If Steve Jobs Had Known

Laser Targeting

Treating cancer- it’s a huge industry. The estimate? Glad you asked: The number is so large, I couldn’t even find an estimate. One study shows Americans lose $2.3 billion every year waiting for cancer treatment.

The answer on how much is spent is many billions. Cancer is a wide ranging term, so numbers are only available for specific types of cancer. $1 billion is spent on research for breast cancer alone. The estimate for therapy costs- $13.9 billion for breast cancer. That’s a whole bunch of billions.

Chemotherapy- the introduction of chemicals that kill tumors, is one tried and true therapy for either slowing down the spread of cancer, and/or sending it into remission. However, the downside of chemotherapy- it’s a shot gun effect treatment. Another words, patients are heavily dosed with poisons that have been shown to greatly effect specific kinds of cancers. In many cases, the treatment is worse than the disease, and patients often opt to live out their lives without the aggressive therapy.

A new delivery system known a “Bioencapsulation”- nicknamed and copy writed as “Cell-in-a-Box” has been designed to significantly increase the locally available amount of an active cancer drug directly to the tumor- thereby minimizing the surrounding damage and reducing harmful side effects.

Rather than the shotgun effect- this is a laser targeted “Sniper” effect designed just to kill the tumor: Read on…..

Pancreatic Cancer - Hard to Diagnose and Quickly Fatal

Pancreatic Cancer is a solid tumor with a very poor prognosis and extremely limited treatment options. The median survival time from this difficult to diagnose condition is less than 6 months. There’s about 120,000 cases diagnosed annually in the US, Europe, and Japan combined.

US based Nuvilex (OTC BB: NVLX) has acquired the rights from SG Austria to develop and market this revolutionary “Cell-in-a-Box” therapy that has been proven effective in a Phase I/II clinical trial on Pancreatic Cancer patients in Germany. The trial was performed on 14 patients at the Rostock Medical University.

For those of you who are not familiar with the FDA process for drug approval, here’s the overview for dummies like me:

  • A Phase I trial is used to prove the therapy won’t kill you
  • A Phase II trial is used to demonstrate the product has some level of effectiveness on a small sampling of patients
  • A Phase III trial is a much larger patient study and is the last step prior to an FDA approval- if one is granted.

It takes about $1 billion and many years to get a new drug through the FDA process. Sometimes, depending on the severity of the disease being treated, studies are combined for patients with little other recourse- another words- extreme terminal situations.

Such is the case with the Phase I/II trial performed on 14 Pancreatic Cancer patients in Germany.

The patients’ median survival rate doubled compared to historical controls when using Chemo drug Gamzar. The one year survival rate tripled, and only 1/3 the standard chemo dosage was used.

Pain was diminished and quality of life was improved considerably while visible tumors stabilized during the course of treatment.

How It Works

NVLX’s cancer therapy is not a new drug. It is a new way to laser target the delivery of an existing drug. The delivery system works something like GoreTex- the water proof fabric that breathes. With GoreTex, the pores in the fabric are designed so that smaller air molecules can pass through, but water molecules cannot. Hence- the fabric breathes, but you stay dry.

The drug is “bioencapsulated” in a cell and injected into the body near the site. Immune cells- like water molecules with GoreTex are too large to attack the “Cell-in-a-Box”, so they are ignored by the immune system.

However, small cells can pass out of the Bioencapsuled cell and attack the tumors in the immediate vicinity.

Using a catheter, the Bioencapsulated cells containing 1/3 the normal dosage of the cancer drug were introduced near the tumors using a catheter. These x-ray images show the actual catheter and subsequent implantation of the “Cell-in-a-Box” placement.

Now- are you ready for the eye opening results?:

The patients’ median survival rate doubled compared to historical controls when using chemo drug Gamzar. The one year survival rate tripled, and only 1/3 the standard chemo dosage was used.

Pain was diminished and quality of life was improved considerably while visible tumors stabilized during the course of treatment.

There’s More

Here’s what one of these capsules looks like- this is an actual photographic image.

Pancreatic Cancer has been the first target for a clinical trial- mostly because it’s so difficult to treat and nearly always fatal. The harsh reality is exotic and unusual therapies are easier to get into trials when patients and doctors have little recourse.

However, the whole process of bioencapsulation has far greater potential uses.

Plans are underway to use Encapusation technology for many other purposes. This same technology can be used to laser target Stem Cells.

It is also suggested Encapsulation can be used to target infectious diseases such as Hepatitis C Virus, West Nile, Dengue, Influenza, and HIV.

Diabetes is also a potential disease for NVLX to pursue. Early studies suggest encapsulated cells can still deliver insulin 6 months after implantation.

And, of course, other and more widespread forms of cancer could become targets for its use- such as Lung, Breast to name two obvious candidates.

Various therapies are being explored in joint activity between NVLX’s us operations in Silver Spring, MD, and the SG Austria operations in Singapore.

Where to From Here?

There’s a lot more to cover on NVLX. I’m just showing you the recent developments in this first edition. More to come as I’ve committed to follow every move this company makes for at least 6 months.

I’m very intrigued by the potential for this therapy- here’s the hook- At $.06, the market is saying this company is worth about $20 million.

The therapy they own for market in the US just demonstrated in could DOUBLE THE SURVIVAL RATE of 14 terminal Pancreatic cancer patients, using 1/3 the normal dosage of chemotherapy, and double their life expectancy.

True- it’s a small sampling of patients, but $20 million is equivalent to about zero in the biotech world. As this story develops, I could easily see this stock trading at $.50 as the company works towards a partnership to go into Phase III clinical trials and turns its attention to other potential uses for Bioencapsulation.

As you can see from the chart- buyers have been coming for this stock. About 10 days ago this stock traded nearly 13 million shares over two days.

It surged from $.03 to $.09 and settled back at about $.06. Someone decided they needed to own a bunch of this one in a hurry.

I say we give the company 6 months to thrill the market as it develops this Bioencapsulation technology.

We can sit around and guess all day where the stock might go- that’s a “subjective” issue.

However, double the survival rate, tripling the one year survival rate, and doing it with 1/3 the chemotherapy dosage is a fact- there’s nothing subjective about it.

This little $.06 gem is just starting to show up on some radar screens- Long term, I like it for $.50. Short term- it’s hard to predict- a break above that $.09 surge would give the stock a ceiling of anyone’s guess. It might happen today, in two days or two months.

It’s easy to hold since the company has proven it can help extend life.

Let’s at least go for $.12, or a double in the next 30 days. $.50 longer term. For those who feel they need an SSL, use $.03- the level the last surge started from.

If Steve Jobs had only met NVLX sooner- who knows?

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