Chris Stern Blog

You may have noticed the numerous acronyms in our latest press release. We have always had strong backing in the military, but we did not consequently follow a strategy towards a goal in this sector. That has changed. As part of our Purple Heart Injury Laboratories (PHIL) initiative we have defined Defense Medicine™ as an important part of our business model and will position Oxycyte whenever used by warfighters as a Defense Biomedical™.

Only results count, so I am really excited about our signing of a Limited Purpose Cooperative Research and Development Agreement (LP-CRADA) with the Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research (WRAIR).

As we said in our news release, our company will provide information that would be used by NMRC and WRAIR for preparation, writing, and submission to the FDA of an Investigational New Drug (IND) application for the use of Oxycyte® for the treatment of decompression sickness (DCS). We are providing information but retaining ownership of the underlying intellectual property.

What this means to the company is that the U. S. Navy wants to formally begin testing Oxycyte to determine whether it is safe and effective in treating decompression sickness and arterial gas embolism (AGE) and, with positive outcomes, to submit an application package to the FDA for approval to use Oxycyte in humans. The Navy’s research effort is budgeted at about $3.8 million. That is research money to develop Oxycyte that the company does not have to come up with.

The Navy is undertaking this research because there is currently no proven adjunctive therapy for DCS and AGE available.  The gold standard for treatment (recompression therapy) may not be readily available under a variety of circumstances, for instance if a disabled submarine is on the seafloor in a remote or dangerous location. Researchers who have been looking at this believe the most promising candidate for adjunctive therapy is emulsified PFC - Oxycyte.  However, it is not currently known if Oxycyte or any other PFC can actually treat DCS and AGE nor is there an FDA-approved PFC product available.

When you are an early-stage company, it is great to have someone with urgent needs and the funds to finance the research on using your product for an unsolved problem.

If their research is successful and the Navy gets FDA approval to use Oxycyte this way, the company will have an exclusive option to license the rights to these new indications.

NMRC and our primary research partner, Virginia Commonwealth University Reanimation Shock Center (VCURES), have developed a coordinated, comprehensive, multi-center, $3.8 million research program dedicated to determining the efficacy of PFCs for treating DCS and AGE. The planned studies are aimed at providing the necessary components to support an FDA application for Oxycyte use in DCS and AGE under the “two animal rule,” which is used when human efficacy studies are not feasible or ethical.  The program’s ultimate goal is to make a PFC preparation - Oxycyte - available for the operational treatment of DCS and AGE in the Fleet by the fiscal year 2012.

In my next Blog I am planning to discuss our upcoming TBI trials in Switzerland and Israel in more detail. We are on target with our efforts to gain approval in both countries. We will bring site after site “online” to take advantage of our learning curve. The first site under contract is the Insel Hospital of Berne in Switzerland, where we already have submitted to the Ethics Committee. Eleven other sites in Switzerland and Israel are being added as you are reading this.