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Aphios Corporation Awarded SBIR Grant from NCCAM, NIH
for Standardized and Improved Saw Palmetto Product

Woburn, Mass. — October 03, 2000 — Aphios Corporation has been awarded a SBIR grant from the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) for developing a standardized and improved Saw Palmetto product.”

Saw Palmetto, derived from the Native American palm tree Serenoa repens, has been clinically proven to be as effective as conventional medications in providing symptomatic relief for benign prostatic hyperplasia (BPH), a non-malignant prostate enlargement that is common in older men. This condition typically causes frequent urination. Products, such as Saw Palmetto, 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.

Aphios Corporation is improving the quality and manufacturing of Saw Palmetto by utilizing its proprietary SuperFluids™ , supercritical fluids and near-critical fluids w/wo polar cosolvents such as alcohols, technology. These fluids are gases such as carbon dioxide that, when compressed, exhibit enhanced thermodynamic properties that can be “fine-tuned” for rapid and selective extraction of bioactive molecules. SuperFluids™ provide the opportunity for more rigorous standardization of nutraceuticals and potential herbal Rx products such as Saw Palmetto and for achieving formulations, which may not be possible with conventional organic phase manufacturing. Such products are also free of toxic organic solvents, environmentally friendly and truly “green.”

In this program, Aphios Corporation is collaborating with Paracelsian, Inc., Ithaca, NY to develop an enhanced and standardized Saw Palmetto product. Paracelsian, Inc., has developed a BioFIT™ “functional” quality assurance in vitro biological assays for Saw Palmetto. The BioFIT™ system incorporates both human digestive and bioavailability models for defining and validating “structure/function” claims for herbal products.

Currently, there are three drugs approved by the FDA to treat the symptoms of BPH - Proscar^®, Hytrin^® and Cardura^®, with estimated combined sales of over $1.5 billion. In the U.S., an estimated 30 million men over 50 have enlarged prostates. The incidence of BPH for men in their fifties is 50% and rises to 80% by the age of 80. Conventional drugs for BPH cause diminished libido and sexual dysfunction in some patients and, in certain cases, about 3-4% of patients experiences impotence. Saw Palmetto is a natural alternative to these drugs - it is effective with fewer side effects.

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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