-- Insulin-PH20 Combinations Demonstrated Significantly Faster Glucose Metabolism --
SAN DIEGO--(BUSINESS WIRE)--May. 29, 2009--
Halozyme Therapeutics, Inc. (Nasdaq: HALO), announced publication of a
Phase 1 study reporting an acceleration of insulin absorption and
increased insulin effects within minutes after co-administration of its
hyaluronidase (PH20) enzyme with two mealtime
insulin products, Humulin® R (regular human insulin) and
Humalog® (insulin lispro). A rapid and short-acting insulin
profile would more closely mimic the mealtime insulin release that
occurs in non-diabetics and could lead to improved treatment for
diabetes patients. These results were published in the June 2009 issue
of the journal Diabetes Technology & Therapeutics.
“The faster onset and faster offset of glucose effects for insulin plus
PH20 observed in this study may lead to a superior treatment for
diabetes,” stated Douglas B. Muchmore, M.D., vice president,
endocrinology clinical development at Halozyme. “That profile may meet
the postprandial insulin needs of both type 1 and type 2 diabetics with
greater precision and efficacy.” The benefits of more rapidly acting
insulin may lead to a lower incidence of hypoglycemia, insulin dose
reduction, greater convenience to the patient, or less weight gain.
This Phase 1 study investigated the pharmacokinetics (PK) and
glucodynamics of Humalog and Humulin R with and without Halozyme’s
recombinant human hyaluronidase enzyme in 26 healthy male volunteers.
After fasting overnight on two separate occasions, 12 subjects received
20 U of insulin lispro with and without PH20 and 14 subjects received 20
U of regular insulin with and without PH20 as subcutaneous injections in
the abdomen. A euglycemic clamp procedure was performed and maintained
for 6 hours. Administration of hyaluronidase facilitates the dispersion
and absorption of co-injected drugs by allowing greater capillary bed
Key Findings from the Published Study
This clinical trial demonstrated faster systemic insulin absorption,
enhanced systemic exposure, and accelerated glucose metabolism for both
of the insulin plus PH20 combinations compared to either insulin alone.
All injections were well tolerated.
PH20 reduced the time to maximum glucose infusion rate (tGIRmax)
by 41% for Humalog (P = 0.006) and by 35% (P = 0.01) for Humulin R.
The addition of PH20 significantly increased early glucose metabolism
during the first two hours after injection and significantly reduced
late metabolism, 4-6 hours after injection.
The time to maximum (tmax) insulin concentration
with co-administration of PH20 was reduced for Humalog by 51% (P =
0.0006) and for Humulin R by 58% (P = 0.0002). This indicates faster
insulin absorption with PH20.
Co-administration of PH20 increased maximum insulin concentration (Cmax)
for Humalog by 90% (P = 0.0003) and for Humulin R by 142% (P < 0.0001).
The addition of PH20 significantly reduced intersubject variability as
measured by the standard deviation for insulin tmax
and for the coefficient of variance for Cmax for
both of the insulin-PH20 combination treatments.
Additional clinical trials investigating Halozyme’s Insulin-PH20 are
currently underway and more trials are planned. Interim results of a
Phase 2 investigation will be presented at the upcoming American
Diabetes Association 69th Scientific Sessions on June 6,
2009 in New Orleans.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the endocrinology,
oncology, dermatology and drug delivery markets. The company's portfolio
of products and product candidates is based 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 Roche to apply Enhanze Technology to
Roche’s biological therapeutics for up to 13 targets and with Baxter
BioScience to apply Enhanze Technology to Baxter’s biological
therapeutic compound, GAMMAGARD LIQUID™. The product
candidates in Halozyme’s research 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, (i)
statements concerning the efficacy and benefits of insulin plus PH20
combinations, (ii) clinical trial results and the conclusions drawn from
such trials, and (iii) the expected initiation of future clinical
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.
Source: Halozyme Therapeutics, Inc.
Robert H. Uhl