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Aphios Corporation, 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, 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.
Posted May 26th, 2009
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