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About Us
The cornerstone of
Cell>Point is metabolic imaging and therapeutic
targeting through intranuclear chelation
technology. The company is developing universal
oncology, cardiology, stroke and diabetes
molecular imaging agents, and intranuclear
metallic therapeutics. Cell>Point is a privately held biotechnology company headquartered in Centennial, Colorado. The company's
five technology platforms, ethylenedicysteine
drug conjugate technology (“EC Technology”),
In-Situ Hydrogel (“In Situ Hydrogel
Technology”), tetraazacyclopentadecane
technology (“N4 Technology”),
oligosaccharide conjugate technology (“Dual
Agent Technology”) and mechanism-based targeted
pancreatic beta cell technology (“Beta Cell
Technology”) are being developed to create new
radiodiagnostic imaging agents, new intranuclear
therapeutic agents, and high yield delivery
systems for the administration of local regional
radio/chemotherapy. In radiodiagnostic imaging,
the company is developing agents for single
photon emission computed tomography (“SPECT”)
cameras, positron emission tomography (“PET”)
cameras and dual agents for SPECT or PET cameras
in combination with either computed tomography
(“CT”) cameras or magnetic resonance imaging
(“MRI”) cameras.
EC Technology
Cell>Point’s proprietary
derivation of ethylenedicysteine (EC) is being
used as an exceptionally stable functional
chelate that provides significant versatility to
facilitate the development of cellular-targeted
analogues for applications in diagnostic
imaging, cold metallic therapy and radiotherapy.
Cell>Point is currently sponsoring Phase II/III
clinical trials for its first 99mTc
labeled sugar analogue, 99mTc-EC-Glucosamine
(99mTc-EC-G), for radiodiagnostic
imaging in oncology. The multicenter clinical
trial is comparing 99mTc-EC-G /SPECT
imaging with FDG-PET imaging for assessing and
staging patients with (non-small cell) lung
cancer. The sites for the clinical trial include
Johns Hopkins, Mayo Clinic, Montefiore Medical
Center, Miami Baptist, Decatur Memorial
Hospital, the University of Chicago, and British
Columbia Medical Center (Canada). Following
non-small cell lung cancer, the company plans to
sponsor Phase IV clinical trials to evaluate
99mTc-EC-G in lymphoma, non-Hodgkin’s
lymphoma, breast, colon, liver, head and neck,
colorectal, and prostate cancer. Recent canine
studies conducted at the University of Virginia
indicate that 99mTc-EC-G may have
application as a functional imaging agent for
assessing myocardial ischemia, myocardial
viability, cardiotoxicity, and congestive heart
failure. The company is preparing to file a
cardiology IND with the FDA during the 1st
Quarter 2010 for authorization to commence a
Phase II/III clinical trial study. In addition
to labeling EC-G with 99mTc for SPECT
imaging, EC-G can also be labeled with 68Ga
for PET imaging. 68Ga is a generator
produced medical isotope and it is the company’s
understanding that the first pharmaceutical
grade gallium generator should be approved for
commercial availability by the 4th quarter 2010
or early 2011. On the therapy side, EC-G is the
backbone for the company’s first intranuclear
cold metallic therapeutic, 187Re-EC-G,
which is currently in preclinical studies. The
company plans to clinically study the
therapeutic use of 187Re-EC-G in
patients with lymphoma beginning late 2010 or
early 2011. 187Re-EC-G functions
similar to a chemotherapeutic drug except that
187Re-EC-G will be a targeted
therapy. Following 187Re-EC-G will be
188Re-EC-G, which will be an
intranuclear radiotherapeutic agent. On the
diagnostic side, 99mTc-EC-Metronidazole,
a hypoxia imaging agent, will follow 99mTc-EC-G.
The company believes that this product may prove
clinically useful in providing critical
information to the physician whether a patient
has suffered an ischemic or hemorrhagic stroke.
By the end of 2009, the GMP synthesis of the
compound should be complete.
Cell>Point believes that
99mTc-EC-G will have the capacity to
assess pharmacological response and biochemical
process thus providing staging, grading,
treatment follow-up and assistance in the
selection of patients who should be more
responsive to the particular treatment being
considered. The versatility of EC Technology has
been demonstrated in (i) receptor targeting
(EGF, ER, AR, HER 2, LH, somatostatin,
transferrin, etc.), (ii) transcriptional
targeting (glucosamine, deoxyglucose,
doxorubicin, etc.), (iii) tissue hypoxia
targeting (metronidazole), (iv) apoptosis
targeting (annexin V), (v) vascular targeting
(e.g. angiostatin, interferon alpha, colchicine,
paclitaxel, etc.), (vi) gene expression
targeting (penciclovir, 5-flurocytidine) and
(vii) enzymatic targeting (cox-2, mmp-2 and
mmp-9).
Beta Cell Technology
The diagnostic objective
of the Beta Cell technology platform is to
target beta cell function in the pancreas. The
first diagnostic agent developed from the Beta
Cell platform is 99mTc-DTPA-Glipizide.
The GMP synthesis of the compound has been
completed and a preclinical small animal study
is underway at the University of Chicago using
99mTc-DTPA-Glipizide to evaluate the
therapeutic efficacy of diabetic drugs through
pancreatic beta cell activity. In addition,
99mTc-DTPA- Glipizide will be evaluated in
its ability to distinguish and evaluate Type I
and Type II diabetes and to identify the
presence of early stage pancreatic cancer.
In Situ Hydrogel
The third technology
platform, In-Situ Hydrogel, is being developed
as a site specific regional chemotherapy and
radiotherapy delivery system. By comparison with
other hydrogel technologies, In-Situ Hydrogel is
unique in that it is capable of delivering a
high yield dose of a therapeutic radionuclide,
such as rhenium-188 (“188Re”),
directly to the tumor site without collateral
leakage into surrounding healthy tissue. In
addition, In-Situ Hydrogel is capable of
simultaneously delivering a therapeutic
radionuclide and a chemotoxic drug to treat
solid tumors and surgically unresectable tumors.
The absence of post injection leakage should
help reduce the side-effects experienced by
patients who receive external beam radiation
treatment. Pre-clinical studies have
demonstrated the potential of In-Situ Hydrogel
as an effective high yield delivery system. The
hydrogel formulation traps the radionuclide
and/or chemotherapeutic drug at the tumor site
immediately following administration. The
radionuclide remains trapped within the
polysaccharide matrix while the chemotherapeutic
drug slowly releases.
N4 Technology
The fourth technology
platform, N4 Technology, is a
covalent lipophilic technology that is being
used to develop agents for the treatment of
Alzheimer's, Parkinson’s, Huntington’s disease,
depression and neuroendocrine tumors.
Dual Agent Technology
The fifth technology
platform, Dual Agent Technology, is facilitating
the development of dual use diagnostic agents.
For example, a single agent will combine the
radiopharmaceutical for SPECT imaging with the
contrast marker for MRI or CT without
interference or distortion between the
radiopharmaceutical and contrast marker. The
company plans to develop dual agents for use
with SPECT/CT, SPECT/MRI, PET/CT and PET/MRI
combination cameras. In addition, Dual Agent
Technology will be used to develop special
imaging agents for optical imaging and targeted
radio/chemotherapeutic compounds.
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