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HC Support Network Members help to find the cure

Members and Visitors of Herpes-Coldsores.com,

There have been discussions on our website’s forum about various HSV studies that are occurring throughout the global research community. Specifically, the Finding a Cure section of the forum discusses work that is ongoing by key HSV researchers. Some of these studies are much closer than others and there has been concern over lack of funding to help the key researchers continue their work towards finding a cure for HSV.

Since the United States NIH as well as Global health organizations reserve a small pool of money for HSV each year and since the medical community considers it a non-threatening virus, finding a cure has not a high priority. Therefore, the research teams rely heavily on private funding to help sustain their research projects.

Our mission is to aid researchers with funding support who are the closest to a potential Herpes Cure. We will achieve this mission by forming a grassroots movement in our community, lead by members who are passionate about finding a cure and willing to donate to support this goal. In addition, we will work with herpes sites across the web to build awareness. This work has already begun as we continue to build momentum and gain support from individuals and organizations across the globe.

A prominent goal of the HC Support Community is to raise funds for Dr. David Bloom at the University of Florida.We believe he may be closest to the cure. What Bloom proposes based on his research is a single vaccine that would provide life-long protection against recurrent outbreaks. Imagine never having another outbreak in your entire life?

Our initial donation drive raised $2,000 to start a donation site for the University of Florida. Now Dr. Bloom needs only $40,000 more dollars so that he can complete one more phase of pre-clinical HSV-1 reactivation experiments (in a rabbit model of recurrent herpes simplex virus disease). This should enable him to begin talks with the US Food and Drug Administration (FDA) regarding filing for an Investigational New Drug (IND) to initiate human trials. His plan is then to apply to University of Florida's Clinical and Translational Science Award (CTSA) at that point to obtain $250,000 to help with the necessary toxicology studies for Food and Drug Administration (FDA) approval to go forward with human clinical trials. Dr. Bloom is first focusing on HSV-1 and it is critical he makes it through the various clinical phases successfully so he can move to HSV-2 as well.

How You Can Help

Please become a member of the HC Support Community and donate to Dr. Bloom’s University of Florida research during this critical time! This donation is tax deductible as the University of Florida is a nonprofit institution. Also, please participate in the Finding a Herpes Cure thread below and let us know your thoughts and share your donations.

Remember any amount makes a difference!

For details on everything Bloom—see the FAQ below.

~ HC Support Network

Dr. David Bloom and The University of Florida FAQ

1. Who are the researchers?

Research Team:

The UF researchers have complementary expertise that allowed the development of a novel therapy for this disease. Dr. Alfred S. Lewin, is an expert in the design and exploitation of catalytic ribozymes. He has already contributed to the success of a ribozyme gene therapy approach for curing retinitis pigmentosa that is being tested in large animals. Dr. Lewin’s experience in designing and screening highly active forms of catalytic RNAs has been essential to the success of our approach.

Dr. David C. Bloom is an expert in the area of Herpes Simplex Virus (HSV) pathogenesis and latency and has extensive experience in the regulation of HSV transcription and use of animal models to study HSV pathogenesis. Dr. Bloom’s involvement in the selection and testing of HSV RNA targets and evaluation of the product in mouse and rabbit models of HSV infection has played a key role in product development.

Dr. Sonal Tuli is a corneal expert and has extensive experience in treating patients with ocular herpes infections. Dr. Tuli has added an essential clinical perspective to the design and developmental stages of the products. Dr. Greg Schultz is an expert on the molecular and cell biology of wound healing in the corneal and has extensive experience in delivery of small molecules and nucleotides to the cornea.

2. How will they stop herpes outbreaks?

When administered by a single injection after the initial infection, the therapy provides life-long inhibition of recurring outbreaks.

3.Can you please explain this technology?

By designing special enzymes called hammerhead ribozymes, the researchers were able to target a so-called “late” gene that releases its protein product relatively late after infection. With late genes, partial corruption of the genetic material is sufficient to shut down virus production, as opposed to “early” genes, which would require total inactivation to hinder the process.

“If things worked out the best they could, I think this could be a measure to prevent recurrence, and that would help a lot of people — and even if it just reduced severity, it would give us another therapy in cases where there is drug resistance,” said David Bloom, a virologist at the UF College of Medicine who leads the interdisciplinary research team investigating the new therapy.

4. How can I donate to help Professor Bloom perform more of his pre-clinical reactivation experiments?

There is a way to donate online.

HSV-1 Research Program (016081) - https://www.uff.ufl.edu/OnlineGiving/FundDetail.asp?FundCode=016081

5. Does Dr. Bloom have a current research proposal?

Dr. Bloom Research Proposal

Potential New Herpes Therapy to Block Recurrent Disease

Summary of Research: Researchers at the University of Florida have designed an RNA enzyme (ribozyme) that targets and cleaves the mRNA of an essential gene in Herpes Simplex Virus type 1 (HSV-1). The ribozyme which targets the mRNA of the UL20 gene greatly reduced the level of HSV-1 replication in mice and in ocular infection in rabbits during an initial (acute) infection. The gene-targeting approach uses a specially designed RNA enzyme to inhibit strains of the herpes simplex virus. The enzyme disables a gene responsible for producing a protein involved in the maturation and release of viral particles in an infected cell. The technique appears to be effective in experiments with mice and rabbits, but further research is required to prove effectiveness against recurrent disease and safety before this treatment could be attempted in people who are infected with herpes.

A proportion of people who are infected with HSV-1 develop Herpes Stromal Keratitis (HSK), a chronic disease of the eye that is believed to result from excessive immunological response to reactivations of the latent HSV-1 infection. The standard of care for treating HSK is with one of several antivirals (acyclovir, famciclovir, valacyclovir and triflurodine) and anti-inflammatory steroids. However, these treatments are not cures, and in many cases the cornea is damaged over time. As a result, HSK is the leading cause of infectious blindness in the U.S.
It is estimated in the U.S. that in the U.S. there are currently 38,000 people with recurrent ocular disease requiring treatment annually, along with 20,000 new cases occurring per year (Liesegang 2001). The failure of existing treatments is believed to be due to a combination of factors including lack of good bioavailability of the drugs when delivered to the eye, development of drug toxicity over time, and development of drug resistance.

Need for Additional Funds: Addition funds are needed now that will allow UF Researchers to test the UL20 ribozyme for its ability to block recurrent disease in a rabbit eye model of HSV-1 recurrent disease. The proposed studies could be completed within 12 months and would allow us to determine whether the UL20 ribozyme can block recurrent reactivations in the rabbit. If successful, this critical milestone would allow the UF research team to seek additional funds for pre-clinical safety studies that would be needed to apply for future clinical trials.

All experiments will be conducted in accordance with UF regulations; and all animal experiments will be conducted in accordance with IACUC approval and adhering to AAALAC and ARVO guidelines for the ethical treatment of animals. All animal experiments will be done under the supervision of the UF Animal Care Service Veterinary staff. The funds being requested are for 50% time of a research technician to perform day to day analyses and data collection, supplies for preparing and analyzing the ribozymes, vectors to deliver the ribozymes, and funds to purchase the rabbits and care for them during the course of the study. The lead investigators are not requesting salary support and will contribute their time to this project.

The proposed experiments will yield critical results that will allow us to determine if our new ribozyme approach has the potential to treat recurrent (reactivating) infections of HSV-1 in the eye. If successful, we plan to move forward to further develop this treatment for eye infections of humans. In addition, future studies using a similar approach could be developed to treat oral HSV-1 infections, and to develop HSV-2 ribozymes as an alternative treatment for genital infections of humans.

The process for obtaining FDA approval to initiate clinical trials for a new therapy is a long and expensive process. We are currently at Stage 3, which is to test the ability of the ribozyme to block recurrent disease. If we are successful at reaching this important milestone it would put us in position to apply for funds from the National Institutes of Health (NIH), as well as private capitol sources to carry out the remaining pre-clinical tests that need to be completed before filing with the Food and Drug Administration (FDA). These remaining tests have to be performed by FDA approved labs and could cost between $500,000 - $1,000,000, depending on the final dosing parameters and product formulation. A final point that should be understood, is that after an IND is granted it can take up to five additional years (and additional millions of dollars) before an approved product is available.

Where to Now?

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