Nuvilex Reports Additional Safety and Efficacy Data From Second Phase 2 Pancreatic Cancer Trial
SILVER SPRING, Md., Oct. 8, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology provider of cell and gene therapy solutions, announced the presentation today of additional safety and efficacy data from a second Phase 2 pancreatic cancer clinical trial. The new trial data was presented by Dr. John Dangerfield, COO of the Nuvilex subsidiary Austrianova Singapore Pte Ltd (ASPL) at the ISCGT Meeting. The trial data presented used the same encapsulated cytochrome P450 expressing cells followed by chemotherapy to treat pancreatic cancer that were used in the previously published trial and confirmed results generated in the previous trial.
The Phase 2 pancreatic cancer trial approach being advanced by
Nuvilex, and its subsidiary ASPL, works through the ability of
special, cellulose sulphate encapsulated, living cells expressing
P450 CYP 2B1. These cells are able to convert the inactive chemotherapy drug ifosfamide to its active form at the site they are placed in. As a result, the encapsulated cells create a high level of drug in the area of the pancreatic tumor where the treatment can provide for the greatest anti-tumor effect, coupled with a significant reduction in side-effects since much lower doses of the chemotherapeutic drug need to be used.
The major findings reported at the ISCGT meeting revealed that
safety and efficacy data from a total of 27 patients is now
available, approximately doubling the number of patient data
In this expanded patient group no immunological, capsule, or cell-related adverse events from the live cell encapsulated treatment approach were reported. Moreover and most importantly, the data presented confirmed the approximate doubling of median survival when compared to the data available for the current standard treatment, Gemzar. In addition, there was a doubling of the number of 1 year survivors treated with encapsulated cells plus chemotherapy compared to the standard Gemzar treatment. Another significant finding comes from the fact that the treatment procedure was successfully performed at 4 different cancer treatment centers in Europe by three different interventional radiologists.
ASPL's CEO, Dr Brian Salmons, said, "The additional data
presented at the ISCGT meeting confirms the safety of the capsule
material, the implantation procedure and the long term safety of
implanting cells in the body inside the cellulose sulphate
encapsulation material. Lastly, the survival benefit of the first
trial in terms of median survival and
1 year survival was confirmed and therefore the importance of the treatment was verified."
Dr. Robert F. Ryan, CEO of Nuvilex, said, "This data provides us with additional confidence as we undertake the next steps in the development of the treatment of pancreatic cancer as well as other solid tumors."
Nuvilex, Inc. (OTCQB:NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Substantial progress in multiple areas will be providing the Company with increased potential and we look forward to bringing those forward shortly. Our company's clinical offerings will include cancer, diabetes and other treatments using the company's cell and gene therapy expertise and live-cell encapsulation technology.
The Nuvilex, Inc. logo is available at
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Posted: October 2012