November 2011

Several years ago, we developed a cancer eating bacteria that is incapable of causing disease and that carries an immune stimulant gene directly into tumors. With one oral dose we have seen 60% to 90% tumor destruction without any apparent side effects in several animal models of primary and metastatic cancers. This genetically engineered bacteria is currently undergoing a clinical human trial here at the University of Minnesota
with very promising initial results. In fact, we have been the only lab at the University of Minnesota in the last 25 years to literally take a cancer drug from “lab bench to bedside”.

Our laboratory is now focused on developing the next generation of engineered cancer killing bacteria and we strongly believe we are on the cusp of developing a strategy to impart an even greater cancer killing effect. With the downturn in the economy, many of the traditional sources of medical research funding have been severely affected. Furthermore, our research endeavors represent some very “out of the box” thinking that the traditional chemotherapy touting physicians have not embraced. It is obvious that using one’s own immune system to kill cancer is where we need to focus our efforts rather than develop yet another severely toxic drug that sometimes is worse than the disease itself.

November 2010

The Biotherapy Laboratory within the Department of Surgery at the University of Minnesota has seen remarkable success in developing innovative forms of cancer therapies. Our lab has successfully developed a strain of Salmonella that has been genetically engineered to not cause any disease or side effects. In addition, this bacteria carries the human gene for one of the most powerful immune stimulants known. When ORALLY given, we have seen impressive anti-cancer activity in animal models of metastatic colon cancer to the liver, primary neuroblastoma (a particularly deadly tumor in children), metastatic bone cancer to the lungs, and most recently, pancreatic cancer. This therapy is now in a clinical human trial at the University of Minnesota.

Our laboratory is now focused on developing the next generation of salmonella based cancer therapies. We have literally gone back to the drawing board and looked at the original genetic engineering methods and are now constructing attenuated salmonella that carry a host of genes that have anti-cancer activity. We hope to test these in various models of the most deadly forms of cancer. In addition, we are studying those genes responsible for developing a cancer and looking at methods to neutralize these genes by activating our own immune system with these salmonella based anti-cancer therapies.

We have already been successful in achieving FDA approval for a human trial for our first generation of therapy and although the trial is far from complete, we are seeing very promising results.

December 17, 2008

We are pleased to announce that the FDA has given approval to the application for a Phase I trial of an investigational new drug for the biotherapy cancer treatment. The initial trial will be with a small number of patients and has a primary purpose of establishing safety of the treatment. After many years of laboratory work and animal trials, this will be the first trial in humans. It is expected to last six months. This is a very major milestone in more than 18 years of diligent hard work by Drs. Leonard and Saltzman. While the Phase 1 trial is to establish safety of the biotherapy, it’s anticipated there will be evidence of efficacy or effectiveness as well. There have been many, many people who have made important contributions supporting the work over the years, so for everyone involved, many, many thanks and congratulations!

October 14, 2010

An important review article in Nature acknowledged the seminal contribution of Dr. Leonard and Dr. Saltzman’s laboratory to the rapidly evolving field of bacterial cancer therapy. See the sentence: “Reports describing Il-2 delivery by Salmonella were the first to suggest that this genus could be effectively used as an anticancer agent (73, 80).” on page 4.

Nature Reviews Cancer | AOP, published online 14 October 2010; doi:10.1038/nrc2934

May 15, 2008

We are very proud to announce that the National Institutes of Health just awarded a large federal grant to the laboratory of researchers Dr. Arnold Leonard and Dr. Dan Saltzman. The grant has been awarded to their bioengineering lab at the University of Minnesota which is working on a genetically engineered cancer therapy. This research has garnered national attention from within the medical community, and this NIH grant is a prestigious vote of confidence from the government for this pioneering work involving cancer and the immune system. The $411,000 grant will be used in researching the effects of their therapy on pancreatic cancer.

The Food and Drug Administration has reviewed an investigational new drug application for the biotherapy. Approval was granted and the human Phase 1 trial has begun. This is a big step towards gaining federal approval as a cancer drug. If the human study results are in line with the lab work, the medical community may have an incredible new tool for fighting cancer.

The human Phase 1 trial includes patients with stomach, intestinal, and colon cancers that have spread to the liver and who have no hope for a cure.

In addition to our colon cancer model, we have observed a similar reduction in metastases in neuroblastoma and osteogenic sarcoma models. Neuroblastoma is the deadliest solid tumor found in children, so this would be a major advance for children. Additional work is now being carried out in pancreatic cancer.