SAN DIEGO, June 15, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today presented a scientific
poster highlighting the CONSISTENT 1 trial results at the 74th
Scientific Sessions of the American Diabetes Association in
San Francisco. The CONSISTENT 1
trial is evaluating Hylenex® recombinant and a
new formulation of Hylenex currently under U.S. Food and
Drug Administration (FDA) review, when used as pretreatment of the
insulin infusion site in patients with type 1 diabetes (T1DM)
receiving continuous subcutaneous insulin infusion (CSII) in
comparison to no pre-treatment. Data reported in the presentation
show that the study's primary endpoint of non-inferiority for A1C
at six months between the use of Hylenex and the new
formulation of Hylenex in comparison to no pre-treatment was
met. In addition to other trial data, the poster also
presents data indicating that there was a potential reduction in
the rate of hypoglycemic events associated with the use of the
Hylenex formulations in comparison to no pre-treatment.
ADA Poster Presentation Details
Title:
"Recombinant Human Hyaluronidase Pretreatment of CSII Cannula Sites
Provides Comparable Glycemic Control with Reduced Hypoglycemia in
T1DM Compared to Usual CSII"
Abstract #: 85-LB, June 15,
2014, 12:00 p.m. - 2:00 p.m.
PDT
Category: 01-B Clinical Therapeutics / New Technology -
Insulin
Location: Poster Hall D - North
Additional Study Details
The CONSISTENT 1
(CONtinuous Subcutaneous Insulin infusion
STudy ENrolling Type 1 Diabetes) trial is
evaluating the safety and efficacy of
Hylenex® recombinant and a new
formulation of Hylenex under FDA review in a six month
trial with an 18 month extension phase in 455 patients with type 1
diabetes. The primary efficacy endpoint is comparison of change
from baseline in A1C levels at six months. Secondary endpoints are
hypoglycemia rates, hyperglycemia comparisons, glucose variability
and safety endpoints including adverse events, local tolerability
and immunogenicity.
About Hylenex® recombinant (hyaluronidase
human injection)
Hylenex®
recombinant is a tissue permeability modifier indicated as an
adjuvant to increase the dispersion and absorption of other
injected or subcutaneously infused drugs, to facilitate
subcutaneous fluid administration and in subcutaneous
urography. Hylenex recombinant is contraindicated in
patients with a known hypersensitivity to recombinant human
hyaluronidase or any excipient used to make the drug.
The most frequently reported adverse reactions with
Hylenex recombinant have been local injection site
reactions, such as erythema and pain. For additional information or
full Prescribing Information visit www.hylenex.com or
www.halozyme.com.
About Halozyme
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
oncology, diabetes and dermatology that have significant unmet
medical need today. The Company markets Hylenex®
recombinant (hyaluronidase human injection) and has partnerships
with Roche, Pfizer and Baxter. 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® in the CSII setting) 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 typically, 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 several factors,
including unexpected expenditures and costs, unexpected results or
delays in development and regulatory review, regulatory approval
requirements, unexpected adverse events and competitive conditions.
These and other factors that may result in differences are
discussed in greater detail in Halozyme's Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
May 12, 2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Denise
Powell
510-703-9491
dpowell@wcgworld.com
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SOURCE Halozyme Therapeutics, Inc.