September 18, 2013
Nuvilex’s Cell Cloning News Is a Major Milestone Event
Stocks rise and retreat for both the right reasons and the wrong reasons. From time to time, these moves are associated with news released by the Company or third parties. What can be baffling for company executives is when a stock rises on what could be viewed as incrementally impactful news and yet treads water or declines in conjunction with the release of significant milestone events. A perfect example of this last scenario occurred yesterday with Nuvilex, Inc. (OTCQB – NVLX - $01395 – Spec Buy). The Company released news that should have been received by investors as its most significant event to date, excluding the acquisition of rights to the ground-breaking live-cell encapsulation technology to treat cancer. Instead, it was treated as a ho-hum event. Here’s why investors that missed the significance will be caught napping.
On the heels of last week’s cell storage contract with Fisher BioServices, Nuvilex announced that it has contracted with Inno Biologics for the generation of clones from the cells that are basis of the Company’s future Phase 3 cancer clinical trials. As important as the Fisher BioServices contract is from the developmental and status affirmation perspectives, one could argue that the Inno Biologics deal is an even more significant event. The clone production is the most obvious and tangible illustration that Nuvilex has taken a major step toward future Phase 3 cancer clinical trials, and here is why.
The generation of clones of these cells represents the initial step in the preparation of the large number of cancer drug-activating cells that ultimately will be required for encapsulation. These cells are the same ones used in previous clinical trials and will be used by the Company for cancer trials including its future planned clinical trials against advanced, inoperable pancreatic cancer. Therefore, this event should be interpreted by investors as the greatest tangible evidence of Nuvilex’s direct development activity and its complete commitment to further its advanced clinical trial efforts.
Initially, a large number of individual clones will be generated by Inno Biologics from the cells supplied to them. Isolated clones will be tested to determine the best for Nuvilex’s use through recognizing clones with the highest CYP 2B1 enzyme activity. The CYP 2B1 enzyme is the critical ifosfamide cancer-drug-activating enzyme in these cells that is the basis for the Nuvilex treatment to fight pancreatic cancer.
Once clones have been recognized and undergone initial assessment, the Company will continue to advance the clones through a series of validations necessary to prepare them for use in clinical trials.
In Nuvilex’s treatment for advanced inoperable pancreatic cancer, live cells that express high levels of the enzyme CYP 2B1 will be encapsulated in cellulose-based, pin-head-sized capsules implanted near the pancreas and thus, the tumor itself. Then, the well-known and widely used anticancer drug ifosfamide will be administered intravenously, at low doses, to the patients receiving these encapsulated cells. Since ifosfamide is a prodrug, it must be activated to its cancer-killing form.
The ifosfamide taken up by the cells in the capsule will be activated by the CYP 2B1 enzyme in those cells. Placing the encapsulated cells near the tumor causes it to be exposed to high localized concentrations of activated ifosfamide compared to what is achievable in the absence of the encapsulated ifosfamide-activating cells. This results in increased antitumor efficacy of the anticancer agent used, which, in this case, is ifosfamide.
It is clear that the cell storage and cell cloning are just two of many milestone events for Nuvilex in the near term. Other, future catalytic events include mass production of clones and cells that carry identical properties will be stored by Fisher BioServices for Nuvilex’s use in future trials All in all, Nuvilex’s stock value should be afforded a significant boost with the initiation and completion of each phase, including the just-launched cell cloning activity, as demonstrative progress toward Phase 3 trials occurs.
For more information, refer to our previous NVLX Reports, Updates and Hot Topics by visiting www.GoldmanResearch.com
You Might Also Like
Senior Analyst: Robert Goldman
Goldman Small Cap Research is not affiliated in any way with Goldman Sachs & Co.
The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research did not make an independent investigation or inquiry as to the accuracy of any information provided by the Company, or other firms. Goldman Small Cap Research relied solely upon information provided by the Company through its filings, press releases, presentations, and through its own internal due diligence for accuracy and completeness. Such information and the opinions expressed are subject to change without notice. A Goldman Small Cap Research report, update, article, or note is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed.
This publication does not take into account the investment objectives, financial situation, or particular needs of any particular person. This report does not provide all information material to an investor’s decision about whether or not to make any investment. Any discussion of risks in this presentation is not a disclosure of all risks or a complete discussion of the risks mentioned. Neither Goldman Small Cap Research, nor its parent, is registered as a securities broker-dealer or an investment adviser with FINRA, the U.S. Securities and Exchange Commission or with any state securities regulatory authority.
ALL INFORMATION IN THIS REPORT IS PROVIDED “AS IS” WITHOUT WARRANTIES, EXPRESSED OR IMPLIED, OR REPRESENTATIONS OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE FOR THE QUALITY, ACCURACY, COMPLETENESS, RELIABILITY OR TIMELINESS OF THIS INFORMATION, OR FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES THAT MAY ARISE OUT OF THE USE OF THIS INFORMATION BY YOU OR ANYONE ELSE (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOSS OF OPPORTUNITIES, TRADING LOSSES, AND DAMAGES THAT MAY RESULT FROM ANY INACCURACY OR INCOMPLETENESS OF THIS INFORMATION). TO THE FULLEST EXTENT PERMITTED BY LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE TO YOU OR ANYONE ELSE UNDER ANY TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY, OR OTHER THEORY WITH RESPECT TO THIS PRESENTATION OF INFORMATION.
For more information, visit our Disclaimer: www.goldmanresearch.com