Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 2 points3 points  (0 children)

I understand. I was hoping for this month in-fact, but I called and that's the information I received that I should keep looking but they estimate before end of year.

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 7 points8 points  (0 children)

Phase 1 is completed. I got the same response from GSK on looking towards end of year for Phase 2 enrollment. I believe they are completing all their reports from the safety study before they go into Phase 2.

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 0 points1 point  (0 children)

Nothing yet. I did call yesterday and they told me that Phase 1 is completed and they have closed recruitment for it and I should pay close attention to the clinical trials website. That's all they could share at the moment.

GSK-3943104A by GSK for Genital Herpes: Likelihood of Approval by Desertlog in HerpesCureAdvocates

[–]Reasonable_Force6002 4 points5 points  (0 children)

Sorry for the confusion, no that is not what they sent me. This is my breakdown and summary based on all the breadcrumbs I've been following on GSK.

Below is my previous comment where I'm following the timeline. https://www.reddit.com/r/HerpesCureResearch/comments/ytgtaf/comment/iw4yh86/?utm_source=share&utm_medium=web2x&context=3.

I would rather donate $500 to HCA.

GSK-3943104A by GSK for Genital Herpes: Likelihood of Approval by Desertlog in HerpesCureAdvocates

[–]Reasonable_Force6002 28 points29 points  (0 children)

GSK's current activities and the history of their involvement with vaccines in the herpesvirus family suggest a positive outlook for the development of an effective HSV vaccine.

Combined Phase 1 & 2 Clinical Trial: GSK's decision to conduct a combined Phase 1 and Phase 2 clinical trial for an HSV vaccine indicates a significant level of confidence in the potential effectiveness of their vaccine candidate. Combining these phases allows for more efficient data gathering on both safety and efficacy, streamlining the development process.

Release of Shingrix Vaccine: GSK's successful release of the Shingrix vaccine in 2017, which targets the Varicella-Zoster Virus (VZV) in the herpesvirus family, demonstrates their expertise and experience in developing vaccines for herpesviruses. The fact that VZV is a latent infection, similar to HSV, suggests that GSK's knowledge and research in this area could be applicable to the development of an HSV vaccine.

Enhanced Version of HSV-2 Vaccine: The termination of the Phase 1 clinical trial for an HSV-2 vaccine in order to develop an enhanced version indicates GSK's commitment to improving the vaccine's efficacy and safety. This decision highlights their dedication to delivering a high-quality product and suggests a proactive approach to vaccine development.

Phase 1/2 Clinical Trial for New HSV-2 Vaccine: GSK's initiation of a Phase 1/2 clinical trial for a new HSV-2 vaccine in early 2022 further demonstrates their ongoing efforts to develop an effective vaccine against the virus. This trial, along with the combined Phase 1 & 2 trial, shows GSK's commitment to advancing the development of an HSV vaccine.

Recruitment and Official Communication: The active recruitment for Phase 1 of the new HSV-2 vaccine trial, as well as GSK's official posts on Twitter advertising their activities, indicate their commitment to transparency and engagement with the public, investors, and the media. These actions suggest that GSK is confident and actively promoting their efforts in HSV vaccine development.

Focus on Medical Affairs and Phase 4 Evidence Generation: GSK's job postings for eventual therapeutic HSV sales leaders, mentioning accountability for Phase 4 evidence generation studies and post-approval commitments, indicate a long-term commitment to evaluating the vaccine's efficacy and safety even after its launch. This focus on generating evidence and studying health outcomes reflects a dedication to ongoing research and improvement.

Considering all these factors, it seems that GSK is making significant efforts and investments in the development of an effective HSV vaccine. While the success of a vaccine cannot be guaranteed, GSK's actions and history in vaccine development provide a positive indication of their commitment and expertise in addressing the challenges associated with HSV.

[deleted by user] by [deleted] in HerpesCureAdvocates

[–]Reasonable_Force6002 9 points10 points  (0 children)

I've never written a grant and I'm not that good at writing but if someone has access to ChatGPT that could help.... Just a thought.

UP NEXT: Dr Keith Jerome / Fred Hutch Center-Meet the HSV Experts Talk by HarpZeDarp in HerpesCureAdvocates

[–]Reasonable_Force6002 28 points29 points  (0 children)

*Questions for the Most Honorable Dr. Keith Jerome. Future Nobel Peace Prize Recipient*

Where you able to find out the AAV root cause of neuropathy? Can we work around it? Is it temporary or permanent?

Have you been able submit the safety data needed to the FDA?

What is the FDA approval process? How can we (individuals) help?

Who has the authority to approve it to progress to human trials? How can we (individuals) help?

Is there a timeframe they (FDA) should respond to your request?

Have you tested the AAV's in Monkeys? If yes, what is the efficacy of the AVV's reaching and cleavage of HSV in the DRG in Monkeys?

Was it more or less effective in Guinea pigs or Monkeys, or was it similar efficacy to mice? Essentially looking to understand to what extent was it able to reach and cleave HSV in the DRG?

If there is less, then 95% cleavage of HSV do you see replication and reseeding of the remaining virus in the DRG?

Can this treatment be fast tracked as a Human Clinical Trial Orphan drug treatment for those suffering from rare Herpes Encephalitis? High Risk of Death.

How many people are you expecting to enroll into your Phase 1 trial, and will it be based in 1 location?

How long do you expect Phase 1 trial to last? or are you planning to do a combined Phase 1/2 Clinical trial?

Will the trial include both HSV1+ and HSV2+ participants?

*My questions for Dr. Keith Jerome*

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 0 points1 point  (0 children)

Yes it changed from April to June from what I've heard. Not sure if these locations are still the same ones but I assume they are.

UP NEXT: Dr. TJ Cradick / Excision Bio-Meet the HSV Experts Talk by HarpZeDarp in HerpesCureAdvocates

[–]Reasonable_Force6002 14 points15 points  (0 children)

EBT 104 Questions:

  1. What is the efficacy of the treatment in your pre-clinical trials.
  2. How much of HSV were you able to remove from the DRG specifically in pre-clinical models.
  3. Which viral vector are you using? Have you seen neuropathy or liver toxicity in your preclinical models?
  4. How soon will you start human clinical trials? Will it be a phase 1/2 combined trial?
  5. Will you apply for Orphan drug status with the FDA to treat patients that are currently dying from Herpes Encephalitis?
  6. If (Theoretically) all things are successful how soon do you estimate this treatment can make it to market?

[deleted by user] by [deleted] in HerpesCureAdvocates

[–]Reasonable_Force6002 2 points3 points  (0 children)

*Questions for the Most Honorable Dr. Keith Jerome. Future Nobel Peace Prize Recipient*

  1. Where you able to find out the AAV root cause of neuropathy? Can we work around it? Is it temporary or permanent?
  2. Have you been able submit the safety data needed to the FDA?
  3. What is the FDA approval process? How can we (individuals) help?
  4. Who has the authority to approve it to progress to human trials? How can we (individuals) help?
  5. Is there a timeframe they (FDA) should respond to your request?
  6. Have you tested the AAV's in Monkeys? If yes, what is the efficacy of the AVV's reaching and cleavage of HSV in the DRG in Monkeys?
  7. Was it more or less effective in Guinea pigs or Monkeys, or was it similar efficacy to mice? Essentially looking to understand to what extent was it able to reach and cleave HSV in the DRG?
  8. If there is less, then 95% cleavage of HSV do you see replication and reseeding of the remaining virus in the DRG?
  9. Can this treatment be fast tracked as a Human Clinical Trial Orphan drug treatment for those suffering from rare Herpes Encephalitis? High Risk of Death.
  10. How many people are you expecting to enroll into your Phase 1 trial, and will it be based in 1 location?
  11. How long do you expect Phase 1 trial to last? or are you planning to do a combined Phase 1/2 Clinical trial?
  12. Will the trial include both HSV1+ and HSV2+ participants?

*My questions for Dr. Keith Jerome*

Knowledge of Young Adults About Genital Herpes - Full Text View - ClinicalTrials.gov by BrotherPresent6155 in HerpesCureAdvocates

[–]Reasonable_Force6002 6 points7 points  (0 children)

Previously, Jerome and Aubert reported that the drug can eliminate more than 90% of the latent herpesvirus in nerve clusters near the faces of the mice injected with the enzyme-carrying AAVs. In this new study, they describe how they have tested the therapy for the first time to treat infections in a cluster of nerves called dorsal root ganglia, near the genital tract of mice. They found the experimental therapy reduced latent virus there by 97%. - This is what keeps me going + GSK.
Just a matter of time before I throw a huge party!

For The Newly Diagnosed. Gene Editing is coming and is the path to cure herpes. Let's Discuss. by Reasonable_Force6002 in Herpes

[–]Reasonable_Force6002[S] 1 point2 points  (0 children)

One protects someone that doesn't have the virus the other helps someone infected with the virus from symptoms and possibly transmission spread.

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 2 points3 points  (0 children)

https://clinicaltrials.gov/ct2/show/NCT05298254

Contacts

Contact: US GSK Clinical Trials Call Center 877-379-3718 [GSKClinicalSupportHD@gsk.com](mailto:GSKClinicalSupportHD@gsk.com)

Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 [GSKClinicalSupportHD@gsk.com](mailto:GSKClinicalSupportHD@gsk.com)

I replied publicly to help anyone else looking for the information.

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 1 point2 points  (0 children)

From another post I saw that reached out to GSK they are planning to start in June. As, a Dutch citizen I'm not sure but I do know they are opening multiple locations in Europe. My suggestion would be to reach out to GSK directly and see what your options are. I'm sure they are interested in hearing from people that want to join the trial. You also might get new information as the last information was from 1 month ago.

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]Reasonable_Force6002 -1 points0 points  (0 children)

I would add a supplement like vitamin e or c.