Nuvilex, Inc. (OTCQB: NVLX) announced today successful results for the treatment of breast cancer from preclinical studies. In recently completed work using the Nuvilex live-cell encapsulation technology and a combination of two anticancer drugs, clear positive results of elimination of breast tumors were achieved in preclinical models.

The encapsulated cells used in this study were specifically designed to express at high levels both the normal human cytochrome p450 and human cytosine deaminase enzymes to ensure conversion of both cancer-killing agents.

As a result, our preclinical studies have now revealed the Nuvilex cell encapsulation technology can be applied to the treatment of breast cancer in order to improve the treatments, effectiveness, toxicity reduction and outcomes for this disease. In the preclinical studies being reported, an additive effect on destruction of breast cancer cells was observed. The studies placed live, encapsulated cells into the tumors and then treated animals with two different anticancer agents. To provide a complete assessment for the ability to use this treatment in humans, this study used two different breast cancer models.

Preclinical studies were carried out in mice harboring two different breast cancer types. Encapsulated cells were implanted into the breast tumors and then the drugs, ifosfamide and 5-fluorocytosine, were administered to the mice.

Both drugs used in these studies are inactive and require activation before they kill cancer cells. Ifosfamide is activated by cytochrome p450 enzymes to form phosphoramide mustard and acrolein, and 5-fluorocytosine is activated by the enzyme cytosine deaminase to form 5-fluorouracil (5-FU). Ifosfamide and 5-fluorouracil have long been used for cancer treatment and are still in use today.

After placement of the encapsulated live cells, when ifosfamide was administered alone to the mice, significant anticancer effects were seen, indicating it had been converted to its cancer-killing form, as was previously observed in our preclinical studies and pancreatic cancer clinical trial. However, when both ifosfamide and 5-fluorocytosine were administered, the combination proved to be superior in cancer-killing ability than ifosfamide alone. The results also indicated encapsulated cells were able to activate both of these very different prodrugs simultaneously.

"We are very pleased with the results obtained in these preclinical studies with the combination of our cell encapsulation technology when used with two cancer-killing drugs against breast cancer," remarked Dr. Robert F. Ryan, President and CEO of Nuvilex. "It should be noted that ifosfamide is related to cyclophosphamide, another widely used anticancer agent often employed against breast cancer which also requires activation by p450 enzymes. If these preclinical results can be translated into the clinic, not only will cell encapsulation be further validated, but many women who suffer from this debilitating form of cancer will also benefit from this treatment."

Breast Cancer

Breast cancer is the second-leading cause of death in women. The American Cancer Society has estimated that more than 209,000 new cases were expected to be diagnosed in the U.S. alone in 2010. Breast cancer is often treated with single cancer-killing drugs or with various combinations of such drugs. As a result of the need for multiple drugs in treating most cancers, substantial toxicities are typically the most problematic aspects of cancer treatment.

Source:
Your New Nuvilex