Aphios
Announces Presentation of Phase II/III Clinical Trial Data
on Zindol® for Cancer Chemotherapy Induced Nausea
May
26, 2009
— Aphios Corporation today announced that the
results of a Phase II/III clinical trial of Zindol®
for cancer chemotherapy induced nausea will be presented
at the 45th Annual Meeting of the American Society of Clinical
Oncology (ASCO) being held from May 29 to June 02, 2009
in Orlando, FL. Zindol® is an enhanced ginger product.
Despite the widespread use of the 5-HT3 receptor antagonist
antiemetics, post-chemotherapy nausea and vomiting continue
to be reported by up to 70% of patients receiving chemotherapy.
Furthermore, these antiemetics 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. A desirable
attribute in any substitute or additional antiemetic medication
is 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.
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®. 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 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
antiemetics 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 side effects in this study, but
patients should consult with their physicians before use.
The results of the clinical trial study entitled “Ginger
for chemotherapy-related nausea in cancer patients: A URCC
CCOP randomized, double-blind, placebo-controlled clinical
trial of 644 cancer patients,” will be orally presented
and discussed on Saturday, May 30, 2009 from 1:00 to 4:00
p.m. in the Patient and Survivor Care session (Level 2,
West Hall F5) of ASCO, Orlando, FL.
Aphios Corporation is a biotechnology company that is developing
enabling technology platforms including nanotechnology drug
delivery platforms such as phospholipid nanosomes, biodegradable
polymer nanospheres, and protein and crystal nanoparticles
for the improved delivery and targeting of poorly water-soluble
anticancer drugs, therapeutic proteins and siRNA molecules,
as well as enhanced therapeutic products for health maintenance,
disease prevention and the treatment of certain cancers,
infectious diseases and CNS disorders.
###
