Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

Rock Creek better hurry-up, or their entire platform will be obsolete (of course, I say that in jest -- we know how easy it is to get carried away with new medical approaches and the dreams of wealth that accompany it, don't we?):

http://www.thenewstribune.com/2014/12/22/3534676/early-results-promising-as-a-tacoma.html

Early results for treatment of inflammatory diseases promising for Tacoma-born biotech research company
BY C.R. ROBERTS
Staff writer December 22, 2014


It looks like water, it feels like water and it could change the way medical science attacks disease.

Quietly, slowly, a revolution continues to simmer on the east side of the Thea Foss Waterway at a Tacoma-born biotechnology research firm called Revalesio.

And the world may never be the same.

Founded in 2006 by Tacoma native Eric Russell, the privately held firm has been conducting research into the possibilities offered by bubbles, tiny “nanobubbles” suspended in a saline solution.

Count the several hundred academic papers prepared by researchers worldwide, with 30 to 40 projects being conducted at any one time.

Count the patents so far: 278.

Count the number of diseases that Revalesio’s product, RNS60, might affect: asthma, multiple sclerosis, Parkinson’s disease, dementia, myocardial infarction, endometriosis, eye problems, wound treatment.

And more.

BEGINNINGS

Ten years ago, Eric Russell, grandson of the founder of the investment advisory firm Frank Russell Co., heard of a man in Texas who had developed a process using oxygen-rich bubbles suspended in water with hydroponically grown plants.

Russell secured the rights. The process seemed to increase the yield of vegetables.

But there was something else.

In March 2006, he met with three experts who had inspected his “FoodMachine,” which incorporated the oxygen-bubble technology.

Russell recalls the conversation, when one of the men said the yield increase was amazing, but more significantly there was not just a reduction in plant disease, there was no disease. None.

Russell asked if there might be an effect on human health.

“Nobody in the room had an answer,” he said. “For me, that’s a challenge.”

Within two months, Russell had contacted a Stanford immunologist who tested the water and found it to be, Russell said, “a potent anti-inflammatory.”

“This changed how I thought about what we were dealing with,” Russell said.

BUILDING

Since 2006, Russell and Revalesio have tried to answer three questions:

What is RNS60? What does it do? How does it work?

To help find answers, the company has funded the work of researchers around the world, from the University of Washington in Seattle to the Research School of Physics and Engineering at the Australian National University in Canberra, from Canada to Austria and Switzerland, from Italy to the United Kingdom.

Early animal studies have found RNS60 to be safe, and the most recent results have shown that the product shows promise in treating Alzheimer’s disease and other dementias; multiple sclerosis; Parkinson’s disease; asthma and other inflammatory diseases.

According to the company website, the product has been tested in Phase I trials for asthma, multiple sclerosis and the damage caused by heart attacks. Pre-clinical studies have been conducted for cystic fibrosis, Parkinson’s disease and Alzheimer’s. Phase II studies are in the works for multiple sclerosis and asthma.

Neither the Food and Drug Administration nor the National Institutes of Health would comment on the research, although the FDA, according to Revalesio, has deemed RNS60 to be safe.

The company recently hired a new president, Bert van den Bergh, to move toward commercialization of RNS60 by finding deep-pocket research partners for large Phase III human trials.

Van den Bergh spent 30 years with Eli Lilly & Co. where he served as president of neuroscience products, president of European operations and general manager for the United Kingdom and Germany.

A native of The Netherlands, van den Bergh “was instrumental in the development, commercialization and lifecycle management” of products including Cymbalta, Prozac and Zyprexa, according to a Revalesio news release.

Van den Bergh heard about RNS60 a year ago.

“I had retired from Lilly six years ago,” he said recently at Revalesio headquarters.

“It sounded unbelievable,” he said. “This sounded very fundamental. I had the same skepticism. What are they? How can they alter biology? I got very curious.”

He studied the research, spoke with employees and came away believing that the nanobubbles and their action at the cellular level represent “in a way, new physics. It is novel physics.”

When he told a colleague, a medicinal chemist, that he was moving to Tacoma to work with RNS60, the man scolded, “You’ve gone off the deep end.”

“It’s difficult,” said Russell, “for people to get over the speed bump of ‘What is it?’ The fundamental challenge is that we are physically modifying a fluid and having it do biological work. We’re literally at the leading edge of this new arena of science.”

It’s a place where questions outnumber answers.

“It would be fair to say that when we started in 2004, we had no idea of what we were getting into,” Russell said.

And today, he said, “nobody has clarity on where this will go.”

“Late next year we’ll make a decision on where to focus,” said van den Bergh.

“We’re letting the data drive the map,” said Dr. Richard Watson, chief science officer.

The company is now choosing where to aim its research and resources, whether on dementia, asthma or any of a few other diseases.

“We’ll look at unmet medical needs, the complication of studies, speed of development, market possibilities and regulatory framework,” said van den Bergh.

“Our job is to develop evidence that it works,” said Russell.

OTHER VOICES

The News Tribune contacted two local physicians, both members of the American Academy of Allergy Asthma & Immunology, to review Revalesio data that are publicly available.

Neither was familiar with with RNS60, and both took time to offer an initial reaction.

Dr. Arthur Vegh, in practice for 25 years, serves at Allenmore Medical Center and at a clinic in Federal Way. Along with reading the research, Vegh contacted Revalesio’s Richard Watson for more information.

“It seemed like such a hodgepodge,” Vegh said. “Usually, that makes us think it’s sketchy. But it looks like they’re doing good science.”

“I think it has a chance,” he said. “It sounded like witchcraft, but they’re actually approaching it scientifically. If (proven) safe and effective, it could be a game-changer. This shows some promise biochemically. I still have some of that ‘too good to be true.’ ”

Dr. Kevin Dooms practices at Allergy and Asthma Associates of Bellevue.

“It’s very interesting,” he said after reviewing the data. “I have no idea how it works. It seems to work in a very different way. I’m curious to learn more about it. I’m curious where on the cellular level it makes an effect. This is a novel way of approaching the problem. I’m very excited to see results of Phase II.”

He is excited, he said, “at the opportunity that there may be alternative therapies.”

He manages his patients’ disease, he said, primarily with steroids and albuterol.

“It would be nice to have more tools,” he said.

He said he has seen other new miracle drugs fail to meet expectations.

“We see a lot of it, therapies that look very promising, but they don’t work. One medicine was promising in mice, but when it hit human trials it just fell flat. In the real world, it’s gone nowhere.

“This could be a new way of looking at the cell. On the one hand we’re skeptical, but we’re also very excited that something can come up.”

“Good research and good products don’t go away, but they have their work cut out for them,” he said. “I’d be ecstatic if they were successful.”

IMPLICATIONS

Think of RNS60 as a cellular seltzer with effervescence at the tiniest level. Imagine that those nanobubbles somehow have an inside pressure greater than the pressure exerted by the outside environment. Imagine that those bubbles, surprisingly stable in solution, somehow fortify, protect or nourish cells.

Don’t ask how or why they work. That journey is just beginning.

And don’t look for Revalesio soon to make a splash on “60 Minutes.” It’s too early and the principals at the company are too focused on getting the science right before making claims of cures.

But that hasn’t stopped people from asking for help.

Russell, Watson and van den Bergh regularly hear from people begging to be given the medication for themselves or family members.

“The stories are unbelievable and heartbreaking,” Watson said.

“It gives me a sense of urgency,” said van den Bergh. “You wish you could help.”

“It’s important not to become numb to it,” said Russell.

If all goes better than well, an approved therapy for asthma could be available within five to seven years, he said. Count a dozen years for a dementia therapy.

Russell would not discuss the amount of investment he and his family have made in the company. There have been two outside offerings to investors, from which Revalesio raised $40 million.

The possibilities extend beyond medical applications, Watson said.

“There could be huge implications for sciences in other areas,” he said, naming bioterrorism, chemicals, industrial uses, food production, fermentation, fuel.

He asked, of the medical implications, “Can we generate the environment to germinate the science? We are optimizing, not altering, normal physiology.”

He said the company needs to “get scientists to embrace the questions we’re asking. We want to be the conversation-starter.”

“We have a core technology,” said Russell. “Now we need strategic partners. We see ourselves as stewards of this. Once the evidence and the human studies validate (RNS60), I don’t think we’ll have any trouble getting people’s attention.”

He remains committed to Tacoma, he said, and committed also to a set of core ideals outlined in the company’s statement of its culture, which says in part, “We stand for excellence in all we do and reflect the principles of integrity, compassion and humility.”

The greatest challenge, said van den Bergh, is “translating the story that these little bubbles could have a world-changing impact.”

“Something very unusual is happening in Tacoma,” he said.

It’s something, he said, that can change the way we see physics and biology, and “it’s happening right here. You would expect this in the Bay Area, Boston, Cambridge. That fact is, it’s here.”

“We talk about the story, the journey we’ve been on,” said Russell. “We started with a 10,000-piece puzzle, and we had three pieces. I believe in the end the answers we’ve been pursuing are going to be very elegant and simple.”

Read more here: http://www.thenewstribune.com/2014/12/22/3534676/early-results-promising-as-a-tacoma.html#storylink=cpy