.Halozyme Therapeutics, Inc.
(Nasdaq: HALO), a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix (“Matrix”), 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,
Here's an estimate of the size of the cellulite dollar in the US-
$5.5 BILLION ASTHETIC-CELLULITE LASER MKT- RIPE FOR HTI-501
There are five pure-play publicly traded makers of cosmetic lasers, all with market caps of less than $1 billion: Syneron, Palomar, Cutera, Cynosure and Candela. They're in the business of selling lasers for things like hair removal, cellulite treatment and skin rejuvenation, and business is good.
The market for aesthetic procedures surpassed $3 billion last year and is forecast to grow to $5.5 billion by 2011. About a million women are active users of aesthetic treatments, and there are another 20 million to 30 million women seen as potential patients. Television shows such as "Extreme Makeover" have helped mainstream such procedures, expanding the demographic market to younger people and men. And the relative ease of use of cosmetic-laser consoles offers a new revenue stream for general practitioners, family practitioners and Ob/Gyn's, who formerly had to refer revenue out the door to dermatologists and plastics surgeons.
"I'm absolutely amazed at the unending demand for these types of procedures, and they seem to be the kind of thing where if you get one, you get more," says Thomas Gunderson, an analyst with Piper Jaffray. "From a demand standpoint, it's a bottomless pit."