Fibrocell Science, Inc. (OTCBB:FCSC.OB), an autologous cellular
therapeutic company focused on the development of innovative
products for aesthetic, medical and scientific applications, today
announced the first scientific presentation of data demonstrating
the efficacy of LAVIV™ (azficel-T) in treating moderate-to-severe
depressed acne scars. The data were presented at the American
Society for Dermatologic Surgery (ASDS) annual meeting in
Washington, D.C. LAVIV, which is made from a person’s own
collagen-producing skin cells, is the first and only personalized
cell therapy approved by the FDA for aesthetic use and was recently
approved for the improvement of the appearance of
moderate-to-severe “smile line” wrinkles (nasolabial folds). LAVIV
is being investigated for the treatment of rolling, depressed acne
scars, but is not currently approved for this indication.
According to the American Academy of Dermatology, about 40 to 50
million Americans have acne at any one time. Rolling acne scars are
caused by damage under the surface of the skin and appear as soft,
saucer-like depressions or pits on the skin. The skin typically
loses its underlying support and develops a wavy texture. The scars
tend to be wide and shallow. Research shows that facial acne
scarring is common and affects men and women equally, occurring to
some degree in 95 percent of acne cases. In this study, LAVIV was
injected into the facial acne scars of patients to smooth the skin
depressions.
The study successfully met its two prospectively defined
co-primary endpoints: a 2-point or greater improvement on a 5-point
Subject Live Acne Scarring assessment scale and a 1-point or
greater reduction in cheek acne severity on a physician-assessed,
validated 5-point Evaluator Live Acne Scar assessment scale. Final
assessments were conducted four months after completing the study
treatment regimen.
“Common approaches to treat acne scarring such as laser and
fractional resurfacing can lead to prolonged downtime or
unpredictable pigmentary complications of the skin,” said Girish
(Gilly) Munavalli, M.D., Medical Director, Dermatology, Laser, and
Vein Specialists of the Carolinas, PLLC, Assistant Professor of
Dermatology at Wake Forest University School of Medicine, and
investigator for the study. “Our findings show that using a
person’s own collagen-producing cells in the form of LAVIV may
provide a promising new alternative to improve acne scarring with
minimal downtime and an excellent safety profile.”
According to the study results, a statistically significant
higher percentage of subjects responded to treatment with LAVIV
than with placebo, as rated by both the study investigators (58.7%
vs. 42.2%; p=0.016) and patients (43.1% vs. 18.3%; p=0.000011) at
the final assessment. Patient and Evaluator assessments at earlier
time points during the study also showed a statistically
significant higher proportion of responses with LAVIV than with
placebo at all but one assessment.
All adverse events (AEs) reported during the study were mild or
moderate in severity. No subjects experienced serious adverse
events, discontinued treatment, or withdrew from the study as a
result of an AE. The incidence of adverse events occurring in the
treatment areas was comparable between LAVIV and placebo. The most
common reported AEs were treatment area erythema (occurring in
11.1% of subjects) and swelling (occurring in 10.1% of subjects).
Five of the 12 subjects reporting erythema and five of the 11
subjects reporting swelling had events of moderate severity in the
LAVIV-treated area, whereas all treatment related AEs reported in
the placebo-treated area were of mild severity. Other AEs reported
during the study with a possible relationship to study treatment
included bruising, rash, irritation, nodule, pain, acne, induration
and headache. No clinically meaningful changes in vital signs or
physical exam findings were reported.
The patented technology behind LAVIV is an advanced process that
extracts a person’s fibroblast cells from a small skin sample and
multiplies them in the Fibrocell Science lab. In normal skin,
fibroblasts are responsible for producing collagen. LAVIV is the
resulting formulation of a person’s own fibroblast cells. Each
person’s formulation of LAVIV is unique because it is made from
their own cells.
“Fibrocell Science is committed to exploring the full
therapeutic potential of our personalized fibroblast cellular
treatment for use in diverse medical and aesthetic applications,”
said David Pernock, Fibrocell Science Chairman and CEO. “We are
encouraged by these data and look forward to further investigating
the potential role of LAVIV in treating of acne scars.”
About the Study
The major clinical trial was a multi-center, randomized,
double-blind, placebo-controlled study, enrolling and collecting
skin biopsies from 119 patients who had moderate-to-severe
depressed acne scarring on both sides of the face for at least
three years. Skin biopsies obtained from enrolled patients were
used for fibroblast production. Patients served as their own
controls. Ninety-nine of these patients received up to three
injections with 2 mL autologous fibroblasts
(10 - 20 million cells/mL) on one cheek and placebo
(vehicle control; dye-free cell culture media) on the other at 14
day intervals. Treatment was administered at a dose of 0.1mL/cm2
into areas of acne scarring on the cheek, which were required have
a scarred area of at least 9 cm2. Efficacy was assessed as
described above. Safety was assessed based on the incidence of
adverse events collected throughout the trial. Any injection site
reactions or other localized adverse events were recorded
independently for each side of the face, so that a comparison of
adverse events by treatment could be performed.
Important Safety Information About LAVIV™ (azficel-T)
LAVIV (azficel-T) is an autologous cellular product indicated
for improvement of the appearance of moderate to severe nasolabial
fold wrinkles in adults.
LAVIV is made especially for you from your own skin cells. Using
someone else’s cells can cause a serious reaction. Prior to
injection, confirm with your physician that your information on the
LAVIV vial is correct.
The most common side effects of LAVIV are at the injection-site,
including redness, bruising, swelling, pain, bleeding, lumps,
irritation, and itchiness. In clinical trials with LAVIV, most
injection-site adverse reactions resolved within one week and most
required no treatment.
Your health care provider will help you to decide whether you
are a candidate for LAVIV and may help you avoid some of the
adverse reactions from LAVIV. Before getting LAVIV, tell your
healthcare provider if you have any medical problems including
allergic reactions to any drugs or food, bleeding disorders or take
blood-thinning medicines like aspirin, ibuprofen, or coumadin,
keloids or excessive scarring, skin cancer or any malignancy,
genetic disorders affecting your skin, immune problems or take
medicines that affect your immune system, or any other illness or
medical problem. The full Prescribing Information for LAVIV
includes additional warnings about adverse reactions that occurred
in less than 1% of patients following LAVIV treatment in clinical
trials. Talk to your healthcare provider about these warnings.
Please tell your healthcare provider if you are allergic to the
antibiotics amphotericin or gentamicin, bovine materials (products
made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV
if you have a skin infection on your face because LAVIV treatment
can make the infection worse.
For more information about LAVIV, please see the Full
Prescribing Information at www.mylaviv.com.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB:FCSC.OB) is an autologous
cellular therapeutic company focused on the development of
innovative products for aesthetic, medical and scientific
applications. Fibrocell Science is committed to advancing the
scientific, medical and commercial potential of autologous skin and
tissue, as well as its innovative cellular processing technology
and manufacturing excellence. For additional information, please
visit www.fibrocellscience.com.
Forward-Looking Statements
All statements in this press release that are
not based on historical fact are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and the provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements include, without
limitation, whether LAVIV may in the future provide a promising new
alternative to improve acne scarring with minimal downtime and an
excellent safety profile. While management has based any
forward-looking statements contained herein on its current
expectations, the information on which such expectations were based
may change. These forward-looking statements rely on a number of
assumptions concerning future events and are subject to a number of
risks, uncertainties, and other factors, many of which are outside
of the Company's control, that could cause actual results to
materially differ from such statements. Such risks, uncertainties,
and other factors include, but are not necessarily limited to,
those set forth under Item 1A "Risk Factors" in the Company's
Annual Report on Form 10-K for the year ended December 31, 2010, as
updated in "Item 1A. Risk Factors" in the Company's Quarterly
Reports on Form 10-Q filed since the annual report. The Company
operates in a highly competitive and rapidly changing environment,
thus new or unforeseen risks may arise. Accordingly, investors
should not place any reliance on forward-looking statements as a
prediction of actual results. The Company disclaims any intention
to, and undertakes no obligation to, update or revise any
forward-looking statements. Readers are also urged to carefully
review and consider the other various disclosures in the Company's
public filings with the SEC.
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