World Congress For Hair Research 2017 - Intro

[hanginginthewire]

Merck was well aware of a 5ARI's effect on hair and the prostate. It's hardly the case that proscar just happened to grow hair. It doesn't always end up working that way, and there is no reason for off label use to always be the case. The story of finasteride is so well known that it is posted right here on wikipedia:

"In 1942, James Hamilton observed that prepubertal castration prevents the later development of male pattern baldness in mature men.[44] In 1974, Julianne Imperato-McGinley of Cornell Medical College in New York attended a conference on birth defects. She reported on a group of intersex children in the Caribbean who appeared sexually ambiguous at birth, and were initially raised as girls, but then grew external male genitalia and other masculine characteristic after onset of puberty. Her research group found these children shared a genetic mutation, causing deficiency of the 5α-reductase enzyme and male hormone dihydrotestosterone (DHT), which was found to have been the etiology behind abnormalities in male sexual development. Upon maturation, these individuals were observed to have smaller prostates which were underdeveloped, and were also observed to lack incidence of male pattern baldness.[45][46]

In 1975, copies of Imperato-McGinley's presentation were seen by P. Roy Vagelos, who was then serving as Merck's basic-research chief. He was intrigued by the notion that decreased levels of DHT led to the development of smaller prostates. Dr. Vagelos then sought to create a drug which could mimic the condition found in these children to treat older men who were suffering from benign prostatic hyperplasia.[47]

Finasteride was developed under the code name MK-906.[citation needed] In 1992, finasteride (5 mg) was approved by the U.S. Food and Drug Administration (FDA) for treatment of BPH, which Merck marketed under the brand name Proscar.[citation needed] In 1997, Merck was successful in obtaining FDA approval for a second indication of finasteride (1 mg) for treatment of male pattern baldness, which was marketed under the brand name Propecia."

Source: https://en.wikipedia.org/wiki/Finasteride#History

All that interesting history, science, and human interest and yet propecia is a pile of worthless sh*t. I can only imagine how excited the forums would have been over it had they existed circa 1991 - 97.

 

[H]

I think the suspense is making my hair fall out!...oh wait.

 

[sunchyme1]

@hellouser am i gonna be bald forever?

 

[Trichosan]

@hellouser am i gonna be bald forever?

No, if you are immortal.

 

[kawnshawn]

@hellouser don't mean to be that guy but I'm just wondering when we can expect a data dump? Next weekend? And from what you heard do you still think Shisedio is still on par for a 2018 limited release? Full details in the data dump of course. Just a yes, no or u can't say for certain but are optimistic would suffice. I'm literally losing more hair waiting on your data lol. Fml.

I know it's not gunna make the treatments available any faster but I'm a control freak and I just need to know every last thing up to the minute. It drives me mad not knowing haha.

At this point its completely up in the air in regards to Shisedio because of the curveball the representative said about the project has been "transferred" to replicel. They are still currently doing the trial but Replicel didn't hold their end of the bargin up with Shisedio which has me worried.

 

[bags]

I dunno man. I honestly think like I previously stated they just don't want to say anything to anyone who appears to be from the west, in fear that they maybe working on behalf of Replicell to try and catch Shisedio employees saying something that would fcuk them in the court of law. Especially when they come up to you with recording devices asking questions regarding Replicell like H.U. did.

I know he did not mean any harm or offence but it would have been better if he just asked about them and their progress instead of bringing Replicell name into the question. Oh well I'm just excited to hear what he's got.

I truly believe that what they told him has nothing to do with their progress Good or Bad. I think they just heard Replicell and a huge red flag went up. Like get this guy away from here.


Jm2C

At this point its completely up in the air in regards to Shisedio because of the curveball the representative said about the project has been "transferred" to replicel. They are still currently doing the trial but Replicel didn't hold their end of the bargin up with Shisedio which has me worried.

 

[PJGG]

Shiseido Complaint

In mid‐2016, Shiseido alleged RepliCel’s breach of obligations in the agreement which Shiseido alleged were potentially terminal to future obligations pursuant to the agreement. RepliCel has vigorously denied the existence of such breach and insists on the ongoing validity of the respective obligations on both parties pursuant to the agreement. (Company Filing)

The alleged breach relates to two matters:
1) Loss of a culture medium – RepliCel’s supplier was acquired by GE and then ceased making the medium for the cells. The recipe as transmitted simply did not work and so RepliCel and its contract staff had to recreate the new medium. It’s the same medium now being used by Shiseido in its current trial.
2) RepliCel’s failure to initiate a Phase II trial in pattern baldness. The contract, however, does not state a timeline. While financials have certainly limited RepliCel’s ability to move swiftly, the management maintains its intent to proceed.

There is no litigation that has been triggered. There is a downside for Shiseido: it has access to the technology as it stood when it licensed. A fight to the finish terminates access to improvements.

At its worst, Shiseido receives a royalty-free license to the hair restoration technology. RepliCel loses the following:

1) Up to $31M in milestone payments;
2) Single digit royalties on net sales in Japan, China, South Korea, Taiwan and the ASEAN countries.

If the upcoming milestones are positive, we expect this dispute to resolve. RepliCel will then look more like a viable company and it will get ready for its next set of clinical trials and begin partnering negotiations anew.

 

[kawnshawn]

Shiseido Complaint

In mid‐2016, Shiseido alleged RepliCel’s breach of obligations in the agreement which Shiseido alleged were potentially terminal to future obligations pursuant to the agreement. RepliCel has vigorously denied the existence of such breach and insists on the ongoing validity of the respective obligations on both parties pursuant to the agreement. (Company Filing)

The alleged breach relates to two matters:
1) Loss of a culture medium – RepliCel’s supplier was acquired by GE and then ceased making the medium for the cells. The recipe as transmitted simply did not work and so RepliCel and its contract staff had to recreate the new medium. It’s the same medium now being used by Shiseido in its current trial.
2) RepliCel’s failure to initiate a Phase II trial in pattern baldness. The contract, however, does not state a timeline. While financials have certainly limited RepliCel’s ability to move swiftly, the management maintains its intent to proceed.

There is no litigation that has been triggered. There is a downside for Shiseido: it has access to the technology as it stood when it licensed. A fight to the finish terminates access to improvements.

At its worst, Shiseido receives a royalty-free license to the hair restoration technology. RepliCel loses the following:

1) Up to $31M in milestone payments;
2) Single digit royalties on net sales in Japan, China, South Korea, Taiwan and the ASEAN countries.

If the upcoming milestones are positive, we expect this dispute to resolve. RepliCel will then look more like a viable company and it will get ready for its next set of clinical trials and begin partnering negotiations anew.

Guess we won't know much until Replicel has a meeting with its stock holders.

 

[Pauly198]

I emailed Replicel a few days ago asking if Shiseido is still on track to launch the treatment next year. Lee Buckler got back to me and said that it depends on the clinical data. Shiseido may decide to launch the product after they release the data next year. So it doesn’t sound like anything has changed.

 

[Jonnyyy]

If only I started to go bald this year instead of 3 years ago

 

[kawnshawn]

I emailed Replicel a few days ago asking if Shiseido is still on track to launch the treatment next year. Lee Buckler got back to me and said that it depends on the clinical data. Shiseido may decide to launch the product after they release the data next year. So it doesn’t sound like anything has changed.

I wonder how good the clinical data is gonna have to be for them to launch it.

 

[hellouser]

I emailed Replicel a few days ago asking if Shiseido is still on track to launch the treatment next year. Lee Buckler got back to me and said that it depends on the clinical data. Shiseido may decide to launch the product after they release the data next year. So it doesn’t sound like anything has changed.

?! He got back to you? Can you PM me the email you used?

 

[Pauly198]

?! He got back to you? Can you PM me the email you used?

Hey Hell, I don’t think the site is allowing me to PM since I don’t have many posts but I just looked up Replicel’s contact information on their page and used the email that’s listed.

 

[hellouser]

Just the generic info@replicel.com email?

 

[Pauly198]

Just the generic info@replicel.com email?

Yup, that’s the one

 

[hellouser]

Update: A bunch of new presentations just got posted, with slides;

https://www.hairlosstalk.com/interact/forums/general-discussions-presentations-and-interviews.63/

Note: I didn't get photos of EVERY slide, but for all the important presentations, I have either all or close to all. Still, this is much better than the 2015 congress where we only had audio. Enjoy!

 

[Recon_s]

why is anyone losing their minds about what ever data is still to be uploaded?? the bottom line is there is still no cure

 

[otis]

Merck was well aware of a 5ARI's effect on hair and the prostate. It's hardly the case that proscar just happened to grow hair. It doesn't always end up working that way, and there is no reason for off label use to always be the case. The story of finasteride is so well known that it is posted right here on wikipedia:

"In 1942, James Hamilton observed that prepubertal castration prevents the later development of male pattern baldness in mature men.[44] In 1974, Julianne Imperato-McGinley of Cornell Medical College in New York attended a conference on birth defects. She reported on a group of intersex children in the Caribbean who appeared sexually ambiguous at birth, and were initially raised as girls, but then grew external male genitalia and other masculine characteristic after onset of puberty. Her research group found these children shared a genetic mutation, causing deficiency of the 5α-reductase enzyme and male hormone dihydrotestosterone (DHT), which was found to have been the etiology behind abnormalities in male sexual development. Upon maturation, these individuals were observed to have smaller prostates which were underdeveloped, and were also observed to lack incidence of male pattern baldness.[45][46]

In 1975, copies of Imperato-McGinley's presentation were seen by P. Roy Vagelos, who was then serving as Merck's basic-research chief. He was intrigued by the notion that decreased levels of DHT led to the development of smaller prostates. Dr. Vagelos then sought to create a drug which could mimic the condition found in these children to treat older men who were suffering from benign prostatic hyperplasia.[47]

Finasteride was developed under the code name MK-906.[citation needed] In 1992, finasteride (5 mg) was approved by the U.S. Food and Drug Administration (FDA) for treatment of BPH, which Merck marketed under the brand name Proscar.[citation needed] In 1997, Merck was successful in obtaining FDA approval for a second indication of finasteride (1 mg) for treatment of male pattern baldness, which was marketed under the brand name Propecia."

Source: https://en.wikipedia.org/wiki/Finasteride#History

Nevertheless Proscar was prescribed off label in 5mg dose for hair loss before Merck did trials on it to see what dosage it would help hair loss. .You have just been corrected.

 

[d3nt3dsh0v3l]

Nevertheless Proscar was prescribed off label in 5mg dose for hair loss before Merck did trials on it to see what dosage it would help hair loss. .You have just been corrected.

That's a side point, I think.

If I understood correctly, you were originally suggesting that the next hairloss drug will be a drug developed for other diseases but one that just so happens to grow hair as a side effect; at the point of this serendipitous discovery, the drug is rebranded or otherwise used off label for hair growth. And you have correctly recognized that that was exactly the case with minoxidil, but I disagree with your placement of finasteride in the same category.

As I mentioned earlier, a 5ARI's consequence on both hair and prostate growth were very well elucidated due to the studies on the 5AR-deficient population in the Caribbean. Hair growth was always expected and it is therefore not surprising that Propecia was released a mere 5 years after Proscar. In this case, the brief period of off label use prior to the release of Propecia is due to jumping the gun and off label use of Proscar currently is only done for obtaining finasteride at a lower price.

So, the mere fact that Proscar was (and is) used off label offers no insight into the difficulty of finding a hairloss cure, the manner in which that discovery is made, or the field in which it is made (there are clearly non small molecule approaches such as autologous cell transplantation that show promising, if not more elegant means to cure hairloss; biopharmaceuticals are an emerging important class of drugs that do not fall into the small molecule category).

And so I reject your claim about how the next hairloss drug will arrive to the general public.

The next hair loss drug will be prescribed off label just like Minoxidi and Proscar was.It will be a drug that was made for another use that grows hair. These companys at the conference are just there to keep the investors they are robing happy.

 

[Recon_s]

..haven't you been following organ technologies progress? there just might be something on the horizon, that can be released within 3 years due to japanese stem cell laws...
there are many threads on this.

Horizon me bollox, we have been hearing that for years, oh another 5 years another 10 bla bla bla