New Puretech Article Mentions Follica

Xaser94

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Unfortunately no new info, but I found the following 2 quotes interesting

"There is even a business, Follica, which is well on the way to creating a new hair-loss treatment."
"As these businesses develop, however, PureTech can either keep them and continue to invest in them, go into partnership with larger drug groups or sell them completely. Different options will be chosen for each business, but the group is being closely watched by several of the largest pharmaceutical firms in the world."


http://www.thisismoney.co.uk/money/...hair-loss-tech-firm-turning-concept-cure.html

Sounds like they are getting ready to make money and offer treatments. Hopefully they have started the last trial they need for Follica.
 
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Torin

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Dr. George Cotsarelis recently featured in an article about 3-D printed hair, where he had the following to say.

"The hair being replicated is synthetic and has nothing to do with real hair, noted Dr. George Cotsarelis. "I was hoping to hear that this research would have an impact on developing cell-based treatments for hair loss," said Cotsarelis, chairman of dermatology at the University of Pennsylvania's Perelman School of Medicine, who was not involved in the research."

http://edition.cnn.com/2016/06/22/h...gn=Feed:+rss/cnn_tech+(RSS:+CNN+-+Technology)

If Follica's wounding method was so successful, why would Dr. Cotsarelis be hoping for outside inspiration from 3D printed hair of all things, which however way you look at it, is a completely different method to his hair wounding?

Is Dr. Cotsarelis fresh out of ideas?
 
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Xaser94

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Dr. George Cotsarelis recently featured in an article about 3-D printed hair, where he had the following to say.

"The hair being replicated is synthetic and has nothing to do with real hair, noted Dr. George Cotsarelis. "I was hoping to hear that this research would have an impact on developing cell-based treatments for hair loss," said Cotsarelis, chairman of dermatology at the University of Pennsylvania's Perelman School of Medicine, who was not involved in the research."

If Follica's wounding method was so successful then why would Dr. Cotsarelis be hoping for outside inspiration from 3D printed hair of all things, which however way you look at it is completely different to his hair wounding method?

Is Dr. Cotsarelis fresh out of ideas?


I think your looking into it too much. I dont think they have the cure. Nothing in there documents claim to. They do think they will be an alternative to hair transplants though or at least competitive with them. Not everyone can be cured by a hair transplant either. At the end of the day George Cotsarelis is a researcher and I am sure any new methods in regrowing hair would get him excited.
 
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Torin

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If I remember rightly, Follica's Phase 2 results showed no increase in terminal hairs.

If their method actually worked to create 20+ terminal hairs per cm2, there would surely be no reason why it couldn't be compoundable. Over successive treatments (20 x 5, say) would function as a cure for most.

But the fact that Follica didn't release their product years ago and also the fact that Cots still looks at unrelated novel approaches for inspiration is because his own technique can't produce terminal hairs.
 

Xaser94

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They already confirmed they can create 100 new hairs/cm2. 1/4 of that is terminal which means they can already create 25 hairs/cm2. The other 75 are "neogenic" which most likely means it is vellus and will need the help of a compound to become terminal, which may be minoxidil. Yeah, maybe u can compound the treatment but that doesnt make 3d printing a hair follicle less of an achievement from an academic stand point and it is still another avenue to tackle male pattern baldness. 3d printing would solve the problem for all norwoods. We are not yet sure if Follica will be good for norwood 6 and 7, or even those with darker skin. We will find out more soon enough about Follica. Honestly we all have waited a very long time, and we're closing in on finding out for sure if anything in our lifetime will pan out.
 
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thomps1523

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They already confirmed they can create 100 new hairs/cm2. 1/4 of that is terminal which means they can already create 25 hairs/cm2. The other 75 are "neogenic" which most likely means it is vellus and will need the help of a compound to become terminal, which may be minoxidil. Yeah, maybe u can compound the treatment but that doesnt make 3d printing a hair follicle less of an achievement from an academic stand point and it is still another avenue to tackle male pattern baldness. 3d printing would solve the problem for all norwoods. We are not yet sure if Follica will be good for norwood 6 and 7, or even those with darker skin. We will find out more soon enough about Follica. Honestly we all have waited a very long time, and we're closing in on finding out for sure if anything in our lifetime will pan out.

So hypothetically if you are an nw3, or nw4 this could possibly be a feasible cure of sorts?
 

hellouser

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If I remember rightly, Follica's Phase 2 results showed no increase in terminal hairs.

If their method actually worked to create 20+ terminal hairs per cm2, there would surely be no reason why it couldn't be compoundable. Over successive treatments (20 x 5, say) would function as a cure for most.

But the fact that Follica didn't release their product years ago and also the fact that Cots still looks at unrelated novel approaches for inspiration is because his own technique can't produce terminal hairs.

Where did you see Follica's phase 2 results? Post a link to the source.
 

Xaser94

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Where did you see Follica's phase 2 results? Post a link to the source.

Not who ur asking lol, but I think this is it. I dont think this what he saw.

8.1 STUDY PROTOCOL

[00637] The following protocol describes a Phase Ila clinical study that evaluated the effect of dermabrasion and post-perturbation treatment with a hydrogel (comprising Carbomer (Carbopol 980), glycerol, sodium hydroxide, methylparaben, propylparaben, and purified water) on (i) the formation of neogenic-like or activated or stimulated hair follicle structures (e.g., NL, PEL and PELA as described in Section 5.8.4.1 supra) and (ii) hair growth.

[00638] Diagnosis and main criteria for inclusion are Caucasian males 20-65 years of age, providing written informed consent, who have androgenetic alopecia with the presence of a vertex transition zone defined as an area possessing both terminal and miniaturized hairs, Hamilton-Norwood type 3V, 4, 5, 5A, or 5V, with a vertex area large enough to accommodate both treatment sites, and Fitzpatrick skin type 1-4.

8.1.1 Efficacy objectives

[00639] Primary. To assess changes from Baseline to Day 84 in the number of photographically detected hairs in the target analysis area of the skin of subjects treated with controlled cutaneous perturbation using dermabrasion (DA - a more superficial integumental perturbation) plus the topical application of a hydrogel.

[00640] Secondary, (i) To assess the changes from Baseline to Day 168 in the number of photographically detected hairs in the target analysis area of the skin of subjects treated with controlled cutaneous perturbation using dermabrasion (DA) plus the topical application of hydrogel; (ii) To assess the number of histologically detected neogenic-like hair follicles and other hair follicle structures of interest in biopsies taken on Day 14 from subjects treated with controlled cutaneous perturbation using dermabrasion (DA) plus topical hydrogel; (iii) To assess the number of histologically detected hair follicles in biopsies taken on Day 168 from the site of the first biopsy (allowed to heal by secondary intentions) in subjects treated with controlled cutaneous perturbation using a 4 mm punch biopsy plus topical hydrogel.

[00641] Exploratory, (i) To assess a) at Day 84 and b) at Day 168 the number of photographically detected hairs in subjects treated with controlled cutaneous perturbation using a 4 mm punch biopsy plus the topical application of hydrogel; (ii) To assess a) at Day 84 and b) at Day 168 the h a i r shaft thickness of photographically detected hairs induced by treatment with controlled cutaneous perturbation using a 4 mm punch biopsy plus the topical application of hydrogel; (iii) To assess changes a) from Baseline to Day 84 and b) from Baseline to Day 168 in hair shaft thickness of photographically detected hairs after treatment with controlled cutaneous perturbation with dermabrasion (DA) plus the topical application of hydrogel; (iv) the histological characteristics in a second skin punch biopsy on Day 168.

[00642] Photographic fields of measurement include the Total Analysis Area, which is a 1.13 cm2 circular region in an area that is dermabraded on Day 0, treated with hydrogel, undergoes a 4 mm punch biopsy on Day 14, and then receives additional treatment with hydrogel. Within the Total Analysis Area, there is the Circular Biopsy Area, which is a 0.13 cm2circular region that undergoes a 4 mm punch biopsy, and the Target Analysis Area, which is the Total Analysis Area minus the Circular Biopsy Area, which is a 1.00 cm2 circular region that has received only dermabrasion.

8.1.2 SAFETY OBJECTIVES

[00643] To assess the safety and tolerability of hydrogel in the setting of controlled cutaneous perturbation (dermabrasion and punch biopsy).

[00644] The safety and tolerability of hydrogel gel applied topically and epidermal disruption by dermabrasion and punch biopsies will be monitored through the collection of data from targeted examination of the treated scalp sites and the reporting of adverse events (AEs). Visits on Days 1, 2, 3, 12, 15, 17, 18, 19, 20 and 182 are safety visits to assess the sites (although visits on Days 3, 18, 19 and 20 may be replaced by calls if they fall on the weekend). Adverse events will also be reported at safety phone calls on Days 1 12 and 140. In addition liver and renal function, Hgb- AlC, and urinalysis will be performed at screening and on Days 182. A physical examination will also be performed at screening and Day 182. Vital signs and ECG will be performed at screening. On days 0, 14 168 (when dermabrasion and punch biopsies are performed) and 182 (end of study or at early termination), vital signs will be repeated.

8.1.3 TREATMENT METHODS

[00645] Treatment in this study consists of two treatment modalities:

[00646] 1. Physical perturbation (Dermabrasion and full thickness excision)

[00647] 2. Pharmacological intervention

[00648] Subjects are scheduled to receive hydrogel for 31 days: treatment period 1 (Day 0 until 2 days prior to punch biopsy 1 [Day 11]) and treatment period 2 (Day 17 until end of treatment [Day 35]). The dose of hydrogel is an approximate volume of 0.1 mL applied twice daily to two sites, for a total intended volume of 0.4 mL. Due to droplet size variability, this translates to an actual total volume range of 0.27 to 0.88 mL. [00649] The planned duration of the study per subject is 196 days, comprising a 14 day screening period, and 182 days of treatment and follow-up. The planned total duration of the study is approximately 12 months.

[00650] Once eligibility is confirmed (Day -6 / 0), subjects will have Baseline photography that includes a pin-point tattoo and hair dye. Two sites will be assigned, each measuring 1.5 cm x 1.5 cm and designated right (R) and left (L) with a minimal distance of 2 cm, identified in transitional areas of the balding vertex scalp, which has a very low density of terminal hairs. The hair density of the 2 sites should be as similar as is possible.

[00651] Dermabrasion of two sites per subject will be carried out using a hand-held dermabrader with a standard grit diamond fraise to achieve pinpoint capillary bleeding (estimated depth 100 microns, and therefore not anticipated to cause scarring). After dermabrasion the hydrogel will be applied to the two sites.

[00652] On Day 14, the two dermabraded sites will receive a full thickness 4 mm skin punch biopsy that is allowed to heal by secondary intention without occlusion. In addition to detecting neogenic-like follicles and possibly other activated, stimulated, or reorganized follicular structures of interest (e.g., PEL and PELA as described in Section 5.8.4.1 supra) following treatment with DA (a more superficial perturbation) and hydrogel, the 4 mm punch biopsies also provide a deeper perturbation that will be tested with hydrogel for the induction of neogenic-like follicles and other follicular structures of interest

[00653] Subjects will return after 3 months (Day 84) and 6 months (Day 168) for repeat photographic and clinical evaluations. Monthly safety follow-up phone calls will be performed on Days 112 and 140.

[00654] On Day 168 a second skin punch biopsy will be performed over the 2 dermabraded sites where there was a first punch biopsy on Day 14. In addition to providing samples for an analysis of efficacy, any scar tissue formed from the 4 mm punch biopsies on Day 14 will be excised by this second biopsy on Day 168, which will be closed by sutures. At the discretion of the investigator and if in accordance with the subject's wish, the Day 168 punch of the dermabraded sites will be a 5 mm or 6 mm skin biopsy (or elliptical biopsy by hand, or with an excisor, of a similar size) in order to assure scar removal and photography tattoo removal. The sutures are scheduled to be removed at a safety follow-up 2 weeks later (Day 182).

8.2 RESULTS [00655J A clinical study was carried out in accordance with the protocol described above. A summary of the demographics and characteristics of subjects treated with integumental perturbation and a hydrogel containing no active substance is shown in Table 8.

[00656] It was found that, for subjects treated with dermabrasion plus hydrogel:

• From baseline to Day 84 (3 months), target area hair counts (also referred to as "TAHC") of all hair show substantial increases that are statistically significant (see Table 9). This change in counts of all hair from baseline is maintained through the last day of measurement, Day 168 (6 months; See Table 10) and the change is statistically significant on Day 168.

• From baseline to Day 84 (3 months), target area hair count of only nonvellus-sized hairs, which have hair shafts 30 microns and greater in diameter (widths measured photographically), shows substantial increases that are statistically significant (see Table 11). This change in counts of nonvellus-sized hair from baseline is not maintained through the last day of measurement, Day 168 (6 months; See Table 12).

• From baseline to Day 84 (3 months), target area hair count of only vellus-sized hairs, which have hair shafts less than 30 microns in diameter (widths measured photographically), shows small increases (see Table 13). From baseline to the last day of measurement, Day 168 (6 months), target area hair count of only vellus-sized hairs shows substantial increases that are large (see Table 14).

[00657] As shown in Tables 15 and 16, the sustained positive change in all hair at the 6 month time point is comprised in large part by the striking increase in hair follicles with shafts between 10-20 microns in diameter (widths measured photographically). The increase in follicles with shafts between 20-30 microns has a small contribution to this overall positive change (see Table 14).

[00658] In dermabraded areas of skin, induction of neogenic-like hair follicles and activated, stimulated, or reorganized pre-existing (including vellus-sized) follicles was measured as detected and analyzed by skin biopsy analysis at Day 14. In contrast to what is generally found in unwounded scalp skin, the controlled perturbation in this study 1) induced neogenic-like follicles and 2) placed preexisting follicles into a reorganized and activated state. The structures of interest detected and counted in the Day 14 biopsies are observed only rarely in unwounded skin. Therefore, they are comprised of neogenic-like and activated, stimulated, or reorganized structures. Table 8: Subject Demographics and Characteristics

upload_2016-7-10_12-38-3.png


Table 10: Photographic hair count of all hair on Day 168 in target analysis area subjected to dermabrasion plus hydrogel treatment

upload_2016-7-10_12-38-44.png


Table 11: Photographic hair count of non-vellus hair on Day 84 in target analysis area subjected to dermabrasion plus hydrogel treatment

upload_2016-7-10_12-39-27.png



it keeps going for a bit. Just go down and read it from the source.
https://www.google.com/patents/WO20...ved=0ahUKEwjR_LP1p-nNAhVFeD4KHWzaB6EQ6AEISTAG
 

Torin

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The above was what I was referring to.

"From baseline to Day 84 (3 months), target area hair count of only nonvellus-sized hairs, which have hair shafts 30 microns and greater in diameter (widths measured photographically), shows substantial increases that are statistically significant (see Table 11). This change in counts of nonvellus-sized hair from baseline is not maintained through the last day of measurement, Day 168 (6 months; See Table 12)."
 

Xaser94

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The above was what I was referring to.

"From baseline to Day 84 (3 months), target area hair count of only nonvellus-sized hairs, which have hair shafts 30 microns and greater in diameter (widths measured photographically), shows substantial increases that are statistically significant (see Table 11). This change in counts of nonvellus-sized hair from baseline is not maintained through the last day of measurement, Day 168 (6 months; See Table 12)."

But they did have an increase, you said they didnt see any. You may have to still take finasteride to make sure the new hairs arent getting damaged ,which those trial patients were not on. Or maybe that is why they are looking for the right compound to make sure they stay terminal and to kickstart those other vellus hair. We dont know. But having a way to kick start hair growth is essential for us and this is close to fruition.

Not to mention we havent seen their phase 2b results.
 

NewUser

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Not to mention we havent seen their phase 2b results.

From what I've read on this site, I get the impression that Cotsarelis discovered something new about FGF9 sometime in 2013 and probably at the same time phase II trials were underway. They discovered that FGF9, a protein produced by cells of the immune system, is crucial for follicle neogenesis after disruption of the skin. Apparently after adding FGF9 to mice skin after wounding caused hair growth by factors of 2 and 3 Xs. He said balding people lack pr have insufficient amounts of FGF9 and is probably why humans have little re-growth after doing skin perturbation. So I think they realize now that applying hydrogel after wounding isn't going to grow a lot of hair. In 2013 he mentioned that adding synthetic FGF9 to the protocol should work.

FGF9 production is a function of the immune system? Is it true that ALL of the alopecias, plaque psoriasis, rheumatoid arthritis etc are caused by immune dysfunctions of various kinds? It gives me hope that Christiano and Aclaris are on the right track with JAK-inibs.
 
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Torin

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From what I've read on this site, I get the impression that Cotsarelis discovered something new about FGF9 sometime in 2013 and probably at the same time phase II trials were underway. They discovered that FGF9, a protein produced by cells of the immune system, is crucial for follicle neogenesis after disruption of the skin. Apparently after adding FGF9 to mice skin after wounding caused hair growth by factors of 2 and 3 Xs. He said balding people lack pr have insufficient amounts of FGF9 and is probably why humans have little re-growth after doing skin perturbation. So I think they realize now that applying hydrogel after wounding isn't going to grow a lot of hair. In 2013 he mentioned that adding synthetic FGF9 to the protocol should work.

He also said two years ago that it would take 10+ years to test FGF9 in humans:

"6) And finally I brought up fgf9 and its potentials. He believes fgf9 is still a very new discovery with many years of preclinical research ahead of it, when I asked for an estimated date he said at least 10 years. He then went on to mention that just to go from Rogaine liquid to Rogaine foam it took the company over 8 years of studies and data collection before they were allowed to sell it and Minoxidil has been on the market for many years. Now imagine if we are trying to bring out a completely new agent. The timeframes are quite long indeed."

Better to forget about Follica. Cotsarelis has had more than enough time to come out with something and he hasn't.
 

Xaser94

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He also said two years ago that it would take 10+ years to test FGF9 in humans:

"6) And finally I brought up fgf9 and its potentials. He believes fgf9 is still a very new discovery with many years of preclinical research ahead of it, when I asked for an estimated date he said at least 10 years. He then went on to mention that just to go from Rogaine liquid to Rogaine foam it took the company over 8 years of studies and data collection before they were allowed to sell it and Minoxidil has been on the market for many years. Now imagine if we are trying to bring out a completely new agent. The timeframes are quite long indeed."

Better to forget about Follica. Cotsarelis has had more than enough time to come out with something and he hasn't.

Why forget about Follica? lmao. Cause they may not be using fgf9 at the moment? They have 2 trials in progress already according to their website, both of which we dont know what for and one trial which is already done, which is presumably the device they will wound with. Theres simply not enough information for you to jump to that conclusion. They could even release their device now and we can pair it with whatever compound we want when we get home (at your own risk of course, but something like even Brotzu's lotion may be safe). Not to mention, they are actually finally talking about bringing it to market very soon in the US. I dont really care how long it took them seeing as how they are still one of the first to probably bring another method to grow hair. Id agree with you that they have missed their time if there were a whole lot of other therapies passing fda trials but that is not the case. Their wounding method alone creates 25 hairs/cm2. 75 more neogenic with the right compound can be terminal. What is there to be upset about?
 

NewUser

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Their wounding method alone creates 25 hairs/cm2. 75 more neogenic with the right compound can be terminal. What is there to be upset about?

Yes I agree. I think that nothing on the market now is able to provide hair follicle neogenesis. Besides the WnT mechanisms, very little was known about creating new hair follicles. That was until Cotsarelis discovered that increasing fgf9 causes hair follicle neogenesis of 2-3 Xs the effect with human skin xeno-grafted onto mice. Whether it will be the first effective treatment for baldness, and I am hoping Shiseido and-or Histogen beat Follica's TCP with fgf9 added to their protocol at a later time, is anyone's guess but I don't think so. Surely we will have something more effective than "the big three" within the next two years. And surely those solutions will be displaced by effective "cures" from Aclaris and Follica in 3 to 8 years respectively. There is much more hope for an effective treatment now than there was 10-15 years ago. You younger guys are going to be really lucky I think. I'm 50 and still very hopeful.
 

drakeznathan

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Surprizingly no timeline has been given
 
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