SILVER SPRING, MD--(Marketwired - Nov 4, 2013) - Nuvilex, Inc. (OTCQB: NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that cloning of the cancer-drug-activating cells required for Nuvilex's future Phase 3 clinical trials has begun at Inno Biologics in its cGMP-compliant facilities.
Following receipt by Inno Biologics of four vials of frozen cells capable of converting the well-known anticancer prodrug ifosfamide into its active cancer-killing form, one of the vials was thawed and the cells grown in culture. The cells, which were previously grown by ViruSure in Vienna, were successfully thawed, and approximately 97% of the cells were found to be viable. The contents of the vial were tested and found to be free of the "adventitious agents" bacteria, fungi, and mycoplasma.
The cloning process consists of growing cells in multiple microplates to produce a large number of discrete clones. "State-of-the-art" technology is then used in the cloning isolation process. After additional rigorous biochemical testing, those clones determined to be the "best" for Nuvilex's oncological purposes will be selected and additional testing will be done. Finally, the best clones will be propagated to obtain large numbers of cells required for the late-phase clinical trials of Nuvilex.
Nuvilex's President and CEO, Dr. Robert F. Ryan, stated, "This is a critical juncture on the path to our planned late stage clinical trials. The important steps have and are being carefully planned and timed so as to bring us forward as quickly as possible for our planned pancreatic cancer clinical trials. The high level of viability seen on initial examination by Inno Biologics shows that the cells were grown and stored well by ViruSure prior to thawing. We are confident the companies we have chosen to take care of each of the activities are both competent and well equipped to complete the work."
Nuvilex is a biotechnology company with the rights to a novel cellulose-based live-cell encapsulation technology that will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes may be built. Nuvilex's treatment for pancreatic cancer involves the use of the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its "cancer-killing" form. Nuvilex's wholly owned subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments that are based upon constituents of marijuana. For more information visit: www.nuvilex.com.
This press release may contain forward-looking statements regarding Nuvilex, its future events and results that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding Nuvilex's financial position, business strategy, plans and objectives of management for future operations, business conditions and indebtedness covenant compliance are forward-looking statements. When used in this press release, forward-looking statements are generally accompanied by terms or phrases such as "estimate," "project," "predict," "believe," "expect," "anticipate," "target," "plan," "intend," "seek," "goal," "will," "should," "may" or other words and similar expressions that convey the uncertainty of future events or outcomes. Items contemplating or making assumptions about, actual or potential future sales, market size, collaborations and trends or operating results also constitute such forward-looking statements.
Forward-looking statements involve inherent risks and uncertainties, and important factors (many of which are beyond the control of Nuvilex) that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, the following: general economic or business conditions, nationally and/or in the communities in which Nuvilex conducts business; changes in the interest rate environment, legislation or regulatory requirements; conditions of the securities markets; our ability to raise capital; changes in accounting principles, policies or guidelines; financial or political instability; acts of war or terrorism and other economic, competitive, governmental, regulatory and technical factors affecting the operations, products, services and prices of Nuvilex.
Nuvilex has based these forward-looking statements on its current expectations and assumptions about future events. While management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory and other risks, contingencies, and uncertainties, most of which are difficult to predict and many of which are beyond the control of Nuvilex. Nuvilex does not assume any obligations to update any of these forward-looking statements.