Seattle, WA, Jan. 29, 2019 (GLOBE NEWSWIRE) -- VisionGate, Inc., a clinical stage oncology pharmaceutical and diagnostics company, announces that it has selected PCI Pharma Services to provide comprehensive drug manufacturing services, including formulation and finished product manufacturing, for oral Iloprost – VisionGate’s investigative medicine for lung cancer prevention.
“Iloprost has been described as ‘the most promising lung cancer chemopreventive investigational agent based on a positive Phase 2 randomized controlled trial (RCT)1’ and we are moving aggressively toward the final stages of clinical development for this potentially transformational drug therapy”, said Alan C. Nelson, PhD, Chairman and CEO.
Lung cancer is by far the leading cause of cancer deaths worldwide. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. Early detection and treatment of patients at risk of lung cancer is an area of high unmet medical need. The oral iloprost development program is part of VisionGate’s aspiration to bring forth a new treatment paradigm in Lung Cancer Interception & Prevention.
VisionGate further announces that PCI Pharma Services has received delivery of the initial quantity of iloprost API (Active Pharmaceutical Ingredient) to support VisionGate’s lung cancer prevention clinical development program.
“Our agreement with PCI Pharma Services aligns VisionGate with a highly reputable provider of development and manufacturing services for both investigational and commercial products including molecules that require high-potency specialist handling”, added Dr. Nelson.
PCI Pharma Services will now develop the formulation and finished product manufacturing necessary to support the final stages of oral Iloprost clinical development.
For more information on VisionGate, please visit http://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. In a phase two clinical study, oral iloprost demonstrated a statistically significant reduction in overall bronchial dysplasia in patients who were not current smokers.2 Since bronchial dysplasia is a known pre-cursor to lung cancer, its reduction is expected to translate into a reduction in lung cancer. We are planning to commence a Phase 2/3 pivotal clinical trial of oral iloprost in 2019. In parallel, we are developing the LuCED® lung assay, also targeted for a pivotal clinical study in 2019, as a complementary diagnostic for oral iloprost. VisionGate’s proprietary LuCED lung assay is a non-invasive liquid biopsy assay in development for detection of early-stage lung cancer and pre-cancer3, demonstrating exceptional 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, VisionGate’s proprietary 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 177 issued patents in 13 countries, VisionGate expects to play a leading role in the battle against lung cancer – the world’s deadliest cancer.
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.
1 Kensler, et. al., Transforming Cancer Prevention through Precision Medicine and Immuno-oncology; Cancer Prevention Research, pages 7-8, January 2016
2 Keith, et.al., Oral Iloprost Improves Endobronchial Dysplasia in Former Smokers, Cancer Prevention Research (Phila). 2011;4(6):793-802.
3 Wilbur, et.al., Automated 3-Dimensional Morphologic Analysis of Sputum Specimens for Lung Cancer Detection: Performance Characteristics Support Use in Lung Cancer Screening, Cancer Cytopathology, 2015.
Attachment