CYGX
- Thread starter Captain Crunch
- Start date
CytoGenix Announces Results of Simplivir CY301 Herpes Cream Pre-Clinical Animal Study
Wednesday March 2, 9:50 am ET
HOUSTON--(BUSINESS WIRE)--March 2, 2005--CytoGenix Inc. (OTCBB:CYGX - News) announced today that a pre-clinical animal study has demonstrated that Simplivir(TM) (CY301) reduced the size of herpes lesions compared to placebo. In this study, Simplivir(TM) was applied to herpes infected skin of guinea pigs twice daily for three days.
The treatment with 0.1% Simplivir(TM) resulted in a reduction in the total lesion area when compared to placebo. A trend toward a reduction in the amount of herpes virus was observed as well. Simplivir(TM) activity in this pilot study is encouraging and additional studies to optimize the dose and timing of therapy will follow.
Herpes is a public health problem of major significance in the United States and worldwide. The Centers for Disease Control and Prevention has reported that 45 million people ages twelve and over test positive for the type of herpes most often affecting the genital area. Active lesions from herpes infections can have catastrophic effects on newborn children and are a major risk factor for the transmission of other diseases such as AIDS.
Dr. Malcolm Skolnick, CytoGenix president and CEO, commented, "This is the first in a series of in-life proof-of-principle data we expected based on our earlier observations in cell culture where Simplivir(TM) reduced viral titer load up to 500-fold. These data extend the validation of CytoGenix' proprietary delivery method for topical administration of plasmid DNA-based therapeutics."
CytoGenix Inc. is a Houston-based biopharmaceutical company that develops and markets innovative products and services based on its proprietary ssDNA expression technology. The company has developed a breakthrough synthetic process for large-scale production of high purity DNA at fraction of the cost of traditional fermentation methods. CytoGenix currently has one issued U.S. patent and over 48 international or U.S. pending patent applications claiming methods and materials in connection with this platform technology.
SAFE HARBOR: Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, risks associated with the acceptance of new products, competition, and other factors more fully detailed in the company's filings with the Securities and Exchange Commission. Additional information about CytoGenix and its technology can be found on the Web site at www.cytogenix.com.
--------------------------------------------------------------------------------
Wednesday March 2, 9:50 am ET
HOUSTON--(BUSINESS WIRE)--March 2, 2005--CytoGenix Inc. (OTCBB:CYGX - News) announced today that a pre-clinical animal study has demonstrated that Simplivir(TM) (CY301) reduced the size of herpes lesions compared to placebo. In this study, Simplivir(TM) was applied to herpes infected skin of guinea pigs twice daily for three days.
The treatment with 0.1% Simplivir(TM) resulted in a reduction in the total lesion area when compared to placebo. A trend toward a reduction in the amount of herpes virus was observed as well. Simplivir(TM) activity in this pilot study is encouraging and additional studies to optimize the dose and timing of therapy will follow.
Herpes is a public health problem of major significance in the United States and worldwide. The Centers for Disease Control and Prevention has reported that 45 million people ages twelve and over test positive for the type of herpes most often affecting the genital area. Active lesions from herpes infections can have catastrophic effects on newborn children and are a major risk factor for the transmission of other diseases such as AIDS.
Dr. Malcolm Skolnick, CytoGenix president and CEO, commented, "This is the first in a series of in-life proof-of-principle data we expected based on our earlier observations in cell culture where Simplivir(TM) reduced viral titer load up to 500-fold. These data extend the validation of CytoGenix' proprietary delivery method for topical administration of plasmid DNA-based therapeutics."
CytoGenix Inc. is a Houston-based biopharmaceutical company that develops and markets innovative products and services based on its proprietary ssDNA expression technology. The company has developed a breakthrough synthetic process for large-scale production of high purity DNA at fraction of the cost of traditional fermentation methods. CytoGenix currently has one issued U.S. patent and over 48 international or U.S. pending patent applications claiming methods and materials in connection with this platform technology.
SAFE HARBOR: Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, risks associated with the acceptance of new products, competition, and other factors more fully detailed in the company's filings with the Securities and Exchange Commission. Additional information about CytoGenix and its technology can be found on the Web site at www.cytogenix.com.
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Kind of a vague NR today. Most people on the IHUB board thought they were already past this point with the Herpes trials. Still think there is better news on the way. A couple of the posters who I feel are in the know didn't even respond to todays NR. Kind of strange, and maybe I'm reading to much into it, but their silence is a little odd.
Good Luck
Good Luck
TJ, haven't heard of anything from the company, but from what I have seen other people say on the IHUB board is that a lot of biotechs are not fairing very well these days. Its hard to figure what all shareholders are thinking. A person who worked for the company said that they expected some trial results by the middle of March, but what does everyone consider the "middle of March." Some of the resident whiners at IHUB figured it was March 15, and beings that day has come and gone, they are POed.
I still think something good is coming our way if I'm reading one the of posters over there right. I have had him pegged for a while and I think he knows what is going on. Remember, I have held shares in this company for over five years, so I'm not givin up on it. I know it sux trying to be patient with these things, but I feel good times are ahead for us.
Keep the faith and Good Luck
I still think something good is coming our way if I'm reading one the of posters over there right. I have had him pegged for a while and I think he knows what is going on. Remember, I have held shares in this company for over five years, so I'm not givin up on it. I know it sux trying to be patient with these things, but I feel good times are ahead for us.
Keep the faith and Good Luck
TJ, your in charge for a week. I am going skiing with my daughter in Beavercreek, so I will be out of the loop and won't be following things closely till I get back. Hopefully, while I am out there, they might release something that will give me reason to check into real estate oppurtunities in that area. :em71:
Captain:
Captain:
Did you have a nice trip?
Did you hear any good news regarding CYGX and DMOI lately? Momma needs new shoes....
Captain:
Did you have a nice trip?
Did you hear any good news regarding CYGX and DMOI lately? Momma needs new shoes....
Mags, had a great trip. If you are into snow skiing, I would highly recommend Beaver Creek. They told us at the ski rental shop that this was the busiest week they have EVER had out there, and I never waited more than five minutes in a lift line. The place is so spread out and they have so many lifts, we never waited at all. Not the cheapest place in the world, but for what you get, it was worth the extra coin. You ought to see the Ritz Carlton up there, incredible.
The IHUB board for CYGX has turned into a flame throwing affair. No good info to be found there right now. I still think some good news is on the horizon. How far out it is, I can't say, but as I told TJ a few weeks ago, I have been holding on for five plus years and I believe in the technology, so I'm not about to give up now.
I got an email from the group that gave me the DMOI tip while I was gone and they went over some of the stocks they had profiled in the past, and all they said about DMOI was "that all hell oughta break loose for this company in April." Take that FWIW, but it coincides with what one of the other posters said a few weeks back on the IHUB board. I don't think it will take much to get this one rolling based on what happened the last time they announced some news, and I can't help but think that the next batch of news will be better than the ones before.
I know it sux watching your money not really going the direction we all want it to, but these stocks are definetely more of a gamble than the blue chippers, but the rewards could be astounding if everything falls into place.
If I here of anything worth posting, I will do it as soon as I see it.
Good Luck
I've got a good April Fools prank I am going to pull on some of the aholes on the IHUB board. I will post the link when I do it. Didn't want to do it to this crew as you guys have been more than patient and civil. Hopefully things work out well so that civil part remains the same
and doens't turn into :cursin:
The IHUB board for CYGX has turned into a flame throwing affair. No good info to be found there right now. I still think some good news is on the horizon. How far out it is, I can't say, but as I told TJ a few weeks ago, I have been holding on for five plus years and I believe in the technology, so I'm not about to give up now.
I got an email from the group that gave me the DMOI tip while I was gone and they went over some of the stocks they had profiled in the past, and all they said about DMOI was "that all hell oughta break loose for this company in April." Take that FWIW, but it coincides with what one of the other posters said a few weeks back on the IHUB board. I don't think it will take much to get this one rolling based on what happened the last time they announced some news, and I can't help but think that the next batch of news will be better than the ones before.
I know it sux watching your money not really going the direction we all want it to, but these stocks are definetely more of a gamble than the blue chippers, but the rewards could be astounding if everything falls into place.
If I here of anything worth posting, I will do it as soon as I see it.
Good Luck
I've got a good April Fools prank I am going to pull on some of the aholes on the IHUB board. I will post the link when I do it. Didn't want to do it to this crew as you guys have been more than patient and civil. Hopefully things work out well so that civil part remains the same
and doens't turn into :cursin:
One of the posters who I "think" has an inside track on whats going on with CYGX, posted this on the IHUB board yesterday. I know that Baylor has been testing our technology and I heard the CEO in an interview say that our technology can be applied to "ANY" gene. Hope there is a connection for us.
March 30, 2005, 6:26AM
Institutions taking on genetics of cancer
M.D. Anderson and Baylor are preparing to collaborate
By TODD ACKERMAN
Copyright 2005 Houston Chronicle
Two of Houston's leading medical institutions are poised to participate in a massive new project cataloging the genetic abnormalities that cause cancer.
Officials from Baylor College of Medicine and the University of Texas M.D. Anderson Cancer Center said this week that they look forward to collaborating on the proposed Human Cancer Genome Project, a follow-up to the mapping of the human genetic blueprint.
The cancer project would seek to determine the DNA sequence of tumor samples in hopes of identifying mutations critical in the development of cancers.
"Baylor has the genome-sequencing infrastructure, and M.D. Anderson certainly has tumor samples," said Richard Gibbs, director of Baylor's gene-sequencing center. "This is the kind of project that can bring the two institutions together."
M.D. Anderson President Dr. John Mendelsohn agreed and said the plan would enhance genetic research that is proceeding "like a cottage industry rather than a megaproject." He said other Medical Center institutions likely will work on the project, too.
Baylor was one of a handful of centers that led the Human Genome Project, a recently completed 10-year effort to provide the operating instructions for the human body. M.D. Anderson was not involved, but it is considered the country's pre-eminent cancer facility, seeing more patients and conducting more research than any other institution.
The project hasn't been officially announced yet. The New York Times reported Monday that it's in the planning stages. The complete project ? sequencing each of the 50 major types of cancer ? would cost roughly $1.35 billion, the source of which has not yet been identified.
Gibbs, who has been involved in project planning sessions the past year, said he expects requests for applications to go out soon. He said two areas that Baylor will definitely target are breast cancer and childhood leukemia, two of the college's greatest research strengths.
Margaret Kripke, an M.D. Anderson executive vice president and chief academic officer, said her next step will be to talk with Gibbs to determine areas of compatibility. Besides the areas Gibbs listed, she said she thinks M.D. Anderson would like to target some more intractable cancers, such as lung and pancreatic cancer.
Scientists have already identified 100 to 200 genes involved in cancer, knowledge that has led to smart drugs that target cancer at the molecular level and thus don't harm healthy tissue.
One such drug, Gleevec, is considered a wonder drug because it's proven so successful treating a kind of leukemia.
The project's premise is that scientists will be able to pinpoint mutations responsible for cancer by comparing the order of the letters of the genetic code in tumor samples with one another, and with sequences in healthy tissue. Such a database, say proponents, would provide invaluable clues for developing new ways to diagnose, treat and prevent cancer.
But the proposition is daunting. Each tumor cell holds the full range of human DNA, a string of 3 billion letters of the genetic code. Determining the full sequence of all tumors, according to Dr. Francis Collins, director of the National Human Genome Research Institute, "would be the equivalent of 12,500 human genome projects."
In addition, Mendelsohn cautions that only about half of cancers are caused by genetic mutations. The other half are caused by "epigenetic changes," in which the attachment of a chemical to DNA turns off a gene.
Still, Collins said "the project is going to happen, audacious as it may sound," and Mendelsohn added he's "very excited" about it. M.D. Anderson maintains a database of tissue samples ? nearly 11,000 in a centralized repository plus many more in individual departments.
Baylor used to have 100,000 frozen breast-cancer tissue samples, but they were destroyed by flooding from Tropical Storm Allison. It has accumulated several thousand since then.
March 30, 2005, 6:26AM
Institutions taking on genetics of cancer
M.D. Anderson and Baylor are preparing to collaborate
By TODD ACKERMAN
Copyright 2005 Houston Chronicle
Two of Houston's leading medical institutions are poised to participate in a massive new project cataloging the genetic abnormalities that cause cancer.
Officials from Baylor College of Medicine and the University of Texas M.D. Anderson Cancer Center said this week that they look forward to collaborating on the proposed Human Cancer Genome Project, a follow-up to the mapping of the human genetic blueprint.
The cancer project would seek to determine the DNA sequence of tumor samples in hopes of identifying mutations critical in the development of cancers.
"Baylor has the genome-sequencing infrastructure, and M.D. Anderson certainly has tumor samples," said Richard Gibbs, director of Baylor's gene-sequencing center. "This is the kind of project that can bring the two institutions together."
M.D. Anderson President Dr. John Mendelsohn agreed and said the plan would enhance genetic research that is proceeding "like a cottage industry rather than a megaproject." He said other Medical Center institutions likely will work on the project, too.
Baylor was one of a handful of centers that led the Human Genome Project, a recently completed 10-year effort to provide the operating instructions for the human body. M.D. Anderson was not involved, but it is considered the country's pre-eminent cancer facility, seeing more patients and conducting more research than any other institution.
The project hasn't been officially announced yet. The New York Times reported Monday that it's in the planning stages. The complete project ? sequencing each of the 50 major types of cancer ? would cost roughly $1.35 billion, the source of which has not yet been identified.
Gibbs, who has been involved in project planning sessions the past year, said he expects requests for applications to go out soon. He said two areas that Baylor will definitely target are breast cancer and childhood leukemia, two of the college's greatest research strengths.
Margaret Kripke, an M.D. Anderson executive vice president and chief academic officer, said her next step will be to talk with Gibbs to determine areas of compatibility. Besides the areas Gibbs listed, she said she thinks M.D. Anderson would like to target some more intractable cancers, such as lung and pancreatic cancer.
Scientists have already identified 100 to 200 genes involved in cancer, knowledge that has led to smart drugs that target cancer at the molecular level and thus don't harm healthy tissue.
One such drug, Gleevec, is considered a wonder drug because it's proven so successful treating a kind of leukemia.
The project's premise is that scientists will be able to pinpoint mutations responsible for cancer by comparing the order of the letters of the genetic code in tumor samples with one another, and with sequences in healthy tissue. Such a database, say proponents, would provide invaluable clues for developing new ways to diagnose, treat and prevent cancer.
But the proposition is daunting. Each tumor cell holds the full range of human DNA, a string of 3 billion letters of the genetic code. Determining the full sequence of all tumors, according to Dr. Francis Collins, director of the National Human Genome Research Institute, "would be the equivalent of 12,500 human genome projects."
In addition, Mendelsohn cautions that only about half of cancers are caused by genetic mutations. The other half are caused by "epigenetic changes," in which the attachment of a chemical to DNA turns off a gene.
Still, Collins said "the project is going to happen, audacious as it may sound," and Mendelsohn added he's "very excited" about it. M.D. Anderson maintains a database of tissue samples ? nearly 11,000 in a centralized repository plus many more in individual departments.
Baylor used to have 100,000 frozen breast-cancer tissue samples, but they were destroyed by flooding from Tropical Storm Allison. It has accumulated several thousand since then.
Look what I did to the posters on the IHUB board. I didn't have the heart to do it to you guys. Can't wait to see some of the responses. I bet some of them don't even scroll all the way down to the bottom.
http://www.investorshub.com/boards/read_msg.asp?message_id=5923845
http://www.investorshub.com/boards/read_msg.asp?message_id=5923845
CAPTAIN,
YOU ARE BAD, YOU ARE VERY BAD!!!
YOU'RE MY KIND OF GUY!!!
THANKS FOR ALL YOUR INFO. GOOD NEWS YESTERDAY AND THE STOCK WENT UP. I SAW THAT DR. YEN CHIN MADE A BIG ACQUISITION AND I WOULD HAVE TO THINK ONLY GOOD CAN COME FROM IT. ALL WE NEED IS FOR THE FOOD AND DRUG TO APPROVE SOMETHING. HAPPY TO RIDE THIS ONE WITH YOU.
THANKS
MSM
YOU ARE BAD, YOU ARE VERY BAD!!!
YOU'RE MY KIND OF GUY!!!
THANKS FOR ALL YOUR INFO. GOOD NEWS YESTERDAY AND THE STOCK WENT UP. I SAW THAT DR. YEN CHIN MADE A BIG ACQUISITION AND I WOULD HAVE TO THINK ONLY GOOD CAN COME FROM IT. ALL WE NEED IS FOR THE FOOD AND DRUG TO APPROVE SOMETHING. HAPPY TO RIDE THIS ONE WITH YOU.
THANKS
MSM
MSM, can you provide a link to where you saw that Yin Chen made a big acquisitioin. I can't seem to find it anywhere. TIA
Glad you liked my April Fools joke. :mj07: I had a lot of fun making it up.
Glad you liked my April Fools joke. :mj07: I had a lot of fun making it up.
I CAN'T FIND IT. I THOUGHT IT WAS ON YAHOO FINANCE ON CYGX PAGE UNDER OWNERSHIP - INSIDER TRANSACTIONS. HOWEVER, I LOOKED AND THERE WAS NOTHING RECENT, AND I AM SURE I SAW HE HAD ACQUIRED 100,000 SHARES IN MARCH, BUT NOTHING SHOWS NOW. I HAVE LOOKED AT A COUPLE OF OTHER SITES I DO RESEARCH AND STILL FOUND NOTHING. I'M SURE I WASN'T DREAMING IT BUT I JUST CAN'T LOCATE IT. IF I FIND ANYTHING, I WILL LET YOU KNOW.
SORRY
MSM
SORRY
MSM
In case you missed it. Came out today.
CytoGenix First Quarter 2005 Update
4/14/2005 7:00:05 AM
HOUSTON, Apr 14, 2005 (BUSINESS WIRE) -- CytoGenix, Inc. (OTCBB:CYGX.OB)
Valued shareholders:
CytoGenix is poised for the achievement of significant milestones in the coming fiscal year. We are expanding the application of our highly innovative technology. With continued discoveries in research, aggressive protection of proprietary technology, success in product development, and anticipation of revenues from synthetic DNA sales, this year promises to be an exciting year for the shareholders of CytoGenix.
Analyst Reports
The following evaluations of the Company were performed by two independent firms. The Company commissioned these reports and provided data and response to the analyst's questions; however, the analyst's conclusions were independently constructed.
Bioscience Valuation (BSV GmbH) Report
Bioscience Valuation (BSV) is a management consulting firm located in Grainau, Germany specializing in the evaluation of pharmaceutical R&D projects, portfolios, and platform technologies. BSV uses advanced financial modeling based on thorough market and risk analysis to develop R&D strategies that reduce risk and enhance the value of your projects.
Bioscience Valuation's analysis indicates that CytoGenix is currently significantly undervalued and therefore represents a good opportunity for both existing and prospective shareholders. The forecast models project significant year-by-year growth with an estimated net present value of $1.5BN by 2008.
J.M. Dutton and Associates, LLC
Dutton & Associates is an investment research firm offering high-quality, independent, fundamental research on small cap public companies.
Their continuing year-long program of research coverage allows under-followed companies to gain a thorough, independent analysis of their competitive position along with independently developed earnings and valuation models. The Dutton report concludes that, at current levels, CytoGenix remains an unexploited, virtually undiscovered company with exciting new technology. Dutton rates CytoGenix as a Speculative Buy with a twelve month target price of $0.90 a share.
Product Development Update
CY301 (SIMPLIVIR(TM)) for topical herpes simplex infection
Since our pre Investigational New Drug (IND) meeting with Federal Drug Administration (FDA), we have identified several vendors capable of conducting the required work packages necessary to allow filing of an IND application. Work to be outsourced includes manufacturing of drug substance, formulation of drug product as well as conduct of preclinical safety and biodistribution studies. We expect these IND-enabling studies to be completed this year. The BSV report indicates that the herpes treatment market is $2-3BN annually and this remains a conservative estimate due to the underreporting of the condition.
CY403 for blood-borne Staphylococcus infection
Following on the success in laboratory and animal studies of CY401, a novel drug product, CY403 was added to the company's pipeline. CY403 targets a different gene than CY401 and will be developed for use in the treatment of the most serious unmet medical need in bacterial infectious disease, e.g., multi-drug resistant staphylococcus aureus infections. We have advanced this product from target identification to preclinical testing in less than three months and this efficiency is indicative of our ability to expedite the early drug discovery process. The Centers for Disease Control and the World Health Organization have identified multi-drug resistant bacterial infections as a serious emerging threat to the general public. CytoGenix antimicrobial products address this serious unmet medical need which the government accounting office (GAO) estimates the cost of antibiotic resistance is approximately $5BN annually.
CY303 for topical skin inflammation
The Company's product for topical inflammation, CY302, was renamed CY303 to conform to a standard nomenclature system recently implemented to maintain control of the expanding number of new products being developed by our Research group. CY303 will be tested in several established models in an academic setting to clarify the activity, potency and duration of action prior to the initiation of preclinical animal testing. The combined market for topical dermatologic products treating the target inflammatory conditions such as psoriasis, atopic dermatitis, bed sores and acne is in excess of $10BN annually.
synDNA(TM) process for cell-free DNA production
We are building a commercial scale manufacturing facility to produce mini-circle DNA for our future clinical development needs. Synthetic DNA offers several competitive advantages over the current practice of using bacterial fermentation to produce commercial quantities of clinical grade DNA. These advantages include reduced cost, higher purity, faster production cycle times.
An industry leading engineering firm has been engaged and is currently conducting the preliminary design feasibility study. We have evaluated multinational suppliers for the raw materials necessary for our process and we are currently negotiating pricing to assure a competitive cost of goods for our finished drug substance. We have begun laying the framework for a Quality Assurance plan that will provide the infrastructure to maintain compliance with current Good Manufacturing Procedures (cGMP) necessary for FDA certification. We expect to complete construction of a facility capable of supplying our internal need for DNA as well as selling the extra capacity the general market. The synDNA(TM) technology is particularly well suited for the production of DNA vaccines. Development of DNA vaccines is a major component of the Company's strategic plan.
Intellectual Property
In December of 2004, the Company submitted a new United States Patent Application for the method to produce therapeutic quality DNA. We are inceasing the range and scope of this application with further filings based on new developments and improvements made in the last quarter.
The Company continues to be aggressive in the protection of its proprietary technology capitalizing on the addition of second in-house intellectual property counsel.
Legal Issues
Waldroff/AVGI
(William B. Waldroff and Applied Veterinary Genomics, Inc. v. CytoGenix, Inc.)
CytoGenix filed a Declaratory Judgment action in March 2004 to obtain a finding of non-liability with respect to two license agreements, one for shrimp and one for horses, purportedly issued in 1998 to William B. Waldroff. Waldroff and Applied Veterinary Genomics, Inc. ("AVGI"), a party in interest as a sublicense of Waldroff's, counterclaimed for damages, attorney's fees, unrelated torts, and a permanent injunction to honor the purported licenses.
A jury trial was held in February 2005. Both Waldroff and AVGI also sued three Directors of CytoGenix for interfering with the licenses. The jury did not assess any damages against any of the Directors or against CytoGenix and dismissed Waldroff and AVGI's counterclaims. The court has preliminarily entered a judgment ordering CytoGenix to perform according to the licenses and for attorney's fees. CytoGenix is prepared to comply with the judge's order to provide product at cost plus twenty percent (20%).
CytoGenix First Quarter 2005 Update
4/14/2005 7:00:05 AM
HOUSTON, Apr 14, 2005 (BUSINESS WIRE) -- CytoGenix, Inc. (OTCBB:CYGX.OB)
Valued shareholders:
CytoGenix is poised for the achievement of significant milestones in the coming fiscal year. We are expanding the application of our highly innovative technology. With continued discoveries in research, aggressive protection of proprietary technology, success in product development, and anticipation of revenues from synthetic DNA sales, this year promises to be an exciting year for the shareholders of CytoGenix.
Analyst Reports
The following evaluations of the Company were performed by two independent firms. The Company commissioned these reports and provided data and response to the analyst's questions; however, the analyst's conclusions were independently constructed.
Bioscience Valuation (BSV GmbH) Report
Bioscience Valuation (BSV) is a management consulting firm located in Grainau, Germany specializing in the evaluation of pharmaceutical R&D projects, portfolios, and platform technologies. BSV uses advanced financial modeling based on thorough market and risk analysis to develop R&D strategies that reduce risk and enhance the value of your projects.
Bioscience Valuation's analysis indicates that CytoGenix is currently significantly undervalued and therefore represents a good opportunity for both existing and prospective shareholders. The forecast models project significant year-by-year growth with an estimated net present value of $1.5BN by 2008.
J.M. Dutton and Associates, LLC
Dutton & Associates is an investment research firm offering high-quality, independent, fundamental research on small cap public companies.
Their continuing year-long program of research coverage allows under-followed companies to gain a thorough, independent analysis of their competitive position along with independently developed earnings and valuation models. The Dutton report concludes that, at current levels, CytoGenix remains an unexploited, virtually undiscovered company with exciting new technology. Dutton rates CytoGenix as a Speculative Buy with a twelve month target price of $0.90 a share.
Product Development Update
CY301 (SIMPLIVIR(TM)) for topical herpes simplex infection
Since our pre Investigational New Drug (IND) meeting with Federal Drug Administration (FDA), we have identified several vendors capable of conducting the required work packages necessary to allow filing of an IND application. Work to be outsourced includes manufacturing of drug substance, formulation of drug product as well as conduct of preclinical safety and biodistribution studies. We expect these IND-enabling studies to be completed this year. The BSV report indicates that the herpes treatment market is $2-3BN annually and this remains a conservative estimate due to the underreporting of the condition.
CY403 for blood-borne Staphylococcus infection
Following on the success in laboratory and animal studies of CY401, a novel drug product, CY403 was added to the company's pipeline. CY403 targets a different gene than CY401 and will be developed for use in the treatment of the most serious unmet medical need in bacterial infectious disease, e.g., multi-drug resistant staphylococcus aureus infections. We have advanced this product from target identification to preclinical testing in less than three months and this efficiency is indicative of our ability to expedite the early drug discovery process. The Centers for Disease Control and the World Health Organization have identified multi-drug resistant bacterial infections as a serious emerging threat to the general public. CytoGenix antimicrobial products address this serious unmet medical need which the government accounting office (GAO) estimates the cost of antibiotic resistance is approximately $5BN annually.
CY303 for topical skin inflammation
The Company's product for topical inflammation, CY302, was renamed CY303 to conform to a standard nomenclature system recently implemented to maintain control of the expanding number of new products being developed by our Research group. CY303 will be tested in several established models in an academic setting to clarify the activity, potency and duration of action prior to the initiation of preclinical animal testing. The combined market for topical dermatologic products treating the target inflammatory conditions such as psoriasis, atopic dermatitis, bed sores and acne is in excess of $10BN annually.
synDNA(TM) process for cell-free DNA production
We are building a commercial scale manufacturing facility to produce mini-circle DNA for our future clinical development needs. Synthetic DNA offers several competitive advantages over the current practice of using bacterial fermentation to produce commercial quantities of clinical grade DNA. These advantages include reduced cost, higher purity, faster production cycle times.
An industry leading engineering firm has been engaged and is currently conducting the preliminary design feasibility study. We have evaluated multinational suppliers for the raw materials necessary for our process and we are currently negotiating pricing to assure a competitive cost of goods for our finished drug substance. We have begun laying the framework for a Quality Assurance plan that will provide the infrastructure to maintain compliance with current Good Manufacturing Procedures (cGMP) necessary for FDA certification. We expect to complete construction of a facility capable of supplying our internal need for DNA as well as selling the extra capacity the general market. The synDNA(TM) technology is particularly well suited for the production of DNA vaccines. Development of DNA vaccines is a major component of the Company's strategic plan.
Intellectual Property
In December of 2004, the Company submitted a new United States Patent Application for the method to produce therapeutic quality DNA. We are inceasing the range and scope of this application with further filings based on new developments and improvements made in the last quarter.
The Company continues to be aggressive in the protection of its proprietary technology capitalizing on the addition of second in-house intellectual property counsel.
Legal Issues
Waldroff/AVGI
(William B. Waldroff and Applied Veterinary Genomics, Inc. v. CytoGenix, Inc.)
CytoGenix filed a Declaratory Judgment action in March 2004 to obtain a finding of non-liability with respect to two license agreements, one for shrimp and one for horses, purportedly issued in 1998 to William B. Waldroff. Waldroff and Applied Veterinary Genomics, Inc. ("AVGI"), a party in interest as a sublicense of Waldroff's, counterclaimed for damages, attorney's fees, unrelated torts, and a permanent injunction to honor the purported licenses.
A jury trial was held in February 2005. Both Waldroff and AVGI also sued three Directors of CytoGenix for interfering with the licenses. The jury did not assess any damages against any of the Directors or against CytoGenix and dismissed Waldroff and AVGI's counterclaims. The court has preliminarily entered a judgment ordering CytoGenix to perform according to the licenses and for attorney's fees. CytoGenix is prepared to comply with the judge's order to provide product at cost plus twenty percent (20%).
Phanuel Pursuits
Phanuel Pursuits, Ltd., entered into an option agreement with the Company to obtain licenses to commercialize the Company's anti-herpes product in Peoples Republic of China and India. Phanuel withdrew from the China agreement. Phanuel owes unpaid option fees under the Indian option agreement including a specific payment required to purchase the Company's data needed for submission to the Indian regulatory authorities. Phanuel filed suit October 8, 2004 alleging that the Company had withheld the data and stopped work on herpes product development. Both charges are false. The Company believes the suit is without merit.
Very truly yours,
Malcolm Skolnick, Ph.D., J.D.
President & Chief Executive Officer
Phanuel Pursuits, Ltd., entered into an option agreement with the Company to obtain licenses to commercialize the Company's anti-herpes product in Peoples Republic of China and India. Phanuel withdrew from the China agreement. Phanuel owes unpaid option fees under the Indian option agreement including a specific payment required to purchase the Company's data needed for submission to the Indian regulatory authorities. Phanuel filed suit October 8, 2004 alleging that the Company had withheld the data and stopped work on herpes product development. Both charges are false. The Company believes the suit is without merit.
Very truly yours,
Malcolm Skolnick, Ph.D., J.D.
President & Chief Executive Officer
