2 - Nanoparticulate Paclitaxel Mice
Study:
It is estimated by the American Cancer Society
that over 1.26 million new cancer cases will be diagnosed
in 2001 in the US. Cancer is generally treated with
surgery, radiation, chemotherapy or a combination of treatments.
In chemotherapy there are seven different classes of anti-cancer
drugs currently approved in the US that have their genesis
in natural compounds. In 1999, the global sales of paclitaxel
constituted 22% of all major cytotoxic compounds used in chemotherapy.
Paclitaxel Worldwide sales are estimated to exceed 2 Billion
dollars. Moreover, this taxane is the largest selling cytotoxic
agent in the world despite its major solubility problems,
carrying agent and toxic effect.
CritiTech believes it can achieve similar results
with “nanopaclitaxel” without the toxic effects
of the Cremophor® carrying agent used in the standard
drug formulation. In an experiment carried out in conjunction
with Dr. Katherine Roby from the Kansas University Medical
Center, CritiTech has been able to effectively extend the
life of mice with cancer that were treated with nanoparticulate
Paclitaxel versus those treated with Paclitaxel formulated
with Cremaphore© -the current standard formulation. For
intraperitoneal (IP) dosage, nanopaclitaxel treated mice survived
-on average- about 180 days after tumor induction as compared
to regular paclitaxel treated animals that only survived to
about 105 days. Control animals survived only 87 days. For
intravenous (IV) dosage, nanopaclitaxel and regular paclitaxel
treated mice showed identical survival rates. Therefore, the
data suggests that nanopaclitaxel could provide additional
effectiveness and safety. Because of CritiTech’s ability
to harvest in quantity, the nanoparticulate paclitaxel may
also prove to be more cost effective.
CritiTech had a successful pre-IND meeting
with the FDA in late 2005 on Nanotax®, its proprietary
formulation of pacitaxel and began Phase I trials with Nanotax®
in late 2008. The pilot scale GMP production crystallizer
unit has been installed at CritiTech's GMP production facility.
The trials are to be held at the Kansas University Cancer
Center in Kansas City.
Nanotax
Product Profile
As of October 16, 2001, CritiTech has
a U.S. Provisional Patent Application for the “COMPOSITON
AND METHODS FOR DELIVERY OF POORLY WATER SOLUBLE DRUGS AND
METHODS OF TREATMENT”
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