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LEP-ETU is NeoPharm's NeoLipid® liposomal formulation of the widely used cancer drug, paclitaxel. Paclitaxel, also known as Taxol® (Bristol-Myers Squibb Company), has been approved in the U.S. for the treatment of ovarian, breast and lung cancers. Despite paclitaxel's wide use and tumor cytotoxic characteristics, its effectiveness can be limited by its adverse side effects, which can include nausea, vomiting, hair loss and nerve and muscle pain. Because of the chemical characteristics of paclitaxel, it cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor®) and ethanol, which can lead to significant side effects such as hypersensitivity reactions and cardiac toxicities. The Company hopes to show that its proprietary NeoLipid® technology, which eliminates the need for Cremophor and ethanol, permits delivery of paclitaxel treatment with fewer side effects. In the first quarter of 2009, NeoPharm completed the targeted enrollment of 35 patients for the first part of its Phase II open-label, multi-center outpatient study in India designed to evaluate the anti-tumor effect and safety/ tolerability of LEP- ETU in metastatic breast cancer. All of the patients in the first part of the study have received a dose of 275 mg/m2 every three weeks without the detection of any significant infusion related problems or unexpected toxicities and showed a response rate of 46% compared to 11% with free Taxol® and 22% with Abraxane®. NeoPharm has started another Phase II trial for recurrent breast cancer to enroll 35 more patients while rapidly working to embark on a Phase III randomized trail of LEP with free Taxol® as a comparator arm in metastatic breast cancer patients with the goal being to achieve regulatory approval of LEP as an effective modality for the treatment of cancer patients as early as possible.
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