NEW YORK, NY -- (Marketwired) -- 02/24/14 -- Lincoln Park Capital (LPC) purchased 8 million restricted shares of Nuvilex, Inc. (OTCQB: NVLX) in exchange for an initial $2 million out of what can be viewed as a $27 million "pot of money" to advance the company's late-phase pancreatic cancer clinical trials. Notice we said restricted shares, that's right, LPC has put a great deal of its money on the line with a number of built in protections for Nuvilex. But, is this investment really a risk? It appears the Chicago-based firm knows exactly what the future could hold for Nuvilex, and they're comfortable with paying a premium price to become a long-term investor right along with many others who believe in the small biotechnology firm.
Much like its investment with Elite Pharmaceuticals in April 2013 that has since seen that company's price per share rise to highs of over 500%, LPC could benefit greatly from a much higher price tag when Nuvilex enters late-phase clinical trials, completes those trials and applies for approval with the FDA.
LPC has at least two members of its team, Dr. Michael Beaubaire and Jonathan Cope, who are biotech savvy and have clearly seen the results from two previous independent Phase II clinical trials using the pancreatic cancer treatment that combines Cell-in-a-Box live-cell encapsulation with the anti-cancer drug ifosfamide - a treatment recently licensed by Nuvilex. Those results indicated that this combination treatment 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.
Results from the Cell-in-a-Box-ifosfamide combination in patients with advanced pancreatic cancer included almost a doubling of median survival time from 5.7 months for Gemzar to the 11 months seen with the combination; this compares to the 8.5 months seen with the Abraxane-gemcitabine combination. The results also included a 100% increase in the one-year survival rate as compared to gemcitabine versus a 59% increase for the Abraxane-gemcitabine combination.
The results obtained with the Cell-in-a-Box-ifosfamide combination are even more noteworthy given that only one-third of the dose of ifosfamide normally used to treat other types of cancer was used in the Phase II pancreatic cancer trials. It is likely that this lower dosage also contributed to the fact that there were no significant side effects from the Cell-in-a-Box-ifosfamide combination. However, there were significant and severe drug-associated toxicities seen with both single-agent Gemzar and with the Abraxane-gemcitabine combination.
LPC realizes that if these results can be repeated in Nuvilex's planned late-phase clinical trials, then the FDA approved treatments developed by biopharmaceutical giants Celgene and Eli Lilly will surely be unseated as the "gold standard" treatment for advanced inoperable pancreatic cancer. Keep in mind Eli Lilly has parlayed gemcitabine into more than $10 billion.
Nuvilex owns the exclusive worldwide rights to use the Cell-in-a-Box technology to develop treatments for any type of cancer and for treatments for diabetes as well. The technology has already shown equally amazing results in animal studies in both breast cancer and diabetes. So, it doesn't stop at pancreatic cancer for Nuvilex or any investor with a position in the company's stock, and that includes Lincoln Park Capital.
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