News Release

Tetrodin (HT) Reaches Its Most Important Milestone

Date: 1999/07/19

In 1995 the Federal Government of China modified its new drug license approval process in order to standardize with the USFDA and changed to federal system rather than provincial. At that time, International Wex Technologies Inc. (IWT) had completed more than three years of pre-clinical and clinical testing of Tetrodin(HT) under the old rules. IWT was required to re-do all of the prior testing although the new tests were, for the most part, identical to the original, excluding the testing protocol. IWT was obliged to proceed as if no testing had previously been done.

The positive effects of re-testing have been numerous including, confirmation of favorable test results, compiling a complete set of GLP Standards tests, additional research and development on Tetrodin(HT), and enhancing our proprietary knowledge. IWT is now in a position to secure a National Clinical License for China.

The pre-clinical tests performed by IWT are similar to the requirements of all countries using FDA style approval for Tetrodin (HT).

Pre-clinical tests cover all aspects of the product including the name, packaging, quality testing of all ingredients from the source of the raw material up to the finished product and finally,all of the scientific studies that relate to the product’s use, effects and functions. This pre-clinical testing is carried out in such detail that for each patented new drug that successfully completes a full pre-clinical testing, the pharmaceutical industry can spend hundreds of millions of dollars on research and development.

As of today, we are advised that IWT's Beijing office has formally presented to the official committee of the State Drug Administration Bureau of the Peoples' Republic of China the completed documentation of the pre-clinical testing of Tetrodin(HT) in support of its application for a National New Drug License for China.

A brief summary of our efforts to date are as follow:

The submitted documents of the 24 pre-clinical test categories that address the 52 scientific issues that were required to be researched in order to make the application for the new drug license for Tetrodin (HT) are compiled in 3436 pages. This does not include any of the support documentation from the testing that must be maintained at the independent test facilities and universities in order for the government to access at any time. The company utilized 23 universities, institutions and government organizations. 83 research professionals were employed including 47 professors (12 of whom are world renowned in their field). At least 6,486 animals were used in testing, accounting for thousands of hours spent in laboratories not related to IWT.

The following are the titles and a short description of the 24 pre-clinical test categories of Tetrodin (HT):

1. The registration of the trade name (Tetrodin HT) for the new drug including, all information regarding the purposed uses and functions of the new drug and a summary of the related research.
2. The report containing the full name of the new medicine, the purpose for choosing this project as well as all the research completed domestic and worldwide.
3. The submission of the product’s packaging, labeling & graphic design, and layout.
4. The report containing the finished design, layout and copy of the information/instruction sheet that is to be included with each individual vial of Tetrodin (HT).
5. The report describing the manufacturing system starting from the raw material through to the finished product.
6. The report containing the detailed documentation which confirms the chemical/molecular structure of the active compound in the product.
7. The report containing the research and test data that was utilized to design the production system for Tetrodin (HT) which will provide information that the product will be produced to the required
   consistency;
8. The report containing all of the information used to set the quality of product standards, for example, purity of the active and non-active ingredients. This ensures that the consistency of the product will be maintained.
9. The report containing all of the research and testing data which sets the criteria for the samples deployed in clinical trials.
10. The report on the stability of the product, i.e. expiry date,method of handling and storage, etc.

    
    Tests that required the use of animals and live tissues:

11. Efficacy on opiate withdrawal/ Efficacy on analgesic effect
12. Pharmacology
13. Acute Toxicity
14. Long Term Toxicity/ Repetitive Toxicity
15. Intramuscular Irritation/ Generalized Hypersensitivity
16. Efficacy & Toxicity effect of multiple compound
17. Micronucleus Growth Rate /Somatic Cell Growth Rate
18. Embryotoxicity and Teratogenesis /Chromosome Aberration
19. Carcinogenic
20. Dependency Potential
21. Pharmacokinetics
22. The report of the first full-scale production run of the product using the approved GMP inspection/production methods. This first production run will be used for the clinical (human) testing.
23. The report containing the pharmacology and toxicology reference information and guidelines, to be used by the doctors conducting the clinical (human) testing.
24. The report containing the guidelines and protocols that are to be used by doctors during the clinical (human) testing of Tetrodin (HT).

International Wex Technologies Inc. is developing the patented new pharmaceutical product named Tetrodin(HT). Tetrodin(HT) Heroin Treatment is proven to be a safe, non-addictive analgesic and effective withdrawal treatment for all opiate (heroin, opium, morphine, methadone, etc. ) addictions.

Therefore, R-D Center has decided to cooperate with MLP, in expediting the New Drug License Number process for Tetrodin(HT).

Per: Donna Shum, Corporate Secretary