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neo43

05/07/06 11:27 AM

#34302 RE: LongJohnSilver #34301

LJS, the validation process for synDNA is unrelated to its use in vaccines. Preliminary validation has certainly occurred by virtue of the Hepatitis B vaccine results, but the process is and will be ongoing according to the 10-K. IMHO, it'll take awhile for the process to run its course to the point where major pharmas (and even minor ones) will be willing to begin using it in their vaccines and/or drugs.
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downregul8

05/07/06 5:59 PM

#34305 RE: LongJohnSilver #34301

Long John – there are two parts of your question of - sequence and chemical makeup.

All DNA medicines – vaccines, anti- sense, gene therapies, etc are sequence dependant. The first part of any DNA approach is identifying the genetic sequence – the order of the individual molecules in the DNA chain - needed to create a response. Because there is a huge variety of sequences made from only four components - a lot of them are very similar and just as some people have noticed that we can rcgnze wrds with mssing or raeragned lttrs, our cells can sometimes react to DNA strands or proteins which sequences that are close to the target or manufactured sequence. This could be good or bad. As a result each sequence will have it’s own range of effectiveness, and range of side effects, so each potential cure will have to be tested one at a time. For the most part, the customers will likely identify the vaccine sequences and the effectiveness of that sequence will be independent of the DNA source. So part of the question of whether this stuff will work in some cures and not others is related to the target choice and not directly related to synDNA. If the cure works with other DNA it should work with synDNA but that has not been demonstrated in people yet and leads to the second part, which is related to the chemical makeup.

Some of chemicals that make up the DNA can be substituted without affecting the sequence. So the questions are: If a sequence works, will it work the same, better, or worse with different chemical DNA sources? How long does each type survive (stay intact) in the body? Can the DNA be delivered to the cells where it is needed? Are there any side effects as a result of using one material over another?

From the early testing it synDNA looks like it is better in many ways than fermented DNA. Whether or not synDNA can be substituted at any time in a vaccine test or production phase is a major open question. If cygx could get a broad chemical makeup approval so that it could be substituted at any point it would be great for business but chances are that synDNA will start out getting into a couple Phase I human trials for vaccine candidates where the company intends on using the synDNA material in production. If those trials show success, then it would be worth the investment in time and money to get the broader approval. The only way I know to adequately determine if synDNA could be swapped for other DNA types would be to conduct several side by side tests – likely in parallel with one or more four phase clinical studies - which would be very expensive and could easily take the four years or more mentioned.