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iBio Expands IP Protection of Biotherapeutic Product for Treatment of Fibrosis

Companies mentioned in this article: iBio, Inc.

NEWARK, DE -- (Marketwired) -- 06/10/14 -- iBio, Inc. (NYSE MKT: IBIO), a leading provider of plant-based biotechnology for developing and manufacturing biological products, announced the issue by the U.S. Patent and Trademark Office on May 6, 2014 of a new patent covering the company's idiopathic pulmonary fibrosis (IPF) and systemic sclerosis product pipeline.

The new patent on an invention by Dr. Carol Feghali-Bostwick and colleagues, US 8,716,232 entitled "USE OF ENDOSTATIN PEPTIDES FOR THE TREATMENT OF FIBROSIS," includes claims covering composition of matter and methods of use for endostatin-related peptides.

iBio obtained an exclusive license to patents and related intellectual property developed by Dr. Feghali-Bostwick and then entered a collaboration agreement with the Medical University of South Carolina (MUSC) that will enable iBio to advance the development of this potentially breakthrough biotherapeutic product against otherwise unstoppable fibrotic diseases.

Data published in 2012 by Dr. Feghali-Bostwick, now the Kitty Trask Holt and SmartState® SC Centers of Economic Excellence Endowed Professor at MUSC, demonstrate that certain endostatin-derived peptides are useful for both inhibition and reversal of fibrosis in preclinical mouse models of fibrosis as well as in human skin. iBio has initially expressed the active pharmaceutical ingredient using its patented iBioLaunch™ technology, and plans to make clinical development of this promising product a key priority in the proprietary application of iBioLaunch.

Effective treatment of IPF, systemic sclerosis and localized scleroderma, represents an unmet medical need. There are some limited results being claimed with existing therapies. However, there are currently no effective therapies for stopping or reversing fibrosis. Drug candidates for which Phase 3 clinical results have recently been released represent modest advances and are associated with side effects while failing to halt or reverse the disease progression. Individual patients are unlikely to be able to perceive the benefit, if any, provided by either drug because their disease will continue to worsen, even if at a slightly slower pace than would occur without drug therapy.

The prevalence of systemic sclerosis is 150 to 300 cases per million persons in the U.S. and Europe (Current Opinion in Rheumatology, 2012). The prevalence of IPF, depending on the diagnostic criteria used, ranges from 140 to 279 cases per million persons in the U.S. and up to 234 cases per million in Europe (European Respiratory Review, 2012). According to GlobalData, the market across the U.S. and European Union for IPF therapy is expected to grow from $49 million in 2012 to more than $1.1 billion by 2017 for already existing therapies.

"Our collaboration with Professor Feghali-Bostwick is progressing rapidly toward clinical trials," said Robert B. Kay, iBio's chairman and CEO. "Laboratory results continue to reinforce our confidence in the importance of this program, and we expect to soon expand our team to include a number of world-class clinical advisors."

Dr. Feghali-Bostwick commented: "We are enthusiastic about the plant-based production of our peptide with iBioLaunch technology and the rapid expansion of the translational component of our research program made possible by iBio."

About Systemic Sclerosis and Idiopathic Pulmonary Fibrosis

Systemic sclerosis is a disorder that affects connective tissue of skin and internal organs as well as the walls of blood vessels. Early diagnosis and individualized therapy can be helpful, but treatment of systemic sclerosis is limited to symptom management. No currently approved drug has been proven to arrest the underlying process or processes that drive progression of the disease. Organ fibrosis is responsible for health care costs exceeding $10 billion per year, and it is estimated that the number of deaths due to fibrosis is double the number of deaths due to cancer. Organ fibrosis is responsible for nearly half of deaths in developed countries and results in significant physical, emotional, and financial burdens as well.

IPF is a life-shortening lung disease with a rapidly progressing negative impact on quality of life leading to death within an average of three to five years after diagnosis. IPF has a worse survival rate than most cancers except for pancreatic cancer and certain lung cancers.

About iBio, Inc.

iBio develops and offers proprietary products and product licenses, based on its proprietary iBioLaunch and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines. In Brazil, iBio has been collaborating with Oswaldo Cruz Foundation (Fiocruz) and Fraunhofer Center for Molecular Biotechnology since 2011 to develop a recombinant yellow fever vaccine based upon iBio technology.

The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. The iBioModulator platform is complementary to the iBioLaunch platform and designed to significantly improve vaccine products with both higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. Further information is available at: www.ibioinc.com.

FORWARD-LOOKING STATEMENTS

STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.


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