Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

October 07, 2015

Dr. Aquilur Rahman, President and Chief Executive Officer of NeoPharm commented, "We are very pleased with the high radiographic tumor response rate of LEP in this population of metastatic breast cancer patients as well as the safety profile of LEP. A response rate of 46% (partial and complete responses) is quite noteworthy in this heavily pretreated patient population with advanced breast cancer. In addition, if responses and stable disease are considered together the potential clinical benefit may extend to 75% of patients. Although LEP response rate needs to be replicated in randomized controlled studies it compares quite favorably to Taxol? and Abraxane? study results in metastatic breast cancer patients with response rates of 11% and 21% respectively. We continue to evaluate whether to extend Phase II trials of LEP or to start a Phase III randomized trial with free Taxol? as a comparator arm in metastatic breast cancer patients. Our goal is to be able to embark on the path of regulatory approval of LEP as an effective modality for the treatment of cancer patients as early as possible???