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New Drug for Chronic Lyme Disease – Will Clinical Trials be Approved?

chronic lyme disease inflammation new drug trialA new trial is being planned to look at the use of a new drug for chronic inflammation in Lyme disease. If the clinical trial gains FDA approval then the team of investigators will start recruiting Lyme disease patients to take part in a controlled study.

There is still lots of red-tape to deal with before the study commences, but laboratory success with similar agents for HIV/AIDS, Strep and Staph infections mean that there is optimism for this new treatment for chronic Lyme disease.

Causes of Chronic Lyme Disease Symptoms

Lyme disease is transmitted through tick bite when bacteria in the ticks’ saliva and gut are passed on to the human host. These bacteria, Borrelia burgdorferi, are the cause of the distinctive erythema migrans bullseye rash that occurs in some Lyme disease cases and is a clear sign of the infection. Persistence of symptoms is, by some Lyme disease doctors, put down to persistent infection, even after antibiotic treatment, and evidence that Lyme disease bacteria hide from the immune system may support such a theory. A second hypothesis for chronic symptoms of Lyme disease after treatment is that some patients are genetically susceptible to a post-infectious chronic inflammatory process that continues even after the infection itself is cleared. An even more recent hypothesis is that chronic Lyme disease symptoms are not actually a result of Borreliosis at all but, rather, the symptoms of a viral infection that has been, up until now, unknown.

Chronic Lyme Disease – An Inflammatory Condition?

The new clinical trial will investigate the second hypothesis using a therapy called VGV-L and which substitutes the patients’ own pro-inflammatory peptides with a targeted peptide. This is hoped to reduce inflammation in chronic Lyme disease, redress the faulty immune system response, and relieve chronic Lyme disease symptoms. Similar techniques have been developed for HIV/AIDS and Staphylococcus and Streptococcus infections, all based on the use of immune-based agents rather than antiviral or antibiotic treatments.

Targeted Peptides for Lyme Disease, AIDS, Staph. and Strep.?

There is some evidence to support the efficacy of first-generation VGV-X in humans as early clinical trials do show a reduced viral load in HIV/AIDS patients. Some mice actually made full recoveries when treated with VGV-S for Staph or Strep infection in the laboratory. Mice have also been involved in testing for the new VGV-L agent and no adverse effects of treatment have been reported so far. There is little data on efficacy, however, and so the FDA will likely delay their decision until pharmacological and toxicology safety reports are in.

Lyme Disease and Red-Tape

The principal investigator is Dr. Newell-Rogers from the White Hospital of Texas Agricultural and Mechanical Health Science Center. Her and her team will submit a formal investigational new drug application (IND) and hope to begin clinical trials shortly to look at the potential for this new drug to help chronic inflammation in Lyme disease. A date was set for June 15th for the FDA case reviewers to meet the research team and, should they approve the trial, the scientists will then need to submit the IND request before any chronic Lyme disease patients can be recruited.

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  • Nancy July 21, 2012, 7:51 pm

    Please let me know when VGV-L is approved for clinical trials. I was on antibiotics for 6 years but I have recently stopped them. Please let me know.

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