Nereus Pharmaceuticals - Products in Preclinical Evaluation

Clinical Trials For Plinabulin (NPI-2358) (VDA)

Nereus has conducted a number of clinical trials with plinabulin. The initial Phase 1 study of plinabulin as a single agent in patients with advanced malignancies demonstrated favorable pharmacokinetic, pharmacodynamic and safety profiles. A subsequent Phase 1 study examining the combination of plinabulin and docetaxel produced encouraging safety, pharmacokinetic and activity data for the combination. Based on these results, Nereus initiated a randomized Phase 2 clinical trial (the ADVANCE study) with plinabulin in combination with docetaxel in advanced non-small cell lung cancer (NSCLC).

The ADVANCE study (Assessment of Docetaxel and Vascular Disruption in NSCLC) is a randomized, open-label study comparing docetaxel to plinabulin plus docetaxel in patients with advanced NSCLC who have failed an initial therapy, with the intent of demonstrating an improvement in overall survival. NSCLC was selected as a high priority development target for plinabulin in combination with docetaxel based on relevant preclinical and clinical data, as well as significant opportunities for contribution in patients with limited treatment options such as those with squamous cell carcinoma type of NSCLC. The study is expected to enroll approximately 150 patients from 40 investigators internationally during 2009.

Based on encouraging animal and clinical studies, clinical trials in other types of cancer are in preparation.

To learn more about these clinical trials please visit www.clinicaltrials.gov .

Nereus Pharmaceutical drugs are in preclinical or clinical trail testing, and are not available by prescription from doctors. Patients can only receive these drugs if they are participating in a sponsored clinical trial.
If you are a patient and interested in entering a clinical trial, it is best that you consult your doctor regarding appropriate and available treatments for your condition, and whether or not you should enter a clinical trial. Your physician can find a description and list of participating centers for clinical trials sponsored by Nereus Pharmaceuticals, as well as other clinical trials for patients with cancer, at www.clinicaltrials.gov.
Nereus pharmaceuticals cannot respond to patient inquiries on medical matters.
Clinical trials can only be entered by contacting participating physicians and centers. Patients cannot enter clinical trials by contacting Nereus Pharmaceuticals.