Sunday, February 7, 2010

How Natural Products Can Provide the Basis for New Clinical Candidates

Recently, I was asked about preclinical and clinical development and considerations pertaining to phytochemicals, neutraceuticals, natural products and specifically, potential "antitumor properties" and new therapeutics.

Phytochemicals have potent antitumor properties. There is increasing focus of "designer" targeted therapeutic anticancer agents, the broad spectrum of activity of natural products across multiple signaling pathways remains inadequately explored. The chemical diversity, structural complexity, affordability, lack of substantial toxic effects and inherent biologic activity of natural products makes them ideal candidates for new therapeutics. Natural products not only disrupt aberrant signaling pathways leading to cancer but also synergize with chemotherapy and radiotherapy.

Yes, there is a wealth of scientific, research on phytochemicals, nutraceuticals, bacterial and algae secretory by- and end-products as potential, potent therapeutics in cancer, CNS, and otherwise. Much of the early R&D focuses on mechanism of action of key natural products and there is an abundance of early, promising preclinical data for their efficacy as single agents of in combination with standard therapies. Much of the early work in the area of phytochemicals, neutraceuticals and natural "active" products originate at research institutes and academia. Good science, however, preclinical (and clinical) testing, quality controlled testing, regulatory rigor, data and documentation will be needed to build a "true" therapeutic agent. Safety and efficacy must be measured by quality controlled standards as set forth by FDA compliance and regulatory guidance. Product quality and consistency is a must. Consumer or patient/subject safety is the first concern.

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