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NKTR-102 Demonstrates Significant Efficacy as Single-Agent in Second- or Third-Line Treatment in Metastatic Breast Cancer Patients
Date:12/12/2010

e remains high and failure can unexpectedly occur at any stage for one or more of the cancer indications being studied (i.e. ovarian cancer, breast cancer, and colorectal cancer) due to efficacy, safety or other unpredictable factors even after earlier clinical studies have shown positive results; (ii) the Phase 2 data for NKTR-102 in breast cancer described in this press release remain subject to data audit confirmation procedures, and the final results may change materially and adversely after such review is completed; (iii) additional important data will be reported by Nektar in the future regarding the Phase 2 NKTR-102 clinical study in breast cancer including but not limited to final progression-free survival and overall survival and therefore the complete results for the Phase 2 breast cancer trial may differ materially and adversely from these preliminary results; (iv) the timing or success of the commencement or end of clinical trials and commercial launch of new drugs may be delayed or unsuccessful due to commercial and funding considerations, regulatory delays, clinical trial design, slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets; (v) this early preliminary data from the NKTR-102 Phase 2 clinical study for breast cancer is not necessarily predictive of success in other cancer indications for which NKTR-102 is being studied (i.e. ovarian and colorectal cancers) or success in Phase 3 clinical development; (vi) the data package required and the timing for regulatory approval of a new drug application is very uncertain and difficult to predict due to broad regulatory discretion, changing standards of care, available approved therapies, the size of the completed clinical trials and the statistical significance of the results, the potential need for comparative clinical studies against approved therapies
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SOURCE Nektar Therapeutics
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