Navigation Links
Halozyme's Ultrafast Insulin Demonstrates Reduced Variability of Insulin Absorption for Type 1 Diabetes Patients Using Insulin Pumps
Date:6/24/2011

SAN DIEGO, June 24, 2011 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced final results from a study in type 1 diabetes patients who receive their insulin treatment with a pump demonstrating that Aspart-PH20, a formulation of Halozyme's rHuPH20 (recombinant human hyaluronidase) with the active ingredient in NovoLog®, reduces the variability of insulin absorption and reduces post-meal glycemic excursions compared to NovoLog alone. Halozyme is presenting these findings in a late-breaking poster titled: "Addition of Human Hyaluronidase to Rapid Analog Insulin Reduces the Absolute Variability of Early Insulin Absorption across Infusion Set Life" at the American Diabetes Association 71st Scientific Sessions on Sunday, June 26 in San Diego.  

(Logo:  http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"These additional results from Halozyme's first pump study demonstrate that the faster pharmacokinetic and glucodynamic findings are significantly more consistent and less variable for the Aspart-PH20 combination than for NovoLog alone in the pump setting," stated Doug Muchmore, M.D., vice president of endocrinology clinical development at Halozyme. "More consistent and rapid insulin absorption over the life of the infusion set with the addition of rHuPH20 may help patients using insulin pumps achieve tighter glucose control, better manage their disease and obtain improved outcomes."

The double-blind crossover design Phase 1 clinical trial compared Aspart-PH20 to aspart alone in 16 type 1 diabetes patients who administered their insulin over 72 hours with an insulin pump. The data demonstrated the following key results:

  • Addition of rHuPH20 reduced the absolute variability of early insulin absorption over the 72-hour infusion set life;
  • Addition of rHuPH20 to aspart consistently reduced post-meal glycemic excursions compared to NovoLog alone over the 72-hour infusion set life;
  • Infusion site biopsy data from patients supports the safety of the rHuPH20 enzyme, its local and transient effect at the skin infusion site, and full restoration of hyaluronan within 24 hours after cannula removal; and
  • Individual patient skin biopsy histopathology data demonstrated similar tolerability for Aspart-PH20 compared to NovoLog.

"Patients on an insulin pump face unique challenges over the their three day infusion cycle as analog insulin tends to be absorbed differently over the course of the infusion set life," stated William V. Tamborlane, M.D., Yale University School of Medicine. "Reduced absorption variability attributed to the coadministration of rHuPH20 with analog insulin may offer an intriguing solution to this problem."

The findings from this pump study indicate that the absorption of analog insulin is slowest early in the infusion set life. As a result of these scientific observations, Halozyme has initiated a proof-of-concept study to investigate the administration of a single dose of rHuPH20 at the catheter site before starting the insulin infusion with a pump for a three-day treatment cycle. The presence of rHuPH20 used in this leading edge design may serve to "prime the pump" and reduce the variability of absorption associated with the aging of an infusion set.

About the Phase 1 Pump Study

This Phase 1 double blind crossover design clinical trial conducted in 16 type 1 diabetes patients who administered their insulin over 72 hours with an insulin pump compared Aspart-PH20 to aspart alone. The addition of rHuPH20 to aspart reduced early post meal glycemic excursion significantly, but as the infusion set aged, the difference between study drugs diminished. Individual patient skin biopsy data support previous safety findings and indicate that hyaluronan depletion at the time of cannula removal became fully restored within 18-24 hours. In addition, staining techniques reveal comparable local mild inflammatory response to both treatments at the cannula insertion track.

The cumulative insulin exposure during the first 60 minutes following a bolus infusion was 64% greater for the Aspart-PH20 formulation compared to aspart alone (p < 0.0001). Insulin exposure beyond 2 hours after the bolus decreased by 42% for the combination compared to aspart alone (p = 0.0003). These results clearly demonstrate the faster-in/faster-out pharmacokinetic (PK) profile for the combination Aspart-PH20. The faster PK translated into accelerated insulin action for the combination treatment and consistently reduced glycemic excursions following solid mixed meal dinner challenges with the mean 2 hour post prandial glucose reduced from 146 mg/dL with insulin aspart alone to 121 mg/dL for Aspart-PH20 (p=0.017).

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the insulin, cancer, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Baxter, Roche, ViroPharma and Intrexon to apply Enhanze technology to therapeutic biologics including immunoglobulin, Herceptin®, MabThera®, Cinryze® and alpha 1-antitrypsin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

NovoLog® is a registered trademark of Novo Nordisk®.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning, (i) the timing and results from on-going clinical trials, (ii) the benefits of insulin with rHuPH20 combinations, and (iii) the conclusions drawn from the trials) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also 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 several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Halozyme Contact  
Robert H. Uhl
Senior Director, Investor Relations
(858) 704-8264
ruhl@halozyme.com

Media Contact
Ligia Santos
415-946-1083
lsantos@invigoratepr.com


'/>"/>
SOURCE Halozyme Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
2. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
3. Diabetes Research Institute Invention Promotes Growth of Stem Cells into Insulin-Producing Cells
4. Phosphagenics to Commence Phase 2 TPM/Insulin Clinical Trial
5. Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for Insulin Nasal Spray to Treat Diabetes
6. Retrospective Analysis Finds That Initiation of Insulin Glargine in Patients With Type 2 Diabetes was Associated With a Lower Incidence Rate of Myocardial Infarction as Compared With NPH Insulin
7. Access Pharmaceuticals Demonstrates Ability to Significantly Reduce Glucose Levels in Pre-clinical Testing of Cobalamin(TM) Oral Insulin
8. Arena Pharmaceuticals Announces APD668 Initial Clinical Study Results Suggest Glucose-Dependent Insulinotropic Receptors May Improve Glucose Control in Patients With Type 2 Diabetes
9. DiObex, Inc. Awarded Patent for the Prevention of Insulin-Induced Hypoglycemia
10. New Data Shows Ranexa(R) Increases Glucose-Stimulated Insulin Secretion
11. Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... NEW DELHI , April 27, 2016 ... CSR initiative to save newborns ... ,s hospital for women & newborns in collaboration with Breast ... has launched the first Pasteurized Human Milk Bank, ,Amaara, in ... the best nutritional food source for infants and should be ...
(Date:4/27/2016)... SAN FRANCISCO , April 27, 2016 /PRNewswire/ ... to reach over USD 2.14 billion by 2022, ... Research, Inc.       (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ... key technological advancement affecting the efficiency and accuracy ... hence, the persistent demand for novel urinalysis instruments ...
(Date:4/26/2016)... , April 26, 2016 US ... forecast to expand 4.9 percent annually to $27.6 ... other healthcare facilities to decrease rates of healthcare-associated ... prevention supplies, equipment, and services.  Although declining, the ... significantly above targeted levels set by the CDC.  ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... In 2011, TIME magazine named Herr the “Leader ... biomechatronics, technology that marries human physiology with electromechanics. He continues that work as Director ... Founder of BionX , a leader in the field of prosthetic devices. , ...
(Date:4/28/2016)... ... April 28, 2016 , ... One way to ignore ... This is unfortunately true. But we toss the baby out with the bathwater when ... provides tips for identifying higher-quality studies and otherwise making better use of education policy ...
(Date:4/28/2016)... AZ (PRWEB) , ... April ... ... the AnzuMedical™ Knowledge Sharing and Collaboration Platform™ , today announced a ... platform will provide efficient access to medical knowledge, educational resources, and a ...
(Date:4/28/2016)... ... April 28, 2016 , ... Accreditation ... Community Oncology Pharmacy Association (COPA) to develop a comprehensive Specialty Pharmacy Accreditation with ... introducing an accreditation distinction. ACHC provides a wide range of pharmacy accreditation services ...
(Date:4/28/2016)... , ... April 28, 2016 , ... Denise McCormick Baich had written poetry dating back ... poetry arrived again much like a tsunami and took on a more spiritual tone. The ... encouraged her to do more with it than just file it away. Friends would ask ...
Breaking Medicine News(10 mins):