FDA to rule on testing of Lyme disease drugPublish date: Apr 18, 2012
By: Paul Gillette
Source: Dermatology Times E-News
Email|Print|ShareDel.icio.usDiggRedditFacebook|Save|LicenseWashington — The Food and Drug Administration is expected to soon decide whether VGV-L, a drug candidate from Viral Genetics targeting chronic Lyme disease, can move to human trials.
PRWeb reports that company researchers, working in conjunction with various institutions, submitted a pre-IND (Investigational New Drug) briefing to the FDA, an early step toward eventual clinical testing of the drug.
The pre-IND submission comes after more than two years of testing. A protocol for a human clinical trial was submitted this month to the FDA along with test results.
Existing research has established a link between certain immune characteristics and resistance or susceptibility to developing chronic inflammation as a consequence of infection. The Viral Genetics research team proposes restoring a healthy immune response by replacing or removing the self-peptides with a targeted peptide.
edited to underline and bold CHRONIC.
Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
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