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.

September 14, 2011 — Synedgen, Inc. announces new research results demonstrating that its proprietary chitosan derivative, SYN01, effectively dissolves biofilms, reduces mucus viscosity, and maintains broad antibiotic activity against Pseudomonas aeruginosa, a common cause of lung infection associated with cystic fibrosis.  Pseudomonas aeruginosa settles into the thick mucus trapped in cystic fibrosis (CF) patients’ airways, resulting in a chronic respiratory infection for approximately 60% of cystic fibrosis patients.

The Synedgen researchers measured the impact of SYN01 on multi-drug resistant bacterial isolates obtained from CF patient sputum samples at Seattle Children’s Hospital.  The bacteria in CF patient sputum often develop resistance to antibiotics used over the course of their lifetimes, making the treatment of infections more and more challenging as the patient ages.  When drug resistant P. aeruginosa biofilms were treated with SYN01, the bacterial counts decreased by as much as 4-logs (99.99%) within just a few hours.

Other experiments were designed to look at the effects of SYN01 mixed in low doses with Tobramycin, a commonly prescribed antibiotic for Pseudomonas aeruginosa infection.  These experiments showed a remarkable 32-fold enhancement of the antibiotics effectiveness against the same bacteria.  “Since SYN01 forms holes in the bacteria and causes them to leak, it is highly unlikely that these organisms will develop resistance against this new treatment”, stated Synedgen Senior Microbiologist and principal investigator Dr. Stacy Townsend.

Dr. Townsend also noted that, “these results not only show that SYN01 can safely and effectively dissolve biofilms and reduce the thickness of mucus secretions, but also improve the effectiveness of the current standard of antibiotic therapy. This research offers the potential for new treatment options to safely and effectively improve lung function and to prevent and treat infection.”

Cystic fibrosis causes the body to produce abnormally thick and sticky mucus, which builds up in the lungs, digestive tract, and other areas of the body, resulting in life-threatening lung infections, painful sinusitis and serious digestive problems. The Cystic Fibrosis Foundation estimates the disease effects 30,000 individuals in the United States, and 70,000 worldwide. Although life expectancy for cystic fibrosis patients has increased, patients remain at an increased risk for serious lung infections such as Pseudomonas aeruginosa.

“These results suggest that SYN01 has powerful synergistic interactions with commonly used antibiotics, and could extend their effectiveness in patients who have developed resistance,” notes Dr. William Wiesmann, Synedgen CEO. “We see tremendous opportunity to extend the lifetime of use of standard of care antibiotics while also dissolving the thick secretions that destroy lung function.”

This research will be presented at the 51^st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on September 20 in Chicago, IL, at the New Approaches to Gram-Negative Drug Discovery session. The poster, Novel Biopolymer SYN01 Potentiates Antibacterial Activity of Tobramycin, Dissolves P. aeruginosa Biofilms, and Reduces the Viscosity of Cystic Fibrosis Sputum, summarizes theses findings and demonstrates the potential impact of Synedgen’s chitosan derivative for improving therapeutic options in cystic fibrosis lung infections.

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.

July 13, 2011 — New research conducted jointly between Synedgen, Inc., and the School of Environment, Natural Resources and Geography, at Bangor University, Bangor, UK demonstrates that a novel biocompatible and bactericidal chitosan derivative developed by Synedgen offers a rapid and safe method to significantly reduce bacterial counts and inhibit pathogenic activity from dangerous disease causing pathogens such as E. coli and Salmonella. This derivative is formulated with chitosan acquired from shrimp shells, and appears to have a lasting effect that prevents both food spoilage and lowers the total numbers of tested pathogenic bacteria up to 3 days.

“Food-borne illness remains a serious health concern. This research confirms the ability of our biocompatible derivative to reduce lethal bacteria in food sources, and represents a new way of safely and effectively improving food safety as well as preventing food spoilage and contamination,” remarked Synedgen CEO Dr. William Wiesmann.

Bangor University Professor of Soil and Environmental Science Davey Jones stated, “This research strongly supports the potential of this product to dramatically reduce food-borne related illness, associated conditions, and death.”

According to the Centers for Disease Control and Prevention more than 300,000 people are hospitalized and 5,000 die as a result of food-borne illnesses each year in the United States. Prepackaged raw and cooked foods can pose a threat to consumer health due to the bacterial contamination that may occur during processing or preparation.  Uncertainty regarding the source of food-borne illness increases consumer concerns about food safety, delays effective treatment and impedes food recall notices, as evidenced by the recent outbreak of E. coli in Europe, where the source of the outbreak initially remained elusive.

This research was presented at a poster session at the Society for Applied Microbiology (SfAM) Summer Conference on July 4 in Dublin, Ireland. The poster, Antibacterial action of chitosan-arginine against E. coli O157 in chicken juice, highlights the potential impact of Syndegen’s chitosan derivatives for use in the control of food-borne pathogens.

For the study, the researchers measured the antimicrobial action of the chitosan derivative in poultry juice contaminated with E. coli O157 under simulated refrigeration and room temperature storage conditions.  Poultry juice was utilized because it reflects a typical environment in which E. coli multiplies, and is one of the major risk pathways for surface contamination and subsequent cross-contamination in the home.

The results demonstrate that the chitosan derivative caused significant reductions in pathogen cell counts, and this antimicrobial effect appeared to be immediate. The study also identified critical doses required to prevent pathogen proliferation under both refrigeration and room temperature conditions.

The research will be published in an upcoming article in the Journal of Food Control.

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.

May 20, 2011 — Synedgen will report recent data from its studies of a new wound rinse at a poster session May 23 at ASM 2011, the annual meeting of the American Society for Microbiology in New Orleans. The poster, Novel Antibacterial Chitosan Derivatives with Residual Activity Reduce Multi-Drug Resistant Biofilms and Remove Bacteria from Abraded Skin, highlights the antibacterial and biofilm-reducing activity of Synedgen’s biopolymer derivative based rinse against a broad spectrum of bacteria. The principal investigator of the study, Synedgen’s Senior Microbiologist Stacy Townsend, will present the results.

Biofilms in wounds are a collection of bacteria that adhere to tissue and create a protective environment that make them nearly impervious to traditional antibiotics. The Synedgen study utilized skin wound models to compare the Synedgen wound rinse against the standard of care. Not only did Synedgen’s chitosan derivatives significantly reduce the number of bacteria in the wound, the rinse demonstrated residual activity after treatment. This residual activity demonstrates that the rinse can remain protective on skin for hours after its use. Testing the product in vitro on bacterial biofilms demonstrated its ability to disrupt the biofilms and to kill the bacteria within.

Cleansing wounds to remove debris and control infection is a key component of wound management.  Currently available antiseptic agents can be harmful to human cells and therefore limit wound healing, propelling the need for effective yet non-toxic wound cleaning agents. Synedgen’s wound rinse effectively removes bacteria and biofilms without damaging tissue.

“These results represent a new way of safely treating wounds that have serious infections. The Synedgen technology could be even more useful for chronically infected wounds, removing persistent biofilms and improving outcomes for patients with very few effective options.” remarked Townsend.

Further preclinical studies in vivo are slated for later this year.

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 environmental and therapeutic antimicrobials to reduce bacterial pathogens. Research is focused to specifically address the unmet need for therapies that treat and prevent bacterial infections, primarily from those that have developed resistance to traditional antibiotics.

Synedgen’s corporate headquarters and research facility is in Claremont, CA; Synedgen’s manufacturing facility is in Honolulu, HI.

March 21, 2011 (Honolulu, HI & Claremont CA) – Biotech firm Synedgen announces the award of a competitive Phase II SBIR grant by the National Institutes of Health (NIH) to accelerate the development of Synedgen’s proprietary oral disease treatments. Under this 2-year $1.96 M effort, starting on April 1, Synedgen will accelerate the development of Regenasyn^TM, a topical treatment for oral mucositis that both prevents infection and improves healing.

Oral mucositis is a common debilitating side effect of chemotherapy, radiotherapy and immune compromise, conditions that reduce the ability of cells in the oral cavity to heal and grow. Swelling and ulceration of oral tissues occurs and increases the chances of infection. Patients with severe oral mucositis have painful oral lesions that can significantly reduce their ability to eat and drink.

“Severe oral mucositis is the leading reason cancer patients stop or delay treatment. While there are very limited therapies to reduce the symptoms of mucositis in some chemotherapy and immunosuppressed patients, no current treatment provides successful improvement in radiation-induced mucositis.  This award will accelerate Synedgen’s development of our product to prevent and treat these painful lesions, and support our efforts to prepare for human clinical trials as soon as possible”, stated Synedgen President Shenda Baker.

Laboratory and animal research with Synedgen’s lead products have demonstrated remarkable anti-inflammatory and tissue regenerative properties in injured and damaged tissues. “We are pleased to be working with the NIH on this important need and are dedicated to developing a safe and effective product that reduces the pain and suffering associated with cancer treatment”, remarked Synedgen CEO William Wiesmann.

The project is supported by Award Number 2R44DE019740-02 from the National Institute Of Dental & Craniofacial Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute Of Dental & Craniofacial Research or the National Institutes of Health.

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 the prevention of bacterial infection and the improvement of healing following tissue damage due to infection, inflammation and trauma.

Synedgen’s Corporate Headquarters and Research Laboratories are in Claremont CA; Synedgen’s Manufacturing Facility is in Honolulu HI.

Sept. 30, 2010 — Synedgen and the University of New South Wales (UNSW, Australia) will investigate therapies to improve bone growth and wound healing as part of a new project sponsored by the Australian Research Council’s (ARC) Linkage Project Grants program.

The three-year $540,000AUS project, titled “Targeted growth factor delivery using natural polysaccharide materials for bone regeneration,” will be funded by Synedgen, UNSW and the ARC.

Of the six million bones broken each year in the U.S., approximately 300,000 are slow to heal or do not heal at all with traditional methods. Osteoporosis, a bone disease that increases the risk of fracture, is a major public health threat for an estimated 44 million Americans.

The academic research is led by John Whitelock, professor in the Graduate School of Biomedical Engineering at UNSW. He is one of the world’s experts in deciphering the structures of the sugars on mammalian cell surfaces and tissues known as heparan sulfates that direct bone growth and tissue regeneration.

Synedgen’s focus is on designing and synthesizing new polysaccharide molecules to combat infection and to improve wound healing. It has a number of products in development for use in the home, in hospitals and health care facilities and in the battlefield. Synedgen will provide scientific expertise in the synthesis of new molecules and product development guidance over the course of the project.

The bone regeneration project is designed to engineer biomimetic-inspired polysaccharide (sugar) molecules for the targeted delivery of growth factors to encourage bone regeneration in age-related diseases associated with bone fracture and joint destruction. Over the course of this effort, the team will investigate the body’s molecules that stimulate bone regeneration, synthesize new molecules directed to mimic those molecules, and investigate how the new molecules interact with cells to generate new bone.

“This is an exciting research opportunity that leverages the abilities of both institutions to develop innovative treatments for debilitating, non-healing fractures. We are pleased by the opportunity to expand our research focus, work with this intellectually powerful partner and help advance the field of bone regeneration,” said Synedgen President Shenda Baker. She will serve as the principal investigator for the project for Synedgen, which is the biotech industry partner.

Whitelock stated, “We are very enthusiastic about Synedgen’s participation in this effort. The Synedgen team brings expertise in inventing and designing new molecules based on natural sugars and developing products for treating humans, which will help provide focus for commercial outcomes in the area of new materials for bone regeneration.”

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 a broad base of novel antimicrobials to reduce or eliminate bacterial pathogens. Research is focused to specifically address the unmet need for therapies that treat and prevent bacterial infections, primarily from those that have developed resistance to traditional antibiotics. Synedgen’s Corporate headquarters and research laboratory is in Claremont, Calif.; Synedgen’s manufacturing facility is in Honolulu, Hawaii.

The University of New South Wales is one of Australia’s leading universities and is highly regarded for its research and development of novel biomaterials based on the natural polysaccharide structures.

The Australian Research Council is an agency of Australian government that administers research grants for fundamental and applied research. The ARC’s Linkage Project Grants support collaborative research and development projects between higher education researchers and external industrial partner organizations.

The research, funded by the National Institute of Allergy and Infectious Disease at the NIH, concluded on August 31 and demonstrated the Synedgen rinse effectively aggregated and killed multi-drug resistant (MDR) wound-associated bacterial strains such as Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa (PA), and Methicillin-resistant Staphylococcus aureus (MRSA).

In additional studies, Synedgen has demonstrated the ability of the wound rinse to remove established biofilms—the thick, protective layer that bacteria form when they adhere to tissue and colonize a wound. It also disrupted the viability and coherence of growing biofilms composed of Vancomycin-resistant enterococcus (VRE), MRSA, and PA, some of the most deadly bacterial combinations found in wounds. In just one rinse, it removed significantly more bacteria than the standard-of-care treatment, saline rinse, and demonstrated long-term, residual antibacterial activity on skin.

“These studies are a key step in Synedgen’s development of novel wound therapeutics to prevent and treat multi-drug resistant infections,” stated lead study investigator Stacy Townsend, Synedgen senior microbiologist. “Traditional wound or skin treatments including chlorhexidine, iodine, silver sulfadiazine, and triple antibiotics, can kill bacteria, but they can also damage the tissue in the wound. Our wound rinse demonstrated no disruption of human cell growth, even as it killed and removed bacteria.”

Bacterial infections are the fourth-leading cause of death in hospitals. More lethal and resistant bacteria are overpowering traditional antibiotics every day and contaminated wounds often carry resistant bacteria that no longer respond to traditional antibiotics. As bacteria develop resistance to more and stronger antibiotics, wound infections are becoming increasingly difficult to treat and can often lead to debilitating side effects or death. This NIH-funded study supports Synedgen’s efforts to develop an FDA-approved wound treatment that removes bacteria from chronic and acute wounds and prevents further infection while encouraging wound healing.

Synedgen CEO William Wiesmann, M.D., notes, “The non-toxic active ingredient in this revolutionary new wound rinse forms the basis of a spectrum of wound-care products directed at both hospital-acquired infections, post-surgical infections and wounds—importantly, chronic wounds commonly seen in patients with diabetes and other slow-healing wounds that cause significant disability, particularly among the elderly.”

Synedgen has completed pre-clinical studies and anticipates initiating clinical trials early in 2011.

About Synedgen
Synedgen, Inc. is an innovative biopharmaceutical company focused on developing novel therapies and products through its proprietary biopolymer technology platform. This platform technology provides the foundation for comprehensive pharmaceutical antimicrobials to reduce bacterial pathogens. Research is focused to specifically address the unmet need for therapies that treat and prevent bacterial infections, primarily from those that have developed resistance to traditional antibiotics.

Synedgen’s corporate headquarters and research laboratories are in Claremont, CA; Synedgen’s pharmaceutical manufacturing facility is in Honolulu, HI. Additional information can be found at Synedgen’s web site at www.synedgen.com

Sept. 9, 2010 — Shenda Baker, Ph.D., has been named president and chief operating officer at Synedgen, Inc., a bio-pharmaceutical company committed to developing novel therapies and products to save live in hospitals, on the battlefield, in our food supply and in the home.

The Synedgen board of directors unanimously approved the appointment at its regular meeting in July. Baker replaces co-founder William P. Wiesmann, M.D., who will remain chief executive officer and chairman of the board. Baker previously served as executive vice president and chief operating officer.

“Shenda Baker has had a remarkable impact on the success of Synedgen. Her leadership and management skills, along with her ability to analyze complex business development and financial management issues and her leadership in managing Synedgen’s intellectual property strategies have been essential to the company’s success. She will naturally fill the leadership role of president as we move into more complex business relationships and initiate the exciting clinical trials the company has planned over the next year,” Wiesmann stated.

In May, Synedgen was awarded $2.73 million in funding by the U.S. Army for development of life-saving products and therapies to treat drug-resistant bacteria. It also received a competitive SBIR grant by the National Institutes of Health to accelerate the development of its proprietary wound decontamination rinse that targets multi-drug resistant bacteria and the thick mucus-like biofilms they form.

The company announced promising results from its latest study of an oral rinse to reduce gingivitis and prevent oral plaque accumulation at the 110th General Meeting of the American Society for Microbiology in San Diego, Calif. in May.

Prior to her position at Synedgen, Baker was general partner and president of BioSTAR West and director of pharmaceutical research and development at Hawaii Chitopure Inc. She continues to hold an appointment as professor of chemistry at Harvey Mudd College in Claremont.

At Harvey Mudd College, she earned numerous grants and awards, including the National Science Foundation (NSF) Special Creativity Award from the Division of Materials Research, the Presidential Early Career Award for Scientists and Engineers from the Department of Defense and the NSF CAREER Award.

Baker is a member of numerous scientific societies and organizations and served in leadership capacities for many of them, including the Materials Research Society, the Neutron Scattering Society of America, the Council on Undergraduate Research, the American Physical Society and the American Chemical Society. She is the author or co-author of more than 50 publications and is named on 20 patents.

“I am committed to Synedgen’s mission to develop novel therapies to prevent and treat life-threatening infections. It’s an important time for Synedgen, as we have transitioned from a research-focused company to a pharmaceutical and product development company. I am eager to expedite our clinical trials and develop the relationships that will get these valuable products into the hands of doctors and patients,” notes Baker.

Synedgen’s corporate offices and research and development facilities are located in Claremont, Calif. — a 4,500-square-foot facility that includes equipment for chemical synthesis and scale up, a class 1000/10,000 tissue culture facility and biological research tools, as well as a separate, well-equipped BioSafety Level 2 (BSL 2) microbiology laboratory suite. Synedgen also operates facilities in Honolulu, Hawaii, which include a class 100,000 clean room for GMP (Good Manufacturing Practice) production and fully equipped analytical laboratories.

Synedgen was formed in 2009 through the merger of BioSTAR West LLC and Hawaii Chitopure Inc. BioSTAR West was founded in 2005 to generate research and development expertise in biopolymer processing and polymer interactions with mammalian cells and bacteria. The research led to chemical modifications of a natural biopolymer and examination of the molecular interactions of these derivatives with tissue and bacterial pathogens.