Hough Ear Institute's Hair Cell Regeneration Project

[Justin De Moss]

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 more than $2,500.

Please keep in mind HEI does more than just try to solve the issue for tinnitus but many other clinical indications as well. Donors can choose where to have their funds directed, like tinnitus, SNHL, etc.

Thank you all again, and I hope and pray that all of us will get the relief we seek.

 

[Brian Newman]

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 you run a biotech firm, and 1 out of 10 trials you furnish will fail. Now, HEI comes to you with a drug that has data to support it with SNHL, ototoxicity, and tinnitus. As a biotech firm and part of the FDA approval process, you have to pick one clinical indication to fund for each trial. You can run three trials at $10M a piece or you can collect all the pre-clinical data you can and make an informed decision, reduce your risk of loss, and intentionally choose the indication that is most likely to get FDA approved.

The POC study was requested to see if it worked on chronic tinnitus, to have a larger study done to see if it still works, and other factors - before the Biotech firm decides where to invest $10M; in the clinical indication of tinnitus or some other indication.

You can see that they can move forward right now with any indication they want. They are choosing to play it safe. Also, FYI, the POC study costs $735,000. $300K was supplied thanks to the state of Oklahoma through an OCAST grant, and $300K from the biotech firm.

If you ask me - that says all anyone really needs to know about the science and HEI. We are real researchers, doing real research, for real solutions. If you think non-profits can just get grant money from the government without good science - you are mistaken.

Well thanks for your reply Justin. I appreciate it. Nothing against you personally. I know things take a long time and Hough is playing it safe. Thanks for the informed answer.

"OPI develops novel therapeutics for hearing loss. OPI's lead product, an oral fixed-dose combination of HPN-07 and NAC for treatment of acute sensorineural hearing loss, is scheduled to enter Phase 2 clinical trials in 2016 in Noise-Induced Hearing Loss (NIHL) and tinnitus. Extensive preclinical research, done collaboratively through Oklahoma Medical Research Foundation (OMRF) and HEI and supported by nearly $5.4 million from the Department of Defense, has demonstrated the potential effectiveness of an oral, fixed-dose combination of HPN-07 plus n-acetylcysteine (NAC) to treat NIHL by reducing acute damage and promoting healing and recovery of the injured cochlea."​

This article was in 2016. I know you said you guys chose to play it safe but what has been going on for 5 years? Wouldn't the two years of testing you guys are doing till 2022 to make an informed decision happened by now. It's all just lack of funding?

 

[Justin De Moss]

Well thanks for your reply Justin. I appreciate it. Nothing against you personally. I know things take a long time and Hough is playing it safe. Thanks for the informed answer.

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 miss the mission and raising money for something I love and believe in.

 

[HootOwl]

10 years to get to a phase 2, god damn.

What a joke Hough is when it comes to actualizing their products. They should have spun their research department off into its own biotech a long time ago, because holy shit, this is just embarrassing.

and this is coming from someone who believes in the scientific potential of your compounds.

At HEI we try to be different than everyone

Yep, you sure do.

 

[lymebite]

Thanks, @Justin De Moss, for all the detailed info. Appreciate you filling us all in and appreciate the continuing efforts of you and HEI.

Sure wish I or someone had $50 million to send to speed up trials, but I'm painfully aware how difficult it is to raise funds for tinnitus research. Even the American Tinnitus Association, which has many members and a long history, typically manages to scrape together only around $1 million a year in total donations, and much of that gets spent on administrative salaries and the magazine. In a good year they devote $100k or $200k to fund research, which of course doesn't go very far.

 

[Nobody19]

Thanks for the answers Justin and good luck in your next career.

You say the drug possibly helps with hyperacusis. Where can I read more about that, is there a published paper with this information?

 

[Fields]

Thanks @Justin De Moss for taking the time to answer all of these questions. Best of luck to you in your new career!

 

[Brian Newman]

I wanted to make this post to inform everybody who does not know what's going on. There was a heck of a lot of confusion with that post about compassionate use. Despite what Justin said I talked to somebody from Otologic Pharmaceuticals which is the biotech part of Hough Ear Institute, correct me if I'm wrong. The drug is not owned by Hough Ear Institute; they truly don't know what's going on. Oblato owns the drug now.

And I believe the guy that did the compassionate use was for the treatment of glioblastoma. I believe he had tinnitus and hyperacusis while he got the treatment.

"OKN-007 is a free radical scavenger that eliminates reactive oxygen species and reduces necrosis, hypoxia, inflammation, and angiogenesis, thus normalizing the tumor microenvironment that drives glioblastoma growth.

Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato also plans to conduct a clinical trial for DIPG with OKN-007 in combination with standard of care radiotherapy."​

I haven't been able to get in touch with them. No responses to my email. If anybody wants to call them and ask what's going on and when is the Phase 2 starting for hearing loss and tinnitus that would be perfect. I have catastrophic noxacusis so can't make phone calls.

It also is good news because we all know that when anything has to do with cancer or brain issues it is way more important than hearing issues in the medical world. They are calling the drug OKN-007 now.

2021 February

• Granted Fast Track Designation for OKN-007 to treat Diffuse Intrinsic Pontine Glioma from the FDA

That was also on their website. This drug will actually get approved faster than we think, since Hough Ear Institute is incompetent with managing this drug. It will most likely be the same situation as SPI-1005 (Ebselen) to where it was tested in the past for hearing problems in pre-clinical trials, but gets approved for something else. Once it's approved in the use, it will be much easier to obtain.

 

[Gb3]

I believe the guy that did the compassionate use was for the treatment of glioblastoma. I believe he had tinnitus and hyperacusis while he got the treatment.

That's exactly how I read the article too. And they did confirm the doctor was seeking to use it for compassionate use.

 

[DebInAustralia]

I wanted to make this post to inform everybody who does not know what's going on. There was a heck of a lot of confusion with that post about compassionate use. Despite what Justin said I talked to somebody from Otologic Pharmaceuticals which is the biotech part of Hough Ear Institute, correct me if I'm wrong. The drug is not owned by Hough Ear Institute; they truly don't know what's going on. Oblato owns the drug now.

And I believe the guy that did the compassionate use was for the treatment of glioblastoma. I believe he had tinnitus and hyperacusis while he got the treatment.

"OKN-007 is a free radical scavenger that eliminates reactive oxygen species and reduces necrosis, hypoxia, inflammation, and angiogenesis, thus normalizing the tumor microenvironment that drives glioblastoma growth.

Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato also plans to conduct a clinical trial for DIPG with OKN-007 in combination with standard of care radiotherapy."​

I haven't been able to get in touch with them. No responses to my email. If anybody wants to call them and ask what's going on and when is the Phase 2 starting for hearing loss and tinnitus that would be perfect. I have catastrophic noxacusis so can't make phone calls.

It also is good news because we all know that when anything has to do with cancer or brain issues it is way more important than hearing issues in the medical world. They are calling the drug OKN-007 now.

2021 February

• Granted Fast Track Designation for OKN-007 to treat Diffuse Intrinsic Pontine Glioma from the FDA

That was also on their website. This drug will actually get approved faster than we think, since Hough Ear Institute is incompetent with managing this drug. It will most likely be the same situation as SPI-1005 (Ebselen) to where it was tested in the past for hearing problems in pre-clinical trials, but gets approved for something else. Once it's approved in the use, it will be much easier to obtain.

Is the Hough Ear Institute's pill meant to help chronic tinnitus? Does anyone know this?

 

[Nobody19]

I think we found the holy grail of medicine here.

 

[DimLeb]

So we still don't know if that drug, whatever they call it, is effective for tinnitus...

 

[xyz]

I wanted to make this post to inform everybody who does not know what's going on. There was a heck of a lot of confusion with that post about compassionate use. Despite what Justin said I talked to somebody from Otologic Pharmaceuticals which is the biotech part of Hough Ear Institute, correct me if I'm wrong. The drug is not owned by Hough Ear Institute; they truly don't know what's going on. Oblato owns the drug now.

And I believe the guy that did the compassionate use was for the treatment of glioblastoma. I believe he had tinnitus and hyperacusis while he got the treatment.

"OKN-007 is a free radical scavenger that eliminates reactive oxygen species and reduces necrosis, hypoxia, inflammation, and angiogenesis, thus normalizing the tumor microenvironment that drives glioblastoma growth.

Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato also plans to conduct a clinical trial for DIPG with OKN-007 in combination with standard of care radiotherapy."​

I haven't been able to get in touch with them. No responses to my email. If anybody wants to call them and ask what's going on and when is the Phase 2 starting for hearing loss and tinnitus that would be perfect. I have catastrophic noxacusis so can't make phone calls.

It also is good news because we all know that when anything has to do with cancer or brain issues it is way more important than hearing issues in the medical world. They are calling the drug OKN-007 now.

2021 February

• Granted Fast Track Designation for OKN-007 to treat Diffuse Intrinsic Pontine Glioma from the FDA

That was also on their website. This drug will actually get approved faster than we think, since Hough Ear Institute is incompetent with managing this drug. It will most likely be the same situation as SPI-1005 (Ebselen) to where it was tested in the past for hearing problems in pre-clinical trials, but gets approved for something else. Once it's approved in the use, it will be much easier to obtain.

This has now totally confused me. They are now trialling the HEI bomb blast pill for cancer treatment, seriously? If this won't work, they will probably trial it for MS and in 2030 maybe there is a Phase II trial for tinnitus.

 

[Kam75]

So we still don't know if that drug, whatever they call it, is effective for tinnitus...

My understanding is that they have passed Phase I and are in Phase II, which must mean that their drug works.

However, with the luck we have, it is very likely that they will fail Phase II and we will be left hoping for another drug to work...

 

[DimLeb]

@Kam75, being tested as a cancer treatment sounds (at least) very confusing in terms of how it would actually work either against tinnitus or cancer.

It's either a super drug that has the potential to cure everything or it's just another big failure of a drug that does nothing (like all ear-related medicine at the moment).

 

[Lukee]

My understanding is that they have passed Phase I and are in Phase II, which must mean that their drug works.

However, with the luck we have, it is very likely that they will fail Phase II and we will be left hoping for another drug to work...

No, it means their drug is safe (enough to go to Phase 2). It does not mean it works.

 

[Brian Newman]

Is the Hough Ear Institute's pill meant to help chronic tinnitus? Does anyone know this?

It was originally designed for tinnitus and hearing loss and was tested for years in pre-clinical trials. Never tested on humans...

It did pass Phase 1 clinical trials in 2014 for safety. In Phase 1 they take people who have no ear problems and give them the drug to see what doses are tolerated. All the other research Hough Ear Institute claims is from years of studies in mice and other mammals.

They might still be doing research and testing it - we have no idea. But Oblato is who made the deal with Hough Ear Institute to being the drug through the rest of the trials. I'm guessing they found out half of the drug HPN-07 combined with Temozolomide to treat glioblastoma.

If you look at Oblato's website you will see nothing about hearing loss or tinnitus being treated. To me it looks like Oblato realized there is much more money to be made with cancer treatments and brain problems. They realized tinnitus and hearing loss drugs have for a long time been known to fail notoriously. They don't most likely want to take the chance.

That's good and bad news. We can get our hands on it much easier but there is no solid evidence it works on humans; only mice. Gotta hope for the best.

 

[Brian Newman]

So we still don't know if that drug, whatever they call it, is effective for tinnitus...

Yup, only in mice... And research studies.

 

[Brian Newman]

My understanding is that they have passed Phase I and are in Phase II, which must mean that their drug works.

However, with the luck we have, it is very likely that they will fail Phase II and we will be left hoping for another drug to work...

Well Hough Ear Institute said they haven't even started Phase 2 for tinnitus yet. The said they want to do a 2-year study that ends next year to be sure it works before investing more into the drug. That's what Hough Ear Institute said. Oblato is using the drug for other purposes; they are the biotech company who wants to bring it to market.

To be honest it getting approved specifically for ear problems is unlikely but if it works for cancer stuff then it will definitely get approved. Then all we gotta do is have some people try it out, go to our ENTs with a case that it could help and get it prescribed. Yeah, I have a good hunch the drug could work for some people but I don't have all my bids on it.

 

[Brian Newman]

This has now totally confused me. They are now trialling the HEI bomb blast pill for cancer treatment, seriously? If this won't work, they will probably trial it for MS and in 2030 maybe there is a Phase II trial for tinnitus.

Yeah pretty much. The ear community gets cucked once again. But good news is if it passes for other uses we can get it prescribed. And give it a try.

 

[Mentos]

Yeah pretty much. The ear community gets cucked once again. But good news is if it passes for other uses we can get it prescribed. And give it a try.

Exactly, who gives a duck if it's approved for cancer, tinnitus or acne. Once in a market, one can get it prescribed off label.

 

[OptimusPrimed]

This isn't the drug we're looking for. I mean it's in a clinical trial... FOR CANCER TREATMENT. I seriously doubt this drug does anything for tinnitus. It might prevent tinnitus or lower the odds of hearing damage for those exposed to loud sounds; but I do not believe this is the drug that will treat tinnitus in existing sufferers.

 

[AfroSnowman]

This isn't the drug we're looking for. I mean it's in a clinical trial... FOR CANCER TREATMENT. I seriously doubt this drug does anything for tinnitus. It might prevent tinnitus or lower the odds of hearing damage for those exposed to loud sounds; but I do not believe this is the drug that will treat tinnitus in existing sufferers.

Why?

 

[Brian Newman]

This isn't the drug we're looking for. I mean it's in a clinical trial... FOR CANCER TREATMENT. I seriously doubt this drug does anything for tinnitus. It might prevent tinnitus or lower the odds of hearing damage for those exposed to loud sounds; but I do not believe this is the drug that will treat tinnitus in existing sufferers.

It was originally developed for hearing loss and tinnitus. It can reconnect nerve endings in mice. Years of testing proved this. Humans we don't know. If someone's tinnitus is from nerve/ synapse damage, it could help.

 

[ThomasC]

As long as they don't change the formula, it doesn't sound too bad.

 

[aorelia]

It was originally developed for hearing loss and tinnitus. It can reconnect nerve endings in mice. Years of testing proved this. Humans we don't know. If someone's tinnitus is from nerve/ synapse damage, it could help.

This might've been answered, but how does one measure if tinnitus is from nerve damage?

 

[Brian Newman]

This might've been answered, but how does one measure if tinnitus is from nerve damage?

There is seriously no way to tell for sure. I heard maybe like an ABR test or something like that. I've been talking with a lot of knowledgeable people and the theory is if you have pain hyperacusis, or noise-induced tinnitus and have perfect hearing, then it could most likely be nerve/synapse damage. There is no other explanation how for many years I've had tinnitus in my right ear from a gunshot, but have a perfect audiogram all the way up to 16 kHz.

I actually had mild hearing loss in that ear, then after 6 months it came back. I'm guessing the hair cells were bent and eventually came back up but the nerves/synapses remained damaged causing my permanent tinnitus. Now after suffering a perilymph fistula and acoustic trauma within one year, my audiogram is so good there is no test good enough to measure my hearing. I know I have nerve damage because some of my pain is deep cochlear, and on the Hyperacusis Research pages, they have discovered that noxacusis can be from type 2 nerve fibers getting damaged resulting in constant pain to noise.

I mean I definitely have hair cell damage now as well. But still my audiogram is perfect. There are also a few articles that explain some people can lose up to half of their hair cells, and it won't show up on an audiogram. So it's pretty hard to tell. Usually when people have hearing loss and tinnitus at a certain pitch and a certain amount of hearing loss in that frequency, it's usually hair cells.

 

[Gb3]

Please read the article again. It was used in combination with the other drug. The doctor said that HPN-07 has shown efficacy to treat tinnitus and their person had an acoustic neuroma which can cause tinnitus!

 

[Brian Newman]

Please read the article again. It was used in combination with the other drug. The doctor said that HPN-07 has shown efficacy to treat tinnitus and their person had an acoustic neuroma which can cause tinnitus!

"NHPN-1010, developed by Oblato, a U.S. subsidiary of HLB Therapeutics, is a candidate for the combined use of OKN-007 under development as a therapy for brain tumors and antioxidant ANN-acetylcysteine."​

I could have sworn OKN-007 is HPN-07?

 

[Gb3]

"NHPN-1010, developed by Oblato, a U.S. subsidiary of HLB Therapeutics, is a candidate for the combined use of OKN-007 under development as a therapy for brain tumors and antioxidant ANN-acetylcysteine."​

I could have sworn OKN-007 is HPN-07?

It's not right? Am I reading it wrong? They are referring to two different drugs.