Replies to post #2866 on GTC Biotherapeutics (fka GTCB)

[jessellivermore]

This is good news. The more GTCB gets involved in these "little" projects the more crediblity it gains. The more others are encouraged to come to them with their projects. GTCB is in someways similar to a skilled craftsman.

[ThomasS]

Dew, did Pharmathene ever submit its' IND to the FDA? Are they circumventing this formal process via US Gov?

(btw, did R&R give you a "heads up" a week or so ago? lol...)

"The initial stage of development, for which $34.7 million has been allocated, includes manufacturing process development, preclinical safety and toxicity testing, submission of an Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA), and initiation of a Phase I clinical trial. Following the successful completion of the Phase I clinical trial, the government may exercise its option to fund additional development activities beyond the initial $34.7 million, leading to FDA licensure. The contract also provides the Department of Defense with the option to procure an initial 90,000 doses of Protexia®."

[floblu14]

PharmAthene might be a good fit to develop GTC's future granted patents on Biosensor Technology -
http://www.investorshub.com/boards/read_msg.asp?message_id=16184388

>Biological weapons are used to intentionally disseminate infectious agents or toxins that would otherwise appear only naturally or not at all. Such agents can be divided into bacteria, viruses, rickettsiae, fungi or toxins...
Read More on Biological Defense

Chemical weapons use the toxic rather than the explosive properties of chemical substances to produce physical or physiological effects on an enemy. Classic chemical weapons, such as chlorine and phosgene, were employed during World War I...
Read More on Chemical Defense<
http://www.pharmathene.com/

P.S. I was 1 of 9 (previous post) :-)

[swaziemehesdes]

what I really like about this deal is that one of the big advantages of GTC and Pharmings technology are well read here.

While the utility of human plasma derived butyrylcholinesterase (hBChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities of hBChE due to a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. PharmAthene's recombinant hBChE overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia® available for use by the military and civilian populations.

[DewDiligence]

Correction to message #2866:

In my bracketed annotations about 2/3 of the way into the post it says: “PharmAthene also has a larger Protexia grant from the NIH.”

I should have said smaller, not larger. PharmAthene’s Protexia grant from the NIH ($1.7M) is very much smaller than its Protexia grant from the DoD ($213M, including $35M in the first phase). Apologies for the misstatement.

[Biowatch]

>>Friday March 2, 4:33 pm ET <<

I thought you viewed news released after market close on Fridays as a danger sign.

Aren't government funded bioterror plays somewhat risky too, and subject to the winds and whims of political change? Any proof of concept is a good thing, but they won't have "real" clinical trials in humans for an anti-nerve gas agent, as that wouldn't pass muster before an ethics review board.