Author: Gail Lawrence

Synedgen Announces Presentation of Data at NACFC Demonstrating Prevention of Gastrointestinal Complications with Glycopolymer-Based Therapeutics in a Preclinical Model of Cystic Fibrosis

Posted on by Gail Lawrence

CLAREMONT, Calif. – October 27, 2016 – Synedgen, a company leveraging a unique proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory disorders associated with the lung, skin and mucosal membranes, today announced the presentation of preclinical data demonstrating that treatment with a proprietary modified polysaccharide molecule in an in vivo model of cystic fibrosis prevented the development of distal intestinal obstructive syndrome (DIOS). Data from these studies demonstrated improved survival and growth in treated subjects compared with untreated controls. The studies were completed in collaboration with the laboratory of Steven M. Rowe, M.D. at the University of Alabama at Birmingham and the data will be presented in a poster presentation at the North American Cystic Fibrosis Conference (NACFC), being held from October 27-29 in Orlando, Florida.

“SYGN303 is designed to reduce mucofecal obstruction and reduce inflammatory responses in the mucosal lining of the gastrointestinal tract. These data support our novel approach to treat this serious complication of CF,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “The results of Dr. Rowe’s study provide clear rationale for the continued development of SYGN303 as a potential treatment for DIOS in patients with cystic fibrosis – a complication with no targeted or approved therapeutic options.”

Cystic fibrosis (CF) is a life-shortening genetic disorder that results in the accumulation of thick, sticky mucus in the lungs that clogs airways, leading to infection and chronic inflammation. The mucus also causes blockage and inflammation in the gastrointestinal (GI) tract, a complication known as distal intestinal obstructive syndrome (DIOS). Synedgen is developing a glycopolymer-based therapeutic, SYGN303, as a potential treatment for DIOS, for which there are currently no targeted or approved drugs.

Details of the presentation are as follows:

Session: Formal Poster Session – New Therapies, Biomarkers & Outcome Measures
Date: Thursday, October 27, 2016
Time: 11:15am EDT
Location: Hall C, Orange County Convention Center

Title: CFTR-/- Rat with Distal Intestinal Obstructive Syndrome (DIOS)

In an in vivo preclinical model of cystic fibrosis, oral administration of Synedgen’s proprietary modified polysaccharide molecule once daily for 21 days prevented the development of DIOS and improved survival and growth as compared to untreated controls. In untreated subjects, increased bacterial load and prominent mucosal inflammation was observed.

In addition, preclinical data from Synedgen’s SYGN113 program being developed as an inhaled treatment to improve lung function in patients with cystic fibrosis will be presented. Details of the presentations are as follows:

Session: Formal Poster Session – Infection/Microbiology
Date: Thursday, October 27, 2016
Time: 11:15am EDT
Location: Hall C, Orange County Convention Center

Title: PAAG Removes Biofilms and Potentiates Antibacterial Activity Against Burkholderia cepacia Complex Clinical Isolates

Preclinical studies demonstrated that one-hour treatment of B. cepacia multi-drug resistant and/or mucoid phenotype clinical isolates with Synedgen’s proprietary modified polysaccharide molecule led to dose-dependent reductions in pre-formed complex biofilms. Upon treatment with Synedgen’s modified polysaccharide in combination with the antibiotic compounds tobramycin and meropenam, the proprietary molecule was found to potentiate antibacterial activity, reducing the concentrations necessary to kill bacteria into clinically safe concentrations.

Title: PAAG15A Removes Biofilms Against Nontuberculosis Mycobacteria Clinical Isolates

Preclinical studies demonstrated that treatment of Mycobacterium abscessus complex (MABSC) strains with Synedgen’s proprietary modified polysaccharide molecule once daily for ten minutes significantly reduced nontuberculosis mycobacteria (NTM) biofilms and, after 1-hour treatment, significantly reduced pre-formed NTM biofilms in a dose-dependent manner. The treated NTM biofilms were also found to have fewer live bacteria than untreated biofilms.

About SYGN303

SYGN303 is a glycopolymer-based therapeutic being developed as a potential treatment for distal intestinal obstructive syndrome (DIOS), a complication associated with cystic fibrosis in which thick mucus causes blockage in the intestine, for which there are currently no targeted or approved drugs. As a modified polysaccharide molecule, SYGN303 mimics the barrier function of the polysaccharide layer that lines the intestine to reduce the inflammatory response to damage, prevent further damage, and promote healing of the GI mucosal surface.

About Synedgen

Synedgen Inc. is a pioneering biotechnology company leveraging a unique proprietary glycomics technology platform to develop modified therapeutic polysaccharides that target mucosal surfaces in genetic and acquired disorders. Our programs are designed to meet unmet needs in treating inflammation, infection and mucosal damage and change the progression of disease to improve the quality of patients’ lives. www.synedgen.com

About the North American Cystic Fibrosis Conference

The North American Cystic Fibrosis Conference is sponsored by the Cystic Fibrosis Foundation and is the largest collaborative forum of its kind to advance research for the treatment and cure of CF. This annual meeting brings together scientists, clinicians and caregivers from around the world to discuss and share ideas on the latest advances in CF research, care and drug development and to exchange ideas about ways to improve the health and quality of life for people with CF. More than 4,000 researchers and health care professionals will attend the Meeting.

Media Contacts:
Casey R. Doucette, Ph.D.
MacDougall Biomedical Communications
781-235-3060
cdoucette@macbiocom.com

Synedgen Reports Promising Data Demonstrating Biofilm Disruption and Potentiation of Antibacterial Activity in Burkholderia Clinical Isolates Treated with Glycopolymer-based Therapeutics

Posted on by Gail Lawrence

Preclinical Data to be Presented at North American Cystic Fibrosis Conference

Continue reading “Synedgen Reports Promising Data Demonstrating Biofilm Disruption and Potentiation of Antibacterial Activity in Burkholderia Clinical Isolates Treated with Glycopolymer-based Therapeutics” →

Synedgen to Present New Treatment Options for Gastrointestinal Radiation Injury

Posted on by Gail Lawrence

Innovative Treatment to Reduce Cancer Therapy Complications

Radiotherapy is a well-established treatment for cancer, however pelvic radiotherapy can result in radiation proctitis, or inflammation and damage to the lower parts of the colon, for as many as 75% of radiation treated patients. In severe cases, this complication can result in the need to reduce the intensity of radiotherapy, ultimately jeopardizing a successful cancer prognosis.

Synedgen researchers are developing targeted therapies to reduce the incidence and severity of radiation proctitis by enhancing repair of gastrointestinal damage and modulating inflammation to allow for complete treatment or more aggressive treatment of pelvic cancers currently limited by radiation proctitis.

A poster presentation detailing this research has been accepted for display at Digestive Disease Week (DDW) 2016 at the San Diego Convention Center. The poster, entitled “Novel Therapeutic for the Repair of Gastrointestinal Radiation Injury”, will be exhibited on May 22, 2016 from 9:30 AM to 4:00 PM; lead author VP of Research Stacy Townsend PhD will be on hand to discuss the results from noon-2:00 PM.

The presentation highlights the efficacy of a specific molecule in Synedgen’s new class of targeted GI drugs, PAAG, on animal models of radiation proctitis. PAAG administered either orally or via enema significantly reduced local and systemic inflammation, and endoscopic examination confirmed improvement in the severity of proctitis compared to the control. A comparison between oral and enema administration showed that while both forms of treatment were highly effective, the oral delivery appears to be the optimal administration method.

“PAAG is a promising new drug candidate for reducing the inflammation and gastrointestinal damage associated with radiation therapy affecting the lower bowel,” stated Townsend. “We will continue to investigate its mechanisms of action in reducing radiation proctitis to enhance the development of this critically needed therapy.”

About Synedgen

Synedgen Inc. is an innovative biopharmaceutical company focused on targeting the mucosal interface to treat genetic and acquired disorders in the lungs and digestive tract. Synedgen’s Glycomics Technology Platform produces targeted drugs to meet unmet needs in treating inflammation, infection and mucosal damage. Synedgen’s Corporate Headquarters, Research Laboratories and Manufacturing Facility are in Claremont CA. Additional information can be found at Synedgen’s web site at www.synedgen.com.

About Digestive Disease Week

DDW is the world’s largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Approximately 15,000 GI professionals attended DDW 2015, plus an additional 2,000 to 3,000 exhibitors.

Synedgen Receives FDA Clearance for its SynePure Wound Cleanser

Posted on by Gail Lawrence

CLAREMONT, Calif. — August 24, 2015– Synedgen announces U.S. Food and Drug Administration 510(k) clearance to market its SynePureTM Wound Cleanser (K143444). SynePure Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

The SynePure Wound Cleanser is designed as an advanced irrigation technology to cleanse wounds by providing superior wound cleaning with no deleterious effects on wound healing. The development of the SynePure Wound Cleanser was funded by DARPA, the Defense Advanced Research Projects Agency, to meet the immense challenges of cleansing deep, dirty and complicated wounds often incurred by US soldiers in combat. These wounds are frequently full of debris and contaminated, and if not cleansed early, can lead to significant complications such as wound sepsis and failure of the wounds to heal properly.

SynePure Wound Cleanser is specifically designed to provide immediate and effective irrigation of wounds following injury and could become part of the first aid kit carried by all U.S. soldiers. It is packaged for use in a squeezable bottle fitted with a nozzle to direct a focused stream of cleanser with sufficient force to help dislodge debris and contamination. The advanced technology also aggregates particles in the wound to help facilitate their removal. Synepure Wound Cleanser is also suitable for hospital and emergency care use with clearance for both single and multiple use bottles.

“The SynePure irrigation system is easily delivered with one hand to rinse debris and contamination from wounds, allowing self-application at the time of injury. This design is ideally suited for use in the field and pre-hospital environment in both military and civilian environments,” said Shenda Baker, PhD, Synedgen President and COO. “We worked closely with our military sponsor to develop a highly effective and easy to use product that does not impede wound healing. This clearance is a key step in the roll-out of our comprehensive wound care platform.”

“While this cleanser was tailored to the extreme needs of the military, it has equally great application for the cleansing and rinsing of any skin, external wounds, non-healing ulcers, post surgical wounds, severe burns, and lacerations,” said William Wiesmann, MD, Synedgen CEO.

This material is based upon work supported by SSC Pacific under Contact No. N66001- 14-C-4009. Any opinions, findings, conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the SSC Pacific.

Synedgen President Shenda Baker Featured Presenter at the Grinnell-in-Los Angeles: Scientists Making a Difference in the World Conference

Posted on by Gail Lawrence

Synedgen President Shenda Baker will be a featured presenter at the upcoming Grinnell Scientists: Making a Difference in the World Conference

Continue reading “Synedgen President Shenda Baker Featured Presenter at the Grinnell-in-Los Angeles: Scientists Making a Difference in the World Conference” →

Biotech Firm Synedgen Announces Joint Collaborative Research Agreement with Cystic Fibrosis Experts From the Cincinnati Children’s Hospital Medical Center and the University of Alabama at Birmingham

Posted on by Gail Lawrence

Research Investigates Synedgen’s Promising New Treatment to Help Clear Airways of Cystic Fibrosis Patients

Continue reading “Biotech Firm Synedgen Announces Joint Collaborative Research Agreement with Cystic Fibrosis Experts From the Cincinnati Children’s Hospital Medical Center and the University of Alabama at Birmingham” →

Synedgen’s Synoplex® Receives FDA Indexing for use in the treatment of chronic wounds in pachyderms

Posted on by Gail Lawrence

June 26, 2012 — Claremont CA—Elephants and Rhinoceroses frequently encounter chronic non- healing infected abscesses and cutaneous wounds that become resistant to traditional antibiotics and treatments. Over time, these wounds can have serious long-term consequences such as systemic infections and impaired mobility. Recognizing the difficulty in treating these types of wounds, the FDA’s Center for Veterinary Medicine has recently allowed Synedgen to market Synoplex®, Synedgen’s veterinary wound rinse product, as an FDA Indexed Product to treat infected, chronic and non-infected wounds in elephants and rhinoceroses. Synoplex is intended for the treatment of chronic foot disease (cracked nails, abscesses, lesions, ulcers, fissures) and chronic non-healing dermal or subdermal wounds such as abscesses and pressure sores caused by chronic inflammation or bacterial species. Synoplex® is also intended for use as a regular treatment for non-infected wounds at a lower dose.

Data have shown that Synoplex breaks up established biofilms, flushes the bacteria from the wounds, and inhibits the formation of biofilms, providing a safe, prophylactic and therapeutic treatment for both chronic and acute infections associated with dermal wounds and foot disease in elephants and rhinoceroses. In addition, Synoplex has been shown to encourage wound healing, unlike other topical disinfectants that are damaging to tissue.

“Synoplex provides a breakthrough technology for treating both chronic and acute topical infections by eliminating the need for antibiotics,” stated Synedgen President Shenda Baker. “This product is perfectly suited for large topical wound application in elephants and rhinoceroses, as it is safe for the veterinarian and animal and heals the wound while preventing or treating infection.”

Currently, wounds in elephants and rhinoceroses are treated with systemic or topical antibiotics as well as topical disinfectants, such as chlorhexidine or Betadine. These disinfectants are great at reducing bacteria, but they are very harsh on the wound and can inhibit healing. The cost of systemic antibiotics in these large animal species can be cost prohibitive and disrupt their gut flora. Synoplex can be used for Gram-positive or Gram negative bacterial infections, as well as in non-infected wounds.

An expert panel of renowned veterinarians unanimously concluded that Synoplex is effective and safe for use in the family Elephantidae and the family Rhinocerotidae in December 2011. The panel notes the importance of new treatments for infection in its recommendation, “Often these chronically infected wounds have been treated repeatedly with various antimicrobials resulting in development of multiple drug resistant strains of bacteria. The advantage of treating these infections without use of an antimicrobial is a major benefit to the patients and to the caretakers.” Synoplex Panel Member Head Veterinarian Dr. Ralph Zimmerman of the Albuquerque BioPark remarked, “Synoplex provides a safe, prophylactic and therapeutic treatment for controlling and preventing bacterial biofilms and treating both chronic and acute infections associated with dermal wounds and foot disease. Use of Synoplex has demonstrated effectiveness without any adverse effects. Likewise, there is minimal concern for the veterinarian or other caretakers applying Synoplex to their patients as there have been no known allergic reactions or adverse events reported.”

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) maintains an index of legally marketed unapproved new animal drugs and their designated intended uses for minor species. Synoplex® is legally marketed as an FDA Indexed Product under MIF 900-012.

Biotech Firm Synedgen Reports Promising Research Findings on New Treatment for Radiation Damage to the Digestive Tract and Radiation-Induced Mucositis

Posted on by Gail Lawrence

Federal agencies are highly concerned about potential dangers to the US population by radiation exposures such as the nuclear incident in Japan or the threat of a terrorist dirty bomb

Continue reading “Biotech Firm Synedgen Reports Promising Research Findings on New Treatment for Radiation Damage to the Digestive Tract and Radiation-Induced Mucositis” →