Hough Ear Institute's Hair Cell Regeneration Project

Thanks much. I guess we can only assume the candidate is doing well? I didn't see Justin de Moss answer that question in this thread.

 

Because Justin was from Hough Ear Institute and they did not have anything to do with this compassionate use patient. If they knew something about the patient's progress, they probably wouldn't be allowed to say it.

The patient could now be doing poorly for all we know.

 

We could email the doctor.

 

Yes we could. I have no issue bombarding him lol. Here’s his email address: santosh.kesari@providence.org.

I’m sending an email now.

 

We could stop blowing up the inboxes of people at Hough...

 

Why? What is there to lose at this point?

 

It takes a few people getting too aggressive with bombarding emails for them to get cut off along with the entire community. It's better to work through official channels / events / forums and structure communications in a formal manner. Everyone benefits long term that way.

I see you're new to tinnitus. So, I'll catch you up. This is a really tough community to make happy, so tough that it probably shoots itself in the foot more often than not.

 

The doctor in question doesn’t work at Hough.

 

Doesn't matter. This is almost worse.

 

I contacted Dr. Santosh Kesari of the Saint John's Cancer Institute to make an appointment.

Gonna do a virtual call with him and see if he can apply for the compassionate use on my behalf. This doctor seems top tier in his field.

I’ll keep this thread updated.

 

You make this statement regarding the community. I’m confused as to how they differentiate people from this community, presumably you’re speaking of Tinnitus Talk, from the general public? Is everyone identifying as being from Tinnitus Talk in their emails? Just because people aren’t on Tinnitus Talk doesn’t mean they aren’t sending emails regarding the same things. If they don’t seek out support forums they are probably even more likely to choose direct contact with an individual or entity.

When someone is suffering severely it’s difficult to sit around and wait for answers from these certain channels you speak of. In addition asking questions on this board, they will often go unanswered, especially if they are redundant. But again when you’re suffering severely who wants to go dig through a 300-page thread, read a research paper, run through the entire news history of a company online for the answers they are looking for?

When you speak of the community in regard to the difficulty in making members happy I know what you mean. However, tinnitus has long been inundated with snake oil so the community is very skeptical and untrusting. Yeah it sucks, but it is what it is.

I say all this as someone who has never emailed a researcher myself except to inquire about becoming a trial participant. Still I can empathize with those who send these messages.

The lack of empathy and constant blunt criticism or outright attacks on here are disconcerting as a support community. You stick to the Research News section pretty much and that may speak to your approach to things, but you’ve been harping on this quite a bit now with little consideration of the other side of the coin.

If certain members of this community want others to stop emailing researchers, then knowledgeable posters directly addressing questions that constantly get brought up, amongst other things, would be an avenue to do so. I don’t think airing these frustrations constantly is doing much. As you can see people scroll right past your gripes and email away.

 

Why is that almost worse? This is a doctor. It is their job to consult with patients.

I disagreed with people contacting researchers about trials because they can’t really even discuss outcomes until the trial is completed.

 

How are people going to get access to the drug without contacting the doctor who has it?

 

I wish you the best.

 

The doctor doesn’t have it. He has to apply to get it.

 

Thank you for making efforts to participate in trials.

 

"Dr. Santosh Kesari of the Saint John's Cancer Institute in the U.S., who had conducted clinical trials to treat recurrent glioblastoma of HLB Therapeutics, suggested its possible efficacy in tinnitus."​

Or does he? Maybe he has jars of it. Either way people will have to reach out to him.

 

Seems dismissive as a response to what I wrote.

 

Not at all. I respect your point of view. Should have started with that.

 

Thank you for saying exactly how I feel and much more eloquently if I may add. If I wasn’t in such a severe state of distress it might be easier to pine through hundreds of posts in a thread or a research paper. Hopefully we can all consider this and be more compassionate towards each other. I’ve often found other Tinnitus Talk members’ criticism very harsh that I was even asking questions as opposed to searching through threads or the forum itself.

 

THIS is so much smarter than what I did.

Please keep us posted and I will follow your lead as well.

 

I’ve made a telehealth appt with Dr. Kesari for next week. He wouldn’t tell me anything regarding the existing compassionate use case for obvious reasons I guess but he was very welcoming of my telehealth appt knowing my objective. I’ll keep you all posted. I am half an hour from Oblato Inc.

 

Did you call? I emailed them and sent messages on their website. No response.

 

Hi @Brian Newman, yes I did. Here’s the number for the telehealth line and the email for the coordinator:

310-582-7600
melissa.alvarezamaya@providence.org

 

E-mail I received from Oblato:

Dear Eliot

Thank you for your e-mail and sorry for the late reply.

This NHPN-1010 will be developed for the treatment of Meniere’s Disease, tinnitus, and noise-induced hearing loss and so on. But, the only way to join the clinical trial at this moment is the EAP study below.

Oblato, as a sponsor, can provide the study drug (OKN-007) through the compassionate study for the case of you as requested. Please refer to FDA expanded access (link: https://www.fda.gov/news-events/public-health-focus/expanded-access) for the compassionate study to move further.

There are multiple steps to conduct the compassionate study. In terms of the compassionate study,

1. Physician has to submit Investigational New Drug Application (IND) and get an approval of the compassionate study to FDA as a sponsor-investigator.

2. While the physician’s IND is approved by FDA, Oblato will discuss with the physician for relabeling of the drugs, and supplying to the physician based on the physician's protocol.

3. Oblato will make the confidential & clinical trial agreements with the hospital that the physician will conduct the compassionate study.

4. Once the IND has been approved and the agreements have been executed, Oblato will supply the study drug to the physician.

※ This is not a CLINICAL TRIAL by Oblato, so the physician will be responsible for all about the study and Oblato will only serve the study drug to the physician as a supplier.

I hope this can be helpful and please let me know if you have other questions.

Best regards,
TED
===================================================
Ted UM
Director / Clinical Trial Division Oblato Inc.
US: 116 Village Blvd, Suite 200 Princeton, NJ 08540, USA
Korea: 22nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si,
Gyeonggi-do 13554, Korea T. +82-31-786-7744 F. +82-31-786-7799
===================================================​

 

Thanks!

 

Great share! We appreciate it a lot!

 

I received the same email. I just hope physical distance can be worked out since I'm on the East Coast. Hoping these are general guidelines as opposed to the meds being sent to the doctor and dispensed physically by the doctor.

 

Come on Oblato, get a move on

 

I emailed Oblato asking if they accept foreigners, here is their response:

“Unfortunately, as we don’t have a plan to perform EAP study abroad due to real issue in practice, you need to contact any available US physician who has a positive mind for the EAP study which targets at foreign patients. Though you will meet the US physician who has a plan for the EAP study for you, you need to come and join the EAP study in US and It takes so long time to stay in US to get the intravenous injection by three times a week for 8 weeks for EAP study.”​

I am confused though, I thought this drug was a pill, not an injection. Anyone has an idea?