NeoPharm, Inc. (Other OTC: NEOL.PK) today 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.