May 30, 2013
Nuvilex Could Target Breast Cancer in Future Clinical Trial
Nuvilex Inc. (OTCQB – NVLX - $0.146 – Spec Buy - $0.75 Target) affiliate SG Austria conducted Phase I/II clinical trials in dogs with spontaneously occurring mammary tumors. Results of the study were remarkably similar to its well-known human Phase II pancreatic cancer trial. Therefore, it is evident that the results of this animal trial could lead to a future human breast cancer clinical trial using the Company’s live-cell encapsulation platform. Each year, over 200,000 women in the U.S are diagnosed with breast cancer and over 40,000 deaths are caused by the disease.
On the surface it would seem incongruent that a mammary trial involving dogs and a human breast cancer trial would have a direct correlation. However, further due diligence confirms that a similar Purdue University research study in dogs that was funded by the U.S. Department of Defense demonstrated that such a study could clearly be used as a model for breast cancer treatment.
In the aforementioned Phase I/II clinical trial, cyclophosphamide was chosen as the pro-drug since it is often used for the treatment of mammary cancer in dogs as well as breast cancer in humans. As in the human pancreatic cancer trials, the capsules were well tolerated, 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 was reduced by only 14% while the tumor receiving capsules showed a 70% reduction in tumor volume.
The Purdue study indicated that pre-malignant mammary lesions in dogs and humans display many of the same characteristics, which could lead to a better understanding of breast cancer progression and its prevention. This is significant because pre-malignancy diagnosis is a risk factor for future development of invasive breast cancer. Due to the frequency of lesions, their association with spontaneous mammary cancer and the resemblance to human lesions, one of the study’s conclusions illustrated that dogs may be the ideal model to study human breast cancer progression as well as prevention and treatment.
The Company’s 2 trials clearly illustrate the great potential efficacy in using encapsulated cells with a pro-drug as a targeting device for the treatment of solid pancreatic and mammary tumors. Moreover, the dog trial results will likely carry meaningful weight in determining the timing of the engagement of a breast cancer trial, as the Purdue trial confirmed the substantial correlative value of dog trial results. As a result, Nuvilex Inc. (OTCQB – NVLX) could be viewed as a two-headed oncology treatment entity, rather than a firm with a single, proven oncology indication in its arsenal.
Senior Analyst: Robert Goldman
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