Nuvilex, Inc. (PINK SHEETS: NVLX) announces the favorable results of a completed Phase II clinical trial carried out in Europe against pancreatic cancer. The treatment technology used in this trial was recently acquired by Nuvilex.
The trial demonstrated both efficacy and an improvement in quality of life, due in large part to the reduction in toxicity levels from lower dose chemotherapy. Highlights of the trial, which were compared to Gemzar®, the current gold standard chemotherapy, include:
- Results demonstrated a 100% increase in patients' median survival rate
- The 1-year survival rate was twice that observed with the current gold standard
- Chemotherapy dose needed was only one-third the normal amount
- Improved quality of life was noted in more than half of the patients
Fourteen patients were treated with encapsulated cells placed into their pancreatic tumor. The encapsulated cells converted inactive chemotherapy, given after encapsulated cell placement, into active chemotherapy at the tumor site. Two chemotherapy treatments were given within one month and all patients had either positive responses or had their disease stabilized 20 weeks after treatment. No patients showed disease progression over the course of the trial and obvious tumor shrinkage was observed. The average pancreatic cancer patient survival was extended to 40 weeks compared to only 24 weeks using the gold standard treatment. No serious problems arose during the clinical trial when our treatment was used and the patients had a dramatically improved quality of life as measured by body weight maintenance and decreased pain and analgesic use. One year after treatment, twice the patients were still alive as compared to the gold standard chemotherapy.
Dr. Robert F. Ryan, President and CEO of Nuvilex commented, "These exciting results from the European Phase II trial clearly show the effectiveness of our treatment against pancreatic cancer. Because our treatment doubled the survival rate compared to standard therapy without any adverse effects, we believe this treatment will prove to be an important advance in the therapy of this deadly form of cancer, which kills nearly 37,000 people in the U.S. each year. Nuvilex is aggressively pursuing the next phase of development of this treatment technology."