Some new information
Therapeutic Gene Blocking Topical Applications
CytoGenix has developed antisense and DNA enzymatic systems to down regulate or “turn off” proteins involved in Herpes, Inflammatory processes such as psoriasis and Alopecia (pattern baldness). The Company has combined these DNA systems into creams and lotions for topical application. Animal toxicology tests have shown no negative effects.
The Company believes that the Anti-inflammatory formulation could provide relief to outbreaks of shingles lesions and inflammation due to Psoriasis.
Pre-clinical (animal) studies
The company will begin conducting animal studies at a major cancer center and an academic medical center in collaboration with senior scientists in anticipation of an Investigational New Drug (IND) application to the FDA and subsequent human trials for at least two of these topical preparations. These animal and laboratory studies are designed to demonstrate biological activity and safety of a DNA topical cream and lotion for herpes and contact dermatitis.
The Company intends to engage a firm of FDA consultants as well as a contract research organization (CRO) at the appropriate stages of clinical trials. The following is a projected timeline for regulatory submission activities for two or possibly three indications for transdermal delivery.
Depending on the success of Phase I studies, the Company intends to begin animal studies on DNA topicals against melanoma or HPV the virus that causes most cervical cancers.
Toxicity
The Company believes that unlike synthetic chemicals, these DNA topical lotions and creams will have very low toxicity and side effects because:
They are applied only to the infected site and not systemically throughout the body.
The “active” ingredient is natural DNA created by the cells, not a synthetic chemical.
The carrier cream has been used widely for many years in animal and human health topical applications and is very safe and non-toxic.
Dosage levels are very low (see No. 2 above).
The Company will strive to demonstrate to regulatory agencies that DNA transdermal delivery in small dosages is highly specific, effective and non-toxic.
INSTITUTIONAL OWNERSHIP/ANALYST COVERAGE
Institutional Investors:
• CSI Capital Management, Inc.
• Patten & Patten, Inc.
Analyst Coverage:
J.M. Dutton & Associates
• Sherry Grisewood , CFA
