Researchers presented results from a Phase II clinical trial for advanced pancreatic cancer patients treated with Aphton's anti-gastrin therapeutic vaccine at a meeting of the British Society of Upper Gastrointestinal System Surgeons held recently in the UK. These results showed greater increased survival of patients treated with Aphton's anti-gastrin vaccine as compared to the increased survival results in the first Phase II trial with advanced pancreatic cancer patients.

The study consisted of 33 evaluable patients, all of whom had advanced pancreatic cancer. All patients in the trial received Aphton's anti-gastrin vaccine, at one dose-level, with no additional or concurrent therapies.

Overall median survival of the 33 evaluable patients was 8.6 months post-initiation of therapy (and 10 months post-diagnosis), compared to 6.7 months post initiation of therapy for the first study. The median survivals of both Phase II studies compare favorably with published data showing a median survival of approximately 4.3 months for patients with advanced pancreatic cancer, who either receive no therapy or do not respond to additional therapies. Gemcitabine, the only approved drug in the U.S. for pancreatic cancer, added approximately 5 to 6 weeks to the 4.3 months median survival for advanced pancreatic cancer patients.

Of equal or greater significance, in our view, is that the expected one year patient survival in this study is 30 percent. This compares to an expected one year patient survival of 5 percent for untreated or non-chemo-responding patients, and an expected one year patient survival of 15 percent for patients treated with gemcitabine, as reported in the medical literature.

In addition, it was reported that Aphton's anti-gastrin therapy was well tolerated with no systemic toxicity, consistent with all previous Aphton clinical trials.

Aphton's anti-gastrin vaccine induces antibodies in patients that neutralize (block) gastrin-17. This is believed to be the central growth factor, or initiating signal for cell growth and cell replication, in pancreatic and other gastrointestinal system cancers; this neutralization of gastrin-17 slows the growth, proliferation and spread of pancreatic cancer.

Aphton has commenced two pivotal Phase III clinical trials with patients with advanced pancreatic cancer, one in the U.S. and one in Europe. The U.S. trial will compare patients treated with Aphton's anti-gastrin vaccine in combination with the chemotherapeutic agent gemcitabine, versus patients treated with gemcitabine only.

The European trial will compare patients treated with Aphton's anti-gastrin vaccine only, versus those treated with gemcitabine. Another European trial will compare patients treated with Aphton's anti-gastrin vaccine only, versus those treated with a placebo. Aphton is also in pivotal trials with its anti-gastrin vaccine for chemo-refractory patients with colorectal cancer and in pre-pivotal clinical trials for patients diagnosed with either advanced stomach cancer or with esophageal cancer.