Frequency Therapeutics — Hearing Loss Regeneration

#2,071
#2,073
JohnAdams said:
We won't know anything but whether it was safe, I think.
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That was already confirmed with last year's trial...

"This Phase 1/2 trial builds on the success of our first-in-human study completed last year, which showed FX-322 to be well-tolerated and validated the potential for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery".
 
#2,076
swc5150 said:
That was already confirmed with last year's trial...

"This Phase 1/2 trial builds on the success of our first-in-human study completed last year, which showed FX-322 to be well-tolerated and validated the potential for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery".
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Well, the link above states this:

Frequency Therapeutics Completes Enrollment in Single Dose Safety Trial to Evaluate FX-322, a First-in-Class Drug Candidate for Hearing Restoration

http://www.frequencytx.com/news-events/news-events-press-release-10-4-2018.php

It's from October 4th, 2018.
I understand they are still testing the safety of the cure.
 
#2,078
Flamingo1 said:
They're moving fast! That's good!
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Too bad fast is kinda slow. I understand the need for safety.

What if...... they could evaluate safety and efficacy in one trial? Is that too radical of a notion?

Questionnaire:
1. Did you get cancer?
2. Did your hearing come back?
Approved.

Like others have pointed out, if they move into the next phase it probably means something positive.
 
#2,079
JohnAdams said:
Too bad fast is kinda slow. I understand the need for safety.

What if...... they could evaluate safety and efficacy in one trial? Is that too radical of a notion?

Questionnaire:
1. Did you get cancer?
2. Did your hearing come back?
Approved.

Like others have pointed out, if they move into the next phase it probably means something positive.
Click to expand...

The problem is that there is a protocol that needs to be followed. First you need to show that your drug is safe on healthy subjects before you can test it on sick people. In the case of tinnitus it might be possible to skip this one but what about issues where the sick people are in a really bad physical state that a drug might actually kill them?

Now you might say that there should be some flexibility in the process but that would require a human to have to evaluate on a case to case basis what drug might be able to skip one phase and which ones cannot. And here is where you might run into some serious issues with really bad outcomes.

And that's why there is a strict protocol for drug testing and approval.
 
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#2,080
Silvio Sabo said:
The problem is that there is a protocol that needs to be followed. First you need to show that your drug is safe on healthy subjects before you can test it on sick people. In the case of tinnitus it might be possible to skip this one but what about issues where the sick people are in a really bad physical state that a drug might actually kill them?

Now you might say that there should be some flexibility in the process but that would require a human to have to evaluate on a case to case basis what drug might be able to skip one phase and which ones cannot. And here is where you might run into some serious issues with really bad outcomes.

And that's why there is a strict protocol for drug testing and approval.
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Fair rebuttal. So then why can I get my hands on 7,8-dhf, which is potentially very dangerous, without any FDA approval?
 
#2,081
JohnAdams said:
Fair rebuttal. So then why can I get my hands on 7,8-dhf, which is potentially very dangerous, without any FDA approval?
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Because it's not a drug per se. It's a naturally occurring flavone that can be found in leaves of certain trees. And extracts from plants are usually not considered drugs unless they are to be banned for some reason such as cocaine and marijuana, or they want to get them approved for treatment of a specific health issue. Then they would have to prove efficacy. But instead they are often sold as supplements, not as drugs. Now, you could argue that it should be banned, but that's a whole different discussion.

Also there is a historical aspect that must be weighed in. If something has been used before all the protocols were put in place it rarely has to go through testing. It's been tested by time already so to say. Alcohol and tobacco are prime examples of this. If alcohol or tobacco were to be discovered today they would have been banned for sure. But since we've been using both for thousands of years and they both are such integral part of our culture, it would be very hard to ban them. Something proven by the complete failure of the prohibition laws in the 20th century.
 
#2,082
Silvio Sabo said:
Because it's not a drug per se. It's a naturally occurring flavone that can be found in leaves of certain trees. And extracts from plants are usually not considered drugs unless they are to be banned for some reason such as cocaine and marijuana, or they want to get them approved for treatment of a specific health issue. Then they would have to prove efficacy. But instead they are often sold as supplements, not as drugs. Now, you could argue that it should be banned, but that's a whole different discussion.

Also there is a historical aspect that must be weighed in. If something has been used before all the protocols were put in place it rarely has to go through testing. It's been tested by time already so to say. Alcohol and tobacco are prime examples of this. If alcohol or tobacco were to be discovered today they would have been banned for sure. But since we've been using both for thousands of years and they both are such integral part of our culture, it would be very hard to ban them. Something proven by the complete failure of the prohibition laws in the 20th century.
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3 words: As par tame.
 
#2,085
JohnAdams said:
3 words: As par tame.
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dmorg said:
Aspartame... an artificial sweetener... used in Diet Coke, etc... not real good for humans...

I believe the lad is being facetious.
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Well, Aspartame is a dipeptide (it consists of two amino acids), witch technically makes it a protein. It was actually approved by the FDA in 1981 but was first created in 1965. So it took nearly 20 years before it was approved to be used in food as a sweetener. Aspartame is actually one of the compounds (if not THE compound) that we use that has been researched and tested the most. Or as the FDA put it themselves: "one of the most thoroughly tested and studied food additives the agency has ever approved".
 
#2,087
JohnAdams said:
I think it took a long time to get approved by the FDA because it gave rats tumors. I could be wrong.
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No, it didn't. It's been a lot of trash talking and rumors about aspartame through the years, hence the rigorous testing of it. But it's not dangerous in any way. In fact, in animal testing it was proven to be safe to consume an equivalent of many multitudes higher than what any human could ever consume through food that has aspartame in it.

This is from the American Cancer Society:
"Many studies have looked for health effects in lab animals fed aspartame, often in doses higher than 4 000 mg/kg per day over their lifetimes. These studies have not found any health problems that are consistently linked with aspartame."​

If you translate that to humans, a normal human male that weights 75 kg would have to consume roughly 1 667 cans of Coke Zero per day, every day of his life to reach those kind of doses. As you can imagine it's impossible to do! You would die from encephaloceles (a brain hernia) from the excessive fluid intake long before that.


A can of Coke Zero contains 180 mg of Aspartame.
(4000 * 75) / 180 = 1666,666666667

Sources: https://www.cancer.org/cancer/cancer-causes/aspartame.html
https://en.wikipedia.org/wiki/Aspartame
 
#2,088
Silvio Sabo said:
No, it didn't. It's been a lot of trash talking and rumors about aspartame through the years, hence the rigorous testing of it. But it's not dangerous in any way. In fact, in animal testing it was proven to be safe to consume an equivalent of many multitudes higher than what any human could ever consume through food that has aspartame in it.

This is from the American Cancer Society:
"Many studies have looked for health effects in lab animals fed aspartame, often in doses higher than 4 000 mg/kg per day over their lifetimes. These studies have not found any health problems that are consistently linked with aspartame."​

If you translate that to humans, a normal human male that weights 75 kg would have to consume roughly 1 667 cans of Coke Zero per day, every day of his life to reach those kind of doses. As you can imagine it's impossible to do! You would die from encephaloceles (a brain hernia) from the excessive fluid intake long before that.


A can of Coke Zero contains 180 mg of Aspartame.
(4000 * 75) / 180 = 1666,666666667

Sources: https://www.cancer.org/cancer/cancer-causes/aspartame.html
https://en.wikipedia.org/wiki/Aspartame
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Cool story bro. Here's a study that says that's wrong.

https://www.webmd.com/cancer/news/20051118/rat-study-shows-cancer-aspartame-link

And another one

https://www.sciencedaily.com/releases/2006/02/060213093019.htm

Besides aspartame is made from the cellular waste products of ecoli. And it tastes like dung. Seriously if you're afraid of sugar making you gain weight, drink water.

Aspartame is the absolute dumbest concept next to TRT. Sheeple need to wake up and realize corporations have the power to promote lies to sell their products.

What kind of person wants to drink ecoli poop anyway?
 
#2,089
JohnAdams said:
Cool story bro. Here's a study that says that's wrong.

https://www.webmd.com/cancer/news/20051118/rat-study-shows-cancer-aspartame-link

And another one

https://www.sciencedaily.com/releases/2006/02/060213093019.htm

Besides aspartame is made from the cellular waste products of ecoli. And it tastes like dung. Seriously if you're afraid of sugar making you gain weight, drink water.

Aspartame is the absolute dumbest concept next to TRT. Sheeple need to wake up and realize corporations have the power to promote lies to sell their products.

What kind of person wants to drink ecoli poop anyway?
Click to expand...

Both refer to the same study and it is deeply flawed. Just for one, all rats died from natural causes. Meaning they were all old when they died. Cancer is a disease tightly linked with high age. In autopsies of humans around half of men aged 75 or more were found to have undiagnosed prostate cancer. The thing though is that at around age 100 the fatality rate due to cancer drops to almost 0%, even though a majority of all people who get to live that long tend to have cancer tumors. This is because the disease develops infinitely slow in an aged body. It grows so slow that people have time to die from something else.

What they should have done, and it's mentioned in the article you shared, is to sacrifice animals at certain ages. This is how cancer studies are performed.

Another problem is that they had 100 male and 100 female animals and they used them to test a variety of doses of aspartame. This means that they must have had quite few animals for each dose which could yield unreliable data sets.

Sources:
The High Prevalence of Undiagnosed Prostate Cancer at Autopsy: Implications for Epidemiology and Treatment of Prostate Cancer in the Prostate-Specific Antigen-Era
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485977/

Cancer Suppression at Old Age
http://cancerres.aacrjournals.org/content/68/11/4465

Cancer mortality by age
https://www.cancerresearchuk.org/health-professional/cancer-statistics/mortality/age#heading-Zero
 
#2,090
JohnAdams said:
What kind of person wants to drink ecoli poop anyway?
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Oh and by the way. Genetically modified E-coli is pretty standard for producing certain organic compounds. Genetically modified yeast is another. They are used to produce a variety of drugs such as antibiotics, vaccines and human hormones. Penicillin is also yeast poop. Alcoholic beverages and a variety of dairy products such as cheese all contain microbial "poop". Just sayin...

From the article below:
"Microbial fermentation is the basis for the production of a wide range of pharmaceutical products, targeting practically any medical indication. Examples range from anticancer cytotoxic drugs and vaccines, anti-infectious disease antibiotics and vaccines, to hormonal disorder therapy and many other indications."

Source: https://www.manufacturingchemist.co...ompounds_through_microbial_fermentation/61614
 
#2,092
I had about 20 rats in my life as pets and average lenght of their lifes is 2 years. After that they start to die from many different diseases with diverse forms of cancer in the first place.
 
#2,095
For what it's worth, based on Frequency's latest press release they mentioned pushing this drug into a "Phase 2a" early next calendar year. I personally wasn't quite clear on what a "2a" is, so here's the breakdown:

Phase IIa: Pilot clinical trials to evaluate efficacy ( and safety) in selected populations of patients with the disease or condition to be treated, diagnosed, or prevented. Objectives may focus on dose-response, type of patient, frequency of dosing, or numerous other characteristics of safety and efficacy.

Phase IIb: Well controlled trials to evaluate efficacy ( and safety) in patients with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine's efficacy. Sometimes referred to as pivotal trials.​

This appears to suggest a longer timeline for the drug to come to market, realistically. To go from a 1 to 1.5 to 2a to 2b to 3...... is a lot longer of a path than what I was initially hoping for. To be fair, this is the first drug of its kind, so the lengthy administrative process isn't surprising. CGF166 was first administered to Rob Gerk in 2014 and we won't see the end of the Phase 2 until 2021... 7 years! This speaks a lot to Frequency Therapeutics' ability to administratively navigate FX-322 through the process, even though they are taking the long route.
 
#2,096
Flamingo1 said:
They're moving fast! That's good!
Click to expand...
My guess is we can hope for a phase 2 trial in 2019 and a phase 3 (final?) in 2020.

While indeed the cure must be successful after each phase.

And if successful, how can we define successful from the company's point of view? I personally think this can work as rather pessimistic person, but I really can't say how far it will go.

Can this cure repair your hear even more everytime you take a pill until it's fully restored? Is it a one-shot cure and then you won't be able to improve more? Is all of this just to get your tinnitus from 60 dB to 50 dB? etc.

Many hopes, many questions at this time :)
 
#2,097
I found a couple of ads for postdoctoral fellowships (multiple positions it appears) at Harvard Medical School a while back:

https://jobs.sciencecareers.org/job...-ear-infirmary/?LinkSource=SimilarJobPlatform

From that page:

We have recently uncovered a major mechanism by which adult mammalian inner ear cell types can be induced to divide and differentiate into hair cells with high efficiency by reprogramming. The work sets a stage by which regeneration can be expanded to multiple inner ear cell types to achieve hearing restoration.

https://jobs.sciencecareers.org/job...t-hearing-loss/?LinkSource=SimilarJobPlatform

I thought it was encouraging that research is still continuing strongly there even though many of the big guns are presumably concentrating on Frequency Therapeutics. Also, the two streams within the same lab is interesting. Maybe they see both gene therapy and molecular therapies as working conjointly to achieve hearing restoration. It also emphasises that Frequency Therapeutics is not the only game in town.
 
#2,098
d'Wooluf said:
I found a couple of ads for postdoctoral fellowships (multiple positions it appears) at Harvard Medical School a while back:

https://jobs.sciencecareers.org/job...-ear-infirmary/?LinkSource=SimilarJobPlatform

From that page:

We have recently uncovered a major mechanism by which adult mammalian inner ear cell types can be induced to divide and differentiate into hair cells with high efficiency by reprogramming. The work sets a stage by which regeneration can be expanded to multiple inner ear cell types to achieve hearing restoration.

https://jobs.sciencecareers.org/job...t-hearing-loss/?LinkSource=SimilarJobPlatform

I thought it was encouraging that research is still continuing strongly there even though many of the big guns are presumably concentrating on Frequency Therapeutics. Also, the two streams within the same lab is interesting. Maybe they see both gene therapy and molecular therapies as working conjointly to achieve hearing restoration. It also emphasises that Frequency Therapeutics is not the only game in town.
Click to expand...
How do you know the job listing ISN'T for Frequency Therapeutics?? They are affiliated with Harvard as far as I know.
 

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