|By the end of 2003 :
||To complete Preclinical and Clinical Phase (I) tests.
||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.