Altor BioScience Awarded $3 MM SBIR Phase II Competing Renewal Grant by NHBLI to Complete a Second Phase 2 ALI/ARDS Clinical Trial for its Antibody-based Tissue Factor Antagonist, ALT-836
Miramar, Florida, May 23, 2011 - MIRAMAR, Fla. (BUSINESS WIRE) - Altor BioScience Corporation announced today that the National Heart Lung and Blood Institute (NHLBI) has awarded Altor a Small Business Innovation Research (SBIR) Phase II Competing Renewal Grant. The award of over $3.18 MM over three years will support Altor’s efforts to complete a second Phase 2 clinical trial using ALT-836, an antibody-based tissue factor (TF) antagonist, as a therapy to treat patients with infection-induced acute lung injury/acute respiratory distress syndrome (ALI/ARDS). Patient enrollment of this 90-patient, multi-center, randomized, placebo-controlled trial using a multi-dose regimen of ALT-836 has been initiated. This trial follows a recently completed 60-patient, multi-center, randomized, placebo-controlled trial with a single dose of ALT-836, which was also supported by a Phase II SBIR grant from NHLBI. The results of that recently completed Phase 2 trial suggest that a single dose of ALT-836 provides benefit to patients with ALI/ARDS without additional risks of bleeding complications, a major safety concern associated with this kind of therapy.
Altor’s President & CEO Hing C. Wong, Ph.D., commented, “Based on our results of the first Phase 2 trial, we are excited by the potential of ALT-836 for treating ALI/ARDS and are very interested in confirming and extending these findings in the follow-up study. This is a devastating disease for which there currently is no meaningful medical therapy. We are very grateful for the continued support, particularly in this difficult funding environment, and for the validation provided by the NIH/NHBLI for our approach.”
ALI and ARDS are forms of acute respiratory failure, commonly occurring in patients with severe trauma to the lungs, severe pulmonary infection, and sepsis. These conditions are estimated to occur in more than 150,000 persons each year in the United States, with a fatality rate of 30-50 percent. Estimates of the healthcare costs associated with ALI/ARDS exceed $5 billion per year in the United States alone. There are currently no specific pharmaceutical treatments for ALI/ARDS patients. Treatment in the intensive care unit typically involves the use of mechanical ventilation and other supportive care.
ALT-836, a recombinant human-murine chimeric, IgG4-type monoclonal antibody, is a TF antagonist that blocks TF coagulation activity. In numerous pre-clinical studies, ALT-836 exhibits anti-inflammatory, anti-thrombotic and anti-tumor activities with an excellent safety profile in laboratory animals, including non-human primates. In humans, ALT-836, administered intravenously is safe and exhibits potent antithrombotic and anti-inflammatory effects in patients with coronary artery disease and ALI/ARDS. Additional information on the current Phase 2 ALI/ARDS trial using a multi-dose regimen of ALT-836 can be found at www.clinicaltrials.gov (identifier: NCT00879606). ALT-836 is also being developed under an active IND to treat solid tumors in combination with gemcitabine (identifier: NCT01325558).
About Altor BioScience
Altor is a venture-backed, privately held biotechnology company developing targeted immunotherapies for treating cancer, viral infections, and inflammatory diseases based on its proprietary STARTM, tissue factor antagonist and interleukin-15 platform technologies. Altor currently has three product candidates in mid and late stage clinical development. The cancer trials for ALT-801, its lead STAR product, are supported by an NCI/NIH-SBIR Bridge Grant. Visit www.altorbioscience.com for details.
Altor BioScience Corporation
Peter Rhode, Ph.D., 954-443-8600