PRODUCT DEVELOPMENT

The products we are developing include therapies for cancer, obesity, and other disorders. We are focusing on cancer intervention first. The progress has been smooth so far. We have firmly established ITE efficacy in cancer therapy, ITE preliminary toxicity profile, and ITE formulation for delivery. We are currently developing a chemical process for an efficient and safe production of ITE in a kilogram scale. The compounds so produced could then be used for both GLP toxicity and clinical studies of ITE.

1. ESTABLISHED ITE EFFICACY IN CANCER THERAPY
We have firmly confirmed the efficacy of ITE in inhibiting the growth of both human cancers on xenografting models (human cancer cell lines inoculated into immune compromised mice) and mouse cancers on syngeneic models (mouse cancer cell lines inoculated into mice with healthy immune systems). ITE efficacy has so far been demonstrated with prostate, liver, ovary, and breast cancers of humans and liver and lung cancers of mice. Very importantly, while we confidently demonstrate ITE efficacy in inhibition of cancer growth, latest preliminary data do point to a possibility of cancer eradication.

2. ESTABLISHED AN ITE PRELIMINARY TOXICITY PROFILE
A preliminary, non-GLP, 7-day ITE toxicity study has been conducted to establish a short-term ITE toxicity profile. Testing mice tolerated fairly well to an ITE dose that was four to five times higher than what we usually use for efficacy studies.

3. DEVELOPING AN ITE FORMULATION
A good formulation for ITE delivery has been developed for the preclinical animal studies but it will potentially also be useful for the clinical studies after some minor modifications. The modifications will be tested and a pharmacokinetic (PK) study will soon be conducted to explore the feasibility of the formulation for use in clinical studies.

4. DEVELOPING A PROCESS FOR ITE PRODUCTION
A chemical process for an efficient, safe, stable, and controlled large-scale production of ITE has been developing. Currently, we have discovered an efficient synthetic route. We will optimize conditions for the route and then use the process for a scaled-up production (at a kilogram level, for example) to demonstrate the capability.

We will post more detailed information as we progress. Meanwhile, please contact us if you have any question, comment, or suggestion. We will be happy to hear from you.