P. 1
ISHRS - GNaughton - HSC Clinical Update

ISHRS - GNaughton - HSC Clinical Update

|Views: 1.892|Likes:
Publicado porErin Aguilar

More info:

Published by: Erin Aguilar on Nov 01, 2012
Direitos Autorais:Attribution Non-commercial


Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less





Scalp Injection of Active Embryonic-like Cellsecreted Proteins and Growth Factors

Gail K. Naughton, Ph.D.


Conflict of Interest
DISCLOSURES: Speaker has disclosed conflict of interest. Dr. Gail K. Naughton serves as CEO and Chairman of the Board for Histogen, Inc.


Technology Focus: Regeneration
Histogen’s technology focuses on stimulating a patient’s own stem cells by delivering a proprietary complex of human proteins that have been shown to support stem cell growth and differentiation.
This multipotent cell conditioned media has a broad range of applications in both aesthetics and therapeutics: Current and near-term: Skincare and Cosmetics First therapeutic, no reimbursement: Hair growth Second therapeutic: Oncology Other Opportunities for soluble and insoluble extracellular matrix: Wound care, Device Coating, Bone and Muscle regeneration, Dermal filler Bioactive human growth factors VEGF KGF Follistatin Stem Cell Factor Human matrix components Collagens Laminin GAG Decorin Fibronectin C-propeptide

ReGenica skincare Hair Stimulating Complex (HSC)
Cells grow in suspension under low oxygen, simulating embryonic environment Stem Cell signaling proteins are secreted into the growth medium


Intradermal injection of HSC stimulates hair follicle stem cells to create new hair


– 56 men (50 to complete) MPHL. 21-65 years old

Treatments (at Baseline, 6 weeks)

Phase I/II Clinical Trial
Double-blind, placebo controlled, randomized, each subject acts as their own control

– Control (DMEM, Dulbecco’s Modified Eagles Medium) – Hair Stimulating Complex (HSC) concentrated/conditioned

Assessment Times
– Baseline, Week 12, Wk 24, Wk 48 – Wk 36 supplemental informational visit (EC approved)

– Primary: Safety Clinical Evaluation for SAEs or AEs Blood and urine for liver and kidney tox ADA analysis – Secondary: Safety Investigator and Subject self assessments – Primary: Efficacy (12 weeks) Trichoscan (Macrophotography, FotoFinder) quantify change in total and non-vellus hair counts and hair thickness – Secondary: Efficacy Clinical macrophotography (hair counts, etc.) 21 CFR Part 11 compliant (closed system) Single Treatment Site

HSC Baseline + 6 wks

Control Baseline + 6 wks

– Dr. Julieta P. Arambulo and Dr. Theresa Reyes Cacas

Hair Stimulating Complex (HSC) – Phase I/II Clinical Trial
Subjects sites treated with HSC - representative samples


3 month

3 month

Hair count + 61.41% Terminal hair + 55.63% Thickness + 63.03%


Hair count + 35.88% Terminal hair + 45.83% Thickness + 42.76%

Total Hair Count – 12 Weeks
• Phase I/II trial design produced 46.5% better results in total hair count than the pilot trial at 12 weeks • A 10.45% Increase in Mean Total Hair Count over baseline was seen • The increase in hair count is statistically significant, unlike the pilot trial, at 12 weeks
16 14 12


% Change

10 8 6 4 2 0


Pilot Honduras

Phase I/II Philippines


Terminal & Vellus Hair Counts – 12 Weeks
• Statistically significant increase in terminal hair count, a primary efficacy measure • An increase in vellus hair count was also seen, supporting the hypothesis that HSC rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle.
28 23


% Change

18 13 8 3 -2


Vellus Hair Count

Terminal Hair Count

Hair Thickness – 12 Weeks
An increase in hair thickness density is a result of: 1) An increase in hair count, 2) An increase in the number of terminal hairs and 3) An increase in hair shaft diameter, all of which are important to cosmetic impact.

Cm Thickness Density (mm/cm2)

8.60 8.40 8.20 8.00 7.80 7.60 7.40 7.20



12 Weeks


Clinical Chemistry

No indication of toxicity or blood/urine abnormalities in the patient population following both sets of HSC injection. Clinical evaluation of blood serum chemistry, hematology and urinalysis showed no changes from baseline over the course of the treatment. No evidence of toxicity is observed in any of the clinical indicators.

Trend Analysis
35% 30% 25% 20% 15% 10% 5% 0% Philippines Honduras

Following the trend, a 25% increase is forecasted for the 48 week timepoint.




• HSC injections result in the stimulation of bulge stem cells and the conversion of vellus to terminal hairs follicles from late telogen to anagen.to result in increased terminal and vellus hairs at the 12 week time point. • HSC injections are compressing the anagen phase and accelerating the catagen and telogen cycles which explains the decline in terminal and increase in vellus at 24 weeks and subsequent increase in 11 total, terminal, and vellus hairs at week 48.

Philippines Phase I/II Regional Data
Mid-Scalp Treatment Locations
30 25 % Change from Baseline 20 15 10 5 0 12 Weeks 24 Weeks 36 Weeks % Change from Baseline 30 Total Hair Count 25 Terminal Density 20 Vellus Density 15 10 5 0 12 Weeks 24 Weeks 36 Weeks

Vertex Treatment Zones

• Graphs show the % Change in Total, Terminal and Vellus Densities at each time point. • Mid-Scalp and Vertex treatment regions show similar growth trends and are consistent with the trends shown to date

Philippines Phase I/II Regional Data
• • % Change each time point for treatment zones in the Temporal Recession shown below Unlike currently available treatments, HSC produced visible growth in subjects treated in TR region.

Temporal Recession
30 25 20 15 10 5 0 -5 -10 12 Weeks 24 Weeks 36 Weeks
Total Hair Count Terminal Density Vellus Density


36 Weeks


Age Analysis
Unlike current non-surgical treatments, with efficacy limited to younger patients or earlier stages of hair loss, HSC has the potential to expand the hair restoration market by offering a successful option to older patients.

Subjects Age 40+
% Change from Baseline

Total 12wk 24wk 19.35 13.39

Terminal 39.11 16.96

Vellus 15.67 17.26

Cosmetically significant results seen in subjects 40-59 years of age in both trials.

Pilot Trial -Subjects Age 40+
% Change from Baseline

Total 12wk 24wk 48wk 8.52 5.42 18.30

Terminal 21.94 12.88 37.17

Vellus 5.09 -0.05 18.34

Dr. Ziering - Phase I U.S.
IRB approved Original Design: • Open Label, safety study
• 10 Subjects (5 Female and 5 Male) • Baseline, 6 Week repeat dose

• Up to 20 0.1mL injections of HSC in two treatment areas at baseline with an additional 20 0.1mL intradermal injections at Week 6.

Amended Design:
• Patient consent obtained • Up to 40 intradermal injections (0.1mL each) of HSC in broader treatment area (at the 12 week time point and again at 18 week time point) • Subjects who have completed amended design will have a total of 120 injections throughout study

100% Enrollment 100% of Subjects have completed 6 week Repeat dose 100% of Subjects have re-consented and have had increased volume 40 x 0.1cc injections in the same areas and surrounding areas ~97% of the injectate is retained in the tissue

Safety Update: • No SAEs • All injections welltolerated

U.S. Physician-sponsored Trial- Dr. Craig Ziering
Re-consented female subject received an additional 20 injections of 0.1 cc HSC with a repeat dose at 6 weeks. .

*Photo reflects total of 30 injections


19 Weeks

U.S. Physician-sponsored Trial- Dr. Craig Ziering
Female Subject received 20 injections of 0.1cc HSC in area of thinning, with a repeat of this dose at 6 weeks.


19 Weeks

U.S. Physician-sponsored Trial- Dr. Craig Ziering
Re-consented female subject received an additional 20 injections of 0.1 cc HSC in new treatment location- frontal thinning, with a repeat dose at 6 weeks


12 Weeks

U.S. Physician-sponsored Trial- Dr. Craig Ziering
Reconsented male subject received an additional 40 injections of 0.1 cc HSC in the same regions- broadening the treatment area, with a repeat dose at 6 weeks .


24 Weeks

Local Tolerance
Subject Self Assessment on Local Tolerance
Number of Responses 7 6 5 4 3 2 1 0 No Discomfort Mild Discomfort Slightly Painful Moderately Painful Extremely Painful

Subject self assessments (SSA) from IND trial reflect an excellent tolerance for the procedure, with the majority of subjects reporting no discomfort. These results are consistent with those reported in other trials. Visual examination for redness, inflammation, swelling or edema continues to show overall excellent safety profile for HSC in all subjects

Clinical Experience Summary
Proof of Concept Clinical Trial
SAFETY (primary objective) 2 year follow-up • No adverse reactions, hamartomas, toxicity; normal histology EFFECTIVENESS (secondary objective) • 12 Weeks: HSC injection resulted in significant increase in terminal hairs and thickness density  Cumulative thickness density (mm/cm2) p=0.0249  Terminal hair density p=0.029 • 1 Year: HSC injection resulted in continued significant hair growth  Total hair count p=0.032

Phase I/II Clinical Trial – 56 Subjects
PRIMARY SAFETY 12 weeks • Clinical chemistry showed no indication of toxicity or blood/urine abnormalities PRIMARY EFFICACY 12 weeks • 10.45% increase in mean total hair count over baseline p=0.0013 • 19.5% increase in mean terminal hair count over baseline p=0.0135 • Statistical significance in all efficacy measurements • No indication of toxicity or blood/urine abnormalities following both treatment timepoints

Clinical Experience Summary (cont)
U.S. Physician sponsored IND- 10 Subjects
5 men, 5 women • All patients have shown new hair growth by 6 weeks • 9/10 subjects have had 20 injections at baseline and 6 weeks, and achieved safe passage to 40 injections at 12 and 18 weeks. • 4/10 subjects have completed the study • 4/4 of the subjects that have completed the study all answered that they would participate in future clinical studies

Responder rate: • 84.6% in Proof of Concept Trial at 24 weeks
• 86% in Phase I/II at 24 weeks • 100% in Physician IND trial

Clinical Update Summary
Further analysis of the data suggests a tremendous marketing advantage over other approved treatments, offering a treatment option to those patients that currently have none: • Regional analysis shows that HSC grows new hair in all regions of the scalp – temporal recession, mid scalp and vertex. (Minoxidil and Propecia do not have positive results in hard-to-treat temporal regions) • Data shows that men over 40 respond extremely well to HSC, as shown in both Honduras and Philippine trials (current products are most effective in men in their 20s and 30s, in the early stages of hair loss) • Furthermore, investigator-initiated trial shows great efficacy results in women • HSC continues to have a very strong safety profile, even at 36 weeks


Gail K. Naughton, Ph.D. CEO & Chairman of the Board Histogen, Inc. www.histogen.com

Business Model
Histogen’s focus is on the development and manufacturing of products from its novel core technology process. As such, Histogen will achieve profitability through research partnerships, upfront licensing payments and post-commercialization royalty streams attached to each of its product applications.

Research Partnerships
Example: use of Histogen’s extracellular matrix (hECM) as a coating to improve biocompatibility of existing medical devices.

Licensing Deals
Example: license for specific product applications, such as the ReGenica skincare products, hECM for wound healing or soft tissue augmentation, or the HSC injectable for hair growth.

Biomaterial Supplier
Example: supplying of Histogen’s soluble extracellular matrix as a raw material for product formulations such as a private label skin or hair care line. Attachment to material presented on October 19, 2012

Current Private Placement Financing
The Company is currently looking to sell 23 million shares of Series B Preferred Stock at $1 per share to accredited investors (i.e., investors whose net worth, including the
fmv of their home, exceeds $1 million and whose annual income exceeds $200,000).

To date, $3.3 million is committed. The proceeds from the financing will be used to:  Complete large animal and clinical serum (ADA) testing required before starting the next HSC clinical trial  Complete Scale-up of GMP Manufacturing  Complete two preclinical studies with oncology product  Prepare and submit IND for Phase I pancreatic cancer trial  Support worldwide development of patent portfolio
Attachment to material presented on October 19, 2012

You're Reading a Free Preview

/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->