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Nuvilex (NVLX) And Austrianova Announce Results Of Clinical Trial In Dogs With Mammary Tumors Treated With Cell-In-A-Box® Plus Cyclophosphamide



7/17/2014 7:49:57 AM

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SILVER SPRING, Md., July 17, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today announced, in cooperation with its partner Austrianova, the results of a veterinary Phase I/II clinical trial in dogs with mammary tumors who were treated with Cell-in-a-Box® cellulose-based live cell encapsulation plus the widely used anticancer drug cyclophosphamide (Cytoxan®). These results were published in the Public Library of Science journal (PLOS ONE) on July 16, 2014.

Sixteen female dogs were enrolled in the clinical trial. Of those dogs, 12 had a single mammary tumor and 4 had two mammary tumors each. The dogs were divided into two groups – a control group and a study group. The control group consisted of 6 dogs that received cyclophosphamide alone. The study group of 10 dogs had 20 Cell-in-a-Box® capsules implanted around each tumor, and then these dogs were given cyclophosphamide as in the control group. In each of 3 of the dogs with 2 tumors, only one of the tumors was administered the Cell-in-a-Box® capsules prior to being treated with cyclophosphamide.

Six of 11 mammary tumors treated with the Cell-in-a-Box®/cyclophosphamide combination were reduced in size by more than 50%. The other 5 tumors showed a reduction in tumor size of less than 50 % or that no further tumor growth had occurred. For the tumors treated with cyclophosphamide alone, 6 of the tumors remained the same while one showed progression of the disease.

In one of the dogs with 2 mammary tumors, the tumor treated with the combination was reduced in size by 70% whereas the other tumor treated with cyclophosphamide alone was reduced in size by only about 19%. The median reduction in tumor volume for all tumors treated with the combination was 51.3% as compared to 21% for tumors treated with just cyclophosphamide. Although side effects of the treatment were seen, these were attributed solely to the use of cyclophosphamide at its "standard" dose and were expected. No side effects could be attributed to the presence of the Cell-in-a-Box® capsules.

Cyclophosphamide is a "sister" drug to the anticancer drug ifosfamide that is part of Nuvilex's pancreatic cancer treatment. Both cyclophosphamide and ifosfamide are classified as "prodrugs," meaning they must be activated (converted into their cancer-killing forms) for them to be effective as antitumor agents. Normally, both drugs are activated by the cytochrome P450 enzyme system in the liver. The cells encapsulated using the Cell-in-a-Box® technology that are part of Nuvilex's pancreatic cancer express high levels of an isozyme of the cytochrome P450 system known as CYP2B1. These same encapsulated cells were used in this dog study, but in this case cyclophosphamide replaced ifosfamide as the anticancer prodrug.

Cyclophosphamide was used instead of ifosfamide because cyclophosphamide is widely used to treat various forms of breast cancer in humans. According to the American Cancer Society, 10 multi-drug combinations have been used for many years to treat breast cancer. Cyclophosphamide is one of the drugs in 9 of these combination chemotherapies.

PLOS ONE is an international, peer-reviewed, open access, online publication which covers primary research and clinical trial data. The title of the published manuscript is "Phase I/II Clinical Trial of Encapsulated, Cytochrome P450 Expressing Cells as Local Activators of Cyclophosphamide to Treat Spontaneous Canine Tumors." The entire article can be reviewed by clicking here or by inserting the following link into a browser: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0102061.

The term "CapCell" is used in the published manuscript to describe the same encapsulated cells as those utilized by Nuvilex in its treatment of pancreatic cancer. This term is no longer used to describe the encapsulated cancer drug-activating cells; it has been replaced by the term "Cell-in-a-Box®.

Professor Dr. Walter H. Günzburg, Austrianova's Chairman of the Board, stated, "Austrianova is a pioneer in the development of encapsulated cells for the treatment of solid tumors, and this latest clinical data confirms this. Working closely together with Nuvilex, this treatment will be advanced to the market for a variety of tumor types."

In commenting on the article itself, Dr. Brian Salmons, CEO of Austrianova, noted, "We are delighted that this data is in the public domain. It confirms and extends that safety and efficacy data that has been obtained in human clinical trials. These dogs were fully immunocompetent, and the encapsulated cells were shown to survive after implantation for at least 20 weeks under challenging conditions. The treatment regime could form the basis for the treatment of a variety of cancers in companion animals as well as in humans."

Kenneth L. Waggoner, CEO and President of Nuvilex, further commented, "This study of the treatment of spontaneously-occurring mammary tumors in dogs serves as an excellent model for studies of breast cancer treatment in humans. The type of study done here closely mimics the Phase I/II clinical trials that can be conducted in humans with breast cancer. The widespread use of cyclophosphamide in treating breast cancer in humans also gives importance to the findings in this canine clinical trial. Importantly, this clinical trial clearly demonstrates the true "platform" nature of the Cell-in-a-Box® technology. The fact that the combination of Cell-in-a-Box® encapsulated drug-activating cells and the anticancer prodrug cyclophosphamide had such dramatically superior antitumor effectiveness when compared to cyclophosphamide alone, coupled with the excellent safety profile of the Cell-in-a-Box® capsules, suggests that the Cell-in-a-Box® plus cyclophosphamide combination may have a bright future in the treatment of breast cancer in humans."

About Nuvilex

Nuvilex (OTCQB:NVLX) is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced inoperable pancreatic cancer, and diabetes are being built. Nuvilex's treatment for pancreatic cancer involves the widely used anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or "cancer-killing" form. Nuvilex is also working towards clinical trials associated with the symptoms of advanced pancreatic cancer and other abdominal cancers.

Nuvilex's subsidiary, Medical Marijuana Sciences, is dedicated to the development of cancer treatments based upon chemical constituents of marijuana known as cannabinoids. To do so, it will examine ways to exploit the benefits of Cell-in-a-Box® technology in optimizing the anticancer effectiveness of cannabinoids against cancers while minimizing or eliminating the debilitating side effects usually associated with cancer treatments. This provides Medical Marijuana Sciences a unique opportunity to develop "green" approaches to fighting deadly cancers, such as those of the pancreas, brain, breast and prostate, that affect hundreds of thousands of individuals worldwide every year.

About Austrianova

Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system and allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid. More information about Austrianova can be found on their website at www.austrianova.com.

Safe Harbor:

This press release may contain forward-looking statements regarding Nuvilex and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan," "suggest" and similar expressions, as they relate to Nuvilex or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Nuvilex, that could cause actual results to differ materially from those set forth in the forward-looking statements include Nuvilex's ability to continue as a going concern, delays in clinical trials or flaws or defects regarding its clinical trials, changes in relevant legislation or regulatory requirements, uncertainty of protection of Nuvilex's intellectual property and Nuvilex's continued ability to raise capital. Nuvilex does not assume any obligation to update these forward-looking statements.

More information about Nuvilex can be found at www.nuvilex.com. It can also be obtained by contacting Investor Relations.

CONTACT: Investor Relations Contacts: Marlin Molinaro Marmel Communications, LLC Phone: 702.434.8692 mmolinarofc@aol.com

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