Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acn
March 05 2009 - 9:25AM
PR Newswire (US)
-Company Provides Update on Cash Position- EXTON, Pa., March 5
/PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX: ILE) announced
today positive top-line efficacy results from a Phase II/III
clinical study (Study IT-A-008) of the Isolagen Therapy(TM) for the
treatment of moderate to severe acne scars. The study met all
primary efficacy endpoints and was statistically significant,
making this a major clinical milestone for the Company. "This is
very exciting, positive data which continues to support the
potential of the Isolagen Therapy as a platform technology for
aesthetic and therapeutic indications," said Declan Daly, President
and Chief Executive Officer of Isolagen, Inc. "There is a great
need globally for the treatment of acne scars and we believe that
the Isolagen Therapy has a significant role to play in this largely
untapped market." The Phase II/III, placebo-controlled study
investigating the efficacy and safety of Isolagen Therapy(TM) for
the treatment of moderate to severe acne scars evaluated a total of
109 people at seven clinical sites across the United States. In the
study, both the Patient and Evaluator assessments met the
co-primary endpoints and were statistically significant, achieving
p-values of 0.000011 and 0.016, respectively (p-values less than or
equal to 0.05 are considered statistically significant). With
respect to the Patient assessments, 43 percent of patients reported
a response to the Isolagen Therapy-treated side of the face, while
18 percent of patients reported a response on the placebo-treated
side of the face. With respect to the Evaluator assessments,
evaluators reported that 59 percent of patients responded on the
Isolagen Therapy-treated side of the face, and that 42 percent of
patients responded on the placebo-treated side of the face. The
safety data for this study are currently under review; however, no
serious adverse events related to Isolagen Therapy were reported
during the course of the study. "I am very excited about the study
results and the activity seen with the use of the Isolagen Therapy
to treat acne scars," said Girish Munavalli, MD, MHS, Medical
Director, Dermatology, Laser and Vein Specialists of the Carolinas,
Charlotte, North Carolina. "As the co-primary investigator in this
study, I have seen firsthand the benefit of the Isolagen Therapy on
acne scars and the impact the result has on my patients. This is a
unique product and may be life changing for patients with acne
scarring." Stacy Smith, MD, Assistant Clinical Professor, Division
of Dermatology, University of California San Diego, and the study's
other co-primary investigator further commented, "I am very pleased
with the outcome of this study. There are minimal options currently
available for the treatment of acne scars and the results of this
study, coupled with my clinical experience with the Isolagen
Therapy, show that this treatment has the potential to become a
significant product for acne scarring." The Isolagen Process(TM) is
a proprietary cellular processing system that creates a natural,
living cell therapy. By multiplying a person's own
collagen-producing cells, or fibroblasts, into tens of millions of
new cells, a personalized treatment is created that is then
returned to the person's skin. This first of its kind aesthetic
treatment, known as the Isolagen Therapy, is designed to improve
skin damage caused by the normal effects of aging, sun damage, acne
and burns. About the Phase II/III Acne Scar Study The goal of the
Phase II/III multicenter, double-blind, randomized,
placebo-controlled study was to demonstrate the efficacy of three
treatments of Isolagen Therapy on one side of the face as compared
with placebo treatment on the other side of the face for the
treatment of moderate to severe acne scars. The primary efficacy
endpoints are measured four months following the last study
treatment, using the following co-primary endpoints: -- Patient
Live Acne Scarring Assessment: The Patients' live assessment of the
acne scarring of each cheek, using a 5point assessment scale, with
a response defined as a 2-point improvement as compared to
baseline, and an -- Evaluator Live Acne Scar Assessment: The
Evaluators' live assessment of the acne scarring of the treatment
area on each cheek, using a 5-point assessment scale and
photoguide, with a response defined as a 1-point improvement as
compared to baseline. Isolagen's Phase II/III study for moderate to
severe acne scars was conducted under an FDA Investigational New
Drug Application. Although statistically significant, these results
do not guarantee approval of a commercial license or a labeling
claim for this indication. The Company believes that to ultimately
obtain FDA approval with respect to the acne scar indication, the
Company will require FDA concurrence with the use of the Company's
Evaluator Live Acne Scar Assessment scale, which the Company
developed specifically for use in this study and which has not been
previously used in a clinical trial. Further, if the Company
obtains this concurrence from the FDA, then the Company will also
require, at a minimum, one additional Phase III study to complement
study IT-A-008 in order to pursue FDA approval and licensure.
Update Regarding Isolagen's Cash Position and the Biologics License
Application for Wrinkles/Nasolabial Folds Isolagen currently
estimates that its unrestricted, available cash resources will
allow the Company to continue in operation for approximately three
weeks. The Company continues to pursue potential financing
alternatives and potential strategic partnership discussions.
However, there can be no assurance that any such potential
financing alternative will be completed on terms acceptable to the
Company, or successfully completed at all. Further, there can be no
assurance that any potential strategic partnership discussions will
be completed on terms acceptable to the Company, or completed at
all. If the Company does not obtain additional funding, or
anticipate additional funding in the very near future, the Company
may enter into bankruptcy, and possibly cease operations. In
addition, as previously disclosed, the Company currently has a debt
liability of approximately $89.7 million related to its 3.5%
subordinated notes, which could be called due, at the option of the
note holders, as early as November 2009. Interest on the notes is
due semiannually on May 1 and November 1. Further, the Company is
pursuing the potential sale of its 57% ownership interest in Agera
Laboratories, Inc. There can be no assurance that a sale of this
ownership interest will be completed on terms acceptable to the
Company, or successfully completed at all. The Company is preparing
to submit its Biologics License Application (BLA) for Isolagen
Therapy(TM) for the treatment of wrinkles/nasolabial folds and
currently expects this submission to occur within two weeks. About
Isolagen, Inc. Isolagen(TM), Inc. (AMEX:ILE) is an aesthetic and
therapeutic company committed to developing and commercializing
scientific advances and innovative technologies. The company's
technology platform includes the Isolagen Process(TM), a cell
processing system for skin and tissue rejuvenation which is
currently in clinical development for a broad range of aesthetic
and therapeutic applications including wrinkles, acne scars, burns
and periodontal disease. Isolagen also commercializes a
scientifically-advanced line of skincare systems through its
majority-owned subsidiary, Agera(R) Laboratories, Inc. For
additional information, please visit http://www.isolagen.com/.
Isolagen Forward Looking Statements All statements in this news
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. Such statements
include, without limitation, FDA concurrence with the use of the
Company's Evaluator Live Acne Scar Assessment scale, the Company's
ability to complete, at a minimum, an additional Phase III study to
complement study IT-A-008 in order to pursue FDA approval and
licensure, the Company's ability to complete any financings or
enter into any strategic partnerships, and the timely filing of the
Biologics Licensing Application (BLA) with the FDA,. 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 our 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, 2007, as updated in "Item 1A. Risk Factors" in
the Company's Quarterly Reports on Form 10-Q. We operate 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. We disclaim any intention to, and undertake 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 Annual Report on Form 10-K for
the year ended December 31, 2007, as well as other public filings
with the SEC since such date. DATASOURCE: Isolagen, Inc. CONTACT:
Mike Beyer of Sam Brown Inc. for Isolagen, Inc., +1-773-463-4211,
Web Site: http://www.isolagen.com/
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