NeoPharm has reported the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol. The multicenter, open-label trial of LEP was conducted at 5 centers in India.
In the study 35 subjects were enrolled and received LEP doses of 275mg/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.
The data suggested that LEP was well tolerated with sensory polyneuropathy = grade 3 in only one subject and neutropenia = grade 3 in 2 subjects, two common toxicities of Taxol and Abraxane.
Aquilur Rahman, president and CEO of NeoPharm, said: “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 randomised 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 randomised 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.”