Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

Jan 7 2010

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.

Dr. Aquilur Rahman, President and Chief Executive Officer of NeoPharm commented, "We are very pleased with the high radiographic tumor response rate of LEP in this population of metastatic breast cancer patients as well as the safety profile of LEP. A response rate of 46% (partial and complete responses) is quite noteworthy in this heavily pretreated patient population with advanced breast cancer. In addition, if responses and stable disease are considered together the potential clinical benefit may extend to 75% of patients. Although LEP response rate needs to be replicated in randomized controlled studies it compares quite favorably to Taxol® and Abraxane® study results in metastatic breast cancer patients with response rates of 11% and 21% respectively. We continue to evaluate whether to extend Phase II trials of LEP or to start a Phase III randomized trial with free Taxol® as a comparator arm in metastatic breast cancer patients. Our goal is to be able to embark on the path of regulatory approval of LEP as an effective modality for the treatment of cancer patients as early as possible”