The chronic Lyme skeptics should start eating crow.
For a disease that doesn’t exist, the application for pre-clinical trial studies to the FDA, an early step in the multimillion dollar process of getting a drug approved by the FDA, must seem perplexing….why spend over 100 million dollars getting a drug approved for a disease that doesn’t exist? Well, obviously it does exist, and new research has driven investors and charities to step up and put money towards this new and potentially effective drug designed to destroy chronic Lyme disease.
The company on the top of the wave is Viral Genetics (http://www.viralgenetics.com) and the following comes from a recent press release on March 7, 2012 by Business Wire (http://www.marketwatch.com click link to read entire press release in new window):
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 1/2 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.
The written pre-IND response typically provides detailed insight into the FDA’s concerns about available information on a particular drug being proposed for human testing in a particular patient population, and helps preempt any potential deficiencies that the FDA may find upon submission of the full IND application.
This feedback acts as a kind of blueprint that guides the sponsor’s completion of the full IND towards attainment of FDA clearance to proceed with the proposed clinical trial. Post-submission of an IND, FDA reviewers may need clarifications or additional information before making a decision. FDA requirements for an IND include detailed information on all aspects of the proposed product such as manufacturing, preclinical and clinical testing, scientific background, proposed clinical development plan, clinical protocol, etc. This information needs to be presented in a format aimed towards clarifying the rationale of the proposed clinical trial, and for ease of review by the FDA reviewers.
Funding for some of the pre-clinical trial studies leading to the filing was initiated by Viral Genetics advisor, Richard Gerstner, former head of IBM’s Asia operations and later the company’s personal computer division. In April of 2011, Mr. Gerstner, who faced a long battle with Lyme during his tenure at IBM and his subsequent career in the venture capital arena, was a recipient, along with Dr. M. Karen Newell — Rogers, of the Lauren F. Brooks Hope Award, given by the Time for Lyme Foundation. Since the commencement of Time for Lyme’s fundraising efforts in 2001, it has raised nearly $5 million and partnered with Columbia University Medical Center to create its Lyme and Tick-Borne Disease Research Center. Past recipients of the award include Nobel Laureate Dr. Luc Montagnier, also an advisory board member of Viral Genetics, and world-renowned pediatrician Dr. Charles Ray Jones.
This research was further supported by grants from the Time for Lyme and the Turn the Corner Foundation who both saw the promise in Dr. Newell-Roger’s approach, helping it to reach this phase of development and the pre-IND filing. The proposed therapy, like several others in Viral Genetics R&D pipeline, is based on Targeted Peptide technology (TPT) and uses synthetic peptides to “trick” cells that may be responsible for harmful symptoms, making them vulnerable to the body’s natural immune response mechanism.
Emphasizing the platform nature of the TPT approach, Dr. Newell-Rogers expanded on how TPT potentially may be targeted to a number of potential diseases or “indications” that have proved stubbornly resistant to more traditional approaches such as, in this case, chronic Lyme Disease. “The idea behind our research is that those with a genetic blueprint that does not allow certain self-peptides to be processed or removed tend to mount a chronic inflammatory immune response that is not properly controlled. In terms of drug development, we believe that many diseases and chronic illnesses may be dependent in important ways on this harmful type of inflammation,” Dr. Newell stated.
Her theory proposes a “targeted” peptide to replace or remove certain self-peptides and hopefully restore a less harmful and more specific immune response in patients. The studies conducted by Viral Genetics aim to shed light on this chronic inflammatory response and symptoms shared by a significant subset of Lyme disease patients.
Currently there is no treatment for Lyme Disease once it has developed into its chronic, long-term state, other than antibiotics regimens which, while managing the disease for some of those infected, leaves untouched some of the symptoms for a significant portion of those suffering from this debilitating condition.
“Dr. Karen Newell and her team have done a tremendous job unraveling many of the complexities of Lyme disease. We are extremely grateful for the support, heartfelt pleas, and input of so many physicians from the Lyme community. Our focus now is to move this as quickly as possible through the clinical stage with top tier Lyme Literate physicians and research institutions. Our goal has been and will continue to be walking this successfully through approval for the suffering Lyme community that desperately needs it. We could not be happier,” said Monica Ord, SVP of corporate development and communications.
The pre-IND submission filing for VGV-L is one of three drug candidates in Viral Genetics’ pipeline that are nearing FDA review and clinical trial status. This includes an oncology trial at Scott and White hospital of the Company’s Metabolic Disruption therapy which went from being a relatively small, single-site, more traditional ‘physician’s study’ to potentially a dual-site, larger study consisting of upwards of several dozen patients with a second (or ‘co-’) primary investigator that may be a Phase 1 or Phase 2 study.
In a final comment, Mr. Keledjian noted that equity research firm Research 2.0, has completed its latest update on VRAL. The report highlights the exciting “pivotal year ahead”, and details the company’s progress on both the biological sciences front and the algal biofuels opportunity for the company’s VG Energy subsidiary. The report provides insight into the various market opportunities and posits a framework for the company’s growing valuations.
Watch a video from Time For Lyme’s 2011 Gala Fundraising event at Jenna’s Lyme Blog.
Time For Lyme 2011 “Gala video” features the stories of the battles of Tommy Hilfiger’s daughter, Ally Hilfiger’s and former IBM executive Richard (Dick) Gerstner with Lyme disease as well as the very exciting research being done by Dr. Karen Newell, a much lauded scientist at Texas A& M, whose research may hold the key to unlocking the secrets of Chronic Lyme disease and a new therapeutic approach.