REPLICEL Had Double Digit Hair Growth

[Sean]

I got an email this morning. Take a look at the article.

 

Further Analysis Reveals Double Digit Hair Growth in RepliCel's First-in-man Clinical Trial - Yahoo! Finance

 

The stock shot up today as investors are now loading up. I wonder if big pharmaceutical corporations are buying up shares at the low stock prices today. I also wonder which institutional investors are loading up on this stock.

 

The results that were released last time were based on an average and not individual percentages. They finally released the critical details and I think it is somewhat positive result. You have to also factor in the duration of the study on humans. Realizing hamsters/mice which have had a very high response rate age quicker vs human years. On Humans, the results might be coming in slower. This does bring some more hope now.

[HARIRI]

Sean, Im lovin it. Thanks for the update, I can say Replicel is on the right path along with Histogen. One of them will be ready soon. Im keeping my crown restoration to these technologies. I can wait 3-5 years more only. For the mean time, I would just do scar revision to fix my scar and restore my temples with whatever grafts be extracted from the strip maybe 500 grafts if lucky.

[Sean]

Sean, Im lovin it. Thanks for the update, I can say Replicel is on the right path along with Histogen. One of them will be ready soon. Im keeping my crown restoration to these technologies. I can wait 3-5 years more only. For the mean time, I would just do scar revision to fix my scar and restore my temples with whatever grafts be extracted from the strip maybe 500 grafts if lucky.

 

Hariri, thanks for the reply. Aside from Replicel, I am pretty surprised with Histogen's study as well. The "Stimulation of hair growth in humans by cell-secreted proteins" presentation slide they just released showed some adequate growth. Granted, they used a female patient's before and after to showcase the result, but I think in their overall study, there was a positive response rate. If I am not mistaken, Suneva Medical, a privately held company, just signed some agreements with Histogen too. So, lets see how things progress. I think we have probably seen more action from such companies in the past month in terms of results vs from the day they began. So, there is movement, there are signs showing something is happening, but I guess when these things are successfully cleared through the FDA after the trials and finally on the market, we can clearly see how these things can benefit the hair loss community. I also heard the expected costs were possibly on par with the surgical treatments today, so that is not something to be happy about.

[Spanker]

The stock is half of what it was a month ago.

[Sean]

The stock is half of what it was a month ago.

 

You are right. It did take a dive but that was due to what happened April 27 I think.

 

Around April 27, they released a retraction which led to the sudden drop in price.

Source: RepliCel Announces Retraction of Public Disclosure - Yahoo! Finance

 

Around May 2, when they released their findings initially their stock dropped again because of the 6% or so average growth rate. Which seemed really low and worrying.

Source: RepliCel Releases Positive Results from the Interim Analysis of Data from its First-in-man TS001-2009 Clinical Trial - Yahoo! Finance

 

I thought that poor rate was alone to make it dive even more, kind of like what happened to BPAX. Bringing the price down to well below the .50 cent per share range.

 

Around May 17, they clarified what they meant by the averages and that the "first-in-man clinical trial revealed substantial hair growth including seven participants with growth in excess of 10%, including 17.2%, 19.2% and 19.6%". This is when the stock jumped a little and I actually thought it would rise a little higher.

Source: Further Analysis Reveals Double Digit Hair Growth in RepliCel's First-in-man Clinical Trial - Yahoo! Finance

 

The stock jumped from $1.19 to $1.32 but I guess it stopped there and is now at $1.18 as of today.

Source: RepliCel Life Sciences Inc., REPCF Stock Quote - (OBB) REPCF, RepliCel Life Sciences Inc. Stock Price

 

So, it seems to be steady around that level for now. I guess they should definitely plan their PR releases properly and clarify things better in the first place.

 

They were focusing their results on safety more here rather then efficacy of treatment in this last trial. If they can now implement higher doses, which they are considering on doing now for this next trial, which possibly includes more humans in this trial, the response rate of treatment may be higher overall. I am surprised they even got those percentages on some individuals in the first place as I was very skeptical about this initially. So, they got the safety issue out of the way and if this response rate of efficacy is higher, then this stock may very well rocket more. I think the safety issue along with the very small sample of humans they used in the clinical trial was just a major stepping stone they had to cross.

[whacked]

This is by no means directed at you!!! BUT< I am so sick of hearing "it's just 5 MORE years away"

 

Been hearing false hopes like that since I was 25. Im 45

 

NOT

I can wait 3-5 years more only.

[Sean]

I agree. I was extremely skeptical about these things in the past as we have heard the same old story every time regarding 5 years or 10 years and other exaggerations. In the past, such companies focusing on breakthrough treatments have made really bold claims with no significant evidence to back it up based on humans. They were all going at it based on positive results on animals. So many of us have been waiting for years wasting our time for the miracle cure.

 

Now, this company Replicel, has actually done a FIRST-IN-MAN Clinical Trial. What "FIRST-IN-MAN" means is, instead of in vitro animal testing, it is being tested on humans for the first time. So, Replicel has finally tested it on humans based on their method/approach to hair replication which involves the use of dermal sheath cup cells/injection. This recent trial they ran focused on the initial safety/efficacy of the treatment. During this first-in-man trial, Replicel discovered that some people did respond more than others to their initial low level dosing and had more growth VS others in the trial. This is where there was an indication that there was a response on humans for the first time at the doses they initially administered.

 

According to the May 2012 Investor/Replicel Fact Sheet, this is what's written as to what Replicel has accomplished so far:

 

Pre-Clinical= Process was proven safe and highly effective in the standard research Philpott SCID Mice Model.

 

So, the Pre-Clinical is the animal model I was referring to.

 

Phase I/IIa= Studies safety and efficacy of our procedure; 10 men & 9 Women; Randomized; Single-centre; Double-blind; Placebo-controlled

 

Phase I/IIa is when the first-in-man human trails started. They started their first-in-man trial in December 2010. Their last subject from this trial was injected in August 2011. After 6 month post injection, the results were announced May 2, 2012. So, this was not too long ago.

 

So, Replicel has only done a 6 month interim analysis so far which indicated 63% of their subjects had an increase in hair density which was greater than 5% versus the control. However, some participants demonstrated changes from baseline that were as much as 19.6% while others showed decreases as much as 6.2%.

 

According to Clinicaltrials.gov, for this trial:

 

Estimated Study Completion Date: October 2013 Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Here is information regarding that ongoing study: Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia - Full Text View - ClinicalTrials.gov

 

 

 

Now, for their Phase IIb trial: First thing they have to do is to get regulatory approval for this phase of the clinical trial. I personally think that wont be too hard since they did seem to prove safety as well as efficacy in the previous one. Replicel is planning a 12-24 month clinical trial in which they are going to include multiple patients who will get getting different doses of dermal sheath cup cells. So, they will monitor for more efficacy as well as keep an eye on safety.

 

If there is no regulatory hold up to their trials, if they don't have safety issues with other doses, if their efficacy gets better, and so forth, then it could really mean their treatment will be available to the public in the next couple of years. The positive minimal results they posted are a legit jump start and I am starting to think they may really have something here. I am shifting from being skeptical into thinking that ok, now we have numbers, and the numbers are based on humans. Lets hope it keeps up.

 

I don't know if this will be out in 5 years time, but it is quite possible if each phase is to be around 12-24 months. This time it is with a little more certainty because of the response data. I do think it's great news their trial is being conducted in Tbilisi, Georgia. This means it's Europe. I think over 60% of American trials are now conducted in Europe because the FDA here has such strict/time consuming guidelines & that Europe has multiple benefits. One major benefit is that you can get the product to market sooner.

Source for info: http://www.baybio.org/files/AC08_T4S3_Global_Clinical_Trials.pdf

 

At the same time, I wouldn't waste time waiting again but would get a hair restoration procedure because this will take some time. It's not going to happen overnight.

 

Just know the trial has begun with success, there was a response, if it goes with the flow until the end without any disruption, then I think we got ourselves a treatment that can become a permanent solution to hair loss.

 

Read the following for research info: http://www.replicel.com/wp-content/uploads/repilcelfacts_May2012_w.pdf

[whacked]

Killer reply buddy thanks........know what the unfortunate irony is for me tho? "its still 5-10 years out" even IF this works

 

LOL

[jamescarter]

Replicel may still be a very viable treatment, with some of the subjects having over 19% improvement in hair growth. If you consider that this was purely a safety test, then I imagine they can take these results and look at what caused these subjects to gain so much hair, and from there refine the treatment.

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Edited January 15, 2013 by TakingThePlunge
outside link removed.