SOUTH SAN FRANCISCO, Calif., Oct. 23, 2013 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced the election of Laurie Smaldone Alsup, M.D. to KaloBios' Board of Directors.
"Dr. Smaldone Alsup brings to the Board extensive experience in leading teams through the review and approval process of the U.S. Food and Drug Administration, European Medicines Agency and other health authorities," said David W. Pritchard, KaloBios' President and Chief Executive Officer. "Moreover, as a clinician she has led the overall development and commercialization of drugs for a broad range of disease indications including oncology, infectious disease, and inflammatory/ immune-based conditions that are directly relevant to our own portfolio."
"Dr. Smaldone Alsup replaces Dr.
Dennis Henner, whom we thank for his valuable service to KaloBios during an important phase of our company's development and growth," added Mr. Pritchard.
Laurie Smaldone Alsup has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries. Currently, Dr. Smaldone Alsup is President and Chief Scientific Officer of PharmApprove, a regulatory communications consultancy firm. Dr. Smaldone Alsup previously served in clinical and regulatory roles of increasing responsibility and scope while at Bristol Myers Squibb, including Senior Vice President of Global Regulatory Science, Vice President of Infectious Diseases Clinical Research, and also as Director of Cancer Clinical Research. In addition, she served as CEO of Phytomedics, an early stage biopharmaceutical company focused on arthritis and inflammation. Dr. Smaldone Alsup received her M.D. degree at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology.
- 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 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 Pseudomonas aeruginosa ( Pa) infection. KaloBios has retained rights for the cystic fibrosis (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 designation from the European Commission 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.
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