MannKind
Corporation (Nasdaq: MNKD), focused on discovering, developing and
commercializing treatments for diabetes and cancer, announced today that
its Investigational New Drug (IND) application for MKC1106-PP Immunotherapy
in Solid Malignancies, has now been cleared by the U.S. Food and Drug
Administration (FDA). The clearance of the IND means that the Company may
now proceed with the initiation of its Phase 1 clinical trial -- a
multicenter, open label, clinical trial of immune response, safety and
tolerability of a DNA vector with two synthetic peptides in subjects with
solid malignancies, in a plasmid prime-peptide boost treatment. The
clinical study is designed to target two tumor-specific antigens,
preferential antigen of melanoma (PRAME) and prostate specific membrane
antigen (PSMA), on the basis of their level of expression in commonly
occurring adult malignancies, such as ovarian, prostate, renal, pancreatic,
breast, colon carcinoma and melanoma. Enrollment of the first patient is
expected before the end of the year.
"With FDA clearance, we are now able to initiate our first Phase 1
clinical trial of our cancer immunotherapy program. This is a significant
and exciting milestone in our efforts to build an immunotherapy franchise
in MannKind," said Alfred Mann, Chairman and Chief Executive Officer of
MannKind Corporation. "We continue our progress toward building our product
pipeline and demonstrating our commitment to providing therapeutic products
for diabetes and cancer."
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery,
development and commercialization of therapeutic products for diseases such
as diabetes and cancer. Its lead product, the Technosphere(R) Insulin
System, is currently in phase 3 clinical trials in the United States,
Europe and Latin America to study its safety and efficacy in the treatment
of diabetes. For more information on MannKind Corporation and its
technology, visit mannkindcorp.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements related to the plans for MannKind's clinical trials for
MKC1106-PP Immunotherapy in Solid Malignancies, MannKind's ability to
create an immunotherapy franchise or build a product pipeline or provided
therapeutic products for diabetes and cancer, and the results of any
clinical trials. Words such as "believes," "anticipates," "plans,"
"expects," "intend," "will," "goal," "potential" and similar expressions
are intended to identify forward- looking statements. These forward-looking
statements are based upon the Company's current expectations. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of many risks
and uncertainties, which include, without limitation, risks related to the
initiation, progress, timing and results of clinical trials, risks related
to safety and efficacy, intellectual property risks, difficulties or delays
in seeking or obtaining regulatory approval, manufacturing risks, risks
related to competition from other pharmaceutical or biotechnology
companies, risks related to the Company's ability to obtain financing or
enter into collaborations or strategic partnerships to support the
Company's operations and other risks detailed in MannKind's filings with
the SEC, including its Annual Report on Form 10-K for the year ended
December 31, 2005 and periodic reports on Form 10-Q and Form 8-K. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. All forward-looking
statements are qualified in their entirety by this cautionary statement,
and MannKind undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after the
date of this news release.
MannKind Corporation
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