SCOTTSDALE, Ariz.--(BUSINESS WIRE)-- Nuvilex, Inc. (OTCQB: NVLX) announced today it is aggressively engaging the steps necessary to use its encapsulated cell technology for pancreatic cancer in expanded Phase II clinical trials in the United States, Europe and Australia. The Company’s objective is to have a protocol submitted to the regulatory agencies in these countries as quickly as possible.
In conjunction with SG Austria, the world’s leading cell encapsulation technology company based in Singapore, Nuvilex has already activated our plan for rapid entry into expanded pancreatic cancer clinical trials. Necessary funding to initiate this phase of the study has been secured and the principals from both companies are working in close harmony to develop, implement, and oversee plans for the new clinical trials.
Together with SG Austria’s team, we have been refining the technology utilized in the previous Phase I/II clinical trials. This advanced technology will result in having cells capable of converting modern cancer drugs to high concentrations directly at the tumor site. This development should result in even better overall response rates than seen in the original trial. In addition, these advances should also serve to improve other results previously observed including tumor shrinkage.
It is anticipated the improved therapy will increase the median survival of advanced pancreatic cancer patients. Once the newly-refined cells are grown in large numbers, we will have sufficient cells necessary for the clinical trials. Plans for the clinical studies are already being prepared for submission and review by the critical regulatory agencies in the U.S., Europe, and Australia. Regulatory authorities in Europe had previously indicated this encapsulated cell therapy for pancreatic cancer qualifies for “orphan drug” status which should facilitate and accelerate the entire approval process, helping to bring this phase of testing to fruition more rapidly.
Dr. Robert F. Ryan, President and CEO of Nuvilex, stated, “We are looking forward with great anticipation to the initiation of the expanded Phase II clinical studies in pancreatic cancer using the encapsulated cell treatment technology. Successful results from these studies will ultimately lead us to pivotal Phase III trials for this disease and will solidly place Nuvilex on the cusp of a major cancer therapy approval. Most importantly, the use of this treatment option should provide substantial relief for the 43,000 patients in the US alone and 250,000 patients worldwide with newly diagnosed pancreatic cancer.”
We are developing, yet Nuvilex is:
a Green Company believing in “Good for You, Good for the Environment.” We continue our paradigm shift to expand our natural product lines while we make important strides in the biotechnology arena. Our recent acquisition of a live cell encapsulation treatment technology designed to combat pancreatic cancer that has already completed a Phase II clinical trial is actively being prepared for the next stage of development. Other natural product, biotechnology and clinical advances are already aggressively being pursued at Nuvilex and new updates will be announced shortly. Please make sure to check the newly launched website (www.nuvilex.com) including purchasing all Nuvilex products directly from the website and new offerings never previously available. Current products include Cinnergen™, Cinnechol™, and Cinnsational™ to enhance a healthy lifestyle; Talsyn™ and NumaDerm™ for cosmetic use; Reme-Flu™, Legacy Biotechnologies’ flu combating regimen; Virgin® and Infinitink®, heavy-metal-free tattoo inks; and additional developments are ongoing for Citroxin™ and Oraphyte™, Nuvilex’s antimicrobial and antinematodal agents.
Safe Harbor Statement
This information may contain forward-looking statements involving risks and uncertainties. Results, events and performances could vary from those contemplated. These risks and uncertainties may cause actual results, expressed or implied, to differ from predicted outcomes including product demand, market competition, and Nuvilex’s ability to meet current or future plans. Investors should study and understand all risks before making investment decisions. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.
CONTACT:
Investor Relations Contact:
Marmel Communications, LLC
Marlin Molinaro, 702-434-8692
IR email: [email protected]
KEYWORDS: Australia United States Europe North America Australia/Oceania Arizona
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical
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