|
In July 2003, the company completed exclusive license negotiations with
M.D. Anderson for a second technology platform, In Situ Hydrogel, which
will be used for local regional chemotherapy and radiotherapy. In
comparison with other hydrogel technologies, In Situ Hydrogel is the
only hydrogel formulation capable of delivering a high yield load of a
therapeutic radionuclide like 188Re directly to the tumor site without
leakage into surrounding tissue. The In Situ Hydrogel forms a
polysaccharide matrix which encapsulates tumor sites for solid tumors
and surgically unresectable tumors. The polymer and cross-linking
composition are administered separately using a dual compartment
syringe. The polymeric matrix forms at the tumor site almost immediately
following administration of either the anticancer drug or radionuclide
matrix. The matrix remains in tact for a least 48 hours which is
excellent for administering an anticancer drug like cisplatin or a
therapeutic radionuclide like 188Re with a physical half-life of 17
hours and a 2.1 MeV beta emission. In fact, In Situ Hydrogel is capable
of delivering both therapies at once. The company is aware of hydrogels
that can deliver anticancer drugs, however, all of these hydrogels leak
which means they cannot be used for delivering high yield doses of
therapeutic radionuclides. In addition, the other hydrogel formulations
require varying amounts of time to form their matrix which makes them
much less efficient and effective. The polymeric material used for In
Situ Hydrogel is alginic acid which has widespread use and is a
non-toxic substance.
To date, studies on breast tumor-bearing rats have been performed using
In Situ Hydrogel loaded with cisplatin (3mg/kg). Cisplatin was gradually
released into the surrounding tumor tissue. The tumors were completely
suppressed within 16 days following a single injection. In a second
study, In Situ Hydrogel was loaded with 188Re (1 mCi/rodent) and
injected into breast tumor-bearing rats. No post injection leakage into
surrounding tissue was detected. Tumor growth was delayed substantially
compared to free 188Re treated rats. The 188Re studies were completed
several months ago and no tumor regrowth is present. In the next series
of studies, an In Situ Hydrogel cisplatin/188Re cocktail therapy will be
administered. All the studies have used a Siemens m-Cam using a medium
energy parallel-hole collimator. The largest single market for In Situ
Hydrogel therapy will likely be in the treatment of prostate cancer,
however, we feel lymphoma will be significant as well. In prostate
cancer, we believe that In Situ Hydrogel will show more consistent
therapeutic results compared to brachytherapy.
.
|