Monday, August 1, 2011

Advancing the 'state of the art'...

Currently, I am sourcing financing for toxicology testing and human clinical trials - for the new chemical entity, (S)-2-Amino-3-(3-phenylacetylimidazol-4-yl)propanoic acid. The anticipated timeline, here in the USA, will involve a complete toxicology study by a CRO (contract research organization), a pre-IND meeting with the FDA and subsequent human clinical trials (Phase I or a Phase I/II hybrid). If I can find sufficient finances soon - then it is possible to be in human clinical trials as soon as toxicology data is available (approximately six months or less). I anticipate early FDA approval - once the compound has been independently confirmed as 'non-toxic' to healthy tissue. This compound has a wide therapeutic margin and I anticipate utility against most, if not all, neoplasms. Antibiotic indications have also been demonstrated.

I do not concern myself with the 'politics' of pharmaceutical empires, rather, my efforts are directed at advancing the 'state of the art'. The science is undisputed... the impediment, at present, is securing adequate finances to advance the 'process'. And, yes, it is rewarding to know this compound will save lives.