Written by ι Stock Market Media Group Staff — June 26, 2013
Nuvilex, Inc. (OTCQB: NVLX) executives aren’t daunted by the statistics. As a matter of fact, they’re aware the research they do is directed towards attacking what the company’s Chief Operations Officer, Dr. Gerald Crabtree, calls two of cancer’s “hard targets.” “Pancreatic cancer and brain cancers represent two such targets. Pancreatic cancer because it doesn’t present overt symptoms until the cancer is at an advanced stage; therefore, it is more difficult to treat effectively, and the result is that the survival of patients with advanced pancreatic cancer is usually only several weeks to a few months. Brain cancers are a hard target because many of our most effective cancer drugs cannot cross the ‘blood-brain’ barrier to attack the tumor.”
Make no mistake about it — the statistics aren’t pretty. The American Cancer Society estimates that, in 2013, more than 45,000 people will be diagnosed with pancreatic cancer and over 38,000 will die from the disease in the US alone. It is the fourth most deadly form of cancer in the world. It’s a disease where no amount of money or fame will help change those statistics. Recently it has claimed the lives of well known names like Apple’s Steve Jobs, actor Patrick Swayze and Nobel Prize recipient Dr. Ralph Steinman.
Both pancreatic cancer and cancers of the brain are the hard targets that Nuvilex has invested its research into in order to develop treatments with its cell encapsulation technology and future medical marijuana studies. The company has close to $30 million invested in its unique live-cell encapsulation technology, and it’s using that technology, combined with the cancer killing drug ifosfamide, in clinical trials for the treatment of advanced, inoperable pancreatic cancer.
Eli Lilly’s (NYSE: LLY) Gemzar (gemcitabine) is the only drug approved by the FDA as a single agent for the treatment of advanced pancreatic cancer, and is the current “gold standard” for the disease. Eli Lilly has enjoyed sales of over $10 billion for the drug for all indications, but Gemzar accounts for the majority of the sales of all drugs for advanced pancreatic cancer.
It is Nuvilex’s goal to make an impact on that market with its treatment. Over the years, several drugs have been combined with Gemzar in an effort to improve survival, but these efforts have only been marginally successful. In fact, since 1990, 33 pivotal (for marketing approval) Phase III clinical trials have been conducted – only 3 were successful. Clearly there is a great need for the development of new treatments for this devastating form of cancer, and Nuvilex has data from two independent Phase II clinical trials that suggests their cell encapsulation technology combined with ifosfamide could be on the heels of challenging Eli Lilly’s Gemzar.
In January, 2013, Celgene, Corp. (NASDAQ: CELG) announced the results of its large-scale (861 patients, 151 study sites) Phase III trial in advanced pancreatic cancer patients at the 2013 ASCO (American Society of Clinical Oncology) Gastrointestinal Cancers Symposium. Celgene’s trial compared their treatment, which consisted of the combination of nanoparticle-albumin-bound (nab)-paclitaxel (Taxol), or Abraxane, plus gemcitabine (Gemzar) to gemcitabine alone.
Median survival time for patients treated with a combination of Abraxane plus gemcitabine was 8.5 months vs. 6.7 months for gemcitabine alone – an increase of 1.8 months or almost a 30% increase. The one-year survival rate obtained with the Abraxane plus gemcitabine combination showed an increase of 59% over the results seen with gemcitabine alone.
However, in Celgene’s Phase III trial, 40% (38% vs. 27%) more patients experienced neutropenia (depression of white blood cell counts) and far more patients (17% to 1%) experienced neuropathy (nerve pain), as well as other side effects, with the combination therapy when compared with Gemzar alone. The neuropathy was reversible with 44% of patients returning to treatment.
Nuvilex’s two independent Phase II clinical trials in patients with advanced, inoperable pancreatic cancer have been performed using capsules that contained cells capable of converting the widely-used anticancer drug, ifosfamide, into its “cancer-killing” form. A single, “one-time,” implantation of about 300 capsules near the pancreas (and the tumor) was performed followed by two treatments with ifosfamide at 1/3 of the “usual” dose (more than two treatments with ifosfamide are often used in treating other forms of cancer).
The trials were carried out at several study sites. The results from the two Phase II clinical trials indicated that:
>> By using Nuvilex’s treatment, the median survival time and the one-year survival rate of patients were approximately doubled when compared to previously reported data for Gemzar.
>> Side effects usually associated with ifosfamide were greatly reduced in severity, likely because a “lower than usual” dose of ifosfamide was used.
>> No side effects were seen that could be attributed to the presence of the encapsulated cells or the capsules themselves; including no evidence of inflammation of the tissues near where the capsules were implanted.
>> With the use of Nuvilex’s treatment, metastatic tumors in the liver were reduced in size.
>> When the capsules were removed, the cells that had been inside the capsules were still alive and functioning – even after more than two years.
Currently, Nuvilex is preparing for its pivotal Phase III trials. This large-scale clinical trial is required by regulatory agencies such as the FDA, the EMEA in Europe, and the TGA in Australia before marketing approval can be obtained. In these trials, Nuvilex’s pancreatic cancer treatment will be compared “head to head” with Gemzar at its “normally” used dose/schedule. More than two treatments with ifosfamide may be used. Dr. Crabtree says the study will be done at multiple study sites in several countries, and that some of the possible study sites and oncologists at those sites have been identified. The Principal Investigator who will oversee a major portion of the study is a noted gastroenterologist/oncologist.
If the results obtained with Nuvilex’s treatment for advanced, inoperable pancreatic cancer are statistically “better” than those obtained with Gemzar, the company’s treatment could replace Gemzar as the “gold standard” for the treatment of this devastating disease. This success story would be the first for the small Maryland based biotech firm, and most assuredly would put Nuvilex on the map as potentially the new gold standard, but also as a champion of the “hard targets” in the war against cancer.