WINSTON-SALEM … Drug company Pilot Therapeutics Holdings (OTC: PLTT.OB) has entered into an agreement with Ancile Pharmaceuticals, a San Diego firm that focuses on developing botanical drugs, for technical assistance to prepare and file Investigational New Drug Applications, or INDs, for two of Pilot’s botanical drug candidates: PLT 1731 for the treatment of asthma and PLT 732 for the treatment of elevated triglycerides associated with heart disease and stroke.

Acknowledging previous safe human use for many botanicals, the U.S. Food and Drug Administration has adopted different regulatory policies than those applied to highly purified new chemical entities. Botanicals with a documented history of safe human use generally may enter Phase II or III clinical trials, with reduced toxicology and pharmacology documentation. This can lead to greatly reduced development cost, risk and time-to-market for botanical drug products.

“Because Pilot has always taken a pharmaceutical approach to the development of our natural products, whether intended for the pharmaceutical or (over-the-counter) medical food markets, we believe we are well-positioned to accelerate time-to-market and reduce the development costs of our drug candidates,” Pilot President and Chief Executive Floyd Chilton says in a statement. “Collaborating with Ancile should enhance our product registration efforts, as Ancile has significant experience working with the FDA under the new
botanical guidelines.

Ancile currently has three INDs allowed by the FDA for botanical drug candidates.

Pilot has completed safety and efficacy proof-of-principle clinical trials for PLT 1731 and PLT 1732 and is preparing to file an IND under the FDA’s Botanical Drug Guidance later this year for the former. The company’s other pharmaceutical products, PLT 99511 and PLT 99257, are synthetic drugs for the treatment of cystic acne and cancer, respectively. It expects to file INDs and move into Phase I clinical trials in late 2003 for both drugs.