KaloBios' KB001 Anti-Pseudomonas Antibody Study Published in Pediatric Pulmonology Human Safety and PK/PD Data from Phase 1 Study of KB001 Supports Ongoing Phase 2 Clinical Trial of KB001-A in Cystic Fibrosis
SOUTH SAN FRANCISCO, Calif., Sept. 18, 2013 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced the publication of Phase 1 study results for KB001, a first generation, anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody, for use in patients with cystic fibrosis (CF). Data from this initial single dose clinical study supports the continuation of KaloBios' ongoing Phase 2 study of KB001-A, a second generation, anti-TTSS antibody in CF patients with chronic Pa infections.
The Phase 1 study results appear online in the journal Pediatric Pulmonology, authored by Carlos Milla, M.D., of the Center for Excellence in Pulmonary Biology, Stanford University, and other members of the KB001 Study Group.
"Many patients with CF are chronically infected with Pa which contributes to disease progression by causing a strong inflammatory response that destroys lung tissue," said Nestor A. Molfino, M.D., M.Sc, KaloBios Chief Medical Officer. "Treating Pa infection with antibiotics has long been shown to benefit CF patients; however, Pa is not eradicated by such treatments and antibiotic-resistant strains soon emerge. KB001-A is a novel, non-antibiotic agent against Pa that targets and inhibits the bacterium's TTSS that is responsible for Pa's virulence and pro-inflammatory effects.
"The safety, pharmacokinetic and pharmacodynamic results obtained for KB001 in this initial single-dose Phase 1 clinical study supports the continuation of the Phase 2 study currently underway of KB001-A as a potential non-antibiotic treatment to reduce airway inflammation and tissue damage in CF patients with chronic Pa infection," Dr. Molfino concluded.
The published study results showed a single intravenous dose of KB001 to have an acceptable safety profile and a trend toward a short-term reduction in markers of inflammation, particularly neutrophil elastase which has long been recognized as the main enzyme responsible for lung damage in CF patients. The investigators concluded that repeat-dosing studies are required to evaluate the durability of the anti-inflammatory effects and how treatment with KB001 might translate into clinical benefit.
KaloBios is currently enrolling patients in a Phase 2 multi-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa. This 180-patient study is intended to evaluate the efficacy and safety of repeat doses of KB001-A. The primary endpoint is time-to-need for antibiotics. To learn more about this study, including eligibility criteria, please visit www.clinicaltrials.gov.
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.
Currently, KaloBios has three drug development programs:
- KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, is being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a planned 150 patient Phase 2 study in the United States, Europe and Australia.
- KB001-A, an anti-PcrV mAb fragment, is partnered exclusively with Sanofi and is being developed for the prevention and treatment of Pa infection. KaloBios has retained rights for the CF indication and has initiated a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States. KaloBios received Orphan Drug Status from the European Commission regarding its applications for KB001-A for the treatment of Pa lung infection in CF. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation.
- KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies.
All of the company's antibodies were generated using its proprietary Humaneered® technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered® technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
For more information on KaloBios Pharmaceuticals, please visit our web site at http://www.kalobios.com.
Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the company's clinical development of KB001-A, KB003 and KB004 and the potential for KB001-A to be a non-antibiotic treatment to reduce airway inflammation and tissue damage in CF patients with chronic Pa infection. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company's limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that the company has initiated or plans to initiate; the company's dependence on Sanofi Pasteur for the development and commercialization of KB001-A; the company's ability to successfully complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company's ability to protect the company's intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company's products; and other factors listed under "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 1, 2013 and the company's other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Jeffrey H. Cooper
Chief Financial Officer
KaloBios Pharmaceuticals, Inc.
Joan E. Kureczka
Tel: (415) 821-2413
Mobile: (415) 690-0210
SOURCE KaloBios Pharmaceuticals, Inc.