Clinical Trials of D-Methionine: Interview with Kathleen Campbell, PhD

Clinical Trials of D-Methionine: Interview with Kathleen Campbell, PhD

September 13, 2013 Interviews
Douglas L. Beck, AuD, spoke with Dr. Campbell about phase 3 clinical trials of D-Methionine, an oral pharmacologic, which may be beneficial to help reduce or prevent noise-induced hearing loss.

Academy: Good morning, Kathy! Great to see you again!

Campbell: Hi, Doug. Thanks, good to be with you, too!

Academy: This is an incredibly important time for you and your research partners! As best I recall, after more than a decade of research, you're just about to enter Phase 3 clinical trials for (the amino acid called) D-Methionine (D-Met)?

Campbell: That's right. The U.S. Food and Drug Administration (FDA) has approved us for a phase 3 clinical trial, as D-Met has demonstrated enormous protective potential with regard to noise-induced hearing loss, drug-induced hearing loss (with regard to platinum-based chemotherapy), as well as aminoglycoside antibiotics (with regard to moderate to severe infections and for treating radiation-induced oral mucositis following radiation treatment for head and neck cancers). D-Met also may be beneficial to help reduce other side effects from chemotherapy and radiation cancer treatments.

Academy: Fantastic. Can you give me a snapshot of Phase 1 and Phase 2?

Campbell: Sure. Phase 1 studies were completed to assure safety and addressed dose escalation safety studies. Phase 2 studies involved clinical trials to reduce cispatin-induced hearing loss in a variety of cancer patients and on radiation induced oral mucositis, which often occurs following radiation treatment for head and neck cancers. The multiple clinical trials combined involved a variety of subject populations.

Academy: But for now, to prevent noise-induced hearing loss and tinnitus, you're working with the United States Department of Defense (DOD)?

Campbell: Exactly. It's been a fantastic collaboration, and we work very well together. They have amazingly dedicated people, disciplined processes, and protocols but with unavoidable noise exposures. The opportunity to help our troops with an oral pharmacologic that may help reduce or prevent noise-induced hearing loss and tinnitus is so interesting and may prove (in time) to be a significant game changer.

Academy: Absolutely. And as a reminder, Kathy, I believe your group discovered and published (17 years ago!) that D-Met protected against hearing loss caused by cisplatin—which was amazing then, and still seems amazing now. So then, this seems like a good time to ask…what is D-Met?

Campbell: D-Methionine is a micronutrient found in common foods such as cheese and yogurt—so it's not alien to the human digestive system. It's a component of high quality fermented protein in the diet and it's been studied for decades in both human and animal nutrition studies as well as our previous clinical trials for chemotherapy (i.e., cisplatin) induced hearing loss and radiation induced oral mucositis. I should note one simply cannot take a whole lot of protein and hope to get the same result, that won't work! It would take over 5 pounds of cheese for a single dose of D-met. Not much fun!

Of note, none of the subjects demonstrated side effects greater in the D-met group than in the placebo group when given the same dosing level proposed for this study (100 mg/kg/day).

Academy: And one of the most impressive findings so far, has been that you should be able to use D-met to rescue noise induced hearing loss. Is that correct?

Campbell: Yes. According to a variety of pre-clinical studies D-met can apparently reverse hearing loss, if started within (up to) 7 hours after noise cessation. We are funded by the Department of Defense for more work to see if we can even wait a few days after noise to first start the D-met and still prevent permanent hearing loss.

Academy: Has anyone else shown D-met protection from hearing loss?

Campbell: I first discovered it here at SIU and patented it but since that time multiple published research studies around the world have confirmed and expanded our findings.

Academy: And I read that D-met is a direct and an indirect antioxidant? And can you explain what that means, please?

Campbell: Well, these terms are difficult to conclusively define without getting into the real chemistry, but here's a way to think about it...Direct antioxidants are the common ones everyone is used to hearing about. These are found in berries, such a cranberries, blueberries, and blackberries, and there are other sources of antioxidants, too, such as beans, artichokes, pecans, walnuts, and hazelnuts, too.

These foods provide direct antioxidants and these same direct antioxidants interact with free radicals to interrupt oxidation, so as to preserve healthy molecules. However, indirect antioxidants are those which are produced by (and within) the body. D-met is both! Of course there are all different types of antioxidants and they can act in different ways.

Academy: Fascinating! Okay, and so D-met seems to be a bit of a "wonder drug," so to speak.

Campbell: Well, we're very hopeful. However, the reason we've gone through all of this work for the last decade or more is to be sure that when we come out with a statement, it is scientifically correct and well documented. As you know, Doug, there are just hundreds and thousands of supplements and vitamins and non-FDA approved claims made for lotions, potions and pills for everything from tinnitus to dizziness to hearing loss and bogus cancer cures and so much more! Many of the ads and some claims made in non-FDA approved "treatments" are just ridiculous, unproven and in some cases unconscionable.

Academy: And so when you've finished Phase 3, the data will be solid, scientifically sound and the claims or outcomes made at that point will be scientifically proven and statistically beyond reproach?

Campbell: That is exactly the goal. But as per protocol, the FDA will require at least one more confirmatory Phase 3 study prior to approval—but that's a very long story, and we'll save it for another day!

Academy: Kathy, this is fascinating work, and I am so impressed with what you're doing, and I'm, very grateful for your time and explanations this morning!

Campbell: My pleasure, Doug. Thanks for your interest in our work!

Kathleen Campbell, PhD, is the professor and director of audiology research in the Division of Otolaryngology, Department of Surgery at SIU School of Medicine andfaculty researcher at Southern Illinois University School of Medicine.

Douglas L. Beck, AuD, Board Certified in Audiology, is the Web content editor for the American Academy of Audiology.

http://www.audiology.org/news/clinical-trials-d-methionine-interview-kathleen-campbell-phd

 

https://clinicaltrials.gov/ct2/show/NCT01345474

 

Too bad this is another one of those things only useful for acute noise damage.

 

"We are funded by the Department of Defense"

What a pity, what a waste!!!!!!!!!

 

I've email Dr. Campbell directly. She does respond but gives out little information on D-Methionine. I do have high hopes for it even though it's not being used to treat tinnitus discreetly. I've tried to purchase the raw material and have a compounding pharmacy make it for me. This failed unfortunately.

 

Yeah, but I'd happily eat this before going to dentist or some other situation where noise is unavoidable.

 

Where can I buy D-methionine? Should I take it before the noise-exposure or after it?

 

Okay we can buy it from Sigmaaldrich I guess. And I read you have to take it after a maximun of 7 hours after the noise trauma.

Anyone knows what dose should we take if it happens?

 

$107 for 25 grams...

http://www.sigmaaldrich.com/catalog/product/sigma/m9375?lang=en&region=US

 

@Atlantis Yeah thanks! But Have no idea about the dosage to take after the trauma =( 1g, 2g? Do you think Dr. Campbell would respond an email about the dosage to take?

 

On the trial site it says
https://clinicaltrials.gov/ct2/show/NCT01345474

Drug: D-methionine, oral liquid suspension
Two daily doses of up to 100mg/kg/day of D-met for 18 days
Other Name: D-met

Meaning if you weigh 90 kilograms, you take 9 grams twice a day.

 

@Atlantis Thanks a lot. Wow that´s a very very expensive treatment then. I just was thinking about take D-met if I experienced some spike in my T after any loud event. I wonder who would pay 18g during 18 days, thats a lot of money! =(

 

Hey guys, I have found this:

http://www.accelachem.com/cn/productview_goodsid_2427_goodscode_SY004418.html

100g = 110 USD. Why so much difference from Sigmaaldrich? If this is the price, I can give a try

Found this too: https://www.molport.com/shop/molecule-link/MolPort-001-792-019

I dont know why there is so much difference in prices....

 

Are the cheaper prices from China? I don't trust Chinese pharmaceuticals. How would you ascertain their purity?

 

Accelachem is from China, the other ones in the second link I dont know it. Accela says its 97%+ of purity. No idea about how ascertain the purity, but maybe buy 5g from Sigmaaldrich and comparing can be a good aproximation.

Why dont you trust China Pharmaceuticals, some bad experiences with them?

Combi-blocks sell 100g=50 USD 98% purity (with 70 USD of shipping costs) and its from USA. Why the fuck so much difference in prices ?!

Bah I think you have to be in a chemical company otherwise you cannot buy....

 

Seems like DL-met is available in a lot of sources as an homeopathic remedy. Is this a mixture of L-met and D-met?

 

Sigma-Aldrich is not where you buy things for consumption. Moreover, I don't think they will ship to residential addresses.

Jesus I thought I had seen everything.

 

What do you mean? Is the D-Methionine Sigma-Aldrich is selling unfit for human consumption? Harmful? Who is it made for then?

 

Sigma-Aldrich is a chemical company. It is made for research purposes only.

 

Correct. All, go back and read my post. D-Meth in not for sale to the public. I tried to purchase it from Sigma-Aldrich but they will stop you at checkout and ask for research credentials. They sell the raw material. It's not suitable for human consumption in that form. If you are able to get it somehow, a compounding pharmacy can make it for you if you have a prescription. Accelachem looks to be the same as Sigma-Aldrich.

 

So this is not for "chronic" sufferers then?

 

7 hours? How would anyone get treatment in 7 hours.

 

I know... If this is the case, this specific medication would basically prove useless to the vast majority of the population with T.

But maybe they can learn something from it.

 

The ER. Sudden hearing loss is a medical emergency.

 

Why?
It still good to treat in case of a new noise exposure so it won't get worst