SOUTH SAN FRANCISCO, CA (October 15, 2009) -
Phase 1/2 clinical trial results with KB001, a Humaneered™, high-affinity
antibody fragment under development by KaloBios Pharmaceuticals, Inc. in cystic
fibrosis patients showed an acceptable safety profile as well as trends toward
reducing tissue inflammation and clearance of the bacterium. Results of the
multi-center, randomized, double-blind, single-dose, placebo-controlled study
are being presented today at the North American Cystic Fibrosis Conference in
Minneapolis, MN. KaloBios is developing KB001 for the treatment and/or prevention
of Pseudomonas aeruginosa infections in both cystic fibrosis patients and
intensive care patients on ventilation, for whom Pseudomonas-caused pneumonia is
a major costly health care problem.
"KB001 is designed to fight Pseudomonas aeruginosa (Pa) by blocking a virulence
mechanism (the Type Three Secretion System or TTSS) on the bacterium's external
surface that enables Pa to perforate and kill white blood cells and epithelial
cells, and trigger tissue-damaging inflammation," said Dr. Geoff Yarranton,
Kalobios' chief scientific officer. "By blocking Pa's killing mechanism, KB001 is
intended to reduce the inflammation and exacerbations that are associated with
the damage done to the lungs by Pa, and potentially enable the patient's own
immune system to effectively fight and clear the bacterium from sites of
infection. This contrasts with antibiotics like tobramycin that directly kill Pa,
but quickly lose effectiveness if the bacteria become resistant to the drug."
The Phase 1/2 study enrolled two cohorts of approximately 12 patients who were
randomized at a 2:1 ratio to receive a single IV infusion of KB001 or placebo at
either 3.0 mg/kg or 10 mg/kg. Patients were followed for eight weeks. Results
showed KB001 to be safe and non-immunogenic. An analysis of exploratory endpoints
showed that there was an encouraging anti-inflammatory impact as measured by
dose-related reductions in inflammatory markers, including neutrophils, IL-8,
elastase, MPO, macrophages, and IL-1. There was also a trend in reducing mucoid
and total Pa burden at day 56.
"We are very pleased with these initial clinical results for KB001, which we
believe support conducting larger randomized clinical trials to further evaluate
KB001's safety and clinical benefits for patients with cystic fibrosis," said
Tillman Pearce, KaloBios' chief medical officer. "KB001 is a highly novel approach
to treating Pseudomonas and now has shown promising data in both ventilator-associated
pneumonia patients and cystic fibrosis patients."
Pseudomonas infection is a major unmet medical need with strains found all over
the world that are resistant to common antibiotics. KaloBios is actively
seeking a partner to help move this program forward and to ultimately capture
the potential market of over $500 million that would exist for a safe and
effective anti-Pseudomonas therapy.
About KaloBios
KaloBios Pharmaceuticals, Inc., a U.S. based, private monoclonal company, uses
its biologic capabilities and its proprietary platform technology to develop
first-in-class human antibody therapeutics. The company has multiple programs
that have been in seven Phase 1 or 2 clinical trials in 2008/09; KB001 is an
anti-infective for Pseudomonas aeruginosa infections being tested in cystic
fibrosis and in intensive care patients on a ventilator, and KB002 and KB003 are
being evaluated in inflammatory conditions, such as rheumatoid arthritis and
asthma. KB004 is in preclinical development for hematologic malignancies and
solid tumors. The company's Humaneering™ technology offers advantages over
other methods of human antibody creation in terms of immunogenicity, potency,
and manufacturing yields.
For more information, visit www.kalobios.com.
Contact:
Media Contact:
David W. Pritchard
President and CEO
KaloBios Pharmaceuticals, Inc.
(650) 243-3100
Joan E. Kureczka
Kureczka/Martin Associates
(415) 821-2413
