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September 9, 2002
SUMMMARY
I am pleased to report that over the past six months your company has continued development in a number of important areas. Highlights include:
These are described in more detail in the following.
Personnel
Frank Vazquez has accepted the position of Executive Vice President and Chief Operations Officer. Reporting to me, Mr. Vazquez is responsible for the day-to-day operations of the business, with emphasis on the coordination of our scientific and commercial activities. Mr. Vazquez has 38 years of executive, marketing and operations management and entrepreneurial experience in Biotechnology, Pharmaceutical, Computer Software and Telecommunications companies. He was founding President/CEO and Vice Chairman of Lark Technologies, Inc. and founding President/CEO of Medical Metrics, Inc. He is highly experienced in establishing and developing biotechnology and medical products start-up companies. He has held the positions of Vice President Marketing and Sales, Trinity Computing Systems, Inc., Vice President, Operations and Logistics, CooperVision (PR), Inc., Senior Consultant with the firm of Booz Allen and Hamilton, and line management positions with ITT Corporation and IBM Corporation. He holds a B.S. in Economics, from Columbia University and has attended advanced management programs at Stanford University and the University of Chicago. Mr. Vazquez will remain on the Board of Directors until a replacement acceptable to the Board can be identified, invited to join, and accepts.
The Company has made an offer to a candidate for the position of Senior Scientist. This position will work with and report to Dr. Yin Chen, VP for Research.
RESEARCH AND DEVELOPMENT
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 herpesandcontact dermatitis.
The Company has engaged a firm of FDA consultants and intends to engage 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.
| 3rd Q 2002 | 4th Q 2002 | 1st Q 2003 | 2nd Q 2003 | 3rd Q 2003 | 1st Q 2003 | 2nd Q 2004 |
Pre-IND Lab and animal studies. | Complete pre-IND studies for herpes anti-viral. | Submit IND for herpes indication. | Begin Phase I clinical trials. Begin animal studies on 3rd indication perhaps Melanoma or contact dermatitis. | Phase I Complete animal and lab studies on 3rd indication | Phase I Submit IND for 3rd indication. | Begin Phase II clinical trials on herpes anti viral. Phase I clinical trials for 3rd indication. |
Target Validation
Starting in July, the Company initiated marketing a drug target validation service using our technology to down-regulate customer¹s gene of interest to help them identify potential drug targets. We have initiated an advertising campaign in two drug discovery periodicals. The Company is currently conducting a pilot study for a potential customer.
Support of Outside Research
The Company continues supporting three (3) Sponsored Research Agreements (SRA):
Research Publications and Meeting Presentations.
Dr. Yin Chen was invited to write a review of the meeting highlights for the 10th International Conference on Gene Therapy of Cancer held last year in San Diego. The article has been published by the Expert Opinion on Biological Therapy (vol. 4:443-445, 2002).
On June 5, 2002, Dr. Yin Chen presented scientific results on the application of the company's proprietary single-stranded DNA (ssDNA) _expression technology in human lung cancer cells at the 5th Annual Meeting of the American Society of Gene Therapy in Boston, Massachusetts. The title of Dr. Chen's poster presentation is titled "Intracellular Production of DNA Enzymes by a Novel Single-Stranded DNA _Expression Vector.²
A review article entitled ³A Novel Single-Stranded DNA (ssDNA) _Expression Vector² has been accepted for publication by the Expert Opinion on Biological Therapy
A scientific paper entitled ³A Novel System for the _Expression of Single-Stranded DNA in Mammalian Cells² has been submitted to Biotechniques and is currently under revision.
An abstract entitled ³Application of a Novel Single-Stranded DNA _Expression Vector for Gene Regulation² has been submitted to the Eleventh International Conference on Gene Therapy of Cancer.
New SBIR or STTR grant submissions are being prepared in cooperation with several of the researchers now conducting sponsored research.
Cooperative Research
Investigators who have requested use of and have purchased expression system kits to express sequences of interest and control sequences include:
New Research Initiatives
The Company has developed an experimental track to develop an antisense, anti-bacterial agent. This approach will utilize a prokaryotic form of the _expression system to generate cytotoxicity or prevent toxin formation in such organisms as Ecoli, Staphylococcus, Streptococcus, etc.
Toxicology studies have been completed testing the reaction in animals to topical preparations formulated to antisense harmful proteins arising in dermatological conditions. Negotiations are being conducted with several companies interested in licensing and commercializing these formulations.
The Company is conducting negotiations with a number of other firms that have complementary technology or specific oligonucleotide sequences they wish to test. The general approach involves developing agreement on the experimental protocols to be followed and incorporating these in a cooperative research agreement.
Intellectual Property
The Company has a United States patent on its basic two plasmid _expression system and both United States and PCT patents pending on the two plasmid, single plasmid, and enzymatic synthesis _expression systems. The two plasmid system is covered by U.S. Patent No. 6,054,299 entitled, ³Stem-Loop Cloning Vector and Method.² This Patent provides a descriptive example of the two plasmid system. Three PCT patent applications have been published:
The Company has received an International Preliminary Examination Report (IPER) from the World Intellectual Property Organization International Bureau regarding the last cited PCT patent application, ³Altering Gene _Expression with ssDNA Produced In Vivo,² Charles A. Conrad and Yin Chen, Inventors. The Report stated that Claims 1-6 and 8 of the application meet all the requirements of novelty, inventive step/obviousness, and industrial applicability. The IPER further states that the ³prior art does not disclose or suggest the subject matter of Claims 1-6 and 8.² This favorable IPER is a major step in achieving final allowance of Claims and Issue of this International Patent.
The company has filed a United States patent application entitled, "In vivo ssDNA _Expression Vectors for Altering Gene _Expression," invented by Yin Chen, Ph.D., Vice President of Research & Development of CytoGenix and Charles A. Conrad, MD, of M.D. Anderson Cancer Center. The patent application claims a system for delivering the information required for production of single-stranded DNA (ssDNA) in the cells of plants and animals for such purposes as altering gene function and inhibiting the production of harmful disease causing proteins.
The Company is negotiating for additional rights for intellectual property developed as a result of sponsored research.
Yale University has submitted a patent application entitled, ³Methods for correcting genetic defects using triplex forming oligonucleotides produced by a ssDNA _expression system.² Much of the work supporting this patent application was discussed in Dr. Peter Glazer¹s paper, cited above. The ssDNA _expression system was provided by the Company.
Yale University working through the Office of Cooperative Research has supported the creation of a new company, ReGenix, Inc. The new company¹s core technology includes Dr. Glazer¹s latest developments as well as other elements developed and patented by Dr. Glazer and several of Dr. Glazer¹s colleagues. ReGenixuses these patented platform technologies to achieve Targeted Genetic Modification (TGM), either as targeted gene knock out or targeted gene correction.
We will continue providing updates as other activities develop. Please contact us if you have questions or desire additional explanation.
Very truly yours,
Malcolm Skolnick
President/CEO
