SOURCE: PharmaCyte Biotech, Inc.

PharmaCyte Biotech, Inc.

March 18, 2015 09:00 ET

PharmaCyte Biotech's "Factory" of Live Cells Takes Direct Aim at Cancer Tumors Armed With FDA Orphan Drug Status

NEW YORK, NY--(Marketwired - March 18, 2015) - PharmaCyte Biotech (OTCQB: PMCB) is aiming directly at the problem patients with advanced pancreatic cancer face, an inoperable tumor! PharmaCyte owns the exclusive worldwide rights to develop treatments for all types of solid cancerous tumors using its signature Cell-in-a-Box technology combined with low doses of the chemotherapy drug ifosfamide. It is this treatment (Cell-in-a-Box/ifosfamide) that was just awarded with the U.S. Food and Drug Administration's (FDA) Orphan Drug designation. Armed with the FDA's Orphan Drug designation, PharmaCyte can now take direct aim at becoming the treatment of choice for advanced pancreatic cancer.

Here's how it works: About 10,000 live cells capable of converting ifosfamide, an inactive chemotherapy drug when given intravenously, into its cancer killing form are encapsulated into unique and proprietary pin head-sized, porous capsules which form the company's live-cell encapsulation technology. A number of these capsules or "factory" of cells are strategically placed right at the site of the pancreatic tumor. They convert ifosfamide from an inactive drug to an active cancer-killing drug at the source of the cancer, not where it is normally converted -- in the liver.

The chemotherapy drug ifosfamide is carried by the patient's blood through the porous capsules where it is immediately converted into a cancer fighter -- again, right at the site of the tumor. This is targeted chemotherapy in every sense of the word with benefits not normally seen when a patient is undergoing chemotherapy. 

Using Cell-in-Box allows PharmaCyte Biotech to use only one-third the normal dose of ifosfamide normally given to fight cancer. The proximity of the activation to the tumor site lessens the amount of ifosfamide required and, in turn, virtually eliminates the side effects usually seen with chemotherapy. The unique properties of the Cell-in-a-Box capsules cover the gamut of durability and provide the ability to be shipped anywhere in the world to be used when needed. The capsules and the cells within them have the ability to be frozen and stored for, at least, five years and can then be thawed for use to fight cancer in humans. These capsules are designed in such a way that completely protects the cells from any attack by the immune system. No other encapsulation technology in the world has these properties.

Pancreatic cancer is a notoriously stubborn disease that hides behind a fortified wall of tissue while becoming entangled with blood vessels and organs, often creating an inoperable condition with a bleak prognosis of life expectancy -- mostly measured in months, not years. In fact, pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. and has the highest mortality rate amongst major cancers with 74 percent of patients dying within the first 12 months of diagnosis. 

Despite ongoing efforts, this rate of death hasn't changed substantially in nearly four decades. Gemcitabine, sold under the brand name Gemzar™ by Eli Lilly, has long been the industry standard, either as a single agent or as part of a cocktail of drugs. Most recently, Celgene received FDA approval as the gold standard treatment for advanced pancreatic cancer with its Abraxane plus gemcitabine combination. As the numbers show, though, there is still plenty of room to improve clinical outcomes, meaning that a new therapy has the potential to capture a large market share.

With that in mind, encouraging clinical data can be met with great acclaim and financial reward, such as Merrimack Pharmaceuticals striking a deal with healthcare giant Baxter International Inc. in September 2014 to develop and commercialize the experimental cancer drug called MM-398 for pancreatic cancer outside the U.S. and Taiwan. MM-398 is an investigational nanotherapeutic consisting of the chemotherapeutic irinotecan, encapsulated in a liposomal sphere that in a Phase 3 clinical trial in combination with 5-flourouracil and leucovorin in post-gemcitabine metastatic pancreatic patients achieved a median survival rate of 6.1 months versus 4.2 months for patients on 5-flourouracil and leucovorin alone. 

In the agreement, Merrimack received $100 million upfront and is entitled to up to another $870 million in future payments based upon milestones being achieved.

Previously, in a Phase 1/2 study, Cell-in-a-Box plus ifosfamide almost doubled median survival time and the one-year survival rate in patients as compared to historical data for Gemzar. PharmaCyte Biotech is gearing up for a larger Phase 2b study in which their combination will be compared directly to Celgene FDA-approved Abraxane plus gemcitabine combination.

In December, the FDA granted an Orphan Drug designation for Cell-in-a-Box/ifosfamide for the treatment of pancreatic cancer, paving the way for potential developmental and commercialization benefits. Orphan Drug designations from the FDA are provided only to therapies for life threatening or rare diseases, defined by less than 200,000 diagnoses annually. Importantly, the designation validates the technology and brings with it special assistance from the FDA in the development of the drug and up to seven additional years of marketing exclusivity in the U.S. if it makes it to market, in addition to possible exemptions or reductions in regulatory fees and taxes.

PharmaCyte Bioech ($70 million market capitalization) will undoubtedly be looking to follow in the footsteps of its larger peer Merrimack ($1.2 billion market capitalization), who received and Orphan Drug designation for MM-398 for pancreatic cancer in 2011. In November 2014, a Fast Track designation, a status that carries with it different benefits for expediting development, was awarded to MM-398. 

The commencement of PharmaCyte Biotech's Phase 2b clinical trial, expected this year, will be another step in the right direction for proving the potency and low toxicity of Cell-in-a-Box technology. And, taking direct aim at one of the most high profile pancreatic drug combinations today in Abraxane plus gemcitabine will likely increase the profile on PharmaCyte Biotech and the potential prowess of its novel therapy, so much so that it could become the treatment of choice for advanced pancreatic cancer.

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