The development of synDNA™ has enabled expansion of near and long term commercial growth opportunities for CytoGenix. The near term focus of product development at CytoGenix has been appropriately adjusted to devote resources to accelerate the development of several DNA vaccine candidates. We have completed studies in animal models that demonstrated the immunogenic effectiveness and protective abilities of synDNA™ based vaccines. Therefore, a near-term objective of the Company is to advance a DNA vaccine product candidate as quickly as possible with the goal of filing an Investigational New Drug (IND) application with FDA.
We have also re-focused the development of the Company's anti-herpes product, SIMPLIVIR(tm), to use an active ingredient based on synDNA™. While this decision has delayed the filing of the IND for SIMPLIVIR(tm) (and will also delay an IND for CY403, the current lead product candidate in the Antibacterial Program), we think it is in the overall best interest of the Company and will help in both near-term and long-term. By utilizing synDNA™ drug substance we reduce our reliance on costly third party producers of plasmid DNA. Furthermore, as we move products based on synDNA™ through the regulatory approval process, we gain invaluable information to support the marketing of synDNA™ manufacturing for prospective customers.
DNA Vaccines
The Company has tested DNA vaccines against hepatitis B virus, smallpox, HIV, seasonal flu, bird flu (Vietnam strain) in mice, rabbits and non-human primates. These tests have demonstrated the synDNA™ based vaccines are as effective as or more effective than plasmid based DNA vaccines. Tests challenging groups of vaccinated and unvaccinated animals with lethal doses of bird flu virus showed the CytoGenix vaccine protected the vaccinated animals. The Company has entered into cooperative research and developments (CRADA) with the United States Department of Agriculture (USDA) to develop a DNA vaccine against brucellosis and with the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) to develop DNA vaccines against ebola and equine encephalitis viruses.
The common factors in developing synDNA™ based vaccines provide efficient use of resources and enable production of multiple constructs for testing. This is especially advantageous to the Company's plans to address needs stemming from bio-terror and pandemic threats. Choices for disease targets which vaccine to produce are determined by ultimate markets and requirements by strategic partners.
CY301 (SIMPLIVIR(tm)) Anti-viral compound against herpes simplex (HSV), Pre-IND phase
The CDC reports that genital herpes (HSV-2) infection has reached epidemic levels, infecting one million people in the US each year. "Results of a nationally representative study show that genital herpes infection is common in the United States. Nationwide, at least 45 million people ages 12 and older, or one out of five adolescents and adults, have had a genital HSV infection. Between the late 1970s and the early 1990s, the number of Americans with genital herpes infection increased 30 percent. HSV-2 infection is more common in women (approximately one out of four women) than in men (almost one out of five)."
CytoGenix scientists have discovered sequences against genes in Herpes Simplex 1 and 2, that are necessary for viral reproduction or which protect the virus from a host's immune system. CytoGenix has developed a topical cream containing the company's proprietary expression vector technology with sequences against these HSV genes. The topical cream will deliver the DNA expression vector to virus infected epithelial cells where the vector will generate ODN's that will cancel the virus' reproductive capability and strip its ability to migrate to nerve cells.
In vitro (cell) studies have shown a hundred-fold decrease in the viral load following treatment with CY301. While continuing the efficacy test of CY301 in animal model including cotton rats, we will begin absorption, distribution, metabolism, and excretion (ADME) as well as stability testing shortly. Pre-IND discussions with FDA experts in the Division of Cellular and Gene Therapies within CBER [http://www.fda.gov/cber/index.html] have helped to clarify the additional pre-clinical requirements to facilitate filing of an Investigational New Drug (IND) application. When the additional supporting studies following FDA recommendations and using SIMPLIVIR(tm) based on synDNA™ are complete, the Company will file an IND to allow for clinical evaluation of the product. The Company intends to continue to expand its pipeline with the addition of research compounds against other Herpes genes.
Sepsis is a systemic inflammatory response to an infection in the circulatory system, which, if untreated, can lead to organ failure, hypo-perfusion, hypotension and death. The CDC reports that the incidence of sepsis has increased approximately 8.7% annually from 164,000 cases (83 per 100,000 people) in 1979 to 660,000 cases (240 cases per 100,000 people) in 2000. Sepsis is the 11th leading cause of death (9.3% of all deaths) in the United States. For more information please consult the CDC website.
The most common form of sepsis is bacterial sepsis caused by infection by E. coli, S. aureus (staph) or Streptococcus (strep). Sepsis occurs in most individuals from trauma or major surgery, and there is currently a major unmet medical need for treatments that are effective against multi-drug resistant pathogens which account for an increasing percentage of septic patients. Immune compromised individuals (AIDS, transplant recipients, elderly) are more susceptible to infection and thus to sepsis. CytoGenix scientists have used a proprietary genomic screening tool to identify bacterial genes that are critical to bacterial reproduction. ODN sequences to silence these genes have been developed.
Proof-of-concept studies in cells and in animal models of sepsis demonstrate the promising effectiveness of this compound. In mice studies, all the mice infected with E. coli sepsis survived when treated with the anti-bacterial sequences; the untreated groups died. Additional animal testing using clinical isolates of the most resistant strains of staph have shown that a CytoGenix anti-bacterial compound provided protection against infection with this pathogen. Additional pre-clinical studies are being designed and initiated in preparation for a FDA Pre-IND submission.
Inflammatory Disorders
Excessive or otherwise inappropriate inflammation is thought to be causative in many human disorders and conditions. Examples include the formation of atherosclerotic plaque that leads to heart attacks or stroke and rheumatoid arthritis. The biochemical process or "cascade" of inflammation is varied and very complex. Scientists have found common proteins and expression of certain genes in many of these inflammatory reactions. The Company has applied its technology to silence a powerful inflammation-causing gene and, has applied this sequence to a topical formulation against several inflammatory skin conditions.
CY303 Psoriasis Topical Therapeutic
The National Institutes of Health report, "Psoriasis is a chronic (long-lasting) skin disease of scaling and inflammation that affects 2 to 2.6 percent of the United States population, or between 5.8 and 7.5 million people. Although the disease occurs in all age groups, it primarily affects adults. It appears about equally in males and females. Psoriasis occurs when skin cells quickly rise from their origin below the surface of the skin and pile up on the surface before they have a chance to mature." -- http://www.niams.nih.gov/hi/topics/psoriasis/psoriasis.htm Psoriasis is an immune system disorder that triggers an inflammatory response. CytoGenix scientists are developing a topical cream containing the company's proprietary ssDNA expression system engineered to express a sequence that silences a human gene associated with critical early steps in most types of tissue inflammation and several other potential uses for this treatment include dermatitis (contact and atopic), decubitus, acne (juvenile and rosacea).
Cancer Research
For several years, the company has support the work of cancer researchers in various academic institutions. These investigators have used the company's ssDNA expression vector technology to knockdown cancer genes. Outside researchers in collaboration with the Company have used CytoGenix expression vector technology to inhibit or prevent xenografted melanoma tumors in mice.
synDNA™
In addition to use of synDNA™ in CytoGenix's products, we have begun marketing it to other companies. Our present capabilities are production of research grade material. We have identified outside sources that can produce "certified good manufacturing practice" (cGMP) material. This is the standard for clinical grade material. The Company is developing relationships with these sources to utilize their facilities if the need for cGMP material is required before our own production facility is completed and certified.
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