- New Molecular Entity Targeting Structural Proteins in the Matrix -
SAN DIEGO, May 19 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc.
(Nasdaq: HALO), a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix ("Matrix"), today announced the
presentation of new pre-clinical findings on the controlled modification of
the Matrix with HTI-501 at the European Society for Dermatological Research
(ESDR) and Japanese Society for Investigative Dermatology (JSID).
HTI-501 is a new recombinant human lysosomal proteinase under development
at Halozyme that could provide an effective dermatologic treatment by
targeting and degrading the fibrous components of the Matrix in a highly
controlled fashion. This Matrix targeting new molecular entity is being
explored as a potential solution for therapeutic, as well as aesthetic,
dermatology indications for which surgery may be impractical, such as
cellulite and certain forms of scarring.
HTI-501 works by a process called enzymatic subscision, which involves
degradation of fibrous septae (or cords) in a controllable and predictable
manner to release skin tissue from the fibrous cords and smooth out the
surface contour, which could be especially beneficial in aesthetic dermatology
indications. Other proteinases such as collagenases are not generally
feasible therapies for aesthetic dermatology, due to their persistent
degradation of surrounding tissue that may create safety concerns or require
use of sub-potent dosing regimens. As a strictly pH-dependent enzyme, HTI-501
may be capable of exerting its activity in a tightly regulated fashion.
Key findings were as follows:
-- HTI-501 was identified as a member of the lysosomal proteinase family
capable of degrading insoluble collagen in vitro at pH 5-6, but
catalytically inactive at physiologic pH of 7.4.
-- By injection of pH indicators of increasing buffer strength, the study
established that temporal-spatial pH control of the extracellular
environment from 1-20 minutes post injection could be achieved.
-- The efficacy of HTI-501 on fibrous septae in rodent and porcine models
was established by release of hydroxyl-proline and histologic
evaluation in comparison with bacterial collagenase.
-- HTI-501 administration resulted in significant hydroxyproline release
at pH 5 compared to bacterial collagenase, but not at pH 7.4.
Importantly, skin interstitial pH returned to neutrality within 20
minutes of the administration of HTI-501.
"Due to strict pH dependence for enzyme activity, lysosomal proteinases
have been largely neglected as potential therapeutic proteins due to their
inability to digest proteins outside the lysosomal compartment in the cell,"
said Gilbert Keller, PhD, Halozyme's Technical Leader in Dermatology. "By
bringing this intracellular environment to the extracellular matrix in a
temporal fashion, our platform for controlled modulation of the dermal matrix
may provide a novel mechanism for tightly controlled pharmacologic subscision
of collagenous interstitial matrix. Additional pre-clinical studies are
continuing on our lead candidate, HTI-501."
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the drug delivery, oncology
and dermatology markets. The company's portfolio of products and product
candidates is based on intellectual property covering the family of human
enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a
novel drug delivery platform designed to increase the absorption and
dispersion of biologics. Its key partnerships are with Roche to apply Enhanze
Technology to Roche's biological therapeutic compounds for up to 13 targets
and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic
compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA
approval for two products: Cumulase(R), for use in in-vitro fertilization, and
HYLENEX, for use as an adjuvant to increase the absorption and dispersion of
other injected drugs and fluids. HYLENEX is partnered with Baxter
International Inc. The Company also has a number of different enzymes in its
portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation, statements
concerning the pre-clinical results of the company's HTI-501 enzyme program)
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.
CONTACT: Robert H. Uhl, Senior Director, Investor Relations of Halozyme
Therapeutics, Inc., +1-858-704-8264, firstname.lastname@example.org; or media, Karen
Sparks, +1-858-455-5500, ext. 275, email@example.com, or Joleen Schultz,
+1-858-455-5500, ext. 215, firstname.lastname@example.org, both of Mentus for Halozyme
Web site: http://www.halozyme.com/