Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer

LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.
Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell
division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced
toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence
obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered
at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown
positive activity of protein bound taxane therapy in treating patients with pancreatic
cancer. The current Phase II study is designed to accomplish the following objectives:

1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every
three weeks in pancreatic cancer patients with locally advanced or metastatic disease

2. To evaluate the progression-free survival and overall survival

3. To correlate secreted protein acid rich in cysteine expression with tumor response

4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention
as well as myelotoxicity

5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic
endpoints, including toxicities.