KaloBios Announces First Patient Dosed in Phase 1 Study of Lenzilumab for the Treatment of Chronic Myelomonocytic Leukemia
- Lenzilumab offers promise for the treatment of rare leukemia
- Company turns full attention to executing its neglected and rare diseases pipeline
BRISBANE, Calif., July 25, 2016 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today announced that the first patient has been dosed in its open-label, multi-center Phase 1 clinical trial with lenzilumab (formerly KB003) focused on patients with previously-treated Chronic Myelomonocytic Leukemia (CMML).
This multi-center Phase 1 dose escalation trial is being conducted to evaluate the safety, maximum tolerated dose, and preliminary activity of single-agent lenzilumab in subjects with CMML who are relapsed/refractory to, and/or intolerant to, standard-of-care treatments.
“The new KaloBios is now in action mode, and the first dosing of a patient in the lenzilumab study highlights our pivot to swift execution in advancing our pipeline assets,” said Cameron Durrant, MD, KaloBios chairman and CEO. “CMML is a rare and devastating disease for which there are limited effective treatment options currently available. We anticipate this trial will demonstrate lenzilumab’s potential to help patients who need new treatment options and support its continued clinical advancement.”
The study will enroll up to 18 patients and is designed to identify the maximum tolerated dose, or recommended Phase 2 dose, of lenzilumab in subjects with previously-treated CMML. It will also assess preliminary efficacy of single-agent lenzilumab and to provide additional data on pharmacokinetics, pharmacodynamics and safety.
“The first patient to receive treatment in this study also signifies the first of many important clinical milestones ahead for KaloBios, as we seek to tackle neglected and rare diseases through innovative and responsible business models,” added Dr. Durrant.
Lenzilumab is a monoclonal antibody that targets and is an antagonist of soluble Granulocyte Macrophage – Colony Stimulating Factor (GM-CSF), a cytokine suggested to be central to the inflammation and activation of certain immune cells. Lenzilumab has been studied for its ability to limit hypersensitivity to GM-CSF signaling, which appears to be a key feature to many CMML patients and its inhibition may affect the growth of leukemic cells in patients. Lenzilumab has been tested in more than 90 subjects in previous clinical trials in rheumatoid arthritis, asthma and healthy volunteers, and was found to be well tolerated. Data also suggest lenzilumab may have the potential to treat other diseases, including juvenile myelomonocytic leukemia (JMML).
CMML is a rare and aggressive cancer of the blood with approximately 1,500-3,000 new cases per year in the United States. The cancer interferes with normal blood cell production, including red blood cells, white blood cells and platelets. CMML patients have shortened life expectancies, with a median survival rate of one to two years, and approximately 15-30 percent of patients will go on to develop acute leukemia.
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTC:KBIO) is a developmental stage biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios portfolio are benznidazole for the potential treatment of Chagas disease in the U.S., and the proprietary monoclonal antibodies, lenzilumab and ifabotuzumab (formerly KB004), for the potential treatment of various solid and hematologic cancers such as chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia. For more information, visit www.kalobios.com.
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 ability to execute its revised strategy and business plan; the success of the Company’s clinical trials for its product pipeline; the Company’s access to 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 potential timing and outcomes of clinical studies of benznidazole, lenzilumab, ifabotuzumab or any other products undertaken now or in the future; the commercial viability of the Company’s proposed drug pricing program; the ability of the Company to timely source adequate supply of its development products from third party manufacturers on whom the Company depends; the potential, if any, for future development of any of its present or future products; the Company's ability to successfully progress, partner or complete further development of its programs; the ability of the Company to identify and develop additional products; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the uncertainty of receiving a Priority Review Voucher; 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 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.
Media Contact: Lisa Guiterman O: 301-217-9353 C: 202-330-3431 email@example.com
Released July 25, 2016