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Product Pipeline
Despite tremendous advances in recent
years cancer remains the leading cause of death worldwide.
Many of these cancers affect vital organs within the
peritoneal cavity. While surgery followed by intravenous
(IV) chemotherapy or radiation has been and remains
the primary course of action there is some concern that
IV therapy cannot reach all of the small tumors inside
the abdomen. Of the cancers noted above, ovarian cancer
remains one of the great challenges. This approach to
treatment may be changing as recent clinical data1
have demonstrated that IP therapy using currently available
formulations of approved products could extend the lifespan
of later stage patients by a little over a year.
Based on these and other studies the National
cancer Institute (NCI) took the unusual step in January
2006 of encouraging2,3
the more aggressive use of IP therapy in advanced ovarian
cancer. Although the alternative approach of using IP
administration of chemotherapeutics in conjunction with
IV therapy for the treatment of ovarian cancer has been
shown to have considerable therapeutic value, it was
not without problems. Fortunately, it has been noted2
that the decrease in the quality of life for patients
using the existing formulations dissipated with time
and largely disappeared after 12 months. The factors
involved in these side effects may be related to higher
circulating levels of the chemotherapeutics as well
as additional side effects related to the high exposure
to some of the excipients.
CritiTech has two programs in place to
address some of these issues. Both of these programs
use formulations of Nanotax® which do not require
the presence of solubilizing agents thus reducing the
exposure to the body of these materials. The lead program,
Nanotax®, will complete a Phase I human clinical
trial in late 2011 and Phase II/III clinical trials
commencing in 2012 will focus on intraperitoneal
therapy for ovarian cancer. The second program is focusing
on the investigation of the intravenous administration
of slightly different formulation of Nanotax® to
companion animals where formulations containing solubilizing
agents are known to have increased toxicity. A safety
study has been completed and a Phase I/II study in dogs
with various cancers will initiate in June 2011 in collaboration
with the University of Missouri Veterinary Teaching
Hospital.
We have also expanded our oncology portfolio
by processing several other relatively insoluble chemotherapeutics
and developed suspension products for use in IP administration.
The early results from these preclinical studies have
been extremely encouraging showing the same pattern
as seen with Nanotax®. We have evaluated our suspension
products in recognized animal models of colorectal cancer,
ovarian cancer, pancreatic cancer and liver cancer.
There has been no unexpected toxicity while we have
observed significantly increased survival of the animals
versus a variety of positive controls including Mitomycin
C. We anticipate meeting with the FDA later in 2011
to discuss taking our second product into human clinical
studies in 2012. Our draft Phase I clinical protocol
is currently being finalized and our longer term clinical
development plan is under discussion.
References
1. Armstrong DK, Bundy B, Wenzel L,
Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL,
Burger RA. Intraperitoneal cisplatin and paclitaxel
in ovarian cancer. NEJM, January 5, 2006, Vol. 354,
No. 1, pgs. 34-43
2. http://www.cancer.gov/clinicaltrials/ovarian-cancer-updates
3. http://www.cancer.gov/newscenter/pressreleases/IntraperitonealQandA
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