This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Yale Researchers Initiate Clinical Trial Evaluating Halozyme's Recombinant Hyaluronidase In Artificial Pancreas Study

SAN DIEGO, Oct. 15, 2013 /PRNewswire/ -- 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.

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

"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 DetailsApproximately 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.

About HalozymeHalozyme 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.

Investor Contact: David RamsayHalozyme Therapeutics858-704-8260 ir@halozyme.com

Media Contact: Nurha HindiHill+Knowlton Strategies310-633-9434 Nurha.Hindi@hkstrategies.com

SOURCE Halozyme Therapeutics, Inc.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,943.81 +28.74 0.17%
S&P 500 1,967.57 +2.89 0.15%
NASDAQ 4,415.49 +19.2860 0.44%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs