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news.Biopharmaceutical firm NeoPharm has enrolled its first patients in its multi-center open-label, Phase II clinical trial of liposomal paclitaxel for efficacy and safety in patients with metastatic breast cancer.
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The study is designed to evaluate the anti-tumor effect and safety/tolerability of liposomal paclitaxel (LEP-ETU). The study will target enrolling 35 patients in five centers with histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast. The primary objective of the trial will be to assess the overall response rate of patients with metastatic breast cancer after treatment with a dose of 275mg/m2 LEP-ETU administered over 90 minutes, with secondary objectives to evaluate the progression-free survival of patients treated with LEP-ETU and the safety of LEP-ETU, in particular peripheral neuropathy.
Laurence Birch, president and CEO of NeoPharm, said: “We believe LEP-ETU may present an opportunity for reduced side effects including peripheral neuropathy, hypersensitivity reactions, nausea, vomiting, and hair loss, as well as ease of use for patients suffering from multiple forms of cancer.”