You are here

Phase 3 Trial of Insegia in Pancreatic Cancer Does Not Meet Primary Endpoint

PHILADELPHIA--(BUSINESS WIRE)--Feb. 15, 2005--Aphton Corporation (Nasdaq: APHT) announced today that its Phase III study of Insegia(TM) (G17DT immunogen) in combination with chemotherapy did not meet its primary efficacy endpoint of improving overall survival in patients with pancreatic cancer. Insegia is an investigational therapeutic immunotherapy directed at the growth hormone gastrin. This study randomized 383 previously untreated patients with metastatic pancreatic cancer, to receive Insegia plus gemcitabine (Gemzar(R), Eli Lilly) versus gemcitabine alone.

The adverse event profile in this study showed no significant differences between study arms and was similar to the observed events in previous clinical trials.

"While Insegia did not meet the primary endpoint, we are encouraged by results we have observed in patients who achieved an antibody response, in this case approximately 70% of patients. These patients demonstrated prolonged survival over patients treated in the control arm with chemotherapy alone, as well as over patients who did not achieve an antibody response." Patrick Mooney, M.D., Chief Executive Officer of Aphton Corporation, commented. "Results from this study will be important in designing future clinical trials of Insegia in combination with chemotherapy. In addition, we also believe that these results further support the current monotherapy applications of Insegia, as a potential treatment for patients for whom chemotherapy is not an option."

In May 2004, Aphton reported positive data from a Phase II combination therapy trial with cisplatin and 5-Flourouracil in advanced gastric cancer. In addition to the combination studies for Insegia, Aphton has also recently completed and reported positive data from a Phase III monotherapy pancreatic cancer trial, for which it has filed for marketing approval in Canada, Australia and Switzerland.

Aphton has submitted the Insegia Phase III pancreatic data set to the late-breaking session at the upcoming American Society of Clinical Oncology annual meeting, which will occur in May 2005.

About Pancreatic Cancer
According to the World Health Organization more than 216,000 people worldwide are diagnosed each year with pancreatic cancer. The American Cancer Society estimates that in 2005 approximately 32,180 people in the United States will be diagnosed with pancreatic cancer and approximately 31,800 will die of the disease. The majority of patients are in the advanced stages of the disease at the time of diagnosis. Surgery and chemotherapy are the primary treatment options but to date, have shown limited benefit.

About Gastrin
Gastrin is a key hormone in the embryological development of the gastrointestinal (GI) system. Most gastrin receptors as well as gastrin itself continue to be present in the GI system but in a dormant state, except for in the stomach where it is produced as an aid to digestion. However, researchers have found that gastrin expression and the appearance of gastrin receptors have been associated with increasing malignant characteristics of GI tumors. In cancer cells, gastrin may act as a signaling factor for both the growth and proliferation of cancer cells. Researchers have demonstrated such malignant characteristics in cancers of the colon, stomach, liver and pancreas.

About Insegia
Insegia(TM) (G17DT immunogen) is an active immunotherapy designed to target and inhibit the activity of the gastrin hormone. Insegia works by harnessing the body's own immune system to generate high levels of antibodies to gastrin and the gastrin receptor. The intent is to neutralize the ability of the gastrin hormone to further effect the growth and proliferation of particular cancers. Aphton has completed and reported positive results from clinical trials of Insegia as both a monotherapy in pancreatic cancer and in combination with chemotherapy in gastric cancer. The company has filed for marketing approval of Insegia as a monotherapy in Canada, Switzerland and Australia for the treatment of pancreatic cancer.

Source: Aphton Corporation

Recent Headlines

Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
One in Five Kids’ Office Visits Results in an Off-Label Rx
Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds