Continuous subcutaneous
infusion of insulin with rHuPH20 in pumps demonstrated the ultra rapid
profile previously observed with Aspart-PH20 injections -
SAN DIEGO, April 14, 2011 /PRNewswire via COMTEX/ --
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced 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(R), accelerates insulin absorption and shortened its duration of
action. These preliminary results represent the first reported
experience in a clinical trial where patients received rHuPH20 enzyme
combined with an insulin analog as a continuous subcutaneous insulin
infusion (CSII) over 72 hours administered with an insulin pump.
Halozyme presented these results today at the American Association of
Clinical Endocrinologists (AACE) meeting in San Diego.
(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)
"The initial results from Halozyme's first pump study show that the
faster pharmacokinetic and glucodynamic findings consistently
demonstrated with mealtime subcutaneous insulin injections are also
observed in the CSII setting," stated Doug Muchmore,
M.D., vice president of endocrinology clinical development. "The
ultrafast profile of analog insulin with rHuPH20 is well suited for use
with insulin pumps."
Key Findings from Today's Oral Presentation
The first stage of this double blind crossover design Phase 1
clinical trial compared Aspart-PH20 to aspart alone in type 1 diabetes
patients who administered their insulin over 72 hours with an insulin
pump. 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 also translated into accelerated
insulin action for the combination treatment. As demonstrated with a
euglycemic clamp procedure, Aspart-PH20 action in the first 2 hours was
20% greater relative to aspart alone (p = 0.047) with 37% less insulin
action beyond 4 hours after injection (p = 0.008). These results have
been obtained for the first 13 patients and enrollment of an additional 5
patients is continuing for the aspart stage of the study. So far, the
overall safety and adverse event profiles for Aspart-PH20 and aspart
alone were comparable and both treatments were well tolerated.
Additional parameters important for pump use are being tested, with data
available later in 2011.
The goal of Halozyme's Ultrafast Insulin program is to develop a
best-in-class mealtime insulin product compared to the currently
prescribed analogs that participate in the growing $3.8 billion worldwide prandial insulin market. Additional information about Halozyme's on-going Ultrafast Insulin trials can be found at clinicaltrials.gov using the identifiers NCT01275131, NCT01194245 and NCT01194258.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company developing and
commercializing products targeting the extracellular matrix for the
endocrinology, oncology, 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(TM) technology is a novel drug delivery platform designed to
increase the absorption and dispersion of biologics. The company has key
partnerships with Roche to apply Enhanze technology to Roche's
biological therapeutics, including Herceptin(R) and MabThera(R), and
with Baxter BioScience to apply Enhanze technology to immunoglobulin.
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.
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 of 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
SOURCE Halozyme Therapeutics, Inc.