Aphios
Awarded SBIR Grant from NCCAM, NIH for
Standardized & Improved Saw Palmetto Product
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 (www.aphios.com) is a “green” biopharmaceutical
company, which is developing enhanced natural therapeutics
for health maintenance and the treatment of human diseases
with a focus on CNS, cancer and infectious diseases.
Aphios’ principal research and manufacturing
facilities are in Massachusetts at 3-E Gill Street, Woburn,
MA 01801, USA, tel.: (781) 932-6933, fax: (781) 932-6865,
e-mail: aphios@aol.com
.
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