|
BUSINESS STRATEGY
| By the end of 2003 : |
To complete Preclinical and Clinical Phase (I) tests.
|
| Thereafter : |
To seek a pharmaceutical company (by region) to take on the clinical development (from Phase II), manufacturing (API to be supplied by NMR), and marketing of the compound. |
CURRENT STATUS (as of March, 2003)
- The company successfully completed (pending final report on the Repeated Dose, 2 weeks, Dog Studies) all the Preclinical Tests (Animal testing) to prepare for an IND with FDA. The dog test revealed that the compound WAP-8294A2 has a Maximum Tolerance Dose of 25mg/kg. This implies that WAP-8294A2 is safe even at 50 times its effective dose (ED100 at 0.5mg/kg).
- The company has also successfully established commercialization scale up of WAP-8294A2. It will be provided for the cGMP Active Pharmaceutical Ingredients (cGMP API) necessary to produce the final injectable product (Drug Product) at a US firm. The company has also appointed a CRO company in the U.S.A. to coordinate documentation (production SOP, specification of the drug: CMC, Stability, and IND documents).
- With the Steering Committee in place, the company expect to apply for an IND by August. Therefore, the company may complete Phase I in the U.S.A. before October, 2003.
- Presentation and Abstract to ICAAC (International Congress on Antimicrobial Agent and Chemotherapy) will be expected at the conference of this year.
|
