Thursday, February 21, 2013
Gentlemen (& BS) Start Your Regging Pens: Nuvilex (NVLX) Targets $4.5 Billion Brain Cancer Industry with Novel Medical Marijuana Drugs
While other companies in the medical marijuana industry are purporting their presence can yield substantial benefits in the retail sector, Nuvilex (NVLX) potentially presents a far greater upside as a major medical marijuana pure play in the biotechnology arena. The stock is seeing exponential increases in volume spawning from both medical marijuana investors and biotechnology investors as the company continues to release details on its intentions to develop cannabis-based therapeutic candidates for deadly forms of cancer in dire need for new treatment options.
On Thursday, Nuvilex disclosed that the initial target of its wholly-owned subsidiary, Medical Marijuana Sciences, Inc., is glioblastoma multiforme, one of the most aggressive malignant forms of brain cancer that leaves patients with little hope for extended survival times.
The National Cancer Institute estimated that the total costs associated with brain cancer in 2012 were a whopping $4.47 BILLION! Head and neck cancers add another $3.64 billion to the associated expenses.
Glioblastoma Multiforme accounts for 52% of all functional brain tumor cases and 20% of all intracranial tumors and has a median survival time of only 12 to 14 months!
Clearly the mortality rate speaks for itself as to the desperate need for new therapies. Today’s commonly used treatments, such as Merck & Co.’s (MRK) Temodar® (temozolomide) can have debilitating, and even deadly, side effects, such as severe fatigue and nausea and even convulsions and thrombocytopenia (decreased platelets in the blood). Decreased white blood cell counts have also been seen with Temodar®. These side effects often lead to discontinuation of treatment before patients’ lives are jeopardized. For example, thrombocytopenia can result in severe internal bleeding while decreased white blood cell counts can leave patients vulnerable to a variety of serious, life-threatening infections.
The American Cancer Society estimates that about 23,000 people in the U.S. will be diagnosed with malignant brain and spinal cord tumors in 2013 and about 14,000 people with die from these diseases.
We could continue to cite the morbidity issues and mortality rates of cancers originating above the shoulders, but what investors want to know is how Nuvilex is going to potentially make an impact.
Nuvilex is drawing upon years of research data that indicates cannabinoids, including Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), can inhibit the growth of brain cancer cells in the laboratory and in animals, including recent evidence pointing to their potential value when used in the treatment of glioblastoma multiforme. In a pilot clinical study treating glioblastoma multiforme patients with "safe" levels of THC, the median survival of patients was 24 weeks, equaling that of the "benchmark" drug (temozolomide) at that time.
Utilizing knowledge derived from the company-sponsored mid-stage clinical trials of its living cell encapsulation technology as part of a new treatment for pancreatic cancer, coupled with published research, Nuvilex plans to investigate the use of similar technologies to deliver cannabinoids to target indications.
"We believe that this class of therapeutic molecules will enable us to advance new treatments for this form of brain cancer," said Dr. Gerald Crabtree, Chief Operating Officer at Nuvilex.
The U.S. Food and Drug Administration has made it pointedly clear that they are looking to expedite the approval of drugs in areas of high-need, such as that of brain cancer. Janet Woodcock, director for the Center for Drug Evaluation and Research at the FDA, said a week ago that the regulatory agency is considering approving some drugs after JUST ONE Phase I clinical trial if they can show substantial impact in areas of great unmet medical need.
Med.s that can achieve “breakthrough” status will have the FDA’s attention. “We expect many of these would come available very quickly with Phase I data.” - Janet Woodcock
These statements harken key questions of what Nuvilex is working on from brain cancer, as well as its research on pancreatic cancer. Are they novel? Certainly. Can they provide a therapeutic benefit with a solid safety profile? Initial research says, “Yes.”
It’s easy to see why the stock is quickly garnering the attention on several verticals through multiple styles of investors as it could produce incredible gains from current levels of 5.2 cents and a $23 million market cap. Those discerning investors see the massive headroom for share appreciation in both the near and long term for Nuvilex.