PharmaCyte Biotech Inc (OTCMKTS:PMCB) Attempting A Comeback

Shares of PharmaCyte Biotech Inc (OTCMKTS:PMCB) have been on a downtrend for quite some time. Delay after delay has plagued has plagued PMCB. However, we think things are starting to look a little better for the company. We're now including PMCB on our list of potential turnarounds this year.

PharmaCyte Biotech 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 and diabetes are being developed.

PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, a chemotherapy drug which needs to be activated in the body (ifosfamide) is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the chemotherapy drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box technology.

PharmaCyte's encapsulation facility located in Bangkok, Thailand has just recently been approved by the Thai FDA. Now, PharmaCyte’s product for pancreatic cancer can be manufactured in Bangkok. It consists of live human cells that have been genetically engineered to convert the anticancer prodrug ifosfamide into its “cancer-killing” form and then encapsulated using the Cell-in-a-Box encapsulation technology.

In PharmaCyte’s upcoming clinical trial, these encapsulated live cells will be used with low doses of ifosfamide (one third the normal dose) as a “consolidation therapy” with the current standard of care for advanced pancreatic cancer when a patient no longer benefits from first line therapy. PharmaCyte’s therapy will be compared with the combination of the anticancer drug capecitabine plus radiation in patients with locally advanced, non-metastatic, inoperable pancreatic cancer whose tumors are stable or progressing after 4-6 cycles of treatment with either the combination of Abraxane plus gemcitabine or the four-drug combination known as FOLFIRINOX.

Getting the Thai facility online is a critical step for PMCB. The next step for the company is getting its clinical trial in advanced pancreatic cancer underway. The clinical trial will be international (United States, Europe and possibly Australia), multi-site, open-label and randomized. Study sites under consideration in the United States include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center and the Dana-Farber Cancer Institute both in Boston, Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City of Hope Cancer Center in Los Angeles, California, and sites in Germany and Spain. CEO Kenneth Waggoner said:

“We feel that the major factors that needed to be considered for the development of a complete clinical trial protocol have now been addressed. Of course, as we continue to move toward our clinical trial, slight changes that benefit the overall trial design could certainly be addressed and lead to further refinement of the trial. Special appreciation for reaching this point must be given to the renowned pancreatic cancer experts who have played such a major role in the trial design. With these developments, we are yet another step closer to the commencement of our clinical trial which we believe will satisfy the clear unmet medical need experienced by patients with locally advanced, but inoperable, pancreatic cancer who no longer respond to the gold standard of care.”

Currently trading with a market cap of $53 million, PMCB is finally starting to make some serious progress. We have been critical of the company in the past, but we have to say the company has taken our advice and is starting to deliver. PMCB looks to have indeed finally turned the corner. We will be updating Insider Financial as soon as we know more. For continuing coverage on PMCB, sign up to Insider Financial today and get our next hot stock pick!

Disclosure: We have no position in PMCB and have not been compensated for this article.