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Wow
The capital costs for physical plant and on-going fixed and variable operating expenses are projected to be considerably less than the costs of large-scale bioprocess methods. We believe that DNA produced using our cell-free method will be more consistent, of higher purity, with improved stability and will enable delivery of higher concentrations of the active pharmaceutical ingredient, if necessary
Very Very Nice
Cell-free amplification of C-DNA has many important benefits beginning with the size and composition of the plasmid. Under this system, there is no need for bacterial replication genes or selection markers such as antibiotic resistant genes. In most cases, this will reduce the size and weight of the therapeutic C-DNA by at least 3,000 base pairs or a molecular weight of approximately 2,000 kilo Daltons. The total absence of bacteria and growth media assures that there is no need to employ mechanical or chemical purification methods to extract cell or animal proteins, RNA, genomic DNA and backbone molecules. This feature allows the designer more control of coding for non-specific and specific immune responses.
Very Nice
The entire process is bench-scale and requires minimal equipment, space or human intervention in comparison to bioprocess manufacturing facilities. The requirement for numerous cell banks is drastically reduced and no yield optimization steps that can add weeks or months to the production process are required. This process lends itself to liquid-handling automation and one technician can synthesize gram quantities in a fraction of the time required for fermentation working in compact room-sized facilitie
nice.
Our experiments have shown that the biological response to C-DNAs with no vector backbone is higher than using traditional plasmids. Other investigators have reported greater activity levels of in vivo studies using"DNA mini circles'. In terms of cost, this would translate in substantial savings since less DNA would be required for an equivalent effect
Everyone go to Cytogenix web site click on What's New ,Its new.
http://cytogenix.com/index.html
It is our goal to make nucleic acid-based drug substance produced using this cell-free method suitable for use in humans for the purpose of testing under the auspices of the Food and Drug Administration. We intend to implement standard operating procedures and maintain compliance with current good manufacturing practice (cGMP) to allow the production of clinical grade material. Benefits provided by the cell-free synthesis from a regulatory agency review and compliance perspective are significant. By beginning with a well-characterized master construct, there is minimal need for cell bank systems (master or working cell banks), thus reducing the risk and amount of documentation, space and cost. Furthermore, methods for cell collection, processing and culture conditions would no longer be necessary and would substantially reduce QA/QC and compliance overhead costs associated with these activities.
Sanoman you are correct.
skooby, I hear 2 bugs now I guess we are about to rock.The fruit must be sweet if the fly is buzzing .LOL
Tatonkano62 I hear a nervous fly buzzing around today that usually means that things are about to explode up and the fly whats to buy .The news on insider buying is very good and means that we are on track.
My take on DNA vaccines is that it was not cost effective in the past ,It worked great, but with the 250,000 dollar a gram price tag no one could afford the injections .Now along comes Cytogenix with a revolutionary technology , DNA now can be made ,costing pennies on the dollar, and it even works better due to its small strands .It last forever in the body, and very tough even in a storage condition, you can vaccinate against many disease at a time with one injection ,read as much as 18 different disease ,I think in the near future when all this really sinks into our brains we will collectively kick ourselves for not buy more CYGX.
I wonder if any of this money will be used for cytogenix research .
Houston Business Journal - 2:56 PM CDT Monday
Baylor College of Medicine awarded $7.2M grant
The National Cancer Institute has awarded a new five-year, $7.2 million grant to a nationwide program coordinated by Baylor College of Medicine to reduce the number of cancer deaths in minority and impoverished populations.
http://www.bizjournals.com/houston/stories/2005/05/16/daily8.html
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Redes En Acción: The National Latino Cancer Research Network is the most extensive collaboration of organizations ever assembled to address cancer disparities in Latino populations, according to Baylor. This is the second five-year grant awarded to the program.
It is coordinated within the Chronic Disease Prevention and Control Research Center in the BCM Department of Medicine, and directed by Dr. Amelie G. Ramirez, professor of medicine. Ramirez is director of the Baylor Cancer Center Office of Outreach and Health Disparities Research and deputy director of the research center.
The new $95 million NCI initiative, called the Community Networks Program, is aimed at reducing cancer deaths among minority and underserved populations through community-based cancer prevention and control activities in geographically and culturally diverse areas of the country. Redes En Acción (Networks in Action) is one of up to 25 projects to be funded by the networks program initiative targeting cancer disparities in Hispanics/Latinos, African Americans, American Indians and Alaska Natives, Asians, Hawaiian Natives and other Pacific Islanders, and the rural poor.
Of the network programs funded, Redes En Acción is one of only six with a nationwide focus. Other funded programs will have either a local or regional scope of activities.
Redes En Acción regional activities will be coordinated by five program co-principal investigators: Dr. Eliseo J. Perez-Stable, of the University of California, San Francisco; Dr. Gregory A. Talavera, San Diego State University; Dr. Maria E. Fernandez, The University of Texas-Houston Health Science Center, School of Public Health; Dr. J. Emilio Carrillo, The Brooklyn Hospital Center; and Dr. Frank J. Penedo, University of Miami.
holycow I did not know this about DNA vaccines ,WOW.
They are extremely stable. Unlike many conventional vaccines that must be held at a constant temperature, DNA vaccines can be stored under a vast array of conditions either dried or in a solution. This eliminates the need for the "cold chain" -- the series of refrigerators required to maintain a vaccine during distribution. This will greatly improve the ability to deliver vaccines to remote areas in developing countries
It went through at .69 cents 3000 shares ,very happy.
I am putting in a buy order in for 3000 shares at .70 I hope it fills.
Tatonkano62 correct me if I am wrong but vaccines don't have to go through FDA processes like cures do ,If that was the case the latest flew vaccines would take years to be approved ,and half the population would be infected by then .So if we can get into the vaccine business and the DNA selling business we all should be golden.
neo43 Malcolm is looking for investors with a strong Bio background that will hold, with intelligence ,not day trading people looking for a quick dollar .This is a good way of weeding out the day traders ,Cytogenix will eventually get the spot light put on them, in the mean time, buy.
We all knew 7 days ago about this vaccine program ,but I didn't know of the accelerated program.
Posted by: Paulness
In reply to: Paulness who wrote msg# 18548 Date:5/10/2005 10:28:18 PM
Post #of 18679
Cytogenix has a program for making DNA vaccines ,they are working on smallpox and the flu and several other diseases .This is new to me and very exciting.
Also like this.
DNA vaccination provides long-lived immune responses, unlike many component vaccines that require multiple innoculations to maintain immunity
BigB I like this part.
The DNA can be administered either in a saline solution injected through a hypodermic needle or on DNA-coated gold beads propelled into the body using gene guns.
Its like the gun used in Star Trek Bones the Doctor would use it all the time .LOL
Tatonkano62 this I don't like.
We understand that both the FDA and the NIH are considering rules and
regulations that would require public disclosure of commercial development data
that are presently confidential. This potential disclosure of commercial
confidential information, if implemented, may result in loss of competitive
secrets, which could be commercially detrimental
But we have Dr. Cindee Ewell,Ph.D., JD, to help cytogenix in this area.
Cindee Ewell, Ph.D., JD, Intellectual Property Advisor
-------------------------------------------------------
Dr. Ewell brings a combination of scientific and intellectual property
experience that is critical to securing and maintaining the legal protection of
the technology as it develops in the laboratory at CytoGenix. Dr. Ewell holds a
Bachelor of Science degree from Cornell University, a Doctor of Philosophy
degree from the University of Texas Health Science Center at Houston, and a
Juris Doctorate from South Texas College of Law. Prior to graduate school, Dr.
Ewell worked as a researcher in the biotechnology industry as a molecular
biologist where she worked on vaccine development. After she acquired her Ph.D.
where her thesis focused on the genetic regulation of bacterial membrane
synthesis, Dr. Ewell worked as a post-doctoral fellow in the Department of Cell
Biology at Baylor College of Medicine. Her post-doctoral research included
investigating the genetic regulation of aging related processes as well as the
endocrine regulation of gene expression in both reproductive processes and
Alzheimer's Disease. She has worked with various systems including bacteria,
fruit flies, mice, rats, human tissue and mammalian cell culture. Her legal
expertise includes three years of consulting as a technical advisor with two law
firms in the downtown Houston area prior to and during attendance at South Texas
to acquire her law degree. Dr. Ewell has recently joined the staff at CytoGenix
as an intellectual property advisor.
holycow and this I like also.
Synthetic DNA Process
Scientists at CytoGenix have developed a novel method for producing large
amounts of high quality therapeutic circular DNA with significant reductions in
residual contaminants compared to traditional fermentation methods.
Specifically, we have identified and optimized a method for in vitro DNA
synthesis and amplification for the production of good manufacturing practices
(GMP) drug substances.
Cell-free amplification of c-DNA has many important benefits beginning with the
size and composition of the plasmid. Under this system, there is no need for
bacterial replication genes or selection markers such as antibiotic resistant
genes. In most cases, this will reduce the size and weight of the therapeutic
c-DNA by at least 3,000 base pairs or a molecular weight of approximately 2,000
kilo Daltons. The total absence of bacteria and growth media assures that there
is no need to employ mechanical or chemical purification methods to extract cell
or animal proteins, RNA, genomic DNA and backbone molecules. This feature allows
the designer more control of coding for non-specific and specific immune
responses
Like this part
Manufacture milligram quantities consistently, conduct
several animal studies with various plasmids to verify
bioactivity equal to or greater than plasmids produced via
traditional methods. Scale-up to produce gram quantities
Remember.
Sophisticated and expensive purification methods are necessary to remove these toxins, driving the cost of FDA-approved DNA to as much as $250,000 a gram or $250,000,000 a kilogram.
holycow I like this part.
Greater biological activity
Our experiments have shown that the biological response to c-DNAs with no vector
backbone is approximately one and one-half times higher than traditional
plasmids. Other investigators have reported greater activity levels of in vivo
studies using "DNA mini circles". At the molecular level, 100nano grams of
traditional plasmid DNA is equal to 60ng of bacteria-free c-DNA. This may
explain the result of our transfection experiments and suggest that less in
vitro synthesized DNA may be required to generate the same biological effect as
its plasmid counterpart. In terms of cost, this would translate in substantial
savings.
Low risk, low cost and fast cycle time
Our novel process is bench-scale and requires little equipment, space or human
intervention in comparison to bioprocess manufacturing facilities. No cell banks
are needed and no yield optimization steps that can add weeks or months to the
production process. This process lends itself to liquid-handling automation and
one technician can synthesize gram quantities in a matter of days working in
custom manufacturing suites. The capital costs for physical plant and on-going
fixed and variable operating expenses are a fraction of the costs of large-scale
bioprocess methods. We believe that this synthetic process will be more
consistent, yield material of higher purity, and will enable delivery of higher
concentrations of Active Pharmaceutical Ingredient (API) if needed.
Improved regulatory profile
Benefits provided by the cell-free synthesis from a regulatory agency review and
compliance perspective are significant. By beginning with a well-characterized
synthetic master construct, there is no need for cell bank systems (master or
working cell banks), thus reducing the risk and amount of documentation, space
and cost. Similarly, product cGMP manufacturing procedures detailing methods for
cell collection, processing and culture conditions would no longer be necessary
and would substantially reduce quality assurance and quality control ( QA/QC)
and compliance overhead costs.
Cytogenix is carrying out a multi-pronged strategy with the objective of
commercializing this technology within the next year. The following summarizes
our plans:
o Process optimization and scale-up, continued experimentation to
achieve yield optimization, reduced reagent usage and reduced
costs. Manufacture milligram quantities consistently, conduct
several animal studies with various plasmids to verify
bioactivity equal to or greater than plasmids produced via
traditional methods. Scale-up to produce gram quantities.
o Develop reagent suppliers and sourcing, establish relationships
with manufacturers of enzymes. Develop quality parameters.
o Construct cGMP production suite, build and equip a side-by-side
manufacturing suite for simultaneous production of batches cGMP
pDNA.
o Business development, we are currently evaluating options for
industry partnership for continued development of the process
including contract manufacturing
Level 2 today, out of the 35,600 shares traded today 28,600 were buys at 59cents 7000 were sells at 58 cents the pressure is building like a volcano any good news and we will explode up big time ,good night to all.
You didn't listen ? Look ,it's easy, just go to the site, touch the triangle in the circle, sit back and enjoy ,it's about 10 minutes, Malcolm is great .
http://www.audiostocks.com/company.php?id=137
percywhit's did you listen to Malcolm new interview it's exciting they are working on a new DNA vaccine program .
http://www.audiostocks.com/company.php?id=137
Skoobyfl1 you are right on ,now did you listen to the new interview ? what do you think? I am excited about the new DNA vaccine program.
http://www.audiostocks.com/company.php?id=137
Chadman FDA-approved DNA is as much as $250,000 a gram or $250,000,000 a kilogram ,........... So if Cytogenix has a half price sale $125,000 a gram or $125,000,000 a kilogram we will be in the doe.
holycow thanks for your thoughts ,it does look like we are on the right track.The vaccine thing is still good news.
Sanoman or anybody ,did anyone listen to the new Malcolm interview ,there is new information for example, [Cytogenix has a program for making DNA vaccines ,they are working on smallpox and the flu and several other diseases.This is new to me and very exciting.]A DNA vaccine that will stop the flu !
skoobyfl1 did you listen to Malcolm's interview what do you think ?
http://www.audiostocks.com/company.php?id=137
Malcolm said while waiting for the big DNA production lab, Cytogenix will be producing synthetic DNA in smaller amounts for their own experiments and to send out to others for trial ,this is not word for word .About 12 to 15 months to build the plant.
Cytogenix has a program for making DNA vaccines ,they are working on smallpox and the flu and several other diseases.This is new to me and very exciting.
Looks like the building that Cytogenix is in now will be used for the DNA production site .Cytogenix just may end up renting more space in its own building.
Interview is working ,everyone .
http://www.audiostocks.com/company.php?id=137
thaliowizard this coming from the biggest nose on the board .LOL I can't stop laughing.
One last comment we were talking about all the sites within Audio stocks and how all were not working not just CYGX audio but all the audio on each site within Audio stocks site ,I am glad your confusion as cleared up .With your explanation I see your nose has shrunken to normal size. LOL
We all know what you were trying to pull with your last post ,and now your trying to pull your ass out of the fire by saying ABC news etc is working ,We are talking about Audio Stocks site only and you know that ,we caught you ,and you know it .
thaliowizard you and hogger must have the same nose problem
[she said that they have not paid their fee yet] LOL
hogger no other sites are working ,your nose must be getting longer every day .LOL
CD 98 ok ,did you ever get the CYGX interview to work?