LE-DT is NeoPharm's NeoLipid® liposomal formulation of the anti-cancer agent docetaxel, which is the active ingredient in Sanofi Aventis' Taxotere®, approved for use in certain breast cancer, non-small cell lung cancer, gastric adenocarcinoma, head and neck cancer indications, and prostate cancer. 

NeoPharm has completed a multi-center Phase I clinical trial for LE-DT for the treatment of patients with metastatic solid tumors.  This Phase I study was designed to define the maximum tolerated dose ("MTD") and was conducted at The Lombardi Comprehensive Cancer Center at Georgetown University and at TGen Clinical Research Services at Scottsdale Healthcare.  The data from the trial demonstrated that LE-DT has minimal toxicities compared to Taxotere®, in particular, peripheral neurotoxicity and water retention (edema). 

In the first quarter of 2010, NeoPharm expects to enroll patients in a Phase II study of LE-DT for locally advanced or metastatic pancreatic patients.  The open-label, Phase II study is designed to determine the antitumor effect of LE-DT in locally advanced pancreatic cancer patients as evidenced radiologically with CA 19-9 as the surrogate biological marker.

In addition, NeoPharm is planning another Phase II study of LE-DT for prostate cancer patients.  This open-label, Phase II study will define the clinical activity of LE-DT as an antitumor response in soft tissues as defined by the serum Prostate Specific Antigen ("PSA") level as a biological surrogate marker, disease response, progression-free survival and quality of life in patients with metastatic prostate cancer.  NeoPharm anticipates a total of 63 patients to be enrolled in this Phase II trial at up to six locations in the United States and overseas. 

Depending on the outcome of these clinical trials, NeoPharm may decide to undertake multicenter and multinational Phase III trials in these indications after thorough discussions with the FDA.