NeoPharm, Inc. has announced that it has enrolled its first patients in its multi-center open-label, Phase II clinical trial of Liposomal Paclitaxel (LEP-ETU) for efficacy and safety in patients with Metastatic Breast Cancer.
In pre-clinical and Phase I clinical data, LEP-ETU demonstrated a reduced side-effect profile, particularly peripheral neuropathy, as well as the potential for increased dosage and greater efficacy over Taxol®, the standard care for many tumors, principally breast and ovarian cancer.
NeoPharm has developed this liposomal formulation of paclitaxel in an effort to improve the safety profile of the currently marketed paclitaxel formulations by eliminating other toxic excipients, such as Cremophor® and ethanol, which must be co-administered to help decrease unwanted side effects.
Mr. Laurence Birch, President and Chief Executive Officer of NeoPharm Inc. commented, “We are pleased to announce the commencement of our Phase II trial for LEP-ETU. Our NeoLipid™ technology has enabled us to develop a formulation that we hope will eliminate the need for the use of Cremophor® and ethanol when administering paclitaxel. We believe LEP-ETU may present an opportunity for reduced side effects including peripheral neuropathy, hypersensitivity reactions, nausea, vomiting, and hair loss, as well as ease of use for patients suffering from multiple forms of cancer.”
Mr. Birch continued, “The Company’s re-entry into the clinic shows the significant strides that we have made over the last year with our drug candidate portfolio. With a number of structural changes to our operations, as well as a successful evaluation of NeoPharm’s drug product pipeline and intellectual property, we are now in a position to capitalize on the compounds we have developed to date.”
The Phase II open-label, multicenter outpatient study is designed to evaluate the anti-tumor effect and safety/tolerability of LEP-ETU in metastatic breast cancer.
The study will target enrolling 35 patients in five centers with histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
The primary objective of this Phase II trial will be to assess the Overall Response Rate of patients with metastatic breast cancer after treatment with a dose of 275 mg/m2 LEP-ETU administered over 90 minutes, with secondary objectives to evaluate the Progression-Free Survival (PFS) of patients treated with LEP-ETU and the safety of LEP-ETU, in particular peripheral neuropathy.