The University of Minnesota is taking another shot at commercializing a long-promising drug therapy for treating victims of traumatic blood loss developed in the last decade by a trio of U of M researchers.
 
It says it has committed $2.5 million in internal funding to put the technology back in play six years after the failure of a startup company established to launch the “BHB/M” pharma candidate. 
 
In doing so, the U will be trying to overcome longstanding path-to-market obstacles that have vexed the BHB/M therapy ever since its development in 2005 by Matthew Andrews, a University of Minnesota-Duluth biology professor; Dr. Greg Beilman, professor of surgery with the U of M Medical School; and Lester Drewes, head of biochemistry and molecular biology at the UMD medical school.
 
BHB/M combines D-beta hydroxybutyrate (BHB) and melatonin to prolong survival in patients who are at risk for bleeding to death. It is delivered intravenously by paramedics at the scenes of accidents or on military battlefields, effectively prolonging the crucial window for survival until victims can be transported to hospitals. 
 
The treatment arose from a discovery by Andrews, an expert on animal hibernation. In a very fitting bit of serendipity for a U of M effort, he found that gophers produced higher levels of the natural compound BHB while hibernating, and also showed spikes in melatonin during brief mid-hibernation awakenings. That led to a conclusion that BHB and melatonin played a key role in allowing the gophers’ blood flow and metabolism to naturally lower during hibernation without harming vital organs.
 
The idea drew support from the U.S. military. The Defense Advanced Research Projects Agency (DARPA) funded the trio’s initial work at UMD with $3 million in research grants, intrigued by its potential to cut down on battlefield losses. In 2008, the U of M filed for a patent on the biotechnology; the research efforts were moved to the Twin Cities campus and a startup called VitalMedix licensed the know-how—its first bid for commercialization. 
 
Further experiments strengthened the theory that BHB and melatonin could aid survival following severe injuries. For instance, in 2011 a study confirmed that infusion of the BHB/M compound (then known as Tamiasyn) into pigs produced a measurable survival effect after shock from severe blood loss.
 
From the start however, VitalMedix had trouble landing investors, due partly to the Great Recession being at its height, but also because of the dawning era of scarcity in early-stage biotech investors, which has continued to this day.
 
In 2009, VitalMedix relocated to Hudson, Wisconsin, in a bid to tap that state’s well-developed angel investor network—a move that became a cause celebre for Minnesotans alarmed about emerging biotechs fleeing the state due to lack of angel investors. Shortly thereafter, the Minnesota Legislature passed an angel investor tax credit.
 
The startup succeeded in raising $1 million in a funding round led by Wauwatosa, Wisconsin-based Capital Midwest Fund, and with participation from Wisconsin angel funds such as Silicon Pastures, St. Croix Valley Angel Network, Successful Entrepreneur Investors and Wisconsin Investment Partners. But it wasn’t enough – VitalMedix declared bankruptcy in 2010, with the technology transferring back to the U of M.
 
The school, however, still believes in the potential of the BHB/M therapy and revealed this month it has committed significant internal funding to get it back on a commercialization path.
 
U.S. government documents show that the U of M Regents were finally awarded a full patent on the treatment method late last year, naming Andrews, Beilman and Drewes as the inventors. Then on Dec. 20, the U’s Office of the Vice President for Research revealed in a blog post that the BHB/M effort has received $2.5 million in funding from the school’s Center for Translational Medicine.
 
The mission: Resurrect its path to market by funding the preclinical work needed to file for clinical trial approval from the U.S. Food and Drug Administration.
 
The Clinical and Translational Science Institute (CTSI) is set up to function as a “service entity” for medical researchers seeking to translate innovative drugs and therapies into Phase 1 clinical trials, and for BHB/M, it has assembled a team of experts from University units such as the Office of Discovery and Translation and the Office for Technology Commercialization and connected them with outside experts and industry-based drug development consultants – all in a determined bid to finally move the still-promising idea out of the lab, into clinical trials, and ultimately to the market.  
 
“We are working to overcome the challenges of commercialization through this approach, with each group contributing its own expertise,” CTSI program manager Jodi Rebuffoni said in the post. “The team’s efforts have raised the commercialization potential of this therapy and increased the chances that it can someday help real people.”

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