BOZEMAN, MT, USA – Mar. 22, 2013 – Microbion Corporation today announced the appointment of Jared Carney to its Board of Directors. Mr. Carney brings to Microbion a deep knowledge of revenue-accelerating programs, innovations in philanthropy, partnerships and sustainable business development strategies.

“There are few individuals who understand the full spectrum of accelerating development as well as Jared Carney,” said Dr. Brett Baker, Founder and CEO of Microbion, “We will immediately look to his knowledge and experience as we roll out Microbion’s platform technology and continue to expand our relationship with industry partners.”

Prior to founding Lightdale LLC, a management advisory firm serving clients around the globe, in June 2012, Mr. Carney was the Chief Strategy Officer at the Milken Institute for nearly nine years. His leadership was instrumental in putting together a myriad of innovative programs, partnerships and trusted relationships with philanthropists, government leaders, CEOs, leading thinkers and other major constituents to further the goals of job creation, advancing medical research and capital access.

Among the many initiatives Mr. Carney spearheaded were the annual Global Conference (the world’s largest gathering of the capital markets), establishment of the Global Capital Markets Advisory Council, a group of investors with US$14 trillion in Assets Under Management who share ideas about market and policy trends, and the Milken Institute Asia Center in Singapore.

Mr. Carney remains affiliated with the Institute and FasterCures (the Center for Accelerating Medical Solutions) as a Senior Fellow and retains responsibility for the Global Capital Markets Advisory Council and the Asia Center.

“I am inspired by Microbion’s vision in developing a safe, new, and environmentally responsible approach to products designed to overcome antibiotic resistant infections, and microbial biofilms in both health and industry” noted Mr. Carney. “I look forward to the opportunity to help the company engage new partners and execute on its vision as the world progressively understands the pressing need for control of resistant microbial biofilms.”
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Microbion Corporation is a pioneer in developing innovative products that address the issue of microbial control, particularly with respect to antibiotic resistant bacteria and microbial biofilms, both in health and in industry. Microbion’s core focus includes the development of an innovative new class of anti-infective drugs, one of the few that has been discovered over the last 30 years. Microbion is based in Bozeman, Montana. Learn more at microbioncorp.com.

Contact: Dr. Brett Baker at bbaker@microbioncorp.com and 1.406.599.1190

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The funding, awarded to a team consisting of Microbion, University of Pennsylvania, and University of California – San Francisco (UCSF), will help facilitate Phase 2 human trials to treat post-surgical orthopedic infections with Microbion’s innovative antimicrobial drug, currently in regulatory development.

Clinical studies will be carried out at both the Hospital of the University of Pennsylvania, and at UCSF/San Francisco General Hospital. A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma & Fracture Service at the Perelman School of Medicine at the University of Pennsylvania, will work with Microbion and the University of California-San Francisco on the trial, set to begin pending FDA approval of the IND application.

“We’re honored to be given this award from the DoD, and are hopeful that the Phase 2 trial will allow us to offer improved treatments and standards of care to a significant number of patients,” said Mehta. “Orthopaedic trauma and fracture patients are at an increased risk for infection. If successful, this new treatment strategy could be a significant step toward reducing instances of amputation, disability, and even death.”

“We are very pleased with the DoD’s decision,” said Dr. Brett Baker, Microbion’s Founder, President and CEO. “This is our second DoD grant in support of the regulatory development of this drug, and an important step for Microbion as we advance this drug to fight extremely challenging infections associated with orthopedic surgeries, including antibiotic resistant infections. The application process was highly competitive, and it’s an honor for our team to have been selected for this funding. We’re very excited to continue to advance our product through the FDA process.”

In 2011, the World Health Organization identified antibiotic resistance as a global health crisis, and partly in response to this crisis, Congress passed the GAIN (Generating Antibiotic Incentives Now) Act in 2012 with broad bipartisan support. This legislation provides incentives and FDA regulatory priority to companies who are developing new drugs to fight antibiotic resistant infections.

In June 2012, the award team met with the FDA in Washington D.C. to discuss Microbion’s plan to advance to Phase 2 human clinical studies for the treatment of infections associated with orthopedic medical devices. Microbion’s BisEDT therapeutic drug candidate successfully completed Phase 1 human clinical trials in 2011.

It is estimated that over 100,000 patients receiving orthopedic implants in the United States each year will suffer from a post-operative infection. “This is a critically important area for the global community, as almost all current antibiotics are losing effectiveness against antibiotic resistant bacterial and fungal infections,” said Dr. Baker. “This rapidly expanding unmet need in healthcare is creating a global market that must be addressed as a matter of clinical necessity. Our technology has the potential to improve outcomes for patients who develop an infection related to an implanted orthopedic medical device.”

Abstract

Aims: The purpose of this study was to evaluate the antimicrobial efficacy of thirteen bismuth thiol preparations for bactericidal activity against established biofilms formed by two bacteria isolated from human chronic wounds.

Methods: Single species biofilms of a Pseudomonas aeruginosa or a methicillin resistant Staphylococcus aureus were grown in either colony biofilm or drip-flow reactors systems. Biofilms were challenged with bismuth thiols, antibiotics or silver sulfadiazine, and log reductions were determined by plating for colony formation.

Conclusions: Antibiotics were ineffective or inconsistent against biofilms of both bacterial species tested. None of the antibiotics tested were able to achieve >2 log reductions in both biofilm models. The 13 different bismuth thiols tested in this investigation achieved widely varying degrees of killing, even against the same micro-organism in the same biofilm model. For each micro-organism, the best bismuth thiol easily outperformed the best conventional antibiotic.

Against P. aeruginosa biofilms, bismuth-2,3-dimercaptopropanol (BisBAL) at 40–80 lg ml)1 achieved >7.7 mean log reduction for the two biofilm models. Against MRSA biofilms, bismuth-1,3-propanedithiol ⁄ bismuth-2-mercaptopyridine N-oxide (BisBDT ⁄ PYR) achieved a 4.9 log reduction.

Significance and Impact of the Study: Bismuth thiols are effective antimicrobial agents against biofilms formed by wound bacteria and merit further development as topical antiseptics for the suppression of biofilms in chronic wounds.

Download Full Press Release – Microbion Corporation Press Release (07.05.11)

Abstract

Aims: To determine the ability of a bismuth thiol to control floc formation in a multispecies population of micro-organisms obtained from the activated sludge unit of a wastewater treatment plant. The molecular level mechanisms by which bismuth-2-3-dimercapto-1-propanol (BisBAL) inhibits bioaggregation are also elucidated.

Methods and Results: Micro-organisms were grown over a 3-day period in a batch system by adding glucose as an electron donor to stimulate short-term heterotrophic activity. Extracellular polymeric substances (EPS) produced by activated sludge micro-organisms during exponential and stationary growth phases in the presence and absence of BisBAL were characterized using colorimetry, X-ray photoelectron spectroscopy (XPS), and Fourier transform infrared (FTIR) spectroscopy. BisBAL at its minimum inhibitory concentration (MIC, 10 lmol l)1) was most effective in suppressing microbial floc formation. The principal effect of sub-inhibitory concentrations of BisBAL was to decrease total EPS production while largely preserving homology.

Conclusions: Antifouling and bactericidal properties of BisBAL arise from its ability to reduce EPS expression and preferentially suppressing acidic and O-acetylated carbohydrates and certain protein secondary structures viz. b-structures, random coils, and a-and 3-turn helices. As micro-organisms exhibited a much weaker tendency to aggregate at lower concentrations of these specific EPS components, they also appear to be important for the formation of microbial flocs and bioaggregates.

Significance and Impact of the Study: BisBAL was shown to be highly effective against multispecies microbial aggregation. Novel bismuth-based biocides could also be potentially employed to control excess sludge production in wastewater treatment systems by inhibiting EPS expression.

The use of improvised explosive devices (IEDs) in Iraq and Afghanistan has caused a marked increase in severe blast trauma, now responsible for approximately 75% of all injuries, according to the Journal of Orthopaedic Trauma. Many of those who survive such explosive trauma are challenged with healing from severe limb, head, face, and burn injuries that can take years to treat and usually result in significant lifelong impairment. The AFIRM awards represent a national effort to address the health care challenges of these severely injured military personnel.

Microbion Corporation (Microbion) of Bozeman, Montana, is proud to be a corporate partner in one of the two awarded consortia: the Alliance for Regenerative Medicine – RCC AFIRM. Microbion is the sole Montana firm represented in this consortium. The mission of this consortium is to accelerate advances in regenerative medicine, and to translate these advances as quickly as possible into practical, therapeutic tools applied both in military combat and hospital environments. These new therapies will focus on the treatment of burns, regeneration of bone, muscle, tendon, nerve, and blood vessels. It is anticipated that these advanced therapies will prevent loss of life and reduce the likelihood of amputation, both for injured military personnel, and for civilian populations.

Microbion is also a recipient of a separate $2.5 million grant from USAMRMC, and is currently working closely with USAISR to develop an innovative topical antimicrobial therapeutic product to treat burns and complex, open military wounds. Dr. Brett Baker, the President and CEO of Microbion stated “Microbion’s goal in AFIRM is to develop lifesaving products, and to improve long-term quality of life of our wounded military personnel. The products being developed through collaborations within AFIRM and USAISR will benefit the treatment of extensive burns, infections, and a wide variety of other lifethreatening wounds.”

“This is big win for Montana’s biotech industry,” said Sen. Jon Tester, (D-Mont.) “It shows that our companies can play a vital role in some of the most cutting-edge research around. Working with the Defense Department on the AFIRM program, Microbion will be doing medical research that will make a real difference in troops’ lives.”

“This grant will help continue to grow Montana’s biotech industry and at the same time help our heroes, those serving in harms way if they are wounded,” said Governor Brian Schweitzer. “I commend the USAMRMC and Microbion for their innovative leadership.”

“Our consortium is comprised of a core of 15 advanced academic institutions, and approximately 20 leading edge corporate partners working in collaboration with USAISR,” Dr. Baker explained. The core academic institutions, led by Rutgers University and the Cleveland Clinic include: Case Western Reserve University, Carnegie Mellon University, SUNY Stony Brook, Dartmouth College, MIT, Massachusetts General Hospital/Harvard Medical School, the Mayo Clinic, and Vanderbilt University.

“This partnership will bring in good paying jobs to Montana, boost our economy and ensure Montana’s best and brightest can share their expertise in biotechnology,” said Senator Max Baucus (D-Mont.), chairman of the powerful Senate Finance Committee. “The work that AFIRM is doing is truly impressive and incredibly important, and Microbion is a perfect example of the innovative technology companies we have in Montana. Together they can find medical solutions that will ease the suffering and disability of our soldiers on the front lines and we owe our troops the best science can offer.”

Congressman Denny Rehberg (R-Mont.) also commented. “Private entities like Microbion play a critical role in developing cutting edge treatments for those who have been severely injured while bravely serving our country,” said Rehberg. “This funding is a recognition of those efforts. It’s great to see a Montana-based business playing a role in these crucial advancements.”

“Microbion Corporation is ideally suited to play a part in this initiative given their experience in both technology development and commercialization.” said John O’Donnell, TechRanch Executive Director.

Microbion relocated from Anchorage, Alaska to Bozeman, Montana early in 2005. “We immediately became an industrial member of the Center for Biofilm Engineering at Montana State University, a leading research institute in our field. Bozeman offered a highly advanced academic environment, small business development infrastructure, and a growing “critical mass” of biotechnology and pharmaceutical companies. Our medical research relationships with the military were initially facilitated by Ray Friesenhahn of MSU TechLink, to whom we owe a debt of gratitude.” Dr. Baker stated. “As a Bozeman company, we are very proud to participate in AFIRM, as we contribute to Montana’s growing presence in leading edge biotechnology, medical device, and pharmaceutical technologies.”

Reference:

Darby, Creg. Uniquely Insidious: Yersinia pestis biofilms (2008) Trends in Microbiology, 16(4):158-164.

Reference:

Ojha, AK, Baughn, AD, Sambandan, D, et al. Growth of Mycobacterium tuberculosis biofilms containing free mycolic acis and harbouring drug-tolerant bacteria (2008) Molecular Microbiology, 69(1):164-174.

Reference:

Smith, K, and Hunter, IS. Efficacy of common hospital blocides with biofilms of multi-drug resistant clinical isolates (2008) Journal of Medical Microbiology, 57(8):966-973.

Reference:

James, G, Swogger, E, Wolcott, R, Pulcini, EL, et al. Biofilms in chronic wounds (2007) Wound Repair and Regeneration, 16:37-44.