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DewDiligence

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DewDiligence

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Re: DewDiligence post# 3701

Tuesday, 12/14/2004 9:06:01 PM

Tuesday, December 14, 2004 9:06:01 PM

Post# of 252493
Excerpts from Nexia’s end-of-year PR:

[These are the excerpts relating to Protexia and transgenic goats. Please see link below for full press release.]

http://www.newswire.ca/en/releases/archive/December2004/14/c4941.html

>>
Protexia(R) Program Update

…Protexia(R) production in the milk of our transgenic goat herd is being scaled-up as planned. This year our expanding herd surpassed 200 g of Protexia(R) in their milk. This level of production is sufficient for both the ongoing pre-clinical data capture and the development of GMP purification processes for clinical grade Protexia(R). This work is being carried out in conjunction with our CRO, MDS Pharma Services and a Contract Manufacturer. We are now actively breeding Protexia(R) genetics into our existing certified scrapie-free production herd to ensure that we meet the growing demand for Protexia(R).

…In the year ahead, we have three major objectives. We plan first to expand our manufacturing process with more transgenic goats and a larger purification system. Secondly, we will extend our dialogue with government regulators to show Protexia(R)'s performance in specific pre-clinical studies (toxicology, efficacy) prior to clinical studies, which are planned for the first half of 2006. Thirdly, our business development effort will find new healthcare uses for Protexia(R) to diversify our core military marketplace.
…
FDA Provides Clarity

Nexia is in discussions with regulators in the USA and Canada. Protexia(R), like all drugs, must be proven to be safe and efficacious in order to be approved and sold. However, the special nature of counter-terrorist medicines, like Protexia(R), uses a different regulatory mechanism within the US FDA. Termed the "Animal Efficacy Rule", this approved legislation permits the testing of efficacy (Phase II and III) in animal models because human efficacy trials are unethical. Phase I safety trials for Protexia(R) would be completed in humans in the traditional manner. These new rules compress the development timelines and are expected to accelerate the commercialization of Protexia(R).

[As previously reported in #msg-4107224]:

…Nexia signed an exclusive agreement with GTC Biotherapeutics to license its transgenic technology for Nexia to continue the development, manufacture, and sale of Protexia(R). This licensing agreement includes access to GTC's beta casein promoter and an option to license its filtration technology, which has been demonstrated to have utility for initial purification of Protexia(R).
<<

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