NanoPass micro-needles mean that the same vaccine supply can now protect triple the number of people from potentially deadly flu, painlessly.

Just like a mosquito’s stinger, the MicronJet micro-needles developed by Israel’s NanoPass slip though your skin virtually unnoticed. The company’s tiny three-prong needle device delivers a perceptively pain-free alternative to standard vaccination needles.

They’ve arrived in the nick of time, as the world braces for what could be the worst pandemic ever – swine flu, or H1N1. According to company officials, NanoPass needles could dramatically enhance both the effectiveness and the supply of pandemic flu vaccines.

Based on previous clinical findings about regular swine flu, NanoPass executives posit that with their MicronJet micro-needles one unit of swine flu vaccine can be stretched to three. That’s more than good news for health authorities in the US who fear that stocks of anti-virals like Tamiflu and Relenza may not meet the nation’s needs in time for the bigger outbreak expected this winter.

And findings from studies about regular flu vaccines show that the company can provide better immune protection against all viruses. In a randomized clinical trial recently published in the journal Vaccine, NanoPass proved that it can reduce the dose of a seasonal flu vaccine by 80 percent and still preserve its efficacy.

The scientists at the eight-person company believe that they achieve these impressive results with the help of the potent immune cells that live in our skin, and that their technology will have a similar effect in protecting against all types of flu.

Making use of the immune system in the skin, the NanoPass approach in intra-dermal drug delivery is the kind of technology that the National Institutes of Health (NIH) is looking for, and something it is currently exploring in various clinical studies.

More potent or more people protected

“In practical terms it is likely that one can use the same bulk vaccine for three times the people,” NanoPass CEO Dr. Yotam Levin tells ISRAEL21c. “There are some issues with loading the device,” he concedes, but essentially only 20% of a flu vaccine could be needed to provide the same immune protection.

Or the same swine flu anti-viral vaccine could be used in its regular dose, to provide better immunization. “Something closer to 100% of the dose may enhance immune response and protection.

“That would have a completely different effect. You won’t save on the amount [of the swine flu vaccine used] but you’d improve your protection rates for the vaccine,” notes Levin.

To speed up its entry into the US market, NanoPass, based in Ness Ziona in central Israel, is now looking for partners so it can undertake clinical trials and validate its hunch to medical authorities that its impressive results to date will pertain to swine H1N1 as well.

Speeding up FDA approval

Vigorous FDA-supervised clinical trials would be needed immediately to get NanoPass’s device to market in the US and in the meantime the company is close to submitting its FDA application.

NanoPass already has a foot in the door. The company reports that the Infectious Disease Research Institute (IDRI) in the US, a non-profit company, has licensed its MicronJet micro-needle technology for the delivery of drugs against tuberculosis, HIV, malaria, leishmaniasis, leprosy and more.

A new US study would need cooperation with national health authorities in America, and could be sponsored by a drug company or state offices to see fast results. “This is something not easy to prove. And meticulous design of the clinical study would be needed,” adds Levin, who like any other bio-medical high-tech professional takes a cautious stance before making claims.

Without emergency funding, it would take about two years for NanoPass to pass the rigorous US health protocols. But for a pandemic situation it “might be significantly accelerated,” hopes Levin who has been in touch with the NIH. If embarked upon immediately, NanoPass’s solution could be ready by the end of 2009.

The company already has the European FDA equivalent (the CE mark) which means that it’s approved in Europe to deliver substances in drugs approved for intradermal delivery and the device will be available there within the year.

Saying goodbye to the pain

The company is also exploring the use of its needles in delivering insulin to diabetics. It will soon publish the results of a study currently underway that deals with that possibility.

The fact that the micro-needles deliver the vaccine painlessly is also a consideration. “Diabetics are known to be pain-tolerant but for needle-phobes and kids, these needles are a nightmare,” says Dr. Shuki Yeshurun, founder and president of NanoPass, who started the company in 2000.

The NanoPump device was developed by Yeshurun at the Technion Israel Institute of Technology as a means to enable diabetics to painlessly and easily inject insulin.

The needles are barely visible to the naked eye, and are intended to deliver large molecules that cannot pass through the skin directly, or which are degraded too fast in the stomach to be biologically available to the body.

NanoPass is working hard now to accelerate its technology to ensure that there are enough doses for everyone before the next wave of swine flu hits harder. As for anti-virals, “production rates are low, much lower than anticipated,” says Levin. “There will be delays in rolling out vaccines in many countries.”

NanoPass needles may be able to quell the problem and deliver thousands, if not millions of people from harm’s way.