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NeoPharm Presents the Phase II Data of LEP in Patients with Metastatic Breast Cancer
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NeoPharm Presents the Phase II Data of LEP in Patients with Metastatic Breast Cancer

NeoPharm Presents the Phase II Data of LEP in Patients with Metastatic Breast Cancer
News

NeoPharm Presents the Phase II Data of LEP in Patients with Metastatic Breast Cancer

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NeoPharm, Inc. has announced the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol®. This multicenter, open-label trial of LEP was conducted at 5 centers in India.

Thirty-five subjects were enrolled and received LEP doses of 275 mg/m2 administered over 90 minutes every 21 days without routine prophylactic pre-medication for infusion-related reactions. Subjects received a median of 6 cycles (range 2 to 10) with 22 subjects receiving = 6 cycles.

Overall tumor responses with fully audited data were as follows: 16 subjects (46%) with tumor response including 15 partial responses and one complete response; 10 subjects (29%) with stable disease (mean duration, 6 cycles; range, 2-10 cycles); 9 subjects (25%) with progressive disease.

LEP was well tolerated with sensory polyneuropathy = grade 3 in only one subject (3%) and neutropenia = grade 3 in 2 subjects (6%), two common toxicities of Taxol® and Abraxane®. No significant infusion-related reactions were observed as indicated by adverse events or prophylactic pre-medication use.
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