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Nuvilex, Inc. and Celgene Corp. Can Both Replace Eli Lilly’s Cancer Drug Gemzar

Nuvilex, Inc. and Celgene Corp. Can Both Replace Eli Lilly’s Cancer Drug Gemzar

Written by ι Stock Market Media Group Staff — May 20, 2013

The race is on, and patients with advanced stage, inoperable pancreatic cancer will be the recipients of the winner’s treatment.  Two biotechnology companies are registering impressive data in each of their own pancreatic cancer trials, so impressive in fact, Eli Lilly & Co. (NYSE: LLY) is surely feeling its long time reign as the current standard single-drug treatment for the disease being threatened.  Nuvilex, Inc. (OTCQB: NVLX) and Celgene Corp. (NASDAQ: CELG) are the two biotech firms applying the heat.

One thing is for sure – pancreatic cancer drugs are big business.  Eli Lilly & Co.’s sales of its blockbuster cancer drug gemcitabine (Gemzar®) have averaged close to $1.5-billion per year globally since its approval back in 1996.  Gemzar is the only drug approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer.  According to Indianapolis-based Eli Lilly, Gemzar is a nucleoside analogue that interferes with the process of DNA production; thereby preventing cancer cells from replicating and, in turn, slows or stops tumor growth.  The drug is the worldwide standard of care as a single agent for pancreatic cancer and is the “base” upon which combination chemotherapy treatments for the disease is being built.

It’s Time for a Better Treatment

While Gemzar has been the go-to treatment for pancreatic cancer patients for years that might be about ready to change, and the best news of all will be for those who suffer from the tough to treat disease and are in desperate need for better therapies.  Both Nuvilex and Celgene are producing better data with their treatments in clinical trials as compared to the data offered up by Gemzar. 

This is, of course, good news for patients and for both biotech firms as well as they challenge the current standard.  Obviously to knock off the best, you have to beat the best, and both companies are producing numbers that meet that goal. 

Let’s look at the numbers which are shaping up nicely for Summit, New Jersey’s, Celgene and Silver Spring, Maryland’s, Nuvilex.  For Celgene, its treatment includes gemcitabine (Gemzar) in combination with their drug Abraxane, a nanoparticle albumin-bound formulation of paclitaxel (Taxol).

Celgene & Nuvilex Data Suggests Help is on the Way

In recently released data from Celgene’s large scale Phase III trial, Median Survival Time for patients treated with a combination of Abraxane plus gemcitabine was 8.5 months vs. 6.7 months for gemcitabine alone.  This represents 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 just gemcitabine alone. 

Meanwhile in the case of Nuvilex, it is preparing for a large scale Phase III trial of its own using the company’s cell encapsulation technology (“Cell-in-a-Box”) combined with the anti-cancer drug ifosfamide.

In its two already completed Phase II trials using encapsulated cells capable of converting ifosfamide into its “cancer-killing” form, Median Survival Time and the One-Year Survival Rate were about doubled as compared to historical data for Gemzar.  At the time Nuvilex’s clinical trials were conducted, Gemzar’s historical data gave patients a median survival time of 5.5 months; whereas, Nuvilex’s treatment during the two mid-phase trials resulted in a Median Survival Time of 11 months. 

If we were to compare current Median Survival Time numbers based upon recent data, Gemzar offers 6.7 months, Celgene’s treatment offers 8.5 months and Nuvilex’s treatment offers 11 months.  These figures make it clear that both Celgene and Nuvilex have the data in their favor which of course is the first key factor when it comes to gaining FDA approval – that is, can the new treatment offer a better result than the current standard?  Therefore, Eli Lilly should be very concerned that their drug Gemzar’s more than 15 year reign as the “gold standard” and the only drug approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer could come to a screeching halt.

Calling on the FDA to Approve a Changing of the Guard

First up to bat will be Celgene as it has completed the late stage trials needed and will likely seek FDA approval soon.  The company’s case will most assuredly be argued on the fact that its treatment gave about a 30% improvement in the Median Survival Time of patients as compared to gemcitabine alone.

Nuvilex hopes that its pivotal Phase III trials, in which its treatment will go head to head with Gemzar, will confirm the data found in its first two trials, and company executives are more than confident the pivotal trial will do exactly that.  If so, then expect Nuvilex, Inc. to seek FDA approval for its treatment with an argument that it improves Median Survival Time of patients by 100% over Gemzar using historical data from its own trials and 64% over Gemzar based on Celgene’s data for Gemzar in its trials.  It also improves Median Survival Time of patients using Celgene’s treatment by almost 30%. 

An additional argument Nuvilex can make in its fight for approval is that it uses only one drug, ifosfamide, at a low dose in its treatment, thus lowering the toxicity profile.  This is significant because the overall side-effect (toxicity) profile was low with Nuvilex’s treatment as compared to Celgene’s, where two cancer drugs, gemcitabine plus Abraxane, were used in their trials.  In the case of Nuvilex’s two Phase II trials, the results showed no life-threatening or even serious side effects that could be attributed to the company’s treatment. 

In the Celgene trials, serious toxicities were seen.  Nuvilex’s treatment is a cell encapsulation technology plus the drug ifosfamide, and it is likely the severity of ifosfamide’s side effects was reduced as only one-third of its usual dose was used in the trials.  In addition, only two “rounds” of treatment with ifosfamide were given in Nuvilex’s mid-phase trials (normally several rounds of treatment are given in cancer treatment).  So, one must ask “Would even better overall results be obtained if ifosfamide were given for more than two rounds of treatment? 

Will Eli Lilly & Company Go Quietly 

The question now is — will Eli Lilly sit idly by as it is becoming more and more obvious that Gemzar will be put to the test in arguments before the FDA and other drug regulatory agencies around the world?  It is our opinion that Eli Lilly would be wise to make a play for Nuvilex’s technology.  In two trials, Nuvilex’s data outperforms both Eli Lilly and Celgene’s treatments, and of the two competitors, it is the company that would cost Eli Lilly the least. 

Celgene’s gemcitabine plus Abraxane combination could possibly become the new standard treatment for advanced, inoperable pancreatic cancer, wrestling away Gemzar’s long hold on the pancreatic cancer drug market. 

However, Celgene’s reign could be short lived as we feel Nuvilex’s Phase III trials are likely to get underway soon, and if the impressive data shown in their mid-phase trials are repeated in their Phase III trials, we expect the company to receive fast track status for marketing approval by drug regulatory authorities like the FDA.