¡¤ GV1001 for Pancreatic Cancer
Each year around 130,000 people are diagnosed with pancreatic cancer in the Western world (Globocan, 2005). Because of the difficulties of early detection and rapid progression of the disease, pancreatic cancer is the 4th leading cause of cancer death although the disease is only the 9th most commonly diagnosed cancer.
Treatment of pancreatic cancer depends on the stage of the disease. The only way to eliminate pancreatic cancer is an operation to remove the tumor. Unfortunately, this is possible only in a very small percentage of the patients. Chemotherapy, with or without addition of radiotherapy, is the usual treatment for the cancer that has spread to nearby tissues or distant organs.

Clinical trials-1

It is a Sponsor-Investigator Phase III trial, called Telovac, to evaluate gemcitabine, capecitabine, and the GV1001 vaccine in treating patients with locally advanced or metastatic pancreatic cancer. Giving more than one drug, gemcitabine and capecitabine as combination chemotherapy, together with vaccine therapy may kill more tumor cells and consequently, the patients may survive longer. So, the trial will help answer whether a chemotherapy combination of gemcitabine and capecitabin is more effective with or without vaccine therapy in treating pancreatic cancer. Patient recruitment is presently ongoing at several sites in the United Kingdom.

Clinical Trials-2

May 13th, 2008:KAEL-GemVax has decided to stop further enrollment for the PrimoVax phase III trial of GV1001 in pancreatic cancer after a preliminary analysis shows no survival benefit.

The PrimoVax trial is to compare GV1001 and gemcitabine in sequential combination to gemcitabine monotherapy (a standard chemotherapy for pancreatic cancer) in advanced un-resectable pancreatic cancer. The primary objective is to investigate the overall survival in two treatment groups. Secondary endpoints are safety, efficacy of GV1001 monotherapy, immunogenecity and pharmacoeconomics.

¡¤ GV1001 for Liver Cancer
A primary cancer of the liver, also called hepatocellular carcinoma (HCC), is distinguished from liver metastasis which are cancers that have spread to the liver from elsewhere in the body, e.g. the colon and breast. Most cases of HCC are secondary to either a viral hepatic infection (hepatitis B or C in developing countries) or cirrhosis (alcoholism being the most common cause in the developed world). HCC is the 5th most common cancer worldwide and over 600,000 new cases occur worldwide per year (WHO, 2003). Globally, 598,000 patients died with HCC in 2002 (Globocan, 2002).
Typical therapies for cancer are usually not effective against HCC, and only 10-20% of HCC cases can be removed completely by surgery. This, together with the cancer often first being discovered or diagnosed late with large tumors and the fast progression of the cancer results in a poor prognosis or outcome for HCC patients.

Clinical Trials

A Phase II study, called Heptovax, is to evaluate the safety and immunogenicity of the GV1001 vaccine in locally advanced or metastatic liver cancer patients. The anti-tumor efficacy of the GV1001 vaccine will also be evaluated. All patients are initially treated with a single dose of cyclophosphamide to evaluate whether this will have a positive effect on the immunologic response. The study is being conducted in Germany, France and Spain.

¡¤ GV1001 for Lung Cancer
Lung cancer is a disease where internal lining cells (epithelial cells) of tissue in the lung grow out of control. This leads to invasion of adjacent tissue and infiltration beyond the lungs and spread to the distant organs. The cancer is the most common cause of cancer related death in human (WHO, 2004) and is responsible for 1.3 million deaths worldwide annually (WHO, 2006), the figure exceeding the number of deaths from colon, breast, prostate cancer combined and accounting for about 29% of all deaths due to cancer.
The main types of lung cancer are non-small cell lung carcinoma (NSCLC, about 85-90%) and small cell lung carcinoma (about 10~15%). This distinction is important because the treatment varies. Current treatment of patients with NSCLC relies on three therapeutic methods: surgery, radiotherapy and chemotherapy.

Clinical Trials

A Sponsor-Investigator Phase II study, called CTN8, is to evaluate the safety and immunogenicity of the GV1001 vaccine in patients with locally advanced non-small cell lung carcinoma after completion of chemo- and radiation therapy. The anti-tumor efficacy of the GV1001 vaccine will also be evaluated. The trial is being conducted in three research centers in Norway and patient recruitment is presently ongoing.