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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.
Oncology
Intradermal injection of HSC stimulates hair follicle stem cells to create new hair
Subjects
56 men (50 to complete) MPHL. 21-65 years old
Control (DMEM, Dulbeccos 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)
Endpoints
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
Investigators
Dr. Julieta P. Arambulo and Dr. Theresa Reyes Cacas
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Baseline
3 month
3 month
S1016
S2018
% Change
10 8 6 4 2 0
46.5%
Pilot Honduras
p=0.0013
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**
% Change
18 13 8 3 -2
Baseline
12 Weeks
p=0.026
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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.
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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.
12wk
24wk
48wk
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.
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
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Temporal Recession
30 25 20 15 10 5 0 -5 -10 12 Weeks 24 Weeks 36 Weeks
Total Hair Count Terminal Density Vellus Density
Baseline
36 Weeks
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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.
Cosmetically significant results seen in subjects 40-59 years of age in both trials.
Treatment:
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
Enrollment:
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
Baseline
19 Weeks
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Baseline
19 Weeks
17
Baseline
12 Weeks
18
Baseline
24 Weeks
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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
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Questions?
Gail K. Naughton, Ph.D. CEO & Chairman of the Board Histogen, Inc. www.histogen.com
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Business Model
Histogens 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 Histogens 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 Histogens 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
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