Wednesday, February 22, 2012

1 Patent: Viral Genetics Chronic Lyme Disease Treatment

This post is related to an earlier post about Viral Genetics application for a pre-IND to begin clinical trials on their VGV-L product for the treatment of Chronic Lyme disease.


Apparently, I found Viral Genetics' current patent. And as I had previously speculated, I was correct that the treatment is going to modify B cells. I knew it! Buy me a drink, eh?

Here is a link to the patent online:


Inventors: Haig Keledjian (San Marino, CA, US) Michael Agadjanyan (Huntington Beach, CA, US) Martha Karen Newell (Colorado Springs, CO, US) Evan Newell (Menlo Park, CA, US)
IPC8 Class: AA61K3900FI
USPC Class: 4241851
Class name: Amino acid sequence disclosed in whole or in part; or conjugate, complex, or fusion protein or fusion polypeptide including the same
Publication date: 07/01/2010
Patent application number: 20100166789

And here are the excerpts on how the invention will be used to treat chronic Lyme disease (patent text slightly modified to correct spelling errors):

[0114] Lyme Disease is a tick-borne disease caused by bacteria belonging to the genus Borrelia. Borrelia burgdorferi is a predominant cause of Lyme disease in the US, whereas Borrelia afzelii and Borrelia garinii are implicated in some European countries. Early manifestations of infection may include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. Long-term the disease involves malfunctions of the joints, heart, and nervous system. Currently the disease is treated with antibiotics. The antibiotics generally used for the treatment of the disease are doxycycline (in adults), amoxicillin (in children), and ceftriaxone. Late, delayed, or inadequate treatment can lead to late manifestations of Lyme disease which can be disabling and difficult to treat.

[0115] A vaccine, called Lymerix, against a North American strain of the spirochetal bacteria was approved by the FDA and later removed from the market. It was based on the outer surface protein A (OspA) of B. burgdorferi. It was discovered that patients with the genetic allele HLA-DR4 were susceptible to T-cell cross-reactivity between epitopes of OspA and lymphocyte function-associated antigen in these patients causing an autoimmune reaction.

[0116] It is believed according to the invention that Borrelia burgdorferi also produces a Toll ligand for TLR2. Replacement of the CLIP on the surface of the B cell by treatment with a thymus derived peptide with high affinity for the MHC fingerprint of a particular individual, would result in activation of the important Tregs that can in turn cause reduction in antigen-non-specific B cells. Thus treatment with thymus derived peptides could reactivate specific Tregs and dampen the pathological inflammation that is required for the chronic inflammatory condition characteristic of Lyme Disease. With the appropriate MHC analysis of the subject, a specific thymus derived peptide can be synthesized to treat that subject. Thus individuals with all different types of MHC fingerprints could effectively be treated for Lyme disease.

[0117] Chronic Lyme disease is sometimes treated with a combination of a macrolide antibiotic such as clarithromycin (biaxin) with hydrochloroquine (plaquenil). It is thought that the hydroxychloroquine raises the pH of intracellular acidic vacuoles in which B. burgdorferi may reside; raising the pH is thought to activate the macrolide antibiotic, allowing it to inhibit protein synthesis by the spirochete.

Read more:

How will this theoretically stop inflammation present in chronic Lyme disease? What does the above all mean, in English? More details coming soon - for now I wanted to share this.

In the meantime, you might want to review this:

Image credit: Thymus by LearnAnatomy from Wikipedia under a CC 3.0 license.

1 comment:

  1. CO,

    Yes, you definitely deserve a drink -- and an update.

    Here's the latest press release issued by Viral Genetics on March 7th:

    (Sorry, I seem to be having troubling with formatting links)

    Viral Genetics Submits Pre-IND Document for Lyme Disease Drug Candidate to FDA

    First Potential Treatment of its Kind for Chronic Lyme Disease Sufferers is Second Candidate Developed from Company's Targeted Peptides Platform

    Company Also Notes That Research 2.0 Completes Updated Report on VRAL's Growth Prospects

    SAN MARINO, Calif.--(BUSINESS WIRE)--Mar 7, 2012 - Viral Genetics (Pinksheets: VRAL) announced today that it has submitted a pre-IND briefing document to the US Food and Drug Administration (FDA) for its Lyme Disease drug candidate, VGV-L, marking important milestones for both the Company and its supporters in the Lyme community.

    “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 quite some time. We are equally pleased that it represents the second drug candidate we have developed from our licensed Targeted Peptides platform,” said Haig Keledjian, President of Viral Genetics. “Our shareholders should be proud that our team managed to bring a drug candidate to this step of preliminary FDA review within about 30 months. Within the single Targeted Peptides platform, we are also developing candidates for treatment of sepsis, staphylococcus and streptococcus infection, multiple sclerosis and other conditions, while we continue to complete IND-enabling preclinical testing for our HIV/AIDS candidate.”

    The pre-IND submission provides extensive research information gathered by Viral Genetics' researchers over a 2 ½ year period of rigorous and detailed testing which resulted in positive results, to the FDA, along with a protocol for a proposed US 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 at the University of Colorado, Texas A&M University, Scott & White Hospital, and has been led by Viral Genetics Chief Scientist, Dr. M. Karen Newell-Rogers, with significant contributions from several clinicians.

    The Company anticipates that the response to the pre-IND submission will be received in March-April 2012. While the FDA's written responses to pre-IND submissions are typically comprehensive, in some cases the need for additional clarification or discussion necessitates a meeting in person or by teleconference.


    (there's much more contained in the link)


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