Aphios®
Presents Development Through A Multi-Center Clinical Trial
of Enhanced Ginger Product Zindol® at AAPS 2011 Annual
Meeting
Woburn,
MA —
October
21, 2011
—
Aphios® Corporation
today announced that Dr. Trevor P. Castor, company President
and CEO will present “Development through a multi-center
clinical trial of Zindol® for cancer Chemotherapy Induced
Nausea (CINV)” at the American Association of Pharmaceutical
Scientists 2011 AAPS Annual Meeting and Exposition being
held from October 23rd through the 27th at the Walter E.
Washington Convention Center, Washington, D.C.
The development of Zindol®, an enhanced ginger product,
through a multi-center clinical trial will be orally presented
and discussed on Wednesday, October 26, 2011 from 8:30 to
11:00 am EST in the Symposium on “Evaluating Drug
Development Opportunities in Botanical Polymolecular Therapeutics”
at the AAPS 2011 Meeting and Exposition.
Despite the widespread use of the 5-HT3 receptor antagonist
anti-emetics, CINV continues to be reported by up to 70%
of patients receiving chemotherapy. Furthermore, these anti-emetics
have been associated with significant adverse effects, such
as sedation, extra-pyramidal side effects and hypotension
(associated with dopamine antagonists), as well as headache,
diarrhea or constipation. Desirable attributes in any substitute
or additional anti-emetic medication are both efficacy and
the absence of clinically significant adverse effects.
“Zindol® is an enhanced ginger product that is
standardized by the bioactive constituents of ginger, gingerols
and shogaols,” explains Dr. Castor.
“Aphios’ scientists and engineers utilized
a proprietary polarity-guided SuperFluids™ CXF fractionation
technology to establish conditions for the isolation of
the active ingredients of Zindol®,” he continued.
“The technology was then scaled-up for producing large
quantities of the active ingredients utilizing patented
SuperFluids™ CXP manufacturing technologies.”
The enhanced ginger concentrate was then formulated to
achieve a specific concentration of ginger bioactives with
all-natural liquid excipients designed to maximize stability
and bioavailability of bioactive constituents, and encapsulated
in gel capsules (LiCaps™) by Capsugel, Inc., a former
Pfizer subsidiary.
Researchers at the University of Rochester Medical School
conducted a multi-site, Phase II/III randomized, placebo-controlled,
double-blind clinical trial to assess the efficacy of Zindol®
(ginger capsules) for chemotherapy-related nausea in 644
cancer patients. Cancer patients who experienced nausea
were randomized into four arms: placebo and 3 dose-escalation
arms taking ginger capsules equivalent to 0.5, 1.0 and 1.5
grams ginger. All patients received 5-HT3 receptor antagonist
anti-emetics on Day 1 of all cycles. Data from the clinical
trial indicates that all ginger doses significantly reduced
nausea with the middle and lowest doses giving the best
results. Ginger caused no serious side effects in this study.
Aphios® Corporation is a green biotechnology company
developing enabling technology platforms for improved drug
discovery and manufacturing, nanotechnology drug delivery
and pathogenic drug safety. Based on these platforms, Aphios®
is developing enhanced therapeutic products for health maintenance,
disease prevention and the treatment of certain cancers,
infectious diseases such as HIV and influenza, and central
nervous system disorders such as Alzheimer’s Disease.
#####
