Isolagen Modifies Ongoing Clinical Program for Acne Scars
November 27 2007 - 4:15PM
PR Newswire (US)
- FDA Recommends Further Analysis of Evaluator Assessment Scale and
Photo Guide; Company Proposes Amending Previously Announced Phase
III Study as a Phase II/III Study - EXTON, Pa., Nov. 27
/PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX:ILE) announced
today 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 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. 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. DATASOURCE: Isolagen,
Inc. CONTACT: Media: Mike Beyer of Sam Brown Inc., +1-773-463-4211,
, for Isolagen, Inc.; or Investors: Charles Huiner of Isolagen,
Inc., +1-484-713-6200, Web site: http://www.isolagen.com/
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