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05/15/2012 02:01 AM

FDA to Rule/Testing New DrugVGV-L Chronic Lyme

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FDA to Rule on Testing New Drug, drug candidate, VGV-L, for Chronic Lyme

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,”

Stamford, CT (PRWECool April 02, 2012

“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.

Time for Lyme has raised over $5 million since its founding in 1998 to fund research on Lyme and other tick-borne diseases at esteemed institutions across the U.S., including the establishment and endowment of Columbia University Medical Center's Lyme and Tick-borne Disease Research Center.

“Time for Lyme is focused on its clear and single mission of promoting research into Lyme and tick borne diseases,” said Peter Wild, executive director of the organization.

“At present there is no recognized treatment for Lyme once it has developed into its chronic, long-term state.

We are hopeful that Dr. Newell-Roger's work will provide the solution that long-term Lyme disease sufferers have been hoping for, for decades.”

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Post edited by: Bettyg, at: 05/15/2012 02:04 AM


08/23/2012 11:24 AM
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Whats the latest?

08/23/2012 03:42 PM
Posts: 32237
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I'm an Advocate

i've not received anything more on this to date; anyone else know anything??

if there were, we'd be bombarded from all our lyme orgs!!



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