Isolagen(TM), Inc. (Amex:
ILE) announced that the Food and Drug Administration (FDA) has
provided follow-up on the Phase III program investigating the Isolagen
Therapy(TM) for the treatment of moderate to severe acne scars. The FDA
reiterated that there are no safety issues that would prevent the
initiation of the proposed studies. However, the FDA asked the Company to
further clarify certain protocol issues and raised questions related to the
acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended
that in order to address these issues, the Company should conduct a Phase
II study; therefore, the Company will propose modifying the ongoing Phase
III Study IT- A-008 as a Phase II/III study (as discussed further below).
The FDA requests are specific to the acne scar clinical program and do not
impact the Company's ongoing, pivotal Phase III clinical program evaluating
the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.
Isolagen's two randomized, double-blind, placebo-controlled acne scar
clinical trials (IT-A-008 and IT-A-009) of approximately 120 patients each
were designed and powered as Phase III studies. Based on this additional
information from the FDA, Isolagen will propose to modify the initiated
study IT-A-008 to be a Phase II/III study. This study, which is designed to
demonstrate efficacy, will be amended to allow for a closer assessment of
the Evaluator Assessment Scale and Photo Guide. Based on the study's
findings, the Company will propose to continue with the acne scar pivotal
clinical program during 2008. Isolagen believes that the two trials may
have the potential to form the basis of a Phase III trial submission to the
FDA.
"We appreciate the FDA's attention and guidance and are moving forward
to modify our acne scar clinical program," said Nicholas L. Teti, Jr.,
Chairman and Chief Executive Officer of Isolagen. "Little scientific
research has been done previously to establish clinical efficacy
measurements in the area of acne scarring. We feel it is important to
advance our technology in a new therapeutic category for this unmet need,
and we will continue to collaborate with the FDA to move our program
forward."
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 consists of the
Isolagen Therapy. The Isolagen Therapy is a cellular processing system
which creates a natural therapy of living cells by multiplying a patient's
own collagen- producing cells or fibroblasts into tens of millions of new
cells, creating a treatment which is then returned to the patient's skin.
Clinical studies are currently underway investigating the Isolagen Therapy
in aesthetic and therapeutic applications. Isolagen also commercializes a
scientifically- advanced line of skincare systems through its
majority-owned subsidiary, Agera(R) Laboratories, Inc. For additional
information, please visit isolagen.
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. Forward-looking statements
include, without limitation, the FDA's acceptance of our proposed study
amendments, and whether our two clinical trials will have the potential to
form the basis of a Phase III trial submission to 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, 2006,
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,
2006, as well as other public filings with the SEC since such date.
Isolagen, Inc.
isolagen
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