VALENCIA, Calif., Nov. 27 /PRNewswire-FirstCall/ -- MannKind Corporation , 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 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 http://www.mannkindcorp.com.
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
CONTACT: Peter Richardson, Chief Scientific Officer of MannKindCorporation, +1-201-983-5064, prichardson@mannkindcorp.com; Julie Huang(investors), or Robert Stanislaro (media), both of Financial Dynamics forMannKind Corporation, +1-212-850-5600, mnkd@fd.com
Web site: http://www.mannkindcorp.com/
