5 Jun 2012 WDM Group PR Network PISCATAWAY, NJ--(Marketwire - June 4, 2012) - Enzon Pharmaceuticals, Inc. (NASDAQ: ENZN) today presented data from the final analysis of a Phase II study in which PEG-SN38 demonstrated notable activity in patients with previously treated metastatic breast cancer. The data were presented in a poster session (Poster #1017) at the American Society of Clinical Oncology Meeting in Chicago, IL."Despite existing therapies, new and effective treatment options for patients with previously treated metastatic breast cancer are needed," said Joyce A. O'Shaughnessy, MD, a breast cancer specialist at Texas Oncology, Baylor Sammons Cancer Center, and US Oncology, and the principal investigator of the study. "In this study, PEG-SN38 resulted in a significant overall response rate in previously treated patients, as well as in triple negative breast cancer and platinum-resistant patients. These findings provide further clinical evidence indicating the potential of PEG-SN38 to deliver meaningful therapeutic benefit in patients with breast cancer."The study was designed to evaluate the efficacy of single-agent PEG-SN38 in 164 female patients who had previously been treated for metastatic breast cancer with either anthracycline and taxane (AT, up to 2 prior lines of therapy) (n=81), or anthracycline, taxane and capecitabine (ATX, up to 4 prior lines of therapy) (n=83). The primary objective of the study was to determine overall response; secondary objectives included duration of response, progression-free survival (PFS), overall survival (OS) and safety.Overall response was found to be meaningful in both the AT group (25%) and the ATX group (11%). For the AT and ATX cohorts, the response rate and clinical benefit rate among estrogen response positive patients were 15% and 39% (n= 92), respectively. In patients who progressed during or within 30 days of prior platinum-containing regimens, the clinical benefit rate was 18% (n=40). Among triple negative breast cancer patients, the response rate and clinical benefit rate were 23% (n=47) and 32% (n=47), respectively. For triple negative breast cancer patients with prior platinum-containing regimens, the clinical benefit rate was 18% (n=22). PEG-SN38 was generally well tolerated in these heavily pretreated patients, with neutropenia, diarrhea and leukopenia being the most common adverse events. Investigators concluded that PEG-SN38 warrants further clinical study in metastatic breast cancer. Enzon does not intend to pursue development of PEG-SN38 in this indication or in other malignancies on its own, absent a partner. Zhejiang Hisun Pharmaceuticals Co. Ltd recently acquired exclusive development and commercialization rights to PEG-SN38 in China. Enzon is seeking strategic partners for PEG-SN38 in other territories.
About PEG-SN38 (EZN-2208)Through the use of our PEGylation technology, Enzon designed PEG-SN38 (EZN-2208), a PEGylated conjugate of SN38, to offer therapeutic advantages over unmodified SN38 and existing therapies. The PEGylated version allows parenteral delivery, increased solubility, higher exposure, more profound deoxyribonucleic acid (DNA) damage, inhibition of angiogenesis, and longer apparent half-life of SN38 as compared to irinotecan.
About Enzon Enzon Pharmaceuticals, Inc. is a biotechnology company dedicated to the research and development of innovative therapeutics for patients with high unmet medical need. Enzon's drug-development programs utilize two platforms: Customized PEGylation Linker Technology (Customized Linker Technology®) and third-generation mRNA-targeting agents utilizing the Locked Nucleic Acid (LNA) technology. Enzon currently has four compounds in human clinical development and multiple novel mRNA antagonists in preclinical research. Enzon receives royalty revenues from licensing arrangements with other companies related to sales of products developed using its proprietary Customized Linker Technology. Further information about Enzon and this press release can be found on the Company's website at www.enzon.com.
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