Aphios
Corporation awarded Phase II SBIR grant from NCCAM, NIH
for Improved St. John’s Wort Product
May
11, 2000
— Aphios
Corporation has been awarded a Phase II SBIR grant from
the National Center for Complementary and Alternative Medicine
(NCCAM) of the National Institutes of Health (NIH) under
their Fast Track Program. The grant is entitled “Method
for Making an Improved St. John’s Wort Product.” St. John's
Wort (Hypericum perforatum) is a bushy perennial
with yellow flowers which 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
reputation as an effective antidepressant.
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 (U.S. 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.
The Company is currently seeking commercial and financial
partners to launch its SuperCool™
St. John product for the treatment of mild to moderate cases
of depression.
Aphios
Corporation is a privately held, research and development
company headquartered at 3-E Gill Street, Woburn, Massachusetts
01801, USA, tel: (781) 932-6933, fax: (781) 932-6865, e-mail:
aphios@aol.com. The Company is developing therapeutics
for health maintenance and the treatment of human diseases
with a focus on CNS, cancer, and other infectious diseases.
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