August 12, 2013
Is a Breast Cancer Treatment a Sleeper Blockbuster for Nuvilex?
It is only logical that Nuvilex Inc.’s (OTCQB – NVLX - $0.17 – Spec Buy) live-cell encapsulation platform to treat patients with inoperable pancreatic cancer has garnered a great deal of press and accolades in the mainstream press and industry journals, since the therapy has already successfully completed Phase II clinical trials. However, now that the recently announced exclusive rights acquisition to treat all forms of cancer via this platform has had an opportunity to set in for Nuvilex investors and observers alike, it is a great time to lift up the hood and take a closer look at the engine.
When one lifts up the hood, one realizes that a sleeping giant in the form of highly successful animal trials to treat mammary tumors may emerge as a real blockbuster for Nuvilex. This pronouncement should in no way be interpreted as a condemnation of the progress of and prospects for the pancreatic cancer treatment, which offers huge potential and is the Firm’s flagship. On the contrary, it is just reasonable to assume that if Nuvilex is able to move a human trial for breast cancer forward, there is a strong likelihood that given its profile, this treatment would be afforded an even higher valuation than the pancreatic cancer therapy.
Prevention and treatment of breast cancer that is diagnosed in 200,000 women and kills over 40,000 in the U.S. alone each year is now a multi-billion dollar industry unto itself, highlighted by mammograms, other tests, involvement of multiple non-profit organizations, etc. Moreover, breast cancer appears to be affecting younger and younger women each year. As a result, when firms gain even modest success in their quest for ever more effective treatment for breast cancer, their stocks enjoy huge gains.
For example, Synta Pharmaceuticals (NASDAQ –SNTA) recently announced early and favorable results from a Phase II clinical trial. Specifically, the Company announced preliminary treatment results from just 15 patients as compared with the expected 70 patients to be enrolled in the trial. Although management may have jumped the gun, the Street ate it up. Synta’s shares rose 40% for the day, which is equivalent to $140M worth of market value. If Synta’s preliminary and incomplete Phase II breast cancer results are worth a $140M jump, what is the value of Nuvilex’s completed Phase II pancreatic cancer trials? More important, as Nuvilex moves ahead, and is able to post strong results for human breast cancer trials, would it also be worth over $100M in market cap? On an equal playing field, it would appear likely to even the casual observer.
It should be noted that results of the aforementioned Nuvilex Phase I/II clinical trial involving dogs with spontaneously-occurring mammary tumors were remarkably similar to its well-known human Phase II pancreatic cancer trial. In the trial, cyclophosphamide was chosen as the pro-drug instead of the ifosfamide used in the pancreatic trials, since the former is often used for the treatment of mammary cancer in dogs as well as breast cancer in humans. However, since both cyclophosphamide and ifosfamide are “sister” drugs and are converted to their cancer-killing forms in the same way, the same type of encapsulated cells were used in both the pancreatic and mammary cancer studies. As in the human pancreatic cancer trials, the capsules were well tolerated in the mammary cancer trials, with no major safety issues. Importantly, greater degrees of tumor shrinkage were observed in those dogs treated with encapsulated cells as well as the pro-drug versus those receiving cyclophosphamide alone. In the case of a dog diagnosed with two tumors, the tumor that did not receive encapsulated cells but received cyclophosphamide alone was reduced by only 14% while the tumor receiving encapsulated cells plus cyclophosphamide showed a 70% reduction in tumor volume.
Therefore, it is evident that the results of this animal trial could lead to a future successful human breast cancer clinical trial that utilizes the Company’s live-cell encapsulation platform. Such success would likely result in positive share gains rivaling that of Synta and other firms focused on treating breast cancer, providing the Company and its shareholders with the makings of a real blockbuster.
You Might Also Like
Senior Analyst: Robert Goldman
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.