Drug Pipeline Series: Phase III, Nov 6 - Nov 13, 2006

NOVELOS BEGINS ENROLLMENT IN LUNG CANCER STUDY
Novelos Therapeutics announced that the first patient has been enrolled in the pivotal Phase III trial in advanced non-small-cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.
This randomized, open-label, international trial is being conducted under a special protocol assessment and will study 840 patients with Stage IIIb/IV NSCLC. It will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone. The trial, with a primary efficacy endpoint of improvement in median overall survival, will be conducted across approximately 100 clinical sites in 10 countries. Novelos is planning for patient enrollment to be completed in the first quarter of 2008.
NOV-002 is a small-molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. In a controlled, randomized Phase I/II clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response and higher tolerance of chemotherapy versus the control group. In a controlled, randomized Russian trial, when used in combination with cisplatin-based chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17 percent to 63 percent.


OXFORD BIOMEDICA INITIATES TRIAL OF TROVAX IN RENAL CANCER
Oxford BioMedica has announced the start of TRIST, a pivotal, multicenter Phase III trial of TroVax, the company's cancer immunotherapy, in patients with advanced or metastatic renal cell carcinoma (RCC).
TRIST is designed to evaluate whether TroVax immunotherapy, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic, clear-cell renal carcinoma. The trial is a randomized, placebo-controlled, two-arm study that will compare TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies will be interleukin-2, interferon-alpha or Sutent (sunitinib).
Approximately 700 patients will be recruited from about 120 centers in the U.S., the European Union and Eastern Europe. The primary endpoint for the trial is survival improvement, and secondary endpoints include progression-free survival, tumor response rates and quality of life. The protocol includes the appointment of a safety and efficacy monitoring board to assess the safety and potential efficacy of the drug combinations at various time points during the trial.
Median survival for patients with advanced or metastatic RCC is approximately 11 months, according to the company. The duration of the trial will be determined by the number of survival events (deaths) in the study group. The trial is expected to reach a conclusion in 2008 to 2009, which would support the company's objective of reaching product registration in 2009.
In May the company and the FDA reached a special protocol assessment (SPA) agreement for the TRIST study. The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA.