FDA to Rule on Testing New Drug for Chronic Lyme
Stamford, CT (PRWEB) April 02, 2012
Researchers led by Time for Lyme grantee, M. Karen Newell-Rogers, Ph.D, have submitted a pre-IND briefing document to the US Food and Drug Administration, a preliminary step toward developing proposals for clinical testing of a new drug that could one day end the suffering of those with chronic, or long-term Lyme disease.
“To our knowledge this is the first novel drug candidate that has been proposed for study in the treatment of chronic Lyme Disease post-infection in some time,” said a representative of Viral Genetics, that submitted the proposal for its drug candidate, VGV-L, to the FDA. A response is expected in April.
Tests led by Dr. Newell-Rogers, a professor at Texas A&M Health Science Center College of Medicine and Scott & White Hospital, and a scientific advisor to Viral Genetics, have been conducted for over two and a half years. The results were submitted this month to the FDA, along with a protocol for a proposed human clinical trial designed under the guidance of a leading Lyme clinician at one of the nation’s top medical centers. Testing to date was conducted by Dr. Newell-Rogers with significant contributions from other clinicians at the University of Colorado, Texas A&M Health Science Center and Scott & White Hospital in Texas.
Prior research had established the insight that certain immune characteristics may contribute to whether a person is susceptible or resistant to the development of chronic inflammation as a result of infection. Dr. Newell-Rogers theory proposes a “targeted” peptide to replace or remove the self-peptides and restore a healthy immune response in patients.
Much of the funding for the pre-clinical studies leading to the FDA filing was provided by Time for Lyme, acting in concert with Richard Gerstner, the ex-IBM Executive VP who saw the potential applicability of Dr. Newell’s work, to Lyme disease.
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