Bolognese to Provide Statistical Design of Biomarker-Driven Phase 2b Human Efficacy Study in Severe Community-Aquired Pneumonia

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – June 15, 2013) BioAegis Therapeutics announced today that it has engaged Jim Bolognese, Senior Director of Strategic Consulting at Cytel Inc., a leading firm in the design and conduct of adaptive trials. Prior to joining Cytel, Jim Bolognese worked for Merck & Company for 37 years designing clinical trials in various indications.


Supplies to be Used in Forthcoming Human Trials

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – April 15, 2013) BioAegis Therapeutics announced today that it has engaged the Billingham, UK group of Fujifilm Diosynth—a first-tier
contract biologics manufacturer, to manufacture clinical-grade supplies of recombinant human plasma gelsolin, the body’s 4th most abundant plasma protein that becomes depleted in myriad disease condtions and injuries. . BioAegis is preparing for human clinical trials to demonstrate that repletion of plasma gelsolin can prevent prevent excess inflammation that results in organ damage while boosting the body’s response to pathogens. FujiFilm Diosynth Biotechnologies is a tier-1 cGMP Contract Development and Manufacturing Organization (CDMO) that supports the development and production of therapeutic candidates.


Patent Covers Use of Plasma Gelsolin to Treat Multiple Sclerosis and to Diagnose Neurologic Diseases

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – March 4, 2013) BioAegis Therapeutics announced today that broad US patent protection for plasma gelsolin to treat Multiple Sclerosis (MS) and to diagnosis neurological disease. MS affects approximately 400,000 people in the US and 2.5 million worldwide and has enormous unmet need, despite recent product entries. In the US, prevalence estimates are approximately 90 per 100,000 population. MS symptoms can start anywhere between 10 and 80 years of age, but onset is usually between 20 and 40 years, with a mean of 32 years. According to a global study conducted by the World Health Organization, Neurological disorders are responsible for 8 out of 10 disorders in the 3 highest disability classes.


BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – March 1, 2013) BioAegis Therapeutics announced today that it has opened a research laboratory facility at the NJ Commercialization Center of Innovative Technology in North Brunswick, New Jersey.


Plans Phase 2b/3 Trial for Biologic in Prevention of Organ Dysfunction in ICU

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – February 7, 2013) BioAegis Therapeutics announced today that it completed it’s initial $3MM convertible note round to fund the companies operating activites in its effort to commercialize groundbreaking discoveries as to plasma gelsolin’s (pGSN) biological role in inflammation and infection. pGSN is the 4th most abundant protein in plasma and is highly conserved. Its depletion is highly predictive of adverse outcomes while its repletion in numerous animal models has been shown to prevent morbidity and mortality.