VisionGate, Inc., a clinical stage oncology pharmaceutical and diagnostics company, announces that it has finalized an exclusive worldwide license agreement regarding iloprost betadex clathrate and a manufacturing and supply agreement for the substance iloprost with Bayer AG in the field of lung cancer and lung cancer prevention.
Under the agreements, Bayer is granting VisionGate an exclusive worldwide right and license to technology that will support VisionGate in the development, manufacture, use, sale and commercialization of iloprost betadex clathrate; an oral formulation of the substance iloprost in the field of lung cancer and lung cancer prevention. These agreements also provide VisionGate product supply exclusivity and, pursuant to these agreements, Bayer will manufacture and sell iloprost exclusively to VisionGate in the field of lung cancer and lung cancer prevention, while VisionGate retains the right to manufacture Iloprost for such field itself based on an exclusive license to Bayer’s manufacturing technology.
The first intended indication for Iloprost betadex clathrate will be the prevention of lung cancer, the world’s #1 cancer killer, through a mechanism of action that selectively modulates the cellular pathway that suppresses growth of pre-cancer dysplasia. The successfully completed Phase 2 clinical study of iloprost betadex clathrate achieved a 48% reversal of bronchial dysplasia among high-risk patients. If confirmed in additional trials, this remarkable result would translate into a significant impact in preventing lung pre-cancer from progressing to cancer, thus reducing lung cancer incidence. VisionGate remains on track for an FDA meeting to finalize the clinical study protocol and approval path for Iloprost, the first oral lung cancer interception drug.
“Iloprost betadex clathrate is described as ‘the most promising lung cancer chemopreventive investigational drug based on a positive Phase 2 randomized controlled trial (RCT)1’ said Alan C. Nelson, PhD, Chairman and CEO. “Along with our previously announced agreement with PCI Pharma Services for formulation and finished product manufacturing, this agreement with Bayer, a leading global pharmaceutical manufacturer, secures two highly regarded manufacturing partners for VisionGate’s lung cancer interception business” added Dr. Nelson.
Lung cancer is by far the leading cause of cancer deaths worldwide. Each year, more people die of lung cancer than from 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 Iloprost oncology development program is part of VisionGate’s mission to develop a new treatment paradigm for lung cancer interception and prevention. “These agreements secure the expertise necessary for high-potency manufacturing of iloprost betadex clathrate in the field of lung cancer and lung cancer prevention and will enable VisionGate to progress into the final stages of clinical development for this potentially transformational drug therapy”, added Dr. Nelson.
For more information on VisionGate, please visit http://www.visiongate3d.com.
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About VisionGate, Inc.
VisionGate is a clinical stage oncology diagnostics and pharmaceutical company focused on the early detection and prevention of cancer. Our lead investigative pharmaceutical drug is iloprost betadex clathrate. In a Phase 2 clinical study, iloprost betadex clathrate demonstrated statistically significant reduction in overall bronchial dysplasia in high-risk 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 incidence. We are planning to commence a Phase 2/3 pivotal clinical trial of iloprost betadex clathrate and, in parallel, we are developing the LuCED® lung assay, also targeted for a pivotal clinical study, as a complementary diagnostic test for detection of patients with bronchial dysplasia that may be treated with iloprost betadex clathrate. VisionGate’s proprietary LuCED lung assay is a non-invasive liquid biopsy assay for detection of early-stage lung cancer and pre-cancer, demonstrating exceptional sensitivity and specificity in blinded clinical studies3. This assay, based on VisionGate’s mail-in kit for home collection of sputum, 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;123:548–556.
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