NeoPharm, Inc. (Other OTC: NEOL.PK) today announced the results of a Phase I clinical trial of Liposome Encapsulated Docetaxel (LE-DT) an active component of Taxotere® at a joint International Conference of the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC) being held in Boston, MA. This multicenter, open label dose escalation trial of LE-DT was performed at Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC and Scottsdale Clinical Research Institute/TGEN, Scottsdale, AZ.
Patients received 50, 65, 85, 110 and 132mg/m2 doses in a cohort of 3 patients per dose until the maximum tolerated dose (MTD) was defined. The MTD was determined to be 110 mg/m2 with growth factor support (9 patients). Neutropenia was the most common toxicity seen in patients receiving higher doses of LE-DT, which is also observed with Taxotere®. Additionally, toxicities experienced by at least three patients included fatigue, alopecia, rash and diarrhea. Most of the non-hematological toxicities observed with LE-DT were grade 1 in nature. Of particular note, in this heavily pretreated cancer patient population, no patient was observed with clinically significant neuropathy, even those patients who received 15 cycles (110mg/m2) and 24 cycles (50mg/m2) of LE-DT. Ten patients experienced some form of infusion-related reaction with LE-DT including chills, rigor, back pain or nausea which was managed by slowing the rate of infusion, except in a few patients who needed antihistamine support. Also, an additional observation was that none of the patients experienced clinically significant edema, which is the common toxicity of Taxotere® when given with Tween 80.
Dr. Aquilur Rahman, President and Chief Executive Officer of NeoPharm commented, “We are very pleased with the absence of serious toxicities with LE-DT therapy for the majority of cancer patients in this trial, particularly peripheral neuropathy and edema, the two treatment limiting toxicities observed with Taxotere®. We are encouraged with the clinical response of LE-DT in this heavily pretreated cancer patient population suffering from various kinds of cancers. A response rate of 45% (partial response and stable disease) is quite noteworthy. We look forward to the clinical outcome of LE-DT in pancreatic and prostate cancer patients in Phase II trials which are being initiated.”