NeoPharm Presents the Phase II Data of LEP in Patients with Metastatic Breast Cancer
News Jan 07, 2010
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.
More than half of the drugs that have entered the market in Germany since then have emerged from these assessments without any proven added benefit. In a new publication using the first 216 assessments, researchers examine the reasons for this sobering result and develop suggestions for improvements in drug development.READ MORE