$PMCB PharmaCyte’s Innovative Platform Now Set to Target

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$PMCB PharmaCyte’s Innovative Platform Now Set to Target Multiple Deadly Cancers

Recent company news is a strong reminder that the potential value of the PharmaCyte Biotech (OTCQB – PMCB - $0.07 – Spec Buy) Cell-in-a-Box® platform technology is in the billions since it has proven to be effective in treating varying forms of cancer in preclinical and clinical tests. In fact, the Company’s platform could be potentially used to treat over 265,000 new patients suffering from varying forms of abdominal cancer and the 232,000 new patients diagnosed with breast cancer each year.

Abdominal Cancers

According to the American Cancer Society, hundreds of thousands of new cases of abdominal cancers in the U.S. are diagnosed annually. These include but are not limited to:

Colorectal: 132,000

Liver: 62,000

Pancreatic: 49,000

Ovarian: 22,000

To date, PharmaCyte’s live cell encapsulation technology, known as “Cell-in-a-Box®”, plus low-dose ifosfamide has successfully completed mid-stage clinical trials in pancreatic cancer. PharmaCyte could be just months away from a pre-IND meeting with the FDA to discuss plans for the next stage of clinical trials. Leveraging the solid results from completed trials and studies with PharmaCyte’s platform technology, PharmaCyte initiated preclinical studies designed to determine the effectiveness of Cell-in-a-Box® plus ifosfamide therapy in delaying the accumulation of malignant ascites fluid in the abdomen of mice with abdominal tumors.

PharmaCyte’s initial series of preclinical studies were conducted with mice that had been inoculated with a human ovarian cancer. The data is being used as a foundation for future studies on other tumor types. For example, the results from PharmaCyte’s initial series of studies are now being used in connection with new colon cancer studies that may prove to be effective in developing a treatment that delays the production of malignant ascites fluid in cancer patients. In fact, the new study is based upon the results of previous work using this same model system that was performed by Dr. Matthias Löhr, the Chairman of PharmaCyte’s Scientific Advisory Board, and his colleagues at the University of Heidelberg, Germany. The results of the previous study were reported in the scientific publication Cancer Gene Therapy in 2006.

PharmaCyte hopes to replicate the earlier study results which demonstrated that a combination of the Cell-in-a-Box® capsules and ifosfamide is effective in treating the spread of colon cancer that was caused by malignant ascites fluid. This fluid is produced by abdominal cancers and is largely responsible for the spread of cancer cells from the original tumor to other sites in the peritoneal cavity. According to management, if successful, PharmaCyte will have developed a treatment that will help combat the spread of abdominal tumors and reduce the suffering of cancer patients from the production of ascites fluid within the abdominal cavity.

Breast Cancer

PharmaCyte’s platform technology plus low-dose ifosfamide has also achieved enviable success in efforts to develop a treatment for one of the most high profile cancers that are attributed to well over 200,000 new cases annually - breast cancer. In fact, the medical journal PLOS One published a study in which a Phase I/II clinical trials was conducted in dogs with spontaneously occurring mammary tumors which produced stellar results. (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0102061). It should be noted that this animal model is closely related to the development of breast cancer in humans. As one might expect, the study results were remarkably similar to the earlier human Phase I/II pancreatic cancer trial using PharmaCyte’s platform technology.

In the trial, which included 16 female dogs, cyclophosphamide was chosen as the pro-drug instead of the pro-drug the ifosfamide used in the earlier pancreatic trials. That is because cyclophosphamide is a standard chemotherapeutic agent used in combination with others for the treatment of mammary cancer in dogs as well as breast cancer in humans. Since both cyclophosphamide and ifosfamide are “sister” pro-drugs and are converted to their cancer-killing forms in the same way, the same type of encapsulated live 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, far greater tumor shrinkage was observed in those dogs treated with encapsulated cells as well as the pro-drug versus those receiving cyclophosphamide alone.

Interestingly, prior to receiving approval for Abraxane as a treatment for pancreatic cancer, Celgene (NASDAQ – CELG) was awarded FDA approval to use the treatment for breast cancer. Since breast cancer is easier to treat and has a much higher survival rate than pancreatic cancer, it is conceivable that if PharmaCyte is successful in garnering FDA approval for pancreatic cancer, a breast cancer treatment approval could be a slam dunk.

The bottom line? If the favorable data from previous trials and studies for multiple cancer indications are any indication of potential future results, PharmaCyte’s novel approach could emerge as one of the most effective and diverse cancer treatment platforms in the market for solid tumors of all kinds and could be worth billions of dollars.

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