Pancreatic Cancer

Pancreatic cancer is difficult to treat because it is often not diagnosed until it is at an advanced stage and is not surgically removable. Even with the best available therapies, the average life span of patients with advanced pancreatic cancer is less than one year. Only about 38% of patients with this disease survive more than one year. According to the American Cancer Society, in the US alone, more 42,000 new cases of pancreatic cancer will be diagnosed in 2013 and approximately 38,000 people will die from the disease.

Pancreatic cancer is extremely hard to detect since it generally does not show symptoms of its presence until it is at an advanced stage. Only one drug, GEMZAR® (gemcitabine), has been approved (in 1996) by the US FDA (Food and Drug Administration) to date as a single agent for the treatment of advanced disease. GEMZAR® was approved on the basis that it increased average survival of patients by a mere 1.6 months over the best previously available treatment.

More than 30 Phase III clinical trials have been performed since 2000 in which other drugs were added to gemcitabine in an effort to improve upon gemcitabine's efficacy against pancreatic cancer. Of these, only three were deemed to be marginally effective. The only treatment approved by the FDA since GEMZAR®'s approval in 1996 was the combination of gemcitabine plus TARCEVA® (erlotinib), which was approved by the FDA in 2005 as first-line treatment for advanced, metastatic pancreatic cancer.

Early in 2013, the results of a large Phase III clinical trial in advanced pancreatic cancer patients using the combination of gemcitabine and ABRAXANE® (nanoparticle-albumin-bound [nab]-paclitaxel [TAXOL®]) were reported. This combination was better than gemcitabine alone in terms of average survival time (increased by 1.8 months) and one-year survival rate (increased by 59%). Still, however, average survival time of patients was well below one year. The gemcitabine/ABRAXANE® combination was approved on Sept. 6, 2013 by the FDA as first-line treatment for advanced, metastatic cancer, and thus replaces the gemcitabine/TARCEVA® combination as the "gold standard" for this indication.

A four-drug combination known as FOLFIRINOX is also used for the treatment of advanced, inoperable pancreatic cancer. This combination consists of the well-known anticancer drugs 5-fluorouracil, leucovorin, irinotecan (CAMPTOSAR®), and oxaliplatin (ELOXATIN®).

Regardless of whether gemcitabine is used alone, in combination with TARCEVA® or ABRAXANE®, or the FOLFIRINOX combination is used, average survival time for patients with advanced, inoperable pancreatic cancer remains less than one year and one-year survival rates remain below 50%. In addition, all of these treatments are associated with severe side effects. Therefore, there is still a great need for the development of new and better treatments for pancreatic cancer.

The results of preclinical studies of the effectiveness of cannabinoids from Cannabis against pancreatic cancer have been reported in the scientific literature over the past decade. For example, in 2006, a report of research was published in the prestigious scientific publication Cancer Research that revealed that cannabinoids caused the programmed cell death of pancreatic cancer cells both in the laboratory and in animals. These results were also observed with human pancreatic cancer cells implanted in mice with suppressed immune systems (to avoid rejection of the human cells). In the authors' own words, "….results presented here show that cannabinoids exert a remarkable antitumoral effect on pancreatic cancer cells…"

In 2011, the results of studies with the combination of gemcitabine and three different synthetic cannabinoids were published. The combinations produced a strong synergistic (i.e., greater than additive) inhibition of the growth of six different pancreatic cancer cell lines in the laboratory. Furthermore, the anticancer effect of gemcitabine on the growth of human pancreatic cancer cells implanted in mice was significantly enhanced when cannabinoids were included in the treatment regimen.

In addition to the antitumor effects of cannabinoids against pancreatic cancer, these substances are also known to reduce the pain and nausea and vomiting associated with advanced cancers and their treatment. Medical marijuana has also been documented to reduce the cachexia, or "wasting" syndrome (weight loss, muscle atrophy, fatigue, weakness, and loss of appetite), that is associated with advanced-stage cancers, including advanced pancreatic cancer. Therefore, by developing cannabinoid-based treatments, particularly those based on non-psychoactive molecules such as cannabinoid (CBD), we may be able to approach the treatment of this devastating and deadly disease in a two-pronged fashion; namely, by attacking the tumor and also by treating the symptoms associated with it.

Medical Marijuana Sciences, Inc. has a unique opportunity vis-à-vis the development of a new and effective treatment for those suffering from advanced pancreatic cancer by virtue of its relationship with our parent company, Nuvilex, Inc. (OTCQB:NVLX). Nuvilex is currently preparing to conduct late-phase clinical trials of its unique pancreatic cancer treatment in patients with advanced, inoperable disease (see www.Nuvilex.com). These trials will compare Nuvilex's treatment "head-to-head" with gemcitabine. Our parent company's treatment consists of low doses of ifosfamide, a well-established anticancer drug, together with cells encapsulated using the company's proprietary cellulose-based live-cell encapsulation technology. The encapsulated cells are capable of converting ifosfamide into its cancer-killing form. All of this begs the question "Would the effectiveness of Nuvilex's pancreatic cancer treatment be improved if it were combined with a cannabinoid-based treatment?"