Written by Staff and Wire Reports
Tuesday, 26 January 2010 09:23

Not long ago, shortly after he started his company, CEO Michael Wilhelm was scrambling to find a name for his biotech focused, wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS).

“When we started the company, I asked the doctor (who first stumbled upon the discovery of the compound), Explains Wilhelm. ‘What do you think the drug does?’”

“I think it does something with the immune system,” he said. “It must, because anytime there is a compromised animal, that’s exposed to JP-8 jet fuel (radiation) and exposed to Influenza we seem to rev it up.”

Wilhelm decided on the name ImmuneRegen – Immune Regeneration- and it turned out to be a great thing after now identifying the mechanisms of the compound. “We were on the money. We modulate the immune system and we can tell you how you how we do that using Dendritic cell honing and things of that nature.”

ImmuneRegen is a young company, but unlike most newer biotechs of this size and experience in the market, its research seems to be gathering quite a bit of attention from places like the NIH, the National Cancer Institute and many others.

They have forged relationships with investigators at the University of Rochester and the University of Pittsburgh. With the support of those investigators, they have already received $750,000 in grants for research of their compound and have multiple grant submissions in to the NIH and BARDA (Biomedical Advanced Research and Development Authority) , as well as through the Armed Forces Institute of Pathology and Walter Reed Army Medical Center through their Combat Wound Initiative Program.

NIH-funded studies in areas related to Idiopathic Pulmonary Fibrosis, where the Company has filed its first IND (Investigational New Drug application) with the U.S. Food and Drug Administration (FDA), are being pursued at the University of Rochester.

It is rumored that millions in research grant money, are close to being announced from multiple sources.

At first glance, their pipeline appears to cover multiple areas and generally speaking, experienced and institutional investors don’t particularly like that. They like to see focus into the development of a particular drug or two.

In ImmuneRegen’s case, the mechanisms underlying the demonstrated immunostimulatory activity of its development candidate Homspera® are the focus. It just so happens that Homspera® has several broad reaching applications.

Homspera® is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Radilex® is the trade name associated with possible treatments for acute radiation exposure, while Viprovex® is being used for potential treatments in areas such as infectious disease, vaccine adjuvancy and chemical exposures. Both Radilex and Viprovex have the same active ingredient as Homspera. Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems are also on board as partners at various levels of interest and activity.

“Trust me, three years ago we used to sit around the table and the people would say this sounds crazy,” explains Wilhelm. “I mean we went to the head of the NIH who said ‘This is amazing, it seems to work here and it seems to work there, it seems to work in all the areas we need it to work, but how does it work?’ And we said, ‘We don’t know.’

The compound has been modulating the immune system. How it plays a role for various indications has increased the company’s confidence in its candidacy for various large market opportunities as well as a rumored and yet to be publicly announced partnership with one integrated pharmaceutical industry player as they get further into clinical studies. That same company has a high level of interest (as do other entities) in purchasing the company’s compound as a therapeutic for cancer. Melanoma specifically.

“Our focus is to move this through tox and enable the company to be able to submit with the FDA for 4 indications,” says Wilhelm. “There is a value inflection there that you can create value for your portfolio. Also, one of our indications, we feel, will enable us to file for Orphan Drug status and it will do a lot for the upper respiratory area for a compound.

ImmuneRegen’s patents, patent applications and continued research are partially derived from academic discoveries surrounding the function of Substance P, a naturally-occurring protein found throughout the body that acts in both the neuronal and immune systems.

In one case, the US Army and the US Air Force got wind that the company was working exclusively on this compound and had data about it’s treatment against pandemic influenza. “They just threw out a comment,” says Wilhelm. ‘You think your compound would work on radiation exposure?’ Next thing you know, the company is testing it’s compound in scenarios where the drug might have various bio-defense applications.

“We’re simulating a dirty bomb and or toxic therapy for cancer,” explains Wilhelm. “And it’s total body so any other scenario in a (lethal dose level) LD100, they’re all dead. We have a 50% survival. The government model is an LD50, which means obviously, that they expose 10 animals and half of them die and they only went out 30 days. Most of our studies we went 30 days as well but we also went out as far as 90 days so it was exciting for everybody. Our drug has shown efficacy in being delivered intra-nasally which is a partial oral delivery. We have shown oral bio-availability for our compound and that has heightened the interest now from the Armed Forces Radiobiology Research Institute and there are many programs for radiation development – the development of medical counter measures for radiation.”

The early fruits of IRBS’s labor is just starting to come to fruition. As we prepare to start hearing more news from the company in the days ahead, we have gotten commitment from their management team for follow up interviews and more articles.

In the short term, this is certainly a speculative, but intriguing penny stock play that could make some interesting moves on pending good news, especially if multiple research grants are announced.