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Nuvilex Begins Preclinical Studies at Translational Drug Development

SILVER SPRING, Md., Aug. 20, 2014 — Nuvilex, Inc. (NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that studies are underway at Translational Drug Development’s (TD2) facilities in Scottsdale, Arizona, to determine if Nuvilex’s unique cancer treatment can slow the accumulation of fluid, known as “malignant ascites,” in the abdomen that is characteristic of the growth of many abdominal tumors.

Kenneth L. Waggoner, CEO and President of Nuvilex, stated, “The start of these studies at TD2 is a banner day for Nuvilex. We are extremely gratified to have a prestigious organization such as TD2 performing these studies on our behalf. It should be noted that these studies represent the first time that any work, either preclinical or clinical, has been done in the United States with the Cell-in-a-Box cellulose-based live cell encapsulation technology that has such exciting potential.”

Malignant ascites fluid in the abdomen contains cancer cells which can “seed” and form new tumors. Accumulation of this fluid is problematic for cancer patients and can cause significant discomfort. The current standard of care requires that malignant ascites fluid be removed from the abdomen of cancer patients at regular intervals.

In the studies being conducted by TD2, mice that have no immune system, and thus cannot reject foreign tissue from other species, will be injected with human ovarian cancer cells. These particular cells were chosen for these studies because:

(i) they reproduce rapidly and form tumors; and

(ii) the resultant tumors are proficient at producing malignant ascites fluid.

When the tumors have seeded in the abdomen, the mice will be randomized into four groups.

One group of mice will be treated with Nuvilex’s pancreatic cancer treatment consisting of the combination of Cell-in-a-Box encapsulated live cells and the cancer prodrug ifosfamide (the encapsulated cells express an enzyme, CYP2B1, which converts ifosfamide into its cancer-killing form).

A second group of mice will be treated with a drug normally used to treat ovarian cancer.

A third group will be administered the ovarian cancer drug along with Nuvilex’s Cell-in-a-Box encapsulated live cells and ifosfamide combination.

The remaining mice will serve as the “control” group for comparison purposes.

The mice will be followed until humane endpoints have been reached. The time for this to occur for the treated mice will be compared to that for the control group of mice.

Nuvilex’s CEO and President added, “We are confident that this work at TD2 will prove to be just the beginning of a long and fruitful journey for Nuvilex as we strive to develop our unique cancer treatment.”

About Nuvilex

Nuvilex (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.