Viral Genetics Inc.

Company data | Executive Summary | Human Efficacy Profile | New Products in Future | Patents and Copyrights | Management Team | News Update |  Chinese

Company Data

EXECUTIVE SUMMARY

WHO IS VIRAL GENETICS?

Viral Genetics is a California-based company founded in 1995 to develop new treatment modalities for viral diseases. Viral Genetics' core technology revolves around a biologically active linear protein - Thymus Nuclear Protein (“TNP”), first discovered by Dr. Harry Zhabilov, MD, Ph.D. Dr. Zhabilov, a native Bulgarian now residing in the United States, has had extensive research experience in the immunotherapy of cancer and HIV/AIDS infections. Between 1971 and 1992, Dr. Zhabilov was head of the Autoimmune Disease Research Laboratory at the Medical Academy of Sofia.

Thymus Nuclear Protein (“TNP”) or VG 100 is an immune modulator and has been studied to ascertain its safety and potential efficacy in impacting the progression of the Human Immunodeficiency Virus (HIV) - the causative agent in Acquired Immune Deficiency Syndrome (AIDS).

WHAT ARE THE TREATMENT ALTERNATIVES PRESENTLY AVAILABLE FOR HIV/AIDS SUFFERERS?

At the present time, there are many treatment alternatives, but they are costly, carry debilitating side-effects and do not stop the underlying viral infection. The various forms of these treatments are together prescribed to HIV/AIDS patients in Multi-Antiretroviral Cocktails.

This therapy of three or more drugs has become the standard of care for patients with HIV/AIDS. It is generally recognized that 30%-40% of HIV patients on these treatments develop drug-resistant strains of HIV, rendering the treatments increasingly ineffective.

HOW DOES VIRAL GENETICS' VG 100 WORK AGAINST HIV INFECTIONS?

Based on basic research and human clinical response to VG 100, Viral Genetics believes VG 100 works against HIV by three mechanisms of action.

Binding of VG 100 to the HIV-1 envelope protein gp41 as well as to fragments of the CD4 receptor protein may inhibit viral transmission.
Marking HIV-infected immune cells so that the non-infected viable immune cells may recognize them.
Stimulating the dormant immune system of the host to aggressively attack these marked HIV-infected immune cells.

SAFETY PROFILE

ANIMAL SAFETY PROFILE

Acute, sub-acute and multiple dosing studies have demonstrated an excellent safety profile of VG-100. Rabbit, rat, and mouse models, with both intra-muscular and intra-peritoneal dosing have been used to demonstrate the lack of toxicity of VG-100.

HUMAN SAFETY PROFILE

Viral Genetics Inc. has conducted three offshore human clinical trials. All blood work was performed at Specialty Laboratories in Santa Monica, California.

1. First Human Clinical Trial - Safety

   • subjects demonstrated no significant adverse effects at up to 18 months post treatment

2. Second Human Clinical Trial - Relative Safety & Efficacy to Antiretroviral Cocktail

   • 30 patients:

     • 20 administered VG-100

     • 10 received standard multi-antiretroviral therapy

     • VG-100 subjects demonstrated no significant adverse effects up to 9 months post treatment

     • multi-antiretroviral subjects experienced the usual adverse effects associated with these treatments

3. Third Human Clinical Trial - safety and antiviral efficacy

   • 10 HIV-1 infected and fulminate AIDS patients resistant to Multi-Antiretroviral Drug Combination Therapies were each administered VG-100

   • demonstrated no significant adverse effects at up to 12 months post-treatment

   • overall, these ten fulminate AIDS and HIV patients, who had been experiencing severe weight loss before treatment, started to gain weight upon treatment with TNP

HUMAN EFFICACY PROFILE

All patients in all of the treatment groups have demonstrated persistent HIV-1 viral suppression by more than 90% at up to 18 months after the cessation of treatment. In all existing treatment therapies, it is commonly observed that viral activity rapidly resumes within weeks of cessation. In many instances viral activity is noted to actually accelerate despite continued treatment following cessation, presumably due to viral resistance caused by mutation.

SUMMARY OF THE RESULTS OF THE THIRD CLINICAL TRIAL

The group consisted of AIDS patients in the late stage of the disease with severely deteriorated immunological and clinical status. All of these ten patients were treated for many years with combination anti-retroviral drugs and were non-responsive to them.

1. 10/10 - significant improvement in clinical condition

2. 9/10 - weight loss stabilization or substantial weight gain

3. 10/10 - moderate to significant improvement of laboratory results

4. 5/10 - 3 months post-treatment, HIV-1 viral load, measured by PCR showed decrease to undetectable levels

5. 8/10 - 3 months post-treatment, HIV-1 viral load, measured by PBMC showed decrease as follows:

   1. 4/10 - undetectable (1:1,000,000)

   2. 2/10 - decreased significantly (1:500,000)

   3. 2/10 - greatly decreased (1:200,000)

6. 10/10 - experienced steady increase of total lymphocyte counts, up to 30% regeneration of immunologically-competent cells

7. 10/10 - expressed satisfaction for improved clinical condition, good appetite, and lack of new AIDS symptoms

8. 10/10 - experienced only transient and superficial side effects during treatment period; disappeared upon completion of dosing

When comparing Viral Genetics' VG 100 product to existing treatment modalities two striking differences become apparent:

1. VG 100 appears to be free of the major neurologic, gastrointestinal, and hematologic side effects seen in the anti-retrovirals presently in use today

2. VG 100 has demonstrated significant and long lasting viral suppression following the cessation of treatment

Comparison of Features and Benefits of Existing Therapies VS VG 100 Therapy

WHAT ARE THE NEXT STEPS?

Prior to the manufacture and sale of VG 100 in the USA, the FDA will require the filing of an Investigational New Drug Application (IND) and the completion of FDA Phase I, II and III clinical trials, followed by the submission of a New Drug Application.

In international markets, various international regulator bodies will regulate sale and manufacture of VG 100. These regulatory agencies require the filing of drug applications and completion of equivalents to Phase I, II and III clinical trials. Many of the clinical filings necessary to gain FDA approval in the US are directly submittable to international drug agencies for approval as well.

Viral Genetics strongly believes that it will be successful at reproducing the clinical results achieved offshore in a FDA-sponsored US Phase I/II human clinical trial. The Company believes that successful results in the US, even at the six-month milestone, will create numerous opportunities. These opportunities will likely include joint venture licensing agreement(s) with major US and international pharmaceutical companies, and rapid acceptance and approval for sales in international markets.


SCHEDULE OF REGULATORY ACTIVITIES

The following is a summary of Viral Genetics' projected regulatory activities:

1. Start US Phase I/II human clinical studies - 1st Q'02

2. Complete US Phase I/II human clinical studies - 3rd Q'02

3. Start Phase II/III US human clinical studies - 4th Q'02

4. Start Phase I/II human clinical in Canada - 1st Q'02

5. Complete Phase I/II human clinical in Canada - 1st Q'03

NEW PRODUCTS FOR THE FUTURE

Based on the clinical data received to date, TNP appears to have other far reaching applications including but not limited to: use as a HIV Vaccine, the treatment of active Herpes Simplex, treatment of other viral infections such as hepatitis and general boosting of the immune system.

PATENTS AND COPYRIGHTS

Viral Genetics Inc. has filed US patent applications for the TNP protein, the manufacturing of the protein as well as the application of the product for the treatment of HIV-1 infections. In addition, worldwide PCT patent applications have been filed. In a recent office action, the US patent office has indicated the allowance of US patent for VG-100. To date, the Company has been granted patents in Australia, Euroasia, Israel, New Zealand and South Africa.

Viral Genetics Inc. has signed an agreement with the Cedar Sinai Medical Center in Los Angeles, California, whereby the Center will determine the sequence and Genetic code of the TNP protein.

THE MANAGEMENT TEAM

This team of seasoned professionals comes from the pharmaceutical industry, previously having been associated with successful companies and academic institutions such as Allergan Pharmaceuticals, Prima Pharmaceuticals, Medical Academy of Sofia, Tufts University School of Medicine, Johnson and Johnson, and the Xoma Corporation. Combined, the management team has over 100 years of experience in the manufacture and development of pharmaceutical products. New additions to the management team and board of directors are expected in the coming months.

The Management Team

Hampar Karageozian, M.Sc., Pharm D, MBA, CEO
Haig Keledjian, MBA, JD, President

News Update

On November 07, 2001, 5 Starling Online Inc. announced that it has engaged Burlington Capital Markets, Inc. as its investment banker, and has also hired Voluto Ventures, LLC, to provide strategic planning and management consulting services. Burlington has agreed to assist Viral Genetics for listing on NASDAQ or the American Stock Exchange when the Company is able to meet the appropriate listing standards. As part of its October 3rd acquisition of Viral Genetics, Inc., 5 Starling Online Inc. has also mailed out to its shareholders of record as of October 25th a notice of name change. Pursuant to this, the name of 5 Starling Online Inc. will be changed to Viral Genetics, Inc. effective November 20, 2001.

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