Halozyme Presents New HTI-501 Data
Phase 2 study interim analysis indicates positive activity
SAN DIEGO, June 30, 2013
SAN DIEGO, June 30, 2013 /PRNewswire/ --Halozyme Therapeutics, Inc. (NASDAQ:
HALO) today announced interim results from a proof of concept Phase 1/2
clinical trial evaluating the activity and local tolerability of HTI-501, an
investigational biologic, for use in aesthetic dermatology. The data were
presented June 29, 2013 at the 9^th Annual World Congress of Cosmetic
Dermatology in Athens, Greece.
This trial is being conducted outside the US in healthy adult females with
cellulite, known medically as edematous fibrosclerotic panniculopathy. The
Phase 1 dose-escalation portion of the trial was completed in 2012 while the
ongoing Phase 2 portion of the trial is designed to assess the pharmacologic
activity of HTI-501 and extend the safety assessment to multiple injections in
a treatment area. The primary endpoint is physician assessment at Day 28,
supported by secondary endpoints of subject self-evaluations and objective
measurements of changes to the skin topography.
The interim results from 12 of the planned 34 evaluable patients from this
Phase 1/2 trial indicates pharmacologic activity at the primary 28 day
observation point, with 83 percent of subjects (10 of 12) showing improvement
from the pretreatment assessment, with a median improvement of 53 percent
(p=.006) by the primary physician assessment. In comparison, 75 percent of
subjects (9 of 12) showed improvement with a median improvement of 22 percent
(p=.009) for the vehicle injection control at the same observation point. The
objective measure (skin topography) for the treated area showed modest
improvement in 80 percent of evaluable subjects (8 of 10) treated with HTI-501
(p=.042), but was not significantly changed for the vehicle control (p=.84) or
a post-hoc evaluation of non-injected areas. To query the robustness of any
study conclusions, an independent blinded panel evaluation of images will be
performed on the evaluable subjects at one and six months following
"In the initial patients treated thus far, the response to treatment with
HTI-501 has been encouraging. We are particularly interested in subsequent
three and six month observations, which have shown further improvement in some
subjects treated thus far," said Francisco Perez, M.D., immediate past
President of World Congress of Cosmetic Dermatology and principal clinical
investigator. "We look forward to completing enrollment this summer and
conducting final follow-up observations early next year."
The HTI-501 enzyme and its formulation have been well tolerated so far in this
trial at all doses and formulations tested, with no serious or severe adverse
events. The most common side effects have been mild to moderate transient
injection site discomfort and mild to moderate injection site bruising,
resolving within about two weeks without intervention.
HTI-501 is a proprietary recombinant human protease (rHuCAT-L) in a
conditionally active formulation discovered and under development by Halozyme.
HTI-501 is being explored as a potential treatment for both aesthetic and
connective tissue disorders such as keloid and hypertrophic scarring,
localized scleroderma, frozen shoulder syndrome and Dupuytren's contracture.
As Halozyme's first conditionally active biologic, HTI-501 is designed to
degrade the collagenous fibrous components of the extracellular matrix only at
the injection site by tightly controlling the extent and duration of enzyme
activity once injected into the body.
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 absorption and dispersion 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, ViroPharma 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 our future development
plans for HTI-501, anticipated study design, patient enrollment targets and
completion dates for the remainder of the Phase 2 trial for HTI-501 and the
hypothesized method of action or potential benefits for HTI-501. These
forward-looking statements 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 adverse clinical trial
results, delays in development, possible adverse events associated with the
use of the product candidate, regulatory approval requirements and competitive
conditions. These and other risk factors that may result in differences are
discussed in greater detail in the company's Quarterly Report filed on Form
10-Q with the Securities and Exchange Commission on May 8, 2013.
SOURCE Halozyme Therapeutics, Inc.
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