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Targeting the Hexosamine Biosynthetic Pathway and O-linked N-acetylglucosamine cycling for therapeutic and imaging capabilities in diffuse large B-cell lymphoma

http://www.cellpointweb.com/pdf/12413-186535-1-PB-2016-EC-G-Paper.pdf

Cell>Point enters into license agreement with Vyripharm Biopharmaceuticals for the use of Cell>Point’s In-Situ Hydrogel, N4 Technology and Oligosaccharide (Dual Agent) Technology

CENTENNIAL, Colo., August 24, 2016  – Cell>Point today announced it has entered into license
agreements with Vyripharm Biopharmaceuticals for the use of its In-Situ Hydrogel, N4 Technology and
Oligosaccharide (Dual Agent) Technology to develop applications in combination with cannabinoids for
nuclear imaging and therapeutic applications for neurologic disorders including, but not limited to, posttraumatic
stress disorder (“PTSD”), epilepsy and other acute/chronic disorders. As part of the license
Cell>Point will own a majority interest in Vyripharm Biopharmaceuticals.

About Cell>Point, L.L.C.

Cell>Point is a biopharmaceutical company focused on the development of universal molecular imaging compounds and molecular therapeutics for the diagnosis, staging, treatment and treatment monitoring of cancer, cardiovascular disease, and a range of ischemic diseases. Cell>Point has exclusive licenses to five drug-development platforms, all from The University of Texas MD Anderson Cancer Center in Houston, a world leader in cancer research and care. Information on Cell>Point’s product candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The Company has offices in Centennial, Colo. and Houston, Texas.

About Vyripharm Biopharmaceuticals, L.L.C

Vyripharm Biopharmaceuticals is a Delaware limited liability company formed in 2014 for the purpose of treating neurological disorders and cancers. The Company has established a proprietary comprehensive analytical testing, monitoring and tracking system program that it believes will become the standard accepted methodology to help create stability and predictability in the emerging business of medical cannabinoids. The Company will also develop applications (using in-licensed proprietary technologies in combination with cannabinoids) for nuclear imaging and therapeutic applications for neurologic disorders including, but not limited to, post-traumatic stress disorder (“PTSD”), epilepsy and other acute/chronic disorders. The company is located in Houston, Texas.

Cell>Point Announces Postive Results from 99mTc-Oncardia (EC- G) trial at the Unviersity of Chicago Medical Center to image and montior therapy for Head and Neck Cacer.

CENTENNIAL, Colo., January 15, 2015 – Cell>Point announced today positive results following conclusion of a Head and Neck Cancer imaging trial for <sup>99m</sup>Tc-Oncardia conducted pursuant to a  physician initiated IND study at the University of Chicago Medical Center.

The study imaged patients with squamous cell carcinoma of the head and neck (SCCHN) with technetium-99m- labeled Oncardia (Ethylenedicysteine-Glucosamine), Cell>Point’s proprietary nuclear imaging product candidate.   The purpose of the study was to evaluate and study treatment response for patients with SCCHN.  Patients were  imaged prior to starting therapy and at 4 and 10 weeks.  <sup>99m</sup>Tc-Oncardia, as imaged by SPECT/CT, correctly localized  in the SCCHN tumor prior to treatment and images at 4 and 10 weeks properly reflected treatment.   Cell>Point  believes 99mTc-Oncardia will offer better specificity and better predictive values than those achievable from other  imaging modalities in assessing therapeutic response for those patients with locally and advanced head and neck  cancer.

Please see attached poster presentation on preliminary results from The University of Chicago.

About Cell>Point

Cell>Point is a commercialization-stage biopharmaceutical company developing universal molecular imaging agents and molecular therapeutics for the diagnosis, treatment and treatment monitoring of cancer, heart disease,  and other diseases. Information on Cell>Point’s product candidates and licenses, recent press releases, and  patents and patent filings can be obtained through its website at www.cellpointweb.com. The Company has offices  in Centennial, Colo. and Houston, Texas.

Cell>Point Announces Encouraging Results from 99mTc -EC-G Phase 2a Trial in Evaluating Presence and Severity of Coronary Artery Disease

CENTENNIAL, Colo., April 9, 2013—Cell>Point announced today encouraging results following the conclusion of its Phase 2a cardiovascular clinical study performed by Cardiovascular Imaging Technologies of Kansas City, Missouri.

The study imaged patients with technetium-99m-labeled Ethylenedicysteine-Glucosamine (99mTc-EC-G), Cell>Point’s proprietary nuclear imaging product candidate, which is target specific for detecting the presence and extent of  schemia in patients with Coronary Artery Disease (CAD).

The results from the Phase 1 and 2a studies show that 99mTc-EC-G has the potential to accurately diagnose myocardial ischemia (that is, decrease in blood flow and oxygen to heart muscle) in as little as 30 minutes post injection in patients studied at rest only.

“Based on what we have observed in clinical data for Phase 1 and Phase 2a, and assuming further confirmation in Phase 2b, it is our belief that 99mTc-EC-G has the ability to dramatically shift the paradigm for nuclear cardiac imaging in terms of significantly shortening procedure time, increasing diagnostic accuracy, and easing the patient’s experience by eliminating the need in most cases for a separate stress study,” said Cell>Point President David Rollo, M.D., Ph.D.

The multicenter Phase 2b trial will evaluate the diagnostic accuracy (sensitivity and specificity) of a 99mTc-EC-G study performed at rest only compared to a two-day 99mTc-Cardiolite rest/stress study to determine the presence, anatomical location, and severity of ischemia in patients with CAD. Diagnostic catheterization will be used as the standard of truth. Camargo Pharmaceutical Services of Cincinnati will perform the role of general manager over the clinical research and regulatory function for the study. Premier Research of Research Triangle Park, North Carolina, will continue their role as the clinical research organization for the study.

Leading the Phase 2b study as principal investigator will be Gary Heller, M.D., Ph.D., Professor of Medicine and Nuclear Medicine at the University of Connecticut School of Medicine, and a world renowned nuclear cardiologist who has authored several hundred clinical articles and a number of textbooks in nuclear cardiology.

According to the American Heart Association, over 10 million nuclear cardiology scans are performed annually in the United States. Over 90 percent of the scans are Myocardial Perfusion Imaging (MPI) procedures, a $1.8 billion U.S. market.

A typical MPI procedure, which comprises both a rest and stress study, takes between 5 and 7 hours to complete. For the stress component of the MPI study, patients are subjected to physical and/or pharmacologic stress, which is often an issue and an inconvenience for the patient. Because of the required time separation between the stress and rest study, the patient is typically asked to return the next day to complete the full study. This significantly increases the time commitment for the patient and further restricts camera availability for additional patient studies. It is one of Cell>Point’s goals with 99mTc-EC-G to substantially reduce the need for the patient to undergo a stress study, thus positively impacting the patient’s time commitment as well as camera access for additional nuclear cardiac imaging studies.

About Cell>Point

Cell>Point is a commercialization-stage biopharmaceutical company developing universal molecular imaging agents and molecular therapeutics for the diagnosis, treatment and treatment monitoring of cancer, heart disease, and other diseases. Cell>Point has exclusive license to five drug-development platforms, all from The University of TexasMD Anderson Cancer Center in Houston, a world leader in cancer research and care. With the platforms, Cell>Point has created a robust pipeline covering cancer imaging and therapy; cardiovascular imaging; high-yield radio/chemotherapy delivery system for treating inoperable and unresectable tumors; neuroendocrine disease imaging and therapy; diabetes imaging; and dualcompound imaging in cancer for SPECT/CT, SPECT/MRI, PET/CT, and PET/MRI. Information on Cell>Point’s product candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The Company has offices in Centennial, Colo., San Francisco and Houston.

Cell>Point and HYUN IMC Expand License in South Korea to Include Hanmi Pharmaceutical, Co., Ltd for Cancer and Heart Disease Imaging

Third License Completes the Company’s Initiative to Secure a Strong Pharmaceutical  Partner for the South Korean Market

CENTENNIAL, Colo., March 11, 2013—Cell>Point announced today that it entered into a license agreement on December 17,2012 with Hanmi Pharmaceutical Co., Ltd (Hanmi) who is headquartered in Seoul, Korea. The license agreement also includes HYUN IMC as a party (who Cell>Point previously entered into a license with in February 2012 and subsequently amended and restated the license agreement with HYUN IMC on December 4, 2012). The license agreement with Hanmi covers the kit manufacture, marketing and distribution of Cell>Point’s cancer and cardiology imaging product based on its Ethylenedicysteine‐Glucosamine (EC‐G) technology platform. The initial product will be technetium‐99m labeled EC‐G (99mTc‐EC‐G) for SPECT and SPECT/CT imaging. Downstream, the license agreement will cover gallium‐68 labeled EC‐G (68Ga‐EC‐G) for PET/CT imaging. In addition, Hanmi has been granted a Right of First Refusal regarding Cell>Point’s cold metallic therapeutic products Platinum‐EC‐G and 187Rhenium‐ EC‐G, and two imaging products, 99mTc‐EC‐Annexin V to image tumor cell apoptosis, and 99mTc‐EC‐Metronidazole to image tumor cell hypoxia.

Cell>Point receives upfront payments, milestone progress payments, and a royalty on
commercial sales.“We are pleased to associate with such an outstanding pharmaceutical company whose vision is to bring imaging technology to South Korea that has the potential to make high quality cancer imaging more affordable and accessible at a time when the cost of healthcare is becoming a national priority, as it is in many other countries around the world. In addition, Hanmi Pharmaceutical Co is committed to making available cardiovascular imaging technology that has the potential to increase diagnostic accuracy, drastically shorten the time that the patient has to devote to a cardiovascular study, and make the study considerably easier for the patient,” said Cell>Point CEO Greg Colip.
99mTc‐EC‐G, invented at The University of Texas M.D. Anderson Cancer Center and acquired by Cell>Point, is a target‐specific molecular imaging radiopharmaceutical that has moved into a Phase 3 lung cancer imaging trial and Phase 2 cardiology imaging trial.99mTc‐EC‐G is injected intravenously and then imaged using a Single Photon Emission Computed Tomography (SPECT) camera (sometimes referred to as a gamma camera) or a combination SPECT/Computed Tomography (SPECT/CT) camera system. The current standard of care in cancer molecular imaging is fluorine‐18 FluoroDeoxyGlucose (18F‐FDG) imaged using a combination Positron Emission Tomography /Computed Tomography (PET/CT) camera system.

99mTc‐EC‐G Phase 3 lung cancer imaging trial For the Phase 3 lung cancer study, all patients will be imaged with 99mTc‐EC‐G on SPECT/CT and separately imaged with 18F‐FDG on PET/CT cameras. Where combination SPECT/CT cameras are not available, a special workstation will be used to integrate the patient images taken from the stand‐alone SPECT and CT cameras. Using a workstation to integrate the images allows the medical site to take full advantage of 99mTc‐EC‐G without the need for a new combination SPECT/CT camera on the premises. This should significantly expand the utilization of the installed SPECT camera base in the United States and the rest of the world, which is lready
substantially greater than the PET and PET/CT camera base. The lung cancer trial will be followed by Phase 4 trials in lymphoma, breast, liver, colorectal, prostate, and head and neck cancers.

99mTc‐EC‐G Phase 2 cardiology imaging trial In a separate clinical trial, 99mTc‐EC‐G has moved from a Phase 1 to a Phase 2 cardiovascular imaging study. The product is the same as that used in the oncology trials. 99mTc‐EC‐G exhibits minimal uptake in the normal heart; however, it exhibits very high uptake in heart cells that are ischemic (i.e., deprivation of blood flow), such as from atherosclerotic heart disease. The Phase 2 cardiovascular trial involves patients who have suspected coronary artery disease and compares 99mTc‐EC‐G images of the heart with images obtained from the standard of care nuclear cardiology procedure, a full “stress/rest” Myocardial Perfusion Imaging (MPI) protocol.

One of the clinical objectives is to compare the results from the “rest” only portion of the 99mTc‐ EC‐G study to the results from the full “stress/rest” MPI study. Based on clinical evidence from the Phase 1 study, Cell>Point believes clinical information from the 99mTc‐EC‐G “rest” study has the potential for greater diagnostic accuracy in less study time than that required from conducting the full “stress/rest” MPI study. The standard MPI study uses either 99mTc‐sestamibi or thallium 201 for the “stress/rest” images. The traditional “stress/rest” MPI study can take up to 5 to 7 hours to complete, whereas the “rest” only 99mTc‐EC‐G study can be completed in 30 to 45 minutes. This has the potential to dramatically change the logistics of nuclear cardiovascular imaging by providing more comfort and convenience for the patient, by eliminating the need for a stress test and the shorter time required to complete the imaging.

About Cell>Point
Cell>Point is a commercialization‐stage biopharmaceutical company developing universal
molecular imaging agents and molecular therapeutics for the diagnosis, treatment and
treatment monitoring of cancer, heart, and other diseases. Cell>Point has exclusive license to five drug‐development platforms covering cancer imaging and therapy, cardiovascular imaging, high‐yield radio/chemotherapy delivery system for treating inoperable and unresectable tumors, neuroendocrine disease imaging and therapy, diabetes imaging, and dual compound imaging in cancer for SPECT/CT, SPECT/MRI, PET/CT, and PET/MRI, all from The University of Texas M.D. Anderson Cancer Center in Houston, a world leader in cancer research and care.Information on Cell>Point’s drug candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The company is headquartered in Centennial, Colo., and has additional offices in San Francisco and Houston.

About Hanmi Pharmaceutical Co., Ltd
Established in 1973, Hanmi Pharmaceuticals has risen to be one of the top 5 harmaceutical
companies in Korea, and has been the most R&D focused company with the highest R&D
investment for several years. Hanmi Pharmaceuticals has worldwide offices in major countries such as, but not limited to, China, Japan, Europe, and the U.S. The company’s long‐term strategy has been to remain highly flexible, to recognize the need to continuously change and adapt its market and development strategy from its beginnings as a generic pharmaceutical company to Incrementally Modified Drug and Fixed Dose Combination Drugs, and to new drug development including innovative small molecules and biologics. The company has more than 10 FDC pipelines including collaboration projects with Merck, Glaxo SmithKline and Sanofi. During the period of open innovation, Hanmi Pharmaceuticals made multiple strategic collaborations with multinational companies and biotech companies. The company is actively conducting clinical trials for new drug pipelines such as biobetter drugs with LAPSCOVERY (Long Acting Protein‐ Peptide Discovery Platform Technology) and small molecule oncology pipelines in global markets.

About HYUN IMC
HYUN IMC is a South Korean company with interests throughout the Pacific Rim. The company’s core business is in the manufacture and distribution of various medical isotope generators, the production and installation of hot cells, and trading in pharmaceutical raw materials. Through its affiliation with and support from Korean pharmaceutical companies, HYUN IMC made the decision to expand its nuclear medicine business by moving into radio pharmaceutical manufacturing and distribution.

Cardiology Imaging Technologies presents cardiology clinical trial data on EC-G at the American Society of Nuclear Cardiology 2012 Annual Conference

CENTENNIAL, Colo., September 11, 2012 – Cell>Point announced today that Cardiovascular Imaging Technologies presented a Phase 1b clinical trial abstract for its cardiology imaging agent, 99mTc-EC-G (99mTechnetium-EthylenediCysteine-n-acetyl-Glocosamine), used to image ischemic patients during rest and exercise stress testing at the American Society of Nuclear Cardiology 2012 Meeting on September 6, 2012.

http://www.cellpointweb.com/pdf/press/CellPoint-Press-Release-Sept-11-2012.pdf

See the Myocardial Uptake of a Novel Tc-99m Labeled Glucose diagram

Radiation dosimetry and biodistribution of 99mTc-ethylene dicysteine-deoxyglucose in patients with non-small-cell lung cancer.

http://www.cellpointweb.com/pdf/EC-DG%20article%20Phase%20I.pdf

Technologies for Translational Imaging Using Generators in Oncology Short Running Title: Imaging and Oncology

http://www.cellpointweb.com/pdf/Schechter-MS.pdf

Noninvasive Assessment of Tumor Hypoxia with 99mTc Labeled Metronidazole

http://www.cellpointweb.com/pdf/Metronidazole%201999.pdf

In Vivo and In Vitro Measurement of Apoptosis in Breast Cancer Cells Using 99mTc-EC-Annexin V

http://www.cellpointweb.com/pdf/annexin%20Nov%201%202001.pdf

Assessment of Antiangiogenic Effect Using 99mTc-EC-Endostatin

http://www.cellpointweb.com/pdf/Endostatin%20Nov%202002.pdf

Prognostication of Recovery in Patients With Acute Ischemic Stroke Through the Use of Brain SPECT With Technetium-99m Labeled Metronidazole

http://www.cellpointweb.com/pdf/Stroke%20April%202003.pdf

Imaging with 99mTc ECDG Targeted at the Multifunctional Glucose Transport System: Feasibility Study with Rodents1 Radiology

http://www.cellpointweb.com/pdf/Radioilogy%20Feb%202003.pdf

Assessment of epidermal growth factor receptor with 99mTc ethylenedicysteine C225 monoclonal antibody.

http://www.cellpointweb.com/pdf/C%20225%20Jan%202003.pdf

Radiation Dosimetry of 99mTc-Labeled C225 in Patients with Squamous Cell Carcinoma of the Head and Neck.

http://www.cellpointweb.com/pdf/C%20225%20Oct%202004.pdf