NEW YORK, NY--(Marketwired - March 03, 2014) - Nuvilex (OTCQB: NVLX) investors who have patiently waited for the R&D biotech to reach a point where late-phase clinical trials were a reality, are probably relishing these truly exciting times after a Chicago-based institutional investor committed to fund $27 million dollars toward the company’s clinical trials in advanced inoperable pancreatic cancer. Leading up to the aforementioned clinical trials, investors can expect to see a list of milestone developments unfold, and for those who consider themselves biotech junkies, they know this is when the fun begins.
It is likely just a matter of time now before investors start hearing words like Good Manufacturing Practices (GMP), Principal Investigator (PI), Protocol, Contract Research Organization (CRO), Study Sites, etc., and with each of these milestone developments, Nuvilex draws closer to the actual patient recruitment process and eventual patient enrollment for the clinical trials.
Additional news events to pay attention to will be the cloning of the cancer-drug-activating cells that are required for the clinical trials. The cloning began last November at Inno Biologics, and this process is necessary to obtain the large numbers of cells required for the late-phase trials. Also, locating facilities in which the encapsulation of these large numbers of cells can be done according to GMP standards is also crucial, and the company says GMP compliance is an absolute requirement for drug regulatory authorities. With funding now flowing into the company, expect to see activity start to pick up.
For those unfamiliar with where Nuvilex is heading, here’s a quick recap. Nuvilex acquired the exclusive worldwide rights to use the Cell-in-a-Box™ live-cell encapsulation technology to develop treatments for diabetes and any form of cancer. Now the company is preparing to advance late-phase clinical trials using the licensed pancreatic cancer treatment that combines Cell-in-a-Box with the anti-cancer drug ifosfamide to build upon two previous independent Phase II clinical trials.
The excitement for the company and its investors is that, in those two completed Phase II trials, the treatment that Nuvilex owns the rights to use outperformed Eli Lilly’s long-time single-agent treatment for advanced inoperable pancreatic cancer, Gemzar® (gemcitabine), and Celgene’s recently approved drug Abraxane (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine.
If Nuvilex’s late-phase clinical trials can continue to outperform Celgene’s therapy, then the company’s treatment will likely be the new “gold standard” for the disease -- a designation that earned Eli Lilly’s drug Gemzar more than $10 billion when it was the “gold standard” for advanced inoperable pancreatic cancer. It is numbers like this that make it clear why so many have remained patient with their Nuvilex investment, and we haven’t even begun to discuss the company’s future in diabetes!
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