Search results for query: *

My pleasure. At HEI we try to be different than everyone else. I've tried to make it more personal by responding to emails, texts, forums, etc. I tried not to use canned or stock answers/emails. I tried to post on here as much as I could. I have had a lot of joy these last 3+ years and will...

A huge thank you to everyone on here. I hope you all will still consider supporting HEI's research efforts. Right now, any new donor has their gift matched 100% by the JASCO Giving Hope Foundation here in OKC. Anyone who has given in the last two years can have their gift matched if they give...

This is a report from our COO of HEI and our research team on the milestones this year with our proof-of-concept study: We were able to develop a unique model of noise-induced neurodegeneration that does not result in permanent hearing loss but does evoke a chronic tinnitus percept. This is...

Keep in mind this was an article written by a reporter. They don't always get the facts straight. Before we got connected to Dr. Kesari were already working on funding this POC study because we already had pre-clinical data that indicated the pill's efficacy on tinnitus. Dr. Kesari was...

To speed things up takes money. We are a non-profit that relies on government funding and private donations. The two-year proof-of-concept study has several objectives. I will post what milestones we have accomplished in another post. To help you better understand what is happening, imagine...

Hi! I was in the room training the lady you spoke to. Let me clear up a few things that got misunderstood. NHPN-1010 is in a proof-of-concept study (2 years) before tinnitus will be considered for a Phase II study for the clinical indication of tinnitus. That doesn't mean Oblato can't move...

The real term is expanded use. Read more here: https://www.fda.gov/news-events/public-health-focus/expanded-access Read more here: https://www.fda.gov/news-events/public-health-focus/expanded-access

Yes, the cause of one condition can be the cause of a second condition. So, the mechanism of how the drug works can have multiple uses. Also, the drug works in multiple ways. We have data that indicates it works for SNHL, ototoxicity, and tinnitus. We believe it may be helpful for hyperacusis...

Or blast-induced. There are probably several "causes" of tinnitus. We are going after the most prevalent one, at least what is thought to be the most prevalent cause.

Incorrect, the article says patient, singular. Not plural. We also are unsure how accurate this article is and are inquiring. Sometimes we are the last to know ;)

We have data on the pill's efficacy in pre-clinical trials for SNHL, ototoxicity, and tinnitus. We believe it might also be helpful with hyperacusis and Meniere's disease. The pill helps absorb toxins/reduce inflammation and regenerate meaningful nerve connections between the cochlea and the...

We don't know yet. The questions you are asking are generally found when dosing is determined, which is Phase II and III clinical trials. Our estimation is that it would be a one-course treatment. That might be one pill or a month of pills. Our research suggests that once the nerve endings or...

Expanded Use is typically done on a case-by-case basis. Reading the article, it talks about "a chronic tinnitus patient." NOT patients, plural. To be clear ;)

Hi everyone, @Markku asked me to jump on real quick and give everyone an update on the news article from koreamed.com. I read through some of the comments and questions here. I will do my best today to answer them individually - but there are some "repeats" so be sure to check out all the...

We didn't choose cochlear implant trauma. Which indication they (the biotech firm) choose is still in the air right now. The delays in clinical research has to do with the pandemic, and less with what indication is chosen.

I don't think we have ever said 2024. If so, that would have been an error. We have consistently said mid-2020's. However some people thought that meant mid-2020, not 2020s - as in the decade. So we started messaging that it is hoped to be in the market 2025/26. With the global pandemic and...

We have developed a novel way to objectively measure the presence of tinnitus. :) The phase II study with our pill, it is hoped, will be for the primary indication of tinnitus.

PoC studies are not done on humans. The hope is to get it into a phase 2 clinical trial.

I can't speak for Oblato, but I can share with you what they have shared with us. They intended on starting phase 2 trials this year. They would still like to. However, there is a global pandemic that is effecting ALL research right now at the clinical trial level. We are still doing our part at...

The process of a Phase II study and the actual phase 2 study are different, somewhat. The process begins with the study design, funding, securing the research company, etc. Then once all the information is ready to go, it is announced via clinicaltrials.gov. So, the process has started even...

Yes, it is the secondary objective in a phase 2a study. Not a full phase 2 study. It involved less than 100 subjects. A phase 2 study involves hundreds of subjects.

It's complicated. Frequency Therapeutics is doing good work. There are more than likely multiple causes of tinnitus. Their approach might be helpful. Our approach might be helpful. Our hope is to have a phase 2 study, not a phase 2a, with the primary objective in treating tinnitus. We will...

Hi Deb! The PoC study takes a total of 12 months.

Started September 1st. Yay!!!!! We will reach the rest of the goal before the end of the year hopefully!

I don't take it personally. I do however take it professionally when someone accuses me personally and the staff/researchers at Hough Ear Institute as liars. I get people get frustrated. I get frustrated. Heck, you got frustrated with me. But while frustration is expressed, it was always civil...

PoC study will take a total of about 12 months. We should finish by next September. Then it will probably take some time, unknown, for Oblato to decide whether or not they want to run a phase 2 study for the pill for the indication of tinnitus as the primary objective.

There is more data for hearing loss (cochlear implant trauma, NIHL, ototoxicity) than for tinnitus. It has nothing to do with confidence. The PoC study costs $735K. Oblato is paying for $300K of it, the state of Oklahoma is paying for $300K of it. That leaves $135K for us to raise for it. I'd...

@ajc - Thaun cleared up your previous statement in this thread already. I suggest you go back and read it to see how you misinterpreted it.

FDA approval often leads to a fast track with other country's equivalent to the FDA. Also, it fits in our mission. We can purchase the drugs and through our humanitarian efforts - deliver it to those in most need. Our founder and doctors have been to over 80 countries offering their services...

First off, if I said "we are starting phase 2 studies" that was a miscommunication. Hough Ear Institute doesn't run the trials. The biotech company, Oblato, who has exclusive license to the drugs will be running them. The process has started for a phase 2 study. There is a lot to the process...

First off, Hough Ear Institute doesn't run the study. I'm not sure why people keep thinking that we do but we don't. The biotech company does. They will choose whatever indication they want to study. They can choose one, two, three, etc. To be clear - Phase 1 is complete. Phase II is funded...

That is the question the biotech firm has. Before spending millions on a phase 2 study they want some more data.

A PoC study is like a pilot study if you will. Before the biotech company spends millions of dollars for a phase 2 study for another indication, they desire to see some additional results from a larger than already done, but small than phase 2 study. In a lot of respects that is what Frequency...

I wish Frequency Therapeutics the best. We are different in our approach and in what causes tinnitus. We both might be right! It's good to have several approaches in the pipeline. One difference between Frequency Therapeutics and Hough Ear Institute is that we hope to run a phase 2 study that...

The PoC study is to test an objective measurement of tinnitus as well as to see if it works for chronic tinnitus. All of our previous studies indicated that it does, but for chronic tinnitus, the sample size was a little on the small side. Yet, we did have statistical significance. The biotech...

Thank you for doing the research and putting this together. I agree - research is frustrating because it takes so long. Whenever we are frustrated or suffering, the character of a person is in how they respond. Character = civility.

@tommyd87 Thank you for being more gracious about this than @ajc. I really have no idea what you are referring to. I challenged ajc to find where I said Hough would not allow off label use. Maybe you can help him?

When I first started commenting here - nearly everyone was very welcoming and appreciated that I actually engaged rather than share stock answers and not respond at all. Many of them mentioned that very few research institutes or bio orgs would engage, and none like we did. Maybe the reason for...

No, not yet. I need a personal introduction to someone, not just a name of someone famous with tinnitus. I'll check out the thread and twitter!

Yes!

Generally speaking, we need people to fund our research and those of others. For us, we have a $735K proof of concept study. It's funded to $605K. While we are going to go ahead and start it in September - we won't be able to finish it and validate the results until the remaining is funded. We...

No, it has not been submitted for publication. The pill has shown to regenerate meaningful nerve connections between the auditory nerve and the cochlea. Since that is one of the prevailing theories for the "cause" of tinnitus we ran several pre-clinical trials to test it. We had great results...

Thank you!

Much better said than me! Thank you.

Thank you. Agreed, rarely do people throw money away when their motive is to generate a profit.

Yeah, I think I might have had a little to do with it. Just a little :)

No worries. However, also with all due respect, I'll go with the science and the fact that we just received $300,000 from the state of OK and Oblato, a pharmaceutical company, for a proof of concept study for tinnitus, which includes treating chronic tinnitus. All with the hopes of adding a...

Correct!

Once the proof of concept study is done, then Phase II studies may be able to be started for the indication of tinnitus. One thing to keep in mind is that we need to understand timelines. For most of us, if we say we will get X done by the end of the week - we do. Sometimes however something...

We are currently fundraising for a Phase I trial and we are in talks with several venture capital firms that have expressed an interest in financing the Phase I and maybe more clinical trials.

Hi Alex, GREAT NEWS!!!!!!!!!!! We just got word today that our tinnitus proof of concept study received the grants funds necessary and they were matched. What that means is that we don't need to raise $435,000 anymore. We only need to raise $135,000!!!! Really, because of a generous donor who...

I think we started talking with Oblato about 7 years ago give or take. The process takes a while and different cultures approach things differently. The "Asian" culture, in general, tackles things even more methodically and slowly than we do. That said, Oblato has shared with us their desire to...

I have 7 kids and #8 on the way. God has given me ample opportunities to grow in that virtue. Albeit, God had to take me there kicking and screaming!!!

Good info to have. Thank you. If I ever come into contact with them, or someone who can introduce me I'll do my best to make it happen!

Funding. It took 5 years to get Oblato on board with taking it through the remaining clinical trials. We had other companies interested as well but Oblato was the first to agree to reasonable terms. My preference would have been to fundraise for the money for Phase II and then secure even...

Top secret. I don't even know :)

In stroke patients it was not effective.

Your first question: Because we have done additional studies to show that it appears to be effective in chronic cases. Second question: Yes, it was developed for stroke patients as well as Glioblastoma. It didn't work for stroke, but it did for Glioblastoma.

I mentioned it in a previous post. I'll try to find it and re-post it. If I can't I'll get back with the researchers. They know the answer like the back of their hand, whereas I do not and I don't want to mislead you.

That's the rub and it is a little more complicated. I've explained it in previous posts but here is the short-short version: Obalto has told us they hope to start trials this year. With COVID-19 - I would assume that means some delay. We have continued our research despite COVID-19. Fundraising...