HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second...

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Tue Jun 16, 2009 5:43pm EDT

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject
for Second Phase II Study

Multi-Center, Randomized Trial to Test Unique Delivery System Using Living
Cells to Enhance Wound Healing Marks Milestone for Fort Worth, Texas-based
Specialty Biopharmaceutical Company

FORT WORTH, Texas, June 16 /PRNewswire/ -- HEALTHPOINT, Ltd. today announced
that it has enrolled the first of a planned 235 subjects into a Phase II dose
response study investigating an experimental, cell-based wound therapy
---HP802-247---intended for the treatment of venous leg ulcers. HP802-247 is a
topical spray containing living keratinocytes and fibroblasts.  The first
patient was enrolled at The Center for Clinical Research near San Francisco,
Calif., led by the site's principal investigator, Alexander Reyzelman, DPM. 
The study is being conducted by 28 investigators in 18 states.

"The start of enrollment into this multi-center, randomized trial is an
important milestone for HEALTHPOINT," said Bert Slade, M.D., FAAAAI, Chief
Medical Officer at HEALTHPOINT and co-author of the trial protocol. "This is
the largest cell therapy dose ranging trial ever undertaken in the area of
wound healing." 

The trial is the second of two planned-dose response trials, extending the
dose range being tested and exploring two plausible dose frequencies.
Enrollment into the trial is preceded by screening and run-in phases and is
expected to continue through the middle of 2010.  The first trial showed
promising results over a four-fold range of cell concentrations administered
weekly.  

This trial is evaluating the benefits and safety of enhancing wound healing by
using metabolically active donor cells to support the patient's own skin
cells' healing ability.  HP802-247 utilizes allogeneic cells, which are living
human cells derived from an individual donor that are subsequently grown in a
tissue culture, and then applied to an unrelated patient. The HP802-247
product consists of both keratinocytes and fibroblasts, the two major cell
types found in human skin. Using a unique delivery system, the cells are
sprayed onto the wound surface in a self-polymerizing protein mesh intended to
help the cells to adhere to the tissue. 

Previous research strongly suggests that wound healing is accelerated by the
application of living cells, particularly when both keratinocytes and
fibroblasts are present together. By allowing the cells to be in contact with
each other following spraying onto the wound surface, it is thought that
growth promoting and healing signals will be generated that can support
healing of the wound by the patient's own cells.   

Typically caused by impaired microcirculation secondary to venous
hypertension, venous leg ulcers are increasingly common, are costly, and are
often a cause of prolonged suffering for patients. Characterized as difficult
to heal, many such ulcers develop into chronic, nonresponsive wounds despite
application of standard treatments.

"Making an innovative, effective treatment available is a strategy that can
help such high risk wounds and provide tremendous benefits to both patients
and society," said Dr. Slade. "Based on an estimated 2.5 million venous leg
ulcers in the United States alone and actual direct treatment costs reported
to be over $9,000 per patient, the current annual cost of treating these
wounds is likely in the many billions of dollars." 

"We are excited to be working with HEALTHPOINT on this important study," said
Dr. Reyzelman. "We're aided greatly by HEALTHPOINT's investment in cutting
edge technology to support this trial, including new laser-equipped digital
cameras that can measure wound size at each clinic visit."

"We believe development of our HP802-247 product will result in helping
millions of patients worldwide who suffer from these ulcers," said Travis E.
Baugh, President of HEALTHPOINT. "The novel format of this cell-based therapy
shows great potential to deliver a compelling, cost-effective option."

The current trial is part of HEALTHPOINT's ongoing development strategy for
advancing wound care therapies and further enhances HEALTHPOINT's
evidence-based dossier for regulatory filings in both the United States and
Europe, according to Mr. Baugh.

About the Study 
The study is a randomized, double-blind, dose-finding study involving subjects
18 years of age and older who have had venous leg ulcers for a minimum of six
weeks and a maximum of 24 months. The ulcers must be between 2 cm2 and 12 cm2
in area at presentation. The study will assess both the time to complete wound
closure and the proportion of complete wound closures in each cohort. It is
designed to determine the effectiveness of two cell concentrations and two
dosing frequencies of HP802-247 when combined with standard care, compared to
placebo plus standard care, in healing venous leg ulcers over a 12-week
treatment period. All trial patients undergo compression bandaging with a
four-layer system (Profore(R) System) in order to control leg swelling caused
by the underlying vein dysfunction. 

About HP802-247
HP802-247 consists of two components that are sprayed sequentially on the
wound bed at the time of treatment: a fibrinogen solution and a cell
preparation containing a mixture of growth arrested, living, allogeneic
epidermal keratinocytes and dermal fibroblasts. Based on in vitro studies,
HP802-247 is expected to release various growth and angiogenic factors into
the microenvironment of the wound through administration of these living,
metabolically active, but nonproliferating cells that are trapped on the wound
surface in a thin fibrin matrix. The secreted growth and angiogenic factors
are anticipated to stimulate the patient's own cells to heal the wound.

About HEALTHPOINT, Ltd.
Since 1992, HEALTHPOINT has been dedicated to innovative technologies for the
prevention and treatment of acute, chronic and burn-related wounds. The
company is presently focused on the research and development of novel
biologics and pharmaceuticals intended to improve clinical and quality of life
outcomes. Currently marketed products include: Collagenase SANTYL(R) Ointment,
OASIS(R) Wound Matrix, HYDROFERA BLUE(R) Bacteriostatic Wound Dressings, and
SURGICEPT(R) Waterless Surgical Hand Antiseptic. HEALTHPOINT is also committed
to advancing the care and treatment of wounds through support of industry
leading continuing education from THE WOUND INSTITUTE(R). To learn more about
this comprehensive and award winning educational resource, please visit
TheWoundInstitute.com(R). HEALTHPOINT is a DFB Pharmaceuticals, Inc. affiliate
company, and is based in Fort Worth, Texas. For more information, visit the
HEALTHPOINT website at www.healthpoint.com. 

OASIS is a registered trademark of Cook Biotech, Inc.; HYDROFERA BLUE is a
registered trademark of Hydrofera, LLC; and PROFORE is a registered trademark
of Smith & Nephew.

HEALTHPOINT, SANTYL, SURGICEPT, THE WOUND INSTITUTE, and TheWoundInstitute.com
are registered trademarks of HEALTHPOINT, Ltd. 




SOURCE  HEALTHPOINT, Ltd.

Rob Bancroft of HEALTHPOINT, 1-800-441-8227; or Lauren Kwedar of PHPR Inc.,
1-800-776-9720, for HEALTHPOINT
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