Thursday, May 17, 2012

What Did The FDA Rule On Testing New Drug For Chronic Lyme?

So, if there isn't late-stage or chronic Lyme disease, why would the FDA rule on a new drug to treat chronic Lyme?  I have chronic Lyme or late-stage Lyme and we are literally dying to receive a drug treatment.  I have scoured the Internet and the following is the only information I could find.  I could not find the ruling anywhere.


FDA to Rule on Testing New Drug for Chronic Lyme

Published 10:15 a.m., Monday, April 2, 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.

Stamford, CT (PRWEB) 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.”

Press Release
Source: Viral Genetics, Inc.
Viral Genetics Publishes March 2012 Monthly Letter to Shareholders.
Cites Pre-IND Filing with FDA for Lyme Disease, Other Drugs in Pipeline & Progress in Algal BioFuel Subsidiary, VG Energy
Business WireSan Marino, CA (PRWEB) March 14, 2012
Viral Genetics (Pinksheets: VRAL.PK - News) today published its March 2012 Letter to Shareholders. Providing updates on the company’s progress, the letter discusses the recent Pre-IND filing for its Lyme Disease drug candidate, notes other drugs in the pipeline that have developed out of the company’s Metabolic Disruption Technology Platform, and talks about progress in proving the efficacy of the yield enhancement in the company’s algal biofuels subsidiary, VG Energy.
The letter is available on the company’s website at
About Viral Genetics, Inc.
San Marino, California-based Viral Genetics discovers drug therapies from two platform technologies based on over 60 patents: Metabolic Disruption (MDT) and Targeted Peptides (TPT). Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant cancer. A majority-owned subsidiary, VG Energy (, is dedicated to exploring biofuel and agricultural applications for the MDT platform. For more information, visit
About VG Energy
VG Energy Inc. is an alternative energy and agricultural biotech company that is a majority-owned subsidiary of Viral Genetics Inc. Using its Metabolic Disruption Technology (MDT), Viral Genetics' cancer research led to discoveries with major consequences in a wide variety of other industries, including production of biofuel and vegetable oils. VG Energy holds the exclusive worldwide license to the MDT patent rights for use in the increase of production of various plant-derived oils from algae and seeds. Application of MDT technology to the biofuel industry could potentially allow it to overcome its major obstacle in the area of production efficiency: namely, an increase in production yields leading to feasible economic returns on investment, allowing renewable biodiesel to be competitive with fossil fuels. For more information, please visit
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS:This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical trials, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports, including statements about its VG Energy, Inc. subsidiary. None of Viral Genetics' drug compounds are approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world, nor are any non-pharmaceutical products of VG Energy, Inc. commercialized. While Viral Genetics believes that the forward-looking statements and underlying assumptions are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Viral Genetics to establish the efficacy of any of its drug therapies in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of those drug compounds in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests including clinical trials on time or at all, the successful outcome of such studies or tests, or the successful commercialization of VG Energy, Inc.’s non-pharmaceutical products. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved. 
Contact:BlueWater Advisory Group, LLCBryan Crane, 805-294-3723
Contact:Viral Genetics, Inc.Haig Keledjian, 626-334-5310 
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