GLG Pharma, a Jupiter, Florida company developing precision medicines that target the Signal Transducer and Activator of Transcription factor 3 (“p-STAT3 and STAT3”) pathway, Skyline Medical Inc. (NASDAQ:SKLN), and Helomics Corporation today jointly announced a strategic partnership among these three companies, focused on using their combined technologies to bring personalized medicines and testing to ovarian and breast cancer patients, especially those who present with ascites fluid (over one-third of patients).
The partnership brings GLG’s new Cell Capture, Culture and Screening system to help isolate samples of ascites fluids from patients that may contain cancer stem cells, cancer cells and other cells together with the previously announced Skyline-Helomics venture being developed to utilize the STREAMWAY® System for automated, direct-to-drain medical fluid disposal, in combination with the Helomics ChemoFx® diagnostic platform to target patient drug treatment, quickly and cost effectively. “We know that the cancer cells found in the ascites fluid are different than tumor cells. There is increasing evidence that these cells may respond to different chemotherapy protocols,” says Arlette Uihlein, MD, Helomics Medical Director.
The partnership will build on Skyline’s STREAMWAY System to add a collection system for ascites fluids based on GLG’s Capture, Culture and Screening system, that pathologists can then process and send to Helomics for further evaluation in using Helomics’ ChemoFx® diagnostic platform. Together with a combination of STAT3 inhibitors from GLG, the partnership is expected to create new revenue streams to be shared between the Skyline-Helomics venture and GLG. “This new partnership will leverage our existing technologies to further impact precision therapy for women with ovarian and breast cancer,” stated Gerald J. Vardzel Jr. President & CEO at Helomics. “Furthermore, it provides additional rich molecular and patient outcome data to continue the build out of our proprietary D-CHIP™ AI-powered bioinformatics platform within our venture with Skyline, which through partnerships with the Pharma industry, will inform the search for the therapies of tomorrow,” commented Mark Collins Ph.D., VP of Innovation & Strategy at Helomics. “The recently announced establishment of the Skyline-Helomics venture paved the way for us to welcome GLG Pharma back into our family of businesses and underscores Skyline’s commitment to the growth opportunities in personalized medicine," stated Dr. Carl Schwartz, CEO of Skyline Medical.
“This new partnership between the Skyline-Helomics venture and GLG is an important strategic step towards realizing technical and business synergies between our companies that could not have been possible in the past. We are now able to bring to the market a very novel and exciting approach to precision cancer therapies that will benefit oncologists, pathologists and patients while driving real value for our shareholders,” he concluded. In addition, the new partnership will file for a European Grant application in the next few weeks to expand GLG’s and the Skyline-Helomics venture’s product offering first in Poland, then Central Europe and finally across all of Europe. GLG’s division, GLG Pharma, SA (Warsaw NewConnect exchange: GLG), recently was awarded a three year $3.7MM grant for STAT3 inhibitors to treat Triple Negative Breast Cancer, with $2.7MM awarded back to GLG Pharma. Phase 1-2 clinical trials are expected to start in 2018. “We believe that using the Cell Capture, Culture and Screening technology for our patient trials is the first step,” said Richard Gabriel, COO of GLG Pharma. “But we see another opportunity to build out this technology first in Poland and deliver the benefits of precision medicine to patients with Ovarian cancer too.”
About GLG Pharma, LLC Based in Jupiter, Florida GLG Pharma, Inc. (GLG) is a private, clinical-stage biotechnology company delivering next-generation therapies for hyper-proliferative diseases such as cancer (breast, ovarian, glioblastoma), polycystic kidney disease, psoriasis, Crohn’s disease and inflammatory bowel disease. Its therapies are precision medicines that target the STAT3 cancer gateway. The company personalizes therapy by using integrative genomics powered, cell culture platform (Gx-C3TM) which enables it to capture hyper-proliferative patient cells from the body, culture and expand them ex vivo in a biomimetic, three dimensional microenvironment without drift or loss of identity, and systematically screen them against our proprietary library of new chemical and repurposed small molecule Inhibitors to identify the most appropriate compound(s) for each patient’s disease. GLG is currently engaged in clinical trials for Chronic Lymphocytic Leukemia (CLL, GLG-801) and Triple Negative Breast Cancer (TNBC); and in collaboration with the National Cancer Institute, as part of the Cancer Prevention Program, GLG-302 is being developed as a breast cancer preventative. For additional information, connect on Twitter, Facebook, LinkedIn or call 253-709-2924 or connect firstname.lastname@example.org.
About Skyline Medical Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical's STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S. For additional information, please visit www.skylinemedical.com.
About Helomics Corporation Helomics® is a precision diagnostic company and integrated clinical contract research organization whose mission is to improve patient care by partnering with pharmaceutical, diagnostic, and academic organizations to bring innovative clinical products and technologies to the marketplace. In addition to its proprietary precision diagnostics for oncology, Helomics offers boutique CRO services that leverage our patient-derived tumor models, coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and a proprietary bioinformatics platform (D-CHIP) to provide a tailored solution to our client’s specific needs. Helomics® is headquartered in Pittsburgh, Pennsylvania where the company maintains state-of-the-art, CLIA-certified, clinical and research laboratories. For more information, please visit: www.Helomics.com.
Forward-looking Statements Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to the proposed joint ventures with Helomics and CytoBioscience, including the need to negotiate the definitive agreements for the joint ventures; possible failure to realize anticipated benefits of the joint ventures; and costs of providing funding to the joint ventures. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. See the Company's most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.
Contacts: Dr. Jeff Taylor 253-709-2924; email@example.com