SAN DIEGO -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today the first patient has been dosed in a closed loop control ("artificial pancreas") clinical study involving Halozyme's recombinant human hyaluronidase being performed by researchers at Yale School of Medicine in patients with type 1 diabetes. The study will compare blood glucose control observed when using lispro (marketed as Humalog®), a rapid acting analog insulin, alone versus using hyaluronidase in combination with lispro in two different administration formats. Closed loop systems combine continuous glucose monitoring (CGM) devices that provide around-the-clock feedback about blood glucose levels with insulin pumps allowing insulin to be administered throughout the day based on a patient's needs as provided by the CGM.
"A major limitation in closed loop control research is that the currently available analog insulin products act too slow in response to increases in blood glucose," stated Eda Cengiz, M.D., M.H.S., lead study investigator and Assistant Professor of Medicine, Yale School of Medicine. "In this study, we are going to assess whether using hyaluronidase to potentially increase the speed of absorption of analog insulin may allow the artificial pancreas to respond more readily to changes in blood sugar."
In the study, hyaluronidase will be evaluated as to its utility in the closed loop system. The study endpoints include assessment of hyaluronidase treatment in combination with analog insulin compared to analog insulin alone with respect to reduction of post-prandial glucose concentrations, total area under the glucose-time curve following a meal as well as reduction of late post-prandial hypoglycemia. The study will also compare the performance of treatment with a co-formulation of lispro and rHuPH20 to a pre-administration of Hylenex® recombinant (hyaluronidase human injection) with respect to these same study endpoints.
"We are pleased that Yale investigators received grant funding from JDRF to independently test our enzyme in this important research to advance insulin therapy for patients in need," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "We look forward to the results of this novel study."
Additional Study Details
Approximately 20 subjects will be recruited into the clinical study and will stay in the hospital for three and a half consecutive days. Following overnight stabilization of metabolic status, subjects will be treated, in random sequence, with either 1) analog insulin alone; 2) a co-formulation of insulin lispro and rHuPH20; or 3) pre-treatment with 150 units of Hylenex administered through the subcutaneous insulin infusion set followed by use of analog insulin alone. The closed loop system being used in the study does not require active participation by the subject with diabetes to either monitor blood glucose levels or to choose and administer insulin doses. Identical standardized meals will be administered each day, allowing a direct comparison of blood sugar control achieved by each of the three different treatment regimens. The ClinicalTrials.gov identifier number for the trial is: NCT01945099.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible benefits, attributes and outcomes regarding the use of Hylenex® or rHuPH20 in closed loop settings. The forward-looking statements are usually (but not always) identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of risks and uncertainties including clinical trial enrollment, conduct and results, unexpected adverse events and outcomes, unexpected expenditures and costs and unexpected results or delays in development and regulatory review. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2013 under Risk Factors. Halozyme does not undertake to update these forward-looking statements.