7th World Congress for Hair Research (2013)

[john2399]

Does phase IIb and phase 3 run concurrently?

[Thinning87]

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

no one can answer for sure...

[PatientlyWaiting]

Phase I/IIa is the SAFETY trial.

Phase IIb will be the EFFICACY trial. They will increase the number of injections and treatment zone and might add 1-2 extra injection timelines. They will also be monitoring for safety.

Phase III will be IIb but in a much larger population (10x number of subjects)! They will be making sure it is effective & safe in most of the population.

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

[ANW]

Not necessarily .. for some the fact that they wont loose anymore hair is comfort in itself

[Desmond84]

One more question, what is Phase 2b/III all about? what are they gonna get done? Seems like Phase I/II already shows it's safe and effective. So what are the extra phases for? More money for FDA or these phases are actually needed?

Phase I/IIa is the SAFETY trial.

Phase IIb will be the EFFICACY trial. They will increase the number of injections and treatment zone and might add 1-2 extra injection timelines. They will also be monitoring for safety.

Phase III will be IIb but in a much larger population (10x number of subjects)! They will be making sure it is effective & safe in most of the population.

[Thinning87]

What about combining histogen with propecia!? i wish they would do a side study for those already on fin to see if it has any more or less benefit.

Overall 20-25% is massive, I'd be back to NW1 territory, especially considering I have alot of vellus hairs.

Make this stuff come faster! or at least widespread the trials!

well this is not "25% of all your hair" this is "increase what you have by 25%" so if you still have half the hair you used to have (which is your status when you first discoveer hair loss) you're only going to increase up to 62.5% of your full head of hair.... and again this is when you first noticed thinning, i.e. when you had 50% of your original hair...

To me if this is the results, Histogen will only be a stand alone option for those of us who are 15 years old today and have not started balding yet...

[PatientlyWaiting]

What would 25% hair density give a NW3/4 diffuse thinner like me?

Thanks for the news about Histogen Desmond. This is news to actually be positive about man. Great news.

My question is, the dreaded question, when will Phase IIb/III start and when will it end, and when will Histogen be readily available for us? From what I understand Histogen has to find a partner company to start phase III?

One more question, what is Phase 2b/III all about? what are they gonna get done? Seems like Phase I/II already shows it's safe and effective. So what are the extra phases for? More money for FDA or these phases are actually needed?

[hellouser]

What about combining histogen with propecia!? i wish they would do a side study for those already on fin to see if it has any more or less benefit.

Overall 20-25% is massive, I'd be back to NW1 territory, especially considering I have alot of vellus hairs.

Make this stuff come faster! or at least widespread the trials!

Same here, mostly my temples are gone with some thinning, but god damn, Histogen cannot come sooner. I'd like to know what this combined with Aderans can do....

[rdawg]

Combining Propecia with Minoxidil provides a maximum of 10-15% increase in hair density!

Histogen alone has increased hair density by 20%, which is very good. P.S. The younger patients were getting somewhere around 25% increase in hair density whereas those aged over 40 were seeing around 19% increase in density.

What about combining histogen with propecia!? i wish they would do a side study for those already on fin to see if it has any more or less benefit.

Overall 20-25% is massive, I'd be back to NW1 territory, especially considering I have alot of vellus hairs.

Make this stuff come faster! or at least widespread the trials!

[Thinning87]

Combining Propecia with Minoxidil provides a maximum of 10-15% increase in hair density!

Histogen alone has increased hair density by 20%, which is very good. P.S. The younger patients were getting somewhere around 25% increase in hair density whereas those aged over 40 were seeing around 19% in crease in density.

hopefully they know something about how to combine this with existing treatments and HT so to achieve a full head of hair?

Because an increase in hair of 25% in 4 years will bring me up to 1.25 hairs...

[Desmond84]

Combining Propecia with Minoxidil provides a maximum of 10-15% increase in hair density!

Histogen alone has increased hair density by 20%, which is very good. P.S. The younger patients were getting somewhere around 25% increase in hair density whereas those aged over 40 were seeing around 19% increase in density.

[Thinning87]

I don't undderstand the significance of these numbers...what percentage of terminal hair was regrown?

right - it doesn't say how much regrowth they have had at the 48 week timepoint compared to the 0 week timpoint, in other words by how much did it regrow in a year? And taking how many shots?

I guess they'll say that at the presentation...?

[Desmond84]

I don't undderstand the significance of these numbers...what percentage of terminal hair was regrown?

The p-value is a representation of the statistical power of the study NOT percentage of hair growth

If p-value is significantly lower than 1 then the results obtained are clinically significant! E.g. terminal growth (p=0.0135)

[Thinning87]

Hey guys,

Here's the Final Phase 1/2 results for Histogen! Here's what they will be presenting at the "International Investigative Dermatology Congress":

Embryonic-like cell-secreted proteins induce hair growth in a phase I/II trial in male pattern baldness

GK Naughton,1 M Zimber,1 J Peralta-Arambulo,2 T Reyes-Cacas,3 M Hubka,1 D Ehrlich1 and J Mansbridge

Histogen, Inc., San Diego, CA, 2Asian Hair Restoration Center, Pasig City, Philippines and 3Marc Medical Group, Manila, Philippines

A Phase I/II clinical trial was performed to study the safety and efficacy of a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), in stimulating hair growth in subjects with male pattern baldness. HSC contains naturally secreted growth factors known to be important in hair growth, including Follistatin, KGF, and VEGF.

The clinical study was a double-blind, randomized, two center trial in 56 subjects. All subjects tolerated the eight 0.1cc intradermal injections at baseline and 6 weeks well, and no signs of an adverse reaction were reported. Blood and urine samples taken before and after each injection set showed no liver, kidney, or bone marrow toxicity. Trichoscan image analysis of treated sites were taken at baseline, and 12, 24, 36, and 48weeks.

At the 12 week time point significant improvements in total (p=0.0013), terminal (p=0.0135) and vellus (p=0.033) hair growth over baseline was seen as was an increase in cumulative thickness density (p=0026). The primary efficacy endpoint of increased terminal hair at 12 weeks was met, with a 19.5% increase seen, a 49.5% increase over the same endpoint in our proof-of-concept trial. In addition, unlike currently approved products, HSC induced hair growth in the temporal recession as well as vertex and mid scalp regions, and was highly effective in men over 40 years of age. At the 48 week time point there continued to be a significant increase in total hairs over baseline (p=0.028). These results clearly demonstrate the safety and efficacy of intradermal injections of HSC in subjects with androgenetic alopecia.

__________________________________________________ _________

Ok so what this tells us is that

A) they have improved the product by 50% in terms of average regrowth at the 12 week time point

B) they are still seeing significant regrowth at the 48 week timepoint.

About point B:

- what do they mean by "significant": is this like "statistically significant" so to demonstrate the hypothesis that the product works is not false, or "significant" in terms of actual results i.e. the product works significantly well?

- weren't they supposed to show results at the 2 year timepoint?

[jman91]

Hey guys,

Here's the Final Phase 1/2 results for Histogen! Here's what they will be presenting at the "International Investigative Dermatology Congress":

Embryonic-like cell-secreted proteins induce hair growth in a phase I/II trial in male pattern baldness

GK Naughton,1 M Zimber,1 J Peralta-Arambulo,2 T Reyes-Cacas,3 M Hubka,1 D Ehrlich1 and J Mansbridge

Histogen, Inc., San Diego, CA, 2Asian Hair Restoration Center, Pasig City, Philippines and 3Marc Medical Group, Manila, Philippines

A Phase I/II clinical trial was performed to study the safety and efficacy of a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), in stimulating hair growth in subjects with male pattern baldness. HSC contains naturally secreted growth factors known to be important in hair growth, including Follistatin, KGF, and VEGF.

The clinical study was a double-blind, randomized, two center trial in 56 subjects. All subjects tolerated the eight 0.1cc intradermal injections at baseline and 6 weeks well, and no signs of an adverse reaction were reported. Blood and urine samples taken before and after each injection set showed no liver, kidney, or bone marrow toxicity. Trichoscan image analysis of treated sites were taken at baseline, and 12, 24, 36, and 48weeks.

At the 12 week time point significant improvements in total (p=0.0013), terminal (p=0.0135) and vellus (p=0.033) hair growth over baseline was seen as was an increase in cumulative thickness density (p=0026). The primary efficacy endpoint of increased terminal hair at 12 weeks was met, with a 19.5% increase seen, a 49.5% increase over the same endpoint in our proof-of-concept trial. In addition, unlike currently approved products, HSC induced hair growth in the temporal recession as well as vertex and mid scalp regions, and was highly effective in men over 40 years of age. At the 48 week time point there continued to be a significant increase in total hairs over baseline (p=0.028). These results clearly demonstrate the safety and efficacy of intradermal injections of HSC in subjects with androgenetic alopecia.

__________________________________________________ _________

I don't undderstand the significance of these numbers...what percentage of terminal hair was regrown?