St. John's Wort extracts are sold in pharmacies throughout Europe, and are in fact among the most popular OTC "phytomedicines" sold in EEC countries. Among the most widely prescribed antidepressants in the United States are Prozac® from Eli Lilly, Zoloft® from Pfizer and Paxil® from SmithKline Beecham. The worldwide sales of the top-selling antidepressants are approximately $4.8 billion. As people experience adverse side-effects from prescription antidepressants, there has been a concomitant rise in the use of St. John's Wort and other herbs as natural antidepressants. Products such as St. John's Wort are, however, being manufactured without any significant regard to the standardization, reproducibility and validity of the manufacturing process, or the content and quality of the active ingredients.
The overall goal of Aphios' R&D program is to develop an improved St. John's Wort product which can be manufactured in standardized and reproducible manner, and in strict accordance with current Good Manufacturing Practices (cGMP) of the FDA. In Phase I SBIR studies, several experiments were performed to establish best conditions for the SuperFluids™ fractionation of Hypericum biomass and the resulting St. John's Wort products. These experiments were used to measure extraction efficiency, yield, chromatographic and absolute purities, and biological activities (serotonin re-uptake inhibition) as well as chemical and biological activity stabilities of SuperFluids™ St. John's Wort fractions. Standardized St. John's Wort fractions were also evaluated, and an engineering and economic analyses for making an improved and standardized SJW product conducted.
In Phase II, we are building on our Phase I results to optimize the SuperCool™ process, and to design, build, and test a pilot plant. The results of the Phase I & II SBIR research will be used to develop a large scale manufacturing process for an improved St. John's Wort product in a Phase III commercialization effort. To date, a SuperCool St. John product (US Patent Pending) has been developed. Research has established that the product is significantly more potent than marketed products, and is relatively stable in terms of bioactivity and chemistry.
Aphios Corporation is a privately held, research and development company developing therapeutics for health maintenance and the treatment of human diseases with a focus on CNS, cancer, and other infectious diseases.