News News Media CoverageDrug firm given shot in armCash infusion may bring medicines to fight flu, radiation Jane Larson SCOTTSDALE - A small Scottsdale company has finished raising $5.5 million to continue developing a potentially big drug that some day could help human lungs fight influenza or stave off the effects of radiation and anthrax attacks. ImmuneRegen Biosciences Inc. will use most of the money for studies that executives hope will confirm its earlier findings. The funds came as ImmuneRegen was out of cash and had spent most of the year stretching its research dollars. "People had to really dig deep and have faith, and say, 'OK, I think this is the kind of product we can see some real value out of in the long term.' That's what made it hard," Chief Executive Officer Michael Wilhelm said of the fund-raising effort. ImmuneRegen raised the money in three stages, gaining $2.3 million and $2.7 million in October and the final $509,000 in early December. New York investment bank Joseph Stevens & Co. Inc. helped connect the company with private investors nationwide. The firm expects to spend $2 million this year accelerating work on two main drugs it is developing. Its first drug, Viprovex, is aimed at fighting biological substances such as the influenza virus and anthrax bacteria and at toxic chemicals. The second, Radilex, is being developed to treat acute radiation exposure. Both are based on Homspera, a synthetic version of the body's Substance P, a collection of molecules that transmits signals between nerves and other cells. ImmuneRegen is focusing on how the compound affects the nerves in the airways of animals and ultimately people. Wilhelm expects pharmaceutical companies that already sell flu-fighting drugs would be his earliest customers. Feds may want drugs The federal government, specifically homeland security and anti-terrorism agencies charged with maintaining emergency stockpiles, would be next, with a need for both drugs. "The excitement of working in drug development, for me, is compounded by knowing that I'm working on something with potential national security implications," said Hal Siegel, a drug developer who officially joined the company in October as senior director of product development and regulatory affairs. The company plans to reach a pharmaceutical and business milestone this year, when it expects to file one or more applications for an Investigational New Drug with the U.S. Food and Drug Administration. The IND, as it is called, is generally regarded as the result of successful early studies and proof that it is reasonable to advance to human trials. ImmuneRegen owns two U.S. and two foreign patents on their work and has another 27 patents pending. As in much of the traditionally slow-moving world of biotech, development is inching along. ImmuneRegen has sponsored or co-sponsored 16 studies of the compound's effect on radiation exposure. It also has sponsored at least three studies each on anthrax, avian influenza and the compound itself. All the studies so far have been conducted on rodents. The studies showed that up to 50 percent of mice treated with Radilex lived 90 days after being exposed to otherwise lethal doses of radiation, the company said. Their immune systems also appeared to function normally, it said. Having found encouraging results in the mouse studies, the next step would be designing studies on large animals. If those prove the compound is safe and effective, ImmuneRegen would apply for FDA approval of its products. The anti-flu drug would go through the traditional process that includes human trials, but the biodefense applications could be expedited by a 2002 rule that allows the FDA to approve drugs in cases where human testing isn't feasible. The latter route would allow ImmuneRegen to sell the drugs to federal stockpiles. ImmuneRegen, which contracts with outside labs such as Battelle labs to save on overhead costs, is using TGen (Translational Genomics Research Institute) Drug Development Services in Scottsdale on one of its latest projects. Researchers in the TGen lab at Mayo Clinic are looking at whether ImmuneRegen's anti-radiation drug might ease the effects of radiation treatments on cancer patients. The study is still at the test-tube level, but Stephen Gately, director of non-clinical development, said he was intrigued by the positive findings of earlier studies. Still in its development stage, ImmuneRegen hasn't generated revenue since it was founded in 2002. It figures it has spent $1.5 million since its inception on research, development and consulting fees, and expects it will take another two years for its work to turn into viable products. In three of its four years in business, ImmuneRegen's accountants have issued a "going concern" warning. The accountants said the loss, negative cash flow and lack of operational history raised doubts about ImmuneRegen's ability to continue as a going concern. Nearly $815,000 of the new money, in fact, went to repay investors who had made loans to the company earlier this year. But Chief Financial Officer John Fermanis said he expects the warning to be dropped, thanks to the new cash.
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General Inquiries: MEDIA CONTACT Amendola Communications IN-HOUSE INVESTOR CONTACT CORPORATE CONTACT John N. Fermanis, Chief Financial Officer Copyright © 2003-2008, ImmuneRegen Biosciences, Inc. All rights reserved. |
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