Dr. Stephen Sonis has clinical and pre-clinical expertise in radiation research, oral oncology, mucositis, periodontology, allergy and inflammation as well as tremendous experience in drug development to treat chemical, radiation and physical ailments of the gastrointestinal (GI) tract. In particular, his research and publications on inflammation and mechanisms of chronic disease, such as Crohn’s disease and inflammatory bowel diseases, have helped Synedgen to better understand the mechanisms of our primary products in GI and oral treatments.

Dr. Chuck Hofacre is a thought leader in the effects of antibiotic use in animals, the emergence of bacterial resistance, and the role of commensal bacterial in the health of the gastrointestinal tract. He holds patents on novel methods for treating GI inflammation and promoting GI health in animals. He actively advises multinational companies and the US and international governments on issues relating to food safety and animal feed. His insights have helped Synedgen understand the powerful role of our polysaccharides in treating GI infection and our potential to provide alternate methods for food safety.

Dr. Hal Oien is a successful business and thought  leader in oral care with international connections. His own businesses have taken advantage of the types of manufacturing, regulatory strategies, and international outreach that are critical to the success of Synedgen’s oral care programs. His connections and business acumen have advised Synedgen’s strategic development for our oral rinse and a number of device and cosmetic applications underway.

“We are honored to have these esteemed researchers on our Science Advisory Board,” commented Synedgen president Shenda Baker. “Their active engagement with our science team and business development will be a tremendous asset to us as we move towards product launches.”

For more details, please see the brief biographies below:

Stephen T. Sonis MD, DMD, is a Professor of Oral Medicine, Department of Oral Medicine, Infection and Immunity, at the Harvard School Of Dental Medicine, and Chief and Senior Surgeon, Divisions of Oral Medicine, at Dana-Farber Cancer Institute and Brigham and Women’s Hospital.  He has 39 years of academic and clinical research experience with cancer regimen-related mucosal toxicities. He also serves as President of TRIAD Burden of Illness, a not-for-profit research collaborative for outcomes research of regimen-related toxicities, as a Special Government Employee on the Oncologic Drugs Advisory Committee for the U.S. Federal Drug Administration, and as a Partner at Biomodels, LLC.

Dr. Sonis is the recipient of numerous awards and honors including the Tufts Alumni Association Award in Periodontology, the American Academy of Oral Medicine Award, and Distinguished Faculty Award, Harvard School of Dental Medicine.  He has published extensively on the clinical, biological, and health economic aspects of oral complications of cancer therapy.

Charles L. Hofacre, DVM, MAM, Ph.D. is a Professor and the Director of the Clinical Services Department of Population Health at the College of Veterinary Medicine at the University of Georgia, where he has mentored numerous graduate students.  Dr. Hofacre has 23 years in veterinary medicine, and has widely published his research in referred journals, book chapters, and at national and international scientific meetings.

He is a member of the University of Georgia Biomedical and Health Science Institute, and a Faculty member of the University of Georgia Center For Food Safety, and belongs to numerous professional organizations including the American Veterinary Medical Association, the American Association of Avian Pathologists, the World Veterinary Poultry Association, and the United States Animal Health Association. Dr. Hofacre has served on many past and present professional committees, including the National Poultry Improvement Plan (NPIP) General Conference Committee (Advisory Committee on poultry health to the U.S. Secretary of Agriculture), the Board of Governors of American College of Poultry Veterinarians, Chairman of the American Association of Avian Pathologists Committee on Food Safety and Diseases of Public Health Significance, the American Veterinary Medical Association Food Safety Committee of the Council on Public Health and Regulatory Veterinary Medicine, and President of the American College of Poultry Veterinarians.

Hal Oien DMD, MAGD
 was a practicing dentist for 23 years, an innovator in product development and has been conducting medical product R&D since 1995. He is the President of Jordco, Inc., a world class dental products innovation and manufacturing company focused on the research and development of dental products that make procedures easier, safer, and more productive, while meeting evolving infection-control guidelines. He is the President of Interventional Hemostasis Products, a division of GSEM, Inc., and Vice President of HemoBand, Inc., a hands-free compression device company.

Dr. Oien’s current research is focused on long acting topical anesthetics, Hemostatic and healing applications in wound research, next generation wound irrigants, MRSA Antagonist Co Antibiotics, guided bone regeneration, STAMPS: Specifically Targeted Anti Microbial Peptides, and Cystic Fibrosis sinus pathology.

He is a member of the American Dental Association, the Oregon Dental Association, the Washington County Dental Society, the Academy of General Dentistry, the Oregon Academy of General Dentistry, and the OAGD Oral Medicine Study Group.

Synedgen’s newly developed wound irrigation rinse, Catasyn, safely prevents and treats infections in acute wounds and simultaneously stimulates the wound healing process.  DARPA has awarded Synedgen a 12-month, $500k development grant to accelerate the submission of a pre-Investigational New Drug (IND) application to the FDA. This research addresses an urgent need for the prevention and management of wound infections and the healthy regeneration of wound tissue.

Wound care and chronic infection from complications related to Improvised Explosive Devices (IED) injury in soldiers is a major medical concern for DARPA and the US military. Bacterial infections are common in IED and other traumatic injuries, yet increasing rates of antibiotic resistance make the use of prophylactic antibiotics difficult, limiting treatment and recovery. Once the infection takes hold, multi drug resistant bacteria, such as methicillin resistant Staphylococcus aureus and Acinetobacter baumaunnii, are even more difficult to treat because they become protected in the biofilms they form and they have expanding resistance to traditional antibiotics.

This award leverages previous Synedgen wound research, which demonstrated remarkable antimicrobial activity against drug resistant organisms as well as significant ability to promote the healing process.  During this effort, Synedgen will optimize the ability of the rinse to treat and prevent infections as well as stimulate wound healing in animal models. Additionally, Synedgen will optimize the treatment regimen for human use and complete other product validation requirements necessary to begin FDA regulatory approval for use in human subjects.

“While commonly used antiseptics and wound irrigation products are harmful to human tissue, our wound rinse encourages wound closure and is effective against both resistant Gram-positive and Gram-negative bacteria and their biofilms,” remarked Synedgen CEO Dr. William Wiesmann. “Unlike traditional antibiotic based treatments, which are based on killing bacteria and can cause bacterial resistance, our wound rinse prevents binding and invasion of bacteria. Equally important, our rinse has residual activity to provide longer-term protection.”

“Catasyn has been demonstrated to remove established biofilms from infected wounds, which is an unmet need both in military and civilian settings. We are eager to accelerate the development of Synedgen’s wound care products that safely provide a revolutionary breakthrough for preventing and treating drug resistant infections,” stated Synedgen President Shenda Baker.

March 26, 2012—Synedgen VP of Research, Stacy Townsend PhD, has been invited to present recent research results on Synedgen’s proprietary wound treatment at the 112th General Meeting of American Society for Microbiology (ASM2012) in San Francisco on June 16.

The presentation entitled “A Novel Chitosan Derivative is Mucoadhesive and Reduces Binding of MRSA and Acinetobacter baumannii to Epithelial Cells” highlights research examining the ability of Synedgen’s proprietary polysaccharide, SYN01, to protect tissue from these bacteria.  Methicillin resistant staphylococcus aureus (MRSA) is a common drug-resistant bacteria generating growing concern for both hospital and community acquired infections. A. baumannii is an increasing threat to our deployed troops, and also is frequently present in the US hospital environment. The presentation demonstrates the ability of SYN01 used in a wound rinse to limit the invasion and attachment of A. baumannii and MRSA bacteria on epithelial cells, and to provide prolonged, residual reduction of bacterial binding when used as a pretreatment.

After an hour of pretreatment of human epithelial cells with SYN01, the treatment was removed and bacteria were added. Bacterial attachment and invasion were reduced up to 18-fold for MRSA and 20-fold for A. baumannii.  A 10-fold reduction in MRSA invasion was maintained up to 5 hours after pretreatment was removed.

“These results demonstrate that our non-toxic SYN01 is protective to tissue against bacterial infection. The Synedgen technology could help prevent serious infections and complications due to A. baumannii and MRSA soft-tissue and respiratory infections,” remarked Townsend.

Bacterial infections are currently treated with antibiotics; however, more and more bacteria are becoming resistant to these treatments. “We believe that SYN01 provides a revolutionary mechanism to treat and prevent infection. For infection to occur, bacteria must adhere to tissue,” noted Synedgen President and COO, Shenda Baker.  “SYN01 blocks the foothold bacteria need to create infection. Use of traditional antibiotics results in killing both the infectious bacteria and the good, commensal flora, as well as potentially contributing to bacterial resistance. Synedgen is devoted to developing products that address a critical national need with a novel, effective approach that moves away from antibiotics.”

The companies will first launch an oral rinse in Scandinavia, with follow up distribution in Western Europe. The oral rinse contains a unique, new formulation that gently removes plaque while maintaining a natural oral flora and healthy mouth.  Unlike other oral rinse products that contain harsh or environmentally unfriendly chemicals such as alcohol, chlorhexidine, and triclosan, this new product relies on a patented combination of natural-based products that do not damage oral tissue and have no consequence in the environment.

Compared to other brands, Synedgen and Europharma’s oral rinse shows improved efficacy in removing and preventing the build-up of plaque on teeth and gums. It is mouth-friendly, with a neutral pH and fresh taste that doesn’t harm normal or damaged tissue, and will not leave any residual stain on teeth.

The product launch is anticipated for the summer of 2012. “Europharma is an experienced world leader in the production, marketing and distribution of oral care products internationally. We are pleased to work with the knowledgeable team at Europharma and to introduce this and other oral care products based on the Synedgen technology into the marketplace,” said Synedgen President Shenda Baker.

Europharma CEO Declan Lenahan also welcomed the agreement. “The SYN01 oral rinse represents a new era in oral care. This new technology fills an unmet niche in oral health care by providing a safe, highly effective, pleasant tasting oral regimen. Europharma Concepts are very excited about bringing this unique, advanced and safe technology to the oral care market.”

About Synedgen

Synedgen Inc. is an innovative biopharmaceutical company focused on developing novel therapies and products through its proprietary biomaterials technology platform. This platform technology provides the foundation for preventing bacterial growth and disruption of biofilms in human and environmental applications. Product development is targeted to specifically address unmet needs for therapies that treat and prevent infections, primarily from bacteria that have developed resistance to traditional antibiotics.

Synedgen’s Corporate Headquarters and Research Laboratories are in Claremont CA; Synedgen’s Manufacturing Facility is in Honolulu HI. Additional information can be found at Synedgen’s web site at www.synedgen.com

About Europharma Concepts

Europharma Concepts is the world leader in the development and manufacture of oral care products. Europharma Concepts has to date developed and supplied a large number of oral care formulations to the European market place. In 2011, the Irish Exporters Association honored Europharma with the Life Sciences Exporter of the year award.

Europharma is headquartered in Clara, Co. Offaly, Ireland. Additional information can be found at Europharma’s web site at http://www.epc.ie.

Dr. Shenda Baker, Synedgen President and COO remarked, “This is an important milestone for Synedgen as we look forward to translating our discoveries into FDA approved products that will address a wide range of unmet heath care needs.  Dr. Ryan has the right background, energy, and experience to progress these exciting products through the complex intersection of chemistry, analytics and pharmaceutical regulations required for advancing our products into clinical trials and eventual commercialization.”

Dr. Ryan has extensive expertise in polysaccharide structural analysis and interactions of pathogens with human tissue. Dr. Ryan most recently served as a Staff Research Associate at the University of California, Los Angeles (UCLA), where he conducted structural analysis of polysaccharide compounds and natural products from Trichomonas vaginalis as potential drug targets. He wrote and contributed to successful grant proposals, authored protocols and guidelines for biological safety and human subject research, had supervisory responsibilities, and trained undergraduate and visiting researchers in laboratory procedures.  Other appointments include Visiting Scientist at the University of Dundee, in Dundee, Scotland, and Graduate Research Assistant at SUNY at Buffalo, Buffalo, NY.   Dr. Ryan earned his Ph.D. in Microbiology from SUNY Buffalo, Buffalo, NY, and a B.S. in Biochemistry from the University of Rochester, Rochester, NY.

“His experience and expertise in the field of polysaccharide chemistry will help us to rapidly advance throughout the maze of complex studies and analytical requirements over the next several months, and we are fortunate to have Dr. Ryan on our team to help lead these efforts,” remarked Synedgen CEO Dr. William Wiesmann.

Investigations focused on a highly effective chitosan derivative developed by Synedgen to control the spread of food-borne pathogens. The article highlights the potential for Synedgen’s chitosan derivative to provide a new, inexpensive means to improve food safety.

Stacy Townsend PhD, and Shenda Baker PhD, of Synedgen, and Rabya A. Lahmer, A. Prysor Williams PhD, and Davey L. Jones PhD from Bangor University UK, conducted the research described in Antibacterial action of chitosan-arginine against Escherichia coli O157 in chicken juice.

They tested Synedgen’s derivative on chicken juice because it readily accumulates in food packaging and is often implicated in food poisoning incidents, and found that it significantly reduced both the numbers and metabolic activity of E. coli. In addition, it also impeded the growth of general food spoilage bacteria and reduced malodor. Importantly, this effect lasted up to 3 days.

“Food-borne illnesses pose a serious health concern. The results of this research confirms the ability of our biocompatible derivative to reduce lethal bacteria in packaged food sources, and potentially offers a new means to safely and effectively improve food safety, maintain product shelf life and freshness, and prevent food contamination,” remarked Dr. Baker.

This research was also presented at a poster session at the Society for Applied Microbiology (SfAM) Summer Conference.

The article abstract is available at

http://www.sciencedirect.com/science/article/pii/S0956713512000485

Ms. Vu will be instrumental in shaping Synedgen’s ongoing product development and will help ensure regulatory compliance as the company gears up for US clinical trials, veterinary product distribution, and European consumer product distribution slated for this year.

Ms. Vu is Regulatory Affairs Certified and a member of the Regulatory Affairs Professional Society (RAPS), of the Orange County Regulatory Affairs (OCRA) Discussion Group, and the Drug Information Association (DIA).

” We are very pleased to welcome Joyce to our team,” said Synedgen President Shenda Baker. “She brings a wealth of expertise and experience, a deep knowledge of US and European regulatory affairs, and great enthusiasm for helping guide our clinical trial and product development. Her leadership will be a critical asset in achieving our goals of product distribution, European development and clinical trials as Synedgen advances.”

W3 is a by-invitation-only meeting of bioscience women executives and allied service providers affiliated with SoCalBio to encourage networking and mutual support among bioscience women executives and company managers.  The Southern California Biomedical Council is a nonprofit, member-supported trade association that supports and promotes life-science research, development, manufacturing, job creation and overall economic growth in the Greater Los Angeles region.

“I am honored to participate as keynote,” said Dr. Baker.  ”The W3 mixers provide a unique opportunity for local scientific and business networking and meeting other women executives in the biomedical community.”

In addition to his academic appointment, Dr. Wiesmann was also appointed to the Advisory Board of the UC Institute for Military Medicine, which was created in 2009 to conduct clinical and basic research and training in trauma and critical care in alignment with the needs of the US military. Dr. Wiesmann will assist the Institute in strategic planning, and provide programmatic and development support.

Alex B. Lentsch, Ph.D., Professor and Vice Chairman for Research, Department of Surgery, and Director, UC Institute for Military Medicine stated, “I am pleased to welcome back a distinguished alumnus. Dr. Wiesmann’s extensive research and entrepreneurial experience will be a great asset to our students and our Institute.”

“I’m happy to have this opportunity to contribute back and mentor and encourage students in their educational and research pursuits. I look forward to helping the University build upon its terrific research programs,” stated Dr. Wiesmann.

Dr. Wiesmann graduated Cum Laude from the University of Cincinnati with a BA in Chemistry.  In 2008, the University awarded Dr. Wiesmann an Honorary Doctor of Science.