Research Updates
FDA Approves Biotherapy Cancer Treatment Phase I Trial
17 December 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!
Immuno-Viva® Researchers Awarded Prestigious Government Grant
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 Immuno-Viva 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 is reviewing an investigational new drug application for the biotherapy. Upon approval, the doctors will be able to proceed with human clinical trials. This is a big first 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.
We have submitted an application and have been given tentative approval by the FDA to conduct trials in people with stomach, intestinal, and colon cancers that have spread to the liver and who have no hope for a cure. We have finished the additional studies that were requested in the FDA response, have answered the questions, and are waiting for FDA approval.
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.
Published Papers on Lab Work with Pancreatic and Osteosarcoma Cancer
See our most recently published papers on our laboratory work with pancreatic and osteosarcoma cancer by clicking the button below.
