...Previous non-clinical studies in animals demonstrate that rBChE can provide significant protection against chemical nerve agent poisoning when administered prophylactically (prior to exposure to nerve agent) and also may increase survival when administered therapeutically (following nerve agent exposure).
"In addition to these latest nerve agent binding data, we have recently demonstrated that rBChE produced using the PER.C6 ® human cell line is readily scalable with greater than 99% purity," commented Dr. John Troyer, Vice President, Chemical Defense Product Development. "Moreover, the PER.C6 ® manufacturing platform yields up to two thousand-fold more product per liter than human plasma-derived BChE. Pharmacokinetic testing is currently underway and we expect to begin non-clinical efficacy testing in the coming months."
From Pharmathene Transcript:
Moving on, progress in our recombinant bioscavenger program continues to be very strong in 2013. So far this year, all technical milestones under our contract with the Department of Defense have been reached on schedule.
Turning to our chemical defense and nerve agent recombinant bioscavenger program. We are making good headway in 2013. In-vitro testing conducted by the U.S. Army Medical Research Institute for Chemical Defense has recently shown that our recombinant bioscavenger successfully binds to a broad spectrum of nerve agents, including sarin and tabun. As you know, there is widespread reporting in the media about the pre-use -- presumed use of these agents in Syria.
In addition to the latest binding data, we have also recently demonstrated that rBChE produced using the PER.C6 human cell line is readily scalable, resulting in a product with greater than 99% purity and exceptionally high yields. To give you some idea of the magnitude of this achievement, we are able to produce the equivalent amount of BChE in a single 50-liter bioreactor, equal to the amount obtained from 4,000 liters of fractionated human plasma. We are excited about this progress and are moving forward with considerable enthusiasm. Pharmacokinetics and efficacy testing is currently under way, and we expect to have the results early this summer.
Our next-generation human cell approach for the manufacture of recombinant BChE has many advantages, including for streamlined and cost-effective development and production. We are continuing to work collaboratively with the DOD to execute on this contract and position the recombinant platform for the future funding to initiate Phase I clinical development.