KaloBios Initiates Phase 1/2 Trial of Humaneered(TM) Monoclonal Antibody KB001 for...

KaloBios Initiates Phase 1/2 Trial of Humaneered(TM) Monoclonal Antibody KB001 for Treatment of Pseudomonas Infections in Cystic Fibrosis Patients

PALO ALTO, Calif.--(Business Wire)--
KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical
company, today announced the initiation of a Phase 1/2 clinical trial
of KB001, a Humaneered(TM), high-affinity antibody fragment that
KaloBios is developing for the treatment of P. aeruginosa infections.
The trial is being conducted in conjunction with the Cystic Fibrosis
Foundation and its affiliated organizations.

The blinded, placebo-controlled trial, which is being conducted at
over 10 sites across the United States, will enroll up to 48 patients
with cystic fibrosis who will receive either one of two dose levels of
KB001 or placebo. Endpoints for the trial include safety, reduction of
P. aeruginosa bacteria, and inflammatory markers.

"KB001 is a very novel approach that targets the principal
mechanism by which P. aeruginosa becomes pathogenic," said Geoffrey
Yarranton, Chief Scientific Officer. "We have demonstrated in both
laboratory and rodent studies that KB001 is active against drug
resistant strains of this bacterium."

"We are also very pleased that the data from our Phase 1 healthy
volunteer trial demonstrated that KB001 was well tolerated with no
dose limiting toxicities, something very unusual for an
anti-infective," said Tillman Pearce, KaloBios' Chief Medical Officer.
"Furthermore there was no evidence of immunogenicity, a potential
benefit of Humaneering(TM)."

Background Information

P. aeruginosa is an opportunistic pathogen that rarely causes
disease in healthy people, but is a significant problem for critically
ill or immunocompromised individuals. These include the approximately
70,000 worldwide patients with cystic fibrosis where P. aeruginosa is
a major causative agent in the progressive loss of lung function
resulting from recurrent and chronic respiratory tract infections with
the bacterium.

A Phase 1/2 clinical trial in this case means that the data from a
small previously conducted human trial of healthy volunteers indicated
that there were limited or no side effects, and so KB001 is now being
tested in cystic fibrosis patients between 18 and 45 years of age with
P. aeruginosa in their lungs. KB001 is a fragment of a monoclonal
antibody (a biologic drug), which means in this case the drug must be
given intravenously or as an injection, but its effects may last for
weeks. For more information about the trial, go to
http://www.clinicaltrials.gov or
http://www.cff.org/research/ClinicalResearch/Find/. For more
information about cystic fibrosis, please visit www.cff.org.

About Humaneering(TM)

KaloBios' Humaneering(TM) technology is a proprietary method for
converting non-human antibodies into engineered human antibodies.
Humaneered(TM) antibodies are high affinity, but nearer to human
germline sequence than is possible with other available antibody
engineering methods, making them exquisitely suited for repeated use
in the treatment of chronic or other therapies.

About KaloBios

KaloBios Pharmaceuticals, Inc., a U.S.-based, private monoclonal
company, uses its proprietary platform technology to develop first-or
best-in-class human antibody therapeutics. It currently has two
programs that have completed Phase 1 trials and are entering Phase 1/2
trials. KB001 is an anti-infective for Pseudomonas aeruginosa
infections, an issue for cystic fibrosis and intensive care patients
on a ventilator. KB002 is an anti-inflammatory currently being studied
as a potential treatment for rheumatoid arthritis and entering a
clinical trial for persistent asthma patients. The company's
Humaneering(TM) 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.

KaloBios Pharmaceuticals, Inc.
David W. Pritchard, 650-843-1897 ext. 300
President and CEO
or
Kureczka/Martin Associates
Joan E. Kureczka, 415-821-2413
Jkureczka@comcast.net

Copyright Business Wire 2008