Written by ι Stock House Group Staff — March 5, 2013
In late January, those with advanced stage pancreatic cancer received some good news when Celgene, Corp (NASDAQ: CELG) announced the results of its large scale phase III trial at the 2013 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO), held in San Francisco.
Pancreatic cancer is difficult to diagnose and treat until it is at an advanced stage. Survival of patients with advanced, inoperable pancreatic cancer is usually only several weeks or a few months. The National Cancer Institute estimates that, in the U.S. alone, 45,220 new cases of pancreatic cancer will be diagnosed in 2013 and that 38,460 deaths will be attributable to the dreaded disease this year.
But, like two prize fighters, a pair of biotech companies is steadfast in the battle against a common enemy – pancreatic cancer. Both have presented astounding results that leave one to think, we may be extremely close to turning the corner in the fight against this brutal disease.
David and Goliath Strengthen Hand vs. Opponent
One is a Goliath in the biotech world, leaving the other to take on the role of David as a much smaller biotech, but for those who suffer with pancreatic cancer, they don’t see size, they see results. And, the results these two companies are delivering are providing much needed hope to patients, interestingly though, from two completely different approaches.
Goliath in this case is Celgene Corp. The company presented its results from a large phase III trial it sponsored which included 861 patients across 151 clinical sites. Celgene’s trial compared nanoparticle-albumin-bound (nab)-paclitaxel (Taxol®), or Abraxane®, plus gemcitabine (Gemzar®) to gemcitabine alone in patients with advanced, inoperable pancreatic cancer.
Eli Lilly’s (NYSE: LLY) blockbuster drug, Gemzar is the only drug approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer and the drug is considered the “gold standard” by the market.
Dr. Daniel Von Hoff, MD, Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute in Scottsdale, AZ and Consultant to Celgene made the presentation at the Symposium where we learned what this study showed:
• 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.
• One-year survival rate obtained with the Abraxane plus gemcitabine combination showed an increase of 59% over the results seen with gemcitabine alone.
The hope now is that Celgene will receive commercialization approval for the new treatment. In an interview with THE ASCO POST, a newspaper style publication collaborating with the American Society of Clinical Oncology (ASCO, an international organization), Dr. Von Hoff said:
“The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer. I have counted 33 phase III trials since 1990, and only 3 were positive. This has been a frustrating area.”
With that being said, enter Nuvilex, Inc. (OTCQB: NVLX) our David in this story. Nuvilex could very well be on the doorstep of having the next positive phase III trial since 1990. Through two independent mid-phase trials, this international biotechnology company is producing even more dramatic results than those found in the Celgene trials and doing it with a completely different approach.
This difficult to diagnose cancer, could be on the ropes with these two companies showing incredible promise. As Nuvilex prepares to enter a large-scale, late-stage trial with the combination of its living cell encapsulation technology and the widely used anticancer drug, ifosfamide, for the first time since Eli Lilly introduced gemcitabine (Gemzar®) back in 1996; two companies now have real science producing even better results than the current standard.
Different Approach with Big Pharma Results
Nuvilex uses a unique and proprietary technology – Living Cell Encapsulation.
The process forms a “platform” upon which treatments for many serious, debilitating, and even fatal diseases may be built. Some of these diseases include different types of cancer, diabetes, diseases for which stem cell therapies are being developed, and diseases caused by viruses.
While it does sound confusing, in laymen’s terms, the process uses living cells, and the company takes a very specific type of cell to address a specific problem a patient suffers from. Scientists then wrap up cells in a type of cellulose, forming essentially “cotton” capsules with live cells inside that form this “platform” or bundled miniature “house” of cells about the size of the head of a pin. At that point, each bundled platform becomes much like a miniature cell factory with the ability to produce whatever is needed.
Nuvilex has participated in two independent Phase II clinical studies in patients with advanced, non-surgically-removable (inoperable), pancreatic cancer, using the encapsulated cells capable of converting the widely-used anti-cancer drug, ifosfamide, into its “cancer-killing” form.
The latest results using a broader set of data confirmed the results found in the first Phase I/II trial. Both trials offer sets of data that were done at different times, with different populations, and in different hospitals. In the first trial, one location was used; however the second Phase II trial expanded its database by using 4 different hospitals.
Twenty-seven (27) patients were included in the trials and a substantial response was seen in that the use of the living cell encapsulation-ifosfamide combination helped patients to a better outcome than that previously reported with standard single-drug (Gemzar)therapy. Results from these trials included:
• Median Survival Time and One-Year Survival Rate were almost doubled as compared to historical data for Gemzar.
• The severity of ifosfamide’s side effects was reduced because only one-third of its usual dose was used.
• No damage to tissues surrounding capsules was seen.
• Cells within the capsules were protected from attack by the patients’ immune systems.
• Cells inside the capsules were alive and functioning – even after more than two years.
Another notable difference in the two company’s results is found in the side effects that patients have seen. While there were no serious side effects found in Nuvilex’s study, the same can’t be said of the Celgene results as there were 40% more patients experiencing neutropenia (38% vs. 27%) and far more patients demonstrating neuropathy (17% to 1%) amongst other adverse effects with the combination therapy when compared to Gemzar alone. In fairness, the neuropathy was reversible with 44 percent of patients returning to treatment.
It May be Time for Eli Lilly to Share the Space
In 2008, sales of Gemzar exceeded $1.7-billion, and the drug accounts for well over 55% of the sales of all drugs for advanced pancreatic cancer.
This is significant to both companies and certainly added motivation to Nuvilex as it currently prepares for its large scale Phase III pancreatic cancer trial.
In the future Phase III trial, Nuvilex’s pancreatic cancer treatment will be compared “head to head” with Gemzar. Whereas only two cycles of ifosfamide were used in the Phase II trials, for the Phase III trial, more than two cycles will be given, as is often the case when ifosfamide is used in cancer treatment.
If the results obtained with Nuvilex’s treatment 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.
Last week Nuvilex’s subsidiary Austrianova Singapore, reported the successful establishment of a research “cell bank” that will ultimately be used to obtain the numbers of cells necessary for conducting the company’s late-phase clinical trials.
The American Cancer Society says that 80 percent of all people diagnosed with pancreatic cancer will die within 1 year. On a 5-year basis, 96 out of every 100 patients will be dead, leaving the disease, in the words of the Hirshberg Foundation for Pancreatic Cancer Research, as “incurable.”
If Nuvilex’s larger phase III trials confirm the data from mid-stage trials, the company will likely no longer be a small biotech, but one thing is for sure and that is patients have room for greater optimism now more than ever with Celgene and Nuvilex fighting on their behalf to battle an even great Goliath – pancreatic cancer.
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