SEATTLE, WA (April 5, 2018) – VisionGate, a clinical stage oncology pharmaceutical and diagnosticscompany, is pleased to announce today the advancement of its breakthrough technology Cell-CT platform. The first shipment of commercial-capable Cell-CT systems were delivered to VisionGate’s clinical laboratory in Phoenix, Arizona earlier this year, setting the stage for the company’s advancement.
“I am pleased to announce that after years of development and refinement, VisionGate’s proprietary, breakthrough technology, the Cell-CT platform, is poised to be a key component in the cancer continuum of care”, said Alan C. Nelson, PhD, Chairman and CEO in a statement.
Cancer Diagnostics Services: Our initial cancer diagnostic services test, the LuCED® lung test, has been developed to support the early detection of lung cancer. Lung cancer remains the number one cause of cancer mortality in the United States, where an estimated 160,000 people will die of the disease this year alone. Lung cancer survival rates have barely improved over the past two decades, largely because most lung cancers are not detected until they are too far advanced to be treated effectively. There is an urgent need for new cancer detection technologies that identify this deadly disease at its earliest stages. The LuCED test in blinded studies has delivered greater than 90% sensitivity and a specificity of greater than 95% across all stages and types of lung cancers. VisionGate’s aspiration is to establish the LuCED lung test as standard of care for early lung cancer detection beginning with lung nodules assessment. Clinical trials to support potential FDA approval of the LuCED lung test are expected to begin later this year.
Biopharmaceutical Services to Enhance Personalized Medicine: Recent research findings indicate the Cell-CT platform has the potential to detect the presence of specific cancer growth driver mutations entirely through their ‘morphometric’ signatures. Further ongoing research is evaluating the capability to assess cellular level Tumor Mutation Burden (TMB) and Malignancy Associated Changes (MAC). These three areas all have enormous potential for an emerging biopharmaceutical services capability to support oncology drug development and patient clinical decision making including identification of patients appropriate for treatment with immuno-oncology medicines and other targeted cancer medicines. This capability may also enable longitudinal monitoring of potential disease recurrence, may identify therapy escape mechanisms and resistance growth pathways, and thereby support accelerated new drug development.
Cancer Prevention Medicines and Services: Every cancer develops from abnormal precancerous cells called dysplasia. The Cell-CT platform identifies abnormal cells that are precancerous dysplasia cells, as robustly as it identifies cancer cells themselves. This Cell-CT capability provides an opportunity for early identification of patients with pre-cancerous conditions and to intervene with treatment to delay or even prevent cancer from occurring. VisionGate’s lead cancer prevention drug, iloprost, an oral prostacyclin analog, has demonstrated significant reduction of bronchial dysplasia in a Phase II trial and is able to advance into pivotal testing because of VisionGate’s diagnostic technology. “Our objective is to establish oral iloprost as the first treatment for bronchial dysplasia and the first lung cancer prevention medicine,” added Nelson. The Company anticipates further clinical testing of oral iloprost will commence in the first half of 2019.
For more information on VisionGate, please visit www.visiongate3d.com.
About VisionGate, Inc.
VisionGate is a clinical stage oncology pharmaceutical and diagnostics company focused on the early detection and prevention of cancer. Our lead investigative pharmaceutical drug is oral iloprost, currently in clinical development for the treatment of pre-cancerous bronchial dysplasia and the prevention of lung cancer following a successful Phase 2 clinical trial. The LuCED® lung test will be the companion diagnostic for oral iloprost. VisionGate’s proprietary LuCED lung test is a non-invasive liquid biopsy diagnostic test in development for detection of early-stage lung cancer, demonstrating exquisite sensitivity and specificity in blinded clinical studies. This non-invasive sputum test is processed on the world’s first automated 3D single cell imaging and analysis technology, the Cell-CT™ platform, named aptly because it is similar in principle to taking a CT scan of individual cells, but using visible light without harmful radiation. With 176 issued patents in 13 countries, VisionGate expects to play a leading role in the battle against lung cancer – the world’s number one cancer killer. VisionGate, Inc. is led by Dr. Alan Nelson, physicist, bioengineer, and serial entrepreneur who previously developed the world’s first and only automated screening test to detect cervical cancer, marketed globally today as FocalPoint by Becton Dickinson. The LuCED lung test is a product in development and is not currently available commercially.
About the Cell-CT™ 3D Imaging Platform
The automated Cell-CT™ 3-Dimensional Single Cell Imaging and Analysis Platform is the enabling technology which produces high-resolution 3D images of individual cells using a technique called optical computed tomography. This 3D optical CT platform breaks new ground in the field of quantitative cell analysis by its unique ability to compute the true 3D internal structure of cells based on molecular optical absorption densities. The Cell-CT platform produces high-resolution 3D images of individual cells and measures hundreds of critical disease indicators in each cell. Together with advanced artificial intelligence (AI) algorithms, these produce accurate cell classifications that aid in the early detection of disease. Additionally, the Cell-CT platform has the potential to deliver molecular and genetic biosignatures of disease longitudinally to compliment drug development in the biopharma services arena. Cells are not placed on slides, but rather, they are suspended in fluid (liquid biopsy) and injected through a microcapillary tube that permits multiple viewing perspectives around 360°. The Cell-CT platform is a device under development and not currently cleared in the US.
Cautionary Note Regarding Forward-Looking Statements for VisionGate
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and made in reliance on the “safe harbor” provisions of said act. These forward-looking statements are based on estimates, projections, beliefs and assumptions of the Company at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results and conditions that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug and diagnostics development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances. Actual results could differ materially from those projected in these forward-looking statements due to a variety of factors, including, without limitation, the acceptance by customers of our products, our ability to develop new products cost-effectively, our ability to raise capital in the future, the development by competitors of products using improved or alternative technology, the retention of key employees and general economic conditions. Forward-looking statements are subject to change without notice. VisionGate disclaims any intent or obligation to update these forward-looking statements. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.