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Aphios Corporation Granted United States Patent
for Making an Enhanced St. John’s Wort Product

Woburn, Mass. — October 24, 2001 — Aphios Corporation announced today that it was granted United States Patent No. 6,291,241, entitled “Method for Making Hypericum Fractions and St. John’s Wort Products,” on September 18, 2001.

St. John's Wort (Hypericum perforatum) is a bushy perennial with yellow flowers that blooms around St. John the Baptist's day in June. An oil extract of the fresh flowers contains liposoluble napthodianthrones, such as hypericin and hyperforin. These compounds are thought to be responsible for St. John's Wort reputation as an effective antidepressant.

St. John's Wort extracts are in fact among the most popular OTC "phytomedicines" sold throughout Europe and the United States. 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 exceed $8 billion per year. 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. However, St. John’s Wort products are not being manufactured with any significant regard to efficacy, safety and standardization. Often, these products are not standardized to the correct bioactive ingredient, and their content and quality are not reproducible from one batch to the next.

Aphios has discovered and developed a method for standardizing and manufacturing an enhanced efficacy St. John’s Wort product. This method utilizes supercritical fluids and near-critical fluids with or without polar cosolvents such as alcohols (SuperFluids™ ). These fluids are gases such as carbon dioxide which, when compressed, exhibit enhanced thermodynamic properties that can be “fine-tuned” for rapid and selective extraction of bioactive molecules. Such fluids provide for more rigorous standardization of nutraceuticals and potential herbal Rx products such as St. John’s Wort and for achieving formulations that may not be produced with conventional organic phase manufacturing. These products are free of toxic organic solvents, environmentally friendly and truly “green.”

In vitro serotonin reuptake inhibition assays, conducted by an independent testing laboratory, have shown that Aphios’ SuperFluids™ St. John’s Wort product is as effective as Prozac and Zoloft at the 10 to 25 mg level. The bioactive ingredient of the St. John’s Wort product has been identified to be hyperforin with chromatographic and absolute purities as high as 80%. This hypericin-free St. John’s Wort product demonstrates a linear dose-response curve in the in vitro bioactivity assay.

Research leading to this invention was funded, in part, by a Fast Track SBIR grant from the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH).

Aphios Corporation is a biopharmaceutical company that is developing enhanced natural therapeutics for health maintenance and the treatment of human diseases with a focus on infectious diseases, cancer and quality-of-life medicines. Aphios’ product pipeline includes therapeutics from medicinal plants and marine organisms, and improved drug delivery formulations of small anticancer molecules and large protein macromolecules that are crucial to the functioning of the human genome.

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