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CytoGenix Inc. is a biopharmaceutical company headquartered in Houston, Texas that develops molecular gene therapeutic medicine products using a proprietary gene silencing (blocking) technology. CytoGenix is developing therapeutic products for herpes, psoriasis and inflammation. The Company also conducts pre clinical research in cancer and anti bacterial genes.
Drug target validation is a technology aimed at proving that DNA, RNA, or a protein molecule is directly involved in a disease process. Pharmaceutical industry experts agree that drug target validation is the most critical challenge facing large pharmaceutical companies. Given the vast number of potential drug targets that genomics has delivered, it has become crucial to pinpoint those targets that are most likely to be amenable to therapeutic intervention. Thus, target validation technologies are in strong demand. Drug target validation technology allows large pharmaceutical companies the opportunity to significantly reduce new drug discovery costs as well as reducing failure rates.
Technology & Market
CytoGenix has made great strides in developing a core DNA expression technology and using it to develop therapeutic products. The business model that CYGX adheres to is a two-pronged strategy - generating revenue by providing drug target validation services while forming product development partnerships with pharmaceutical and biotechnology companies.
Most diseases are the results of harmful proteins that are produced by genes that are faulty. Infectious agents, such as viruses, invade cells and take control of the DNA apparatus as a way of reproducing and damaging cells. Genetic predisposition or environmental factors can also trigger faulty DNA that can cause many disorders such as Cancer and Alzheimer's disease. Most pharmacological agents act by chemically signaling cells to interrupt or reduce production of the “bad” protein, or by binding to and adjusting the structure of a protein to ameliorate its activity. Traditionally, these agents were discovered by accident. Most drugs are systemic and usually cause side effects. Aside from vaccines, few of today's drugs are curative or preventative.
It is estimated that there are approximately 35,000 human genes, each coding for a different protein. These genes may suffer mutations leading to production of faulty or harmful proteins. Although the molecular nature of many diseases is not yet understood, thousands of researchers in academia, government and industry are working to identify and characterize disease related proteins and genes. Once these disease gene targets are identified, validated, and understood as to their function, then therapeutic agents can be designed to halt, reduce, or correct their disease causing action.
In its basic form, the protein generating mechanism of cells is a biochemical process that starts with the transcription of DNA instructions into messenger RNA (mRNA) followed by the translation of the mRNA into the building blocks of proteins. CytoGenix proprietary technology interrupts the translation of mRNA through a novel method of introducing specific DNA instructions that direct the cell's machinery to cancel translation of the mRNA of a specified gene into a protein. By harnessing the cell's natural internal DNA machinery to replicate the gene blocking instructions, this technology overcomes the limitation of other gene medicine approaches that require the introduction of large concentrations of DNA into the cells from external sources. This technology enables and enhances the performance of gene medicine methods such as antisense and triplex.It also has great promise as a platform for the recently discovered DNA enzyme method.This fundamental molecular control in cells has the potential to be widely applied for the development of therapeutic agents against certain cancers, autoimmune and infectious diseases.
CytoGenix is led by a highly experienced business and scientific management team. A 50% Ph.D. level staff along with outside experts in STD, dermatology, microbiology and gene therapy. Cytogenix is solid with well established proof of concept, published papers in scientific literature, one issued U.S. Patent, approximately 40 U.S. and foreign pending patent applications, and a new patent for anti bacterial filed in June, 2003. The company provides versatile technology that works on many disease targets. CYGX is currently working on a pipeline of three products and five indications addressing a $3 to $4 billion dollar market, including Herpes 1 & 2, Psoriasis, Shingles, and Contact dermatitis.
Recent Developments
On June 18, 2003 the company announced that pre clinical trials show CYGX's anti-genital herpes DNA formulation virtually eliminates the virus. The US Center for Disease Control has classified genital herpes as an epidemic, a serious health problem and reports that "Genital herpes simplex virus type two (HSV2) is one of the most common sexually transmitted diseases in the United States, with as many as one million people becoming infected each year." The data from recent laboratory studies show a 100-fold decrease in the viral load of cells treated with CYGX' DNA formulation as compared to untreated cells when challenged by HSV 2 virus. Industry estimates place the market for herpes Rx products in excess of $1.5 billion dollars.
In July 2003, the Company announced that it licensed the Anti-Herpes DNA formulation for manufacture and distribution in The Peoples Republic of China. Soon after, the licensee exercised a similar license for India.
In August 2003, the Company completed an agreement with BioZone Laboratories, Inc. to investigate the synergy of their technologies to develop new more effective skin delivery formulations. BioZone has developed a new technology to encapsulate a variety of drugs, proteins and peptides at a fraction of the cost of conventional methods.
Also in August, the official journal of the International Society for Cancer Gene Therapy, Cancer Gene Therapy, published the results of a study conducted by CytoGenix Vice President of Research and Development, Dr. Yin Chen along with independent outside collaborators. The study showed the inhibition of growth in lung, breast, and cervical cancer cells when treated with Company’s ssDNA expression system against target cancer related proteins.
Throughout September 2003, to the present CytoGenix has gained attention from the scientific and financial communities. The company is dedicated to creating human benefit and investor value by developing therapeutic agents that regulate genes to cure the root cause of disease rather than ameliorate symptoms. In addition to products in pre clinical development, CytoGenix supports a program of cancer research conducted in several medical research centers. Cytogenix owns patents for its core technology and has over 40 international or US pending patents.
Outlook
Upon successful completion of phase I/II of clinical trials, CYGX intends to seek distribution agreements with domestic and foreign pharmaceutical companies. These agreements will fund the remaining clinical trials and FDA marketing approval steps. A mathematical valuation model produced by Joachim M. Gruel in July 2002, The R&D value conundrum, allows for the following assumptions with respect to CYGX' anti herpes cream from Phase I through to NDA Registration.
Phase I:
Human safety tests performed on 20-80 healthy adults over 6 months with an approximate cost of $500,000.00. A success probability of 25%, (taken from averages of the experience of many pharmaceutical products.) 20 year net cash flow $2 billion dollars. Discounted present value $264,850,000.
Phase II:
Safety and efficacy trials performed on about 200 people over 12 months with an approximate cost of $1.5 million dollars. A success probability of 45%. 20 year net cash flow $2 billion dollars. Discounted present value $476,730,000.
Phase III:
Multi center clinical trials on about 2000 people over 24 months with an approximate cost of $4 million dollars. A success probability of 70%. 20 year net cash flow $2 billion dollars. Discounted present value $741,580,000.00.
Over the next 24 months CYGX intends to accomplish the following milestones:
• Complete pre clinical trials for Herpes, Contact Dermatitis, Psoriasis & Sepsis antibacterial
• Receive FDA approval for human trials for Herpes, Contact Dermatitis & Psoriasis
• Conduct safety and efficacy (phase I and II) trials for Herpes, Contact Dermatitis & Psoriasis
• Develop sepsis antibacterial
• Develop systemic delivery system
• Develop antiseptic agents not susceptible to bacterial resistance.
Conclusion
CytoGenix’ Genetic Therapy promises dramatic change from treating symptoms to eliminating the disease. CytoGenix is positioned to service market share created by the growing demand for drug target validation through delivery of validation services. The company expects to generate revenue that can offset the cost of developing its own line of proprietary therapeutic products.
CytoGenix has a patented core technology exploiting the manipulation of RNA to produce gene-based therapeutics based on gene-silencing, RNA interference, and other gene modification applications. The company is a newcomer on the academic research scene, with its first patent issuing in 2000. The story is largely unknown among investors. However, our scan of patent applications in this area clearly indicates the cusp of a tidal wave of research and development activity in a variety of RNA directed therapeutic strategies. While CytoGenix is young technically, and currently has limited financial resources, its core technology has been developed to the point where commercial target validation tools are available and pre-clinical toxicology and studies can proceed.
CytoGenix’ technology provides a unique alternative to the current "state-of-the-art" and standard practice of vector gene therapies, since it presents a valid means by which to circumvent or ameliorate many existing issues. Though highly speculative due to the limited financial resources at hand, we view the company as a promising member of third-generation genomics therapy companies.
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