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CYTOGENIX SHAREHOLDER UPDATE
January, 2006
Valued Shareholders:
We at CytoGenix send our best wishes to you for a healthy and prosperous New Year. This update marks six years that we have been working on the gene down regulation and expression technology that began with single stranded DNA expression vectors and has progressed to cell-free production of synthetic DNA. The level of activity has reached a point that it will be more efficient to provide the details of Company progress via our web site. We will include details of progress in product development, scientific research results including recently published papers, presentations and attendance at scientific meetings, patent filing activity and plans for Company expansion. Here are a few highlights that will preview items you can review in more detail as the web site is updated.
The Company continued efforts to commercialize the synthetic DNA production process and we are currently evaluating several synthetic DNA constructs as potential additions to developmental products in our pipeline.
The prototype of the synDNA? production module designed in conjunction with Alpha Laval Biokinetics was completed and tested on schedule. The tests were positive and provided valuable information about quality control measures and performance monitoring. As the Company prepares to initiate operation and validation of the module, we will also implement the next stage of planning for construction of the synDNA? processing facility.
Test results show that the synDNA? constructs for smallpox, HA (influenza) and hepatitis B were all effective in stimulating immune responses in animal tests (mice were tested for smallpox, HA and rabbits for hepatitis B). The synDNA? constructs were equally or more biologically active than the equivalent fermentation derived plasmids in these pilot studies. Additional tests of DNA vaccines for additional conditions are scheduled.
Negotiations are concluding with a supplier who makes the chemical constituents required for synDNA? production. The Company expects that it can achieve a long term relationship with terms that enable cost effective manufacture.
Using our screening techniques, we have identified additional bacterial gene targets to extend our anti-bacterial program. Over twenty-five oligonucleotide compounds have been investigated for silencing genes in Escherichia coli, Streptococcus pneumoniae, Streptococcus mutans (the principal cause of sepsis, pneumonia and tooth decay, respectively) and methicillin-resistant Staphylococcus aureus. Several lead compounds are now being tested in animals.
With the capacity to increase production of synDNA?, we will conduct enabling studies required by the FDA pursuant to filing an IND application for Simplivir? and resume testing of CytoGenix?s anti-inflammatory product, CY303. We will continue these developments using the new synDNA? constructs rather than conduct the studies with the fermentation derived plasmids which are much more expensive and less effective.
CytoGenix science and technology are both applicable to problems of increasing scope. An agreement has been executed to work with the Fast Trak Biodefense division of General Electric Healthcare to develop grant and contract proposals. The agreement with GE Healthcare is a model for additional partnerships for exploring the use of CYGX technology in bio-defense applications. The Company will accelerate its efforts to secure contracts with the Departments of Health and Human Services and Homeland Security to develop anti-virals and anti-bacterials. This will include expansion of our development of DNA vaccines to test constructs for avian influenza (H5N1) in both rodents and primates. The immunogenic constructs for smallpox, influenza and hepatitis B will be further tested with challenges to immunized animals. Acquisition of necessary data to comply with regulatory requirements to permit clinical evaluation of Simplivir? will proceed. Advances in the synDNA? production facility will enable increases in cell-free DNA for our own products and for our clients.
In summary, in the coming year, we will intensify our product development efforts with our own synDNA?, increase our efforts to secure government contracts for bio-defense applications, proceed with development of synDNA? production and maintain scientific research necessary to move the company forward. It promises to be an exciting time.
Again, best wishes for the year to come and thank you for your continued support.
Very truly yours,
Malcolm Skolnick
CYTOGENIX SHAREHOLDER UPDATE
January, 2006
Valued Shareholders:
We at CytoGenix send our best wishes to you for a healthy and prosperous New Year. This update marks six years that we have been working on the gene down regulation and expression technology that began with single stranded DNA expression vectors and has progressed to cell-free production of synthetic DNA. The level of activity has reached a point that it will be more efficient to provide the details of Company progress via our web site. We will include details of progress in product development, scientific research results including recently published papers, presentations and attendance at scientific meetings, patent filing activity and plans for Company expansion. Here are a few highlights that will preview items you can review in more detail as the web site is updated.
The Company continued efforts to commercialize the synthetic DNA production process and we are currently evaluating several synthetic DNA constructs as potential additions to developmental products in our pipeline.
The prototype of the synDNA? production module designed in conjunction with Alpha Laval Biokinetics was completed and tested on schedule. The tests were positive and provided valuable information about quality control measures and performance monitoring. As the Company prepares to initiate operation and validation of the module, we will also implement the next stage of planning for construction of the synDNA? processing facility.
Test results show that the synDNA? constructs for smallpox, HA (influenza) and hepatitis B were all effective in stimulating immune responses in animal tests (mice were tested for smallpox, HA and rabbits for hepatitis B). The synDNA? constructs were equally or more biologically active than the equivalent fermentation derived plasmids in these pilot studies. Additional tests of DNA vaccines for additional conditions are scheduled.
Negotiations are concluding with a supplier who makes the chemical constituents required for synDNA? production. The Company expects that it can achieve a long term relationship with terms that enable cost effective manufacture.
Using our screening techniques, we have identified additional bacterial gene targets to extend our anti-bacterial program. Over twenty-five oligonucleotide compounds have been investigated for silencing genes in Escherichia coli, Streptococcus pneumoniae, Streptococcus mutans (the principal cause of sepsis, pneumonia and tooth decay, respectively) and methicillin-resistant Staphylococcus aureus. Several lead compounds are now being tested in animals.
With the capacity to increase production of synDNA?, we will conduct enabling studies required by the FDA pursuant to filing an IND application for Simplivir? and resume testing of CytoGenix?s anti-inflammatory product, CY303. We will continue these developments using the new synDNA? constructs rather than conduct the studies with the fermentation derived plasmids which are much more expensive and less effective.
CytoGenix science and technology are both applicable to problems of increasing scope. An agreement has been executed to work with the Fast Trak Biodefense division of General Electric Healthcare to develop grant and contract proposals. The agreement with GE Healthcare is a model for additional partnerships for exploring the use of CYGX technology in bio-defense applications. The Company will accelerate its efforts to secure contracts with the Departments of Health and Human Services and Homeland Security to develop anti-virals and anti-bacterials. This will include expansion of our development of DNA vaccines to test constructs for avian influenza (H5N1) in both rodents and primates. The immunogenic constructs for smallpox, influenza and hepatitis B will be further tested with challenges to immunized animals. Acquisition of necessary data to comply with regulatory requirements to permit clinical evaluation of Simplivir? will proceed. Advances in the synDNA? production facility will enable increases in cell-free DNA for our own products and for our clients.
In summary, in the coming year, we will intensify our product development efforts with our own synDNA?, increase our efforts to secure government contracts for bio-defense applications, proceed with development of synDNA? production and maintain scientific research necessary to move the company forward. It promises to be an exciting time.
Again, best wishes for the year to come and thank you for your continued support.
Very truly yours,
Malcolm Skolnick
