Critical Biologics Commences Clinical Testing Of Solinex(TM)

Main Category: Pharma Industry / Biotech Industry
Article Date: 19 May 2008 - 2:00 PDT

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Critical Biologics Corporation (CBC) announced the successful enrollment of the first four patients in its "first-in-man" clinical trial for Solinex™, an intravenous formulation of recombinant human plasma gelsolin (rhu-pGSN). The trial is designed to assess the safety and pharmacokinetics of a single intravenous infusion of rhu-pGSN in critically ill patients with profound hypogelsolinemia in cohorts receiving progressively larger doses of the drug. It is planned to enter a total of 40 patients into the double blind, placebo controlled trial being conducted at a leading medical institution in Hong Kong.

"This is an important and exciting development for CBC's Solinex™ program," said Richard Straube, MD, CBC's Chief Medical Officer. "The results of this trial will provide valuable insights into the mechanism of depletion of the naturally occurring plasma gelsolin. They will also help CBC determine the size and frequency of the Solinex™ dosing required to increase blood levels of this important protective protein above a critical threshold in hypogelsolinemic patients with a high mortality risk." Dr. Straube further commented, "We hope this is the first step to demonstrating that using rhu-pGSN replacement therapy to increase plasma gelsolin levels above a critical threshold will prevent critically ill patients from developing many of the life-threatening complications that appear to be strongly associated with hypogelsolinemia, including acute respiratory distress syndrome (ARDS), sepsis syndrome, multiple organ system failure (MOSF) and death."

CBC's Chief Executive Officer, Ashleigh Palmer, praised the efforts of CBC's collaborators in Hong Kong. "We are very pleased to be working with such a capable medical institution," he said. "We are especially grateful for the expertise and devotion of the lead investigator and the institution's team of dedicated clinical trial specialists. In CBC's previous 200 patient plasma gelsolin epidemiology study, this group proved themselves to be a highly competent team of clinical research professionals. Their world-class medical care, compliance to trial procedures, strict adherence to EU and FDA guidelines, and ability to rapidly accrue patients make them an ideal clinical research partner for a development stage company like CBC."

About Plasma Gelsolin

Gelsolin is a highly evolutionary conserved, naturally occurring protein found inside cells as well as in plasma. Circulating plasma gelsolin (pGSN) levels decrease shortly after a variety of tissue injuries such as trauma, major surgery, burns and sepsis. Severe depletion of pGSN has been found to correlate strongly with adverse clinical outcomes in critical care patients such as longer ventilator times, longer duration of ICU stays and death. Experiments in animal models have shown that disease progression and adverse outcomes can be averted by a timely replenishment of pGSN using rhu-pGSN. It is therefore anticipated that, in high-risk critical care patients, the early detection of reduced pGSN levels followed by replacement with rhu-pGSN could provide an efficacious and well tolerated therapeutic intervention.

About Critical Biologics

Critical Biologics Corporation, based in Cambridge, MA, was founded in 2006 with a strategic intent to develop and commercialize theranostics and therapeutics that predict and regulate inflammatory responses to life-threatening diseases. In particular, CBC is currently focused on a theranostic approach to treat critical care patients with low plasma gelsolin (pGSN) levels at high risk of life-threatening complications. Gelsolin was first discovered by Dr. Thomas P. Stossel, American Cancer Society Professor of Medicine at Harvard Medical School and Director of the Translational Medicine Division and Senior Physician in the Hematology Division at Brigham & Women's Hospital. In October 2006, CBC entered into an agreement with Brigham & Women's Hospital to license technology and intellectual property pertaining to the therapeutic and diagnostic use of plasma gelsolin to predict and pre-emptively treat a variety of medically and economically important conditions. In December 2006, CBC successfully closed a Series 'A' financing with a $7 million investment from Morningside Ventures. The Morningside investment has enabled CBC to expeditiously advance the development of its lead therapeutic, recombinant human plasma gelsolin (rhu-pGSN), into Phase-2 human clinical trials. CBC is currently seeking Series 'B' venture funding to accelerate its development programs following the recent analysis of compelling new clinical data.

Critical Biologics