Noveome Debuts with Top-Line Data from Three Phase I Clinical Trials
Noveome Biotherapeutics, Inc., a clinical-stage company focused on the biology of paracrine signaling, today announced that the company, formerly known as Stemnion, Inc., has emerged with a new focus and top-line results from their lead product, ST266, in three Phase 1 clinical trials. The company is the leading innovator in paracrine signaling for the clinical development of novel biotherapeutic products that work safely and effectively in complex biologic processes. In the three clinical trials, where topical ST266 was evaluated for the potential treatment of dermatologic, ocular or oral health conditions, it was found to be well-tolerated and there were no drug-related adverse events reported.
“In pre-clinical and clinical studies, Noveome’s product, ST266, has exhibited biological activity coupled with an attractive safety profile,” said A. Clarke Atwell, Chief Executive Officer, President and Director at Noveome. “Our patent estate and proprietary manufacturing process provides a clear source of competitive advantage, creates a broad number of potential product indications and provides the flexibility of multiple applications for each indication: topical, oral, inhaled and intravenous.”
The company was co-founded in 2000 by William Golden and George Sing of Lancet Capital, as well as John Fung, MD, PhD, George Michalopoulos, MD, PhD and Stephen Strom, PhD, current and former faculty members of the McGowan Institute for Regenerative Medicine. Seed financing was provided by Lancet Capital. Since its inception, the Company has raised $19 million of private equity financing and more than $100 million in non-dilutive funding. Noveome has sufficient sources of committed capital to fund operations and multiple clinical trials into 2017.
“Pittsburgh offers an excellent environment for starting and building a world-class biotechnology company,” said William J. Golden, CFA, Co-Founder, Executive Chairman, Executive VP & CFO. “It has provided Noveome with a talented and committed workforce, proximity to world class medical advisors from local universities, and access to non-equity funding and support from local and state government.”
About the Phase 1 Clinical Trials
Three Phase 1 clinical trials were conducted to assess the safety and tolerability of topical ST266 formulations for potential treatment of dermatologic, ocular and oral health conditions. In the first Phase 1 study, patients with partial thickness burns were administered topical ST266 according to one of three unique dosing regimens over a 21-day period. In the second Phase 1 study, patients with a history of dry eye syndrome were administered ST266 eye drops four times per day for six weeks and then observed for an additional 30 days following treatment. In the third Phase 1 study, patients with gingivitis received intraoral ST266 once daily for two weeks followed by a 30 day observation period. In all three Phase 1 studies, topical ST266 was well tolerated and there were no drug-related adverse events reported.
ST266 is a novel secretome – a rich, complex solution of molecules secreted from proprietary cells. Instead of a single drug and target, the Noveome secretome contains many biologically active molecules, present in physiological concentrations. This secretome is a source of necessary molecules used at critical points in biologic processes, and available at sufficiently low levels to avoid negative effects. ST266 demonstrates the following unique attributes, which can be applied across a wide range of disease indications to improve patient outcomes: modulates inflammation, speeds impaired wound healing, restores bone growth, protects and regrows nerves, regenerates cells, and provides a strong safety profile.
Noveome is a private, clinical stage biotherapeutics company leveraging the science of paracrine signaling to develop safe and effective products that treat complex diseases. The company’s paracrine therapeutic approach has potential to be applied across a wide range of disease indications to improve patient outcomes. The company’s lead product, ST266, will enter Phase 2 clinical testing in 2016. The company, based in Pittsburgh, Pennsylvania, was founded in 2000 by Lancet Capital and faculty members from the McGowan Institute for Regenerative Medicine and has raised $119 million funding to date. For more information, on Noveome visit www.noveome.com.
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