to kill the deer." Dr. MacNab said nearly 40 percent of Nantucket residents have had Lyme disease.
So when he heard that Kevin Esvelt, an evolutionary biologist at the Massachusetts Institute of Technology, wanted to gauge the island's interest in a new approach, he invited the scientist to present it at a public meeting on Monday.
Although deer help spread ticks that carry Lyme, Dr. Esvelt explained to about two dozen residents at yesterday's meeting, the disease can also be controlled earlier in the tick's food chain. Ticks typically contract the pathogen from white-footed mice, which they often feed on while still larvae, passing it on to humans and other mice when they bite again.
Using new genome-engineering tools, he proposes to create mice that are either immune to the Lyme-causing pathogen, or to a protein in the tick's saliva, or both, to break the cycle of transmission.
If that works — and there is reason to think it will — he would then apply for permission to release thousands of the mice on a smaller, uninhabited island. If the number of infected ticks proved to be sufficiently reduced after two years, Nantucket could be next. The release of a few hundred thousand engineered mice over the course of about a year, Dr. Esvelt said, would ensure a stable population of resistant mice.
There is no company behind the project, which Dr. Esvelt estimated could take as long as a decade to complete. But he said he thought he could get government and philanthropic funding because it would provide evidence that might justify the use of another technology he has helped to pioneer, called "gene drive," to attack Lyme disease elsewhere.
In the Northeast and upper Midwest, the areas of the United States where Lyme is most prevalent, it would not be feasible to release enough engineered mice to spread the genes for Lyme immunity through the native mouse population.
An effort on that scale would require the addition of a gene drive, which assures that a given gene is passed to all of an organism's offspring rather than the usual half.
Gene drive technology is complicated because it has the capacity to alter an entire population of a given species, without any sure means of being canceled out if it has unforeseen consequences. It has so far only been used in laboratory experiments.
Dr. Esvelt said he wanted some indication of community support even before he starts looking for Lyme immunity genes in laboratory mice, both because he believes any effort to alter an ecosystem should not go forward without it — and because it would cost tens of millions of dollars. Ultimately, the proposal would need approval from federal and state regulators, as well as a majority of Nantucket's citizens.
"Is this a project you might wish to pursue?'' he asked on Monday. Dr. MacNab, who had anticipated some opposition to the idea, braced himself as Danica Connor, who identified herself as an herbalist, took the microphone.
"I'm the first person to say if you go tinker with Mother Nature we're going to break it,'' she said. "But you know what? Even I want to see where you go with this.''
Nantucket may have competition. Dr. Esvelt said he is scheduled to make a similar presentation on nearby Martha's Vineyard in July.
*A bigger follow-on Lyme Innovation Hackathon is taking place on June 17-19, 2016, at the Microsoft Nerd Center in Cambridge MA and all problem solvers are welcome to participate. (To learn more, please visit LymeInnovation.org.) Before the June event we encourage your participation in our patient-powered initiative. Thank you!
