Navigation Links
Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers
Date:3/16/2009

FORT WORTH, Texas, March 16 /PRNewswire/ -- Healthpoint today announced that it has initiated a Phase II clinical trial investigating the efficacy of HP802-247 in venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. The study 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.

"Commencement of enrollment for this trial represents an important milestone in the development program for this novel biologic therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "This second Phase II study will extend our understanding of this agent, which we believe will add to the promising results obtained in previous European clinical trials."

The study is a randomized, double blind, dose-finding study involving subjects 18 years of age and older with venous leg ulcers of at least 6 week's, but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 400 subjects will be recruited at 25 investigational centers in the United States. The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort.

Venous leg ulcers are increasingly common and costly, and are often a cause of prolonged suffering for patients. These wounds can be characterized as difficult to heal and are typically caused by impaired microcirculation secondary to venous hypertension. Many venous ulcers fail to heal even after 3 months of standard treatment and develop into chronic, non-responsive wounds. Based on an estimated figure of 2.5 million venous leg ulcers in the United States alone and a study of actual direct treatment costs of $9,685 per person, the annual cost of treating these wounds is likely in the many billions of dollars. Accordingly, the availability of innovative and effective treatment strategies for such high-risk wounds could provide tremendous benefits to both patients and society.

"The novel format of this cell-based therapy shows great potential to deliver a compelling clinical and cost effectiveness profile," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint. "The current study is an important part of our ongoing development strategy for advancing wound care therapies and our intended evidence-based dossier for regulatory filings in both the United States and Europe."

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 micro-environment of the wound through administration of these living, metabolically active, but non-proliferating 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.

SANTYL, SURGICEPT, THE WOUND INSTITUTE, and THEWOUNDINSTITUTE.COM are registered trademarks of Healthpoint, Ltd.


'/>"/>
SOURCE Healthpoint, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing
2. Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma
3. Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B
4. Meritage Pharma Initiates Phase 2b Clinical Trial of Oral Viscous Budesonide for Pediatric Patients With Eosinophilic Esophagitis
5. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
6. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
7. Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
8. Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain
9. Solace Pharmaceuticals Initiates Phase IIa Trial of Glial Cell Modulator SLC022 in Post-Herpetic Neuralgia
10. Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix
11. Cylene Pharmaceuticals Initiates Phase I Trial With CX-4945 -Breakthrough First-in Class Inhibitor of CK2
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... February 22, 2017 Indivumed, GmbH (Indivumed), a ... and The Indian Institute of Technology Madras (IITM), the ... the first Indian national cancer data base and biobank for use ... ... term. The collaboration will include collection of many types of cancer, ...
(Date:2/21/2017)... 2017 Micro Guide Catheters Market: Overview ... Micro Guide Catheters are used ... clinics and ambulatory surgery centers etc. Micro guide ... selection of micro guide catheter depends on the ... body. Micro guide catheters are available in different ...
(Date:2/21/2017)... 2017 Diabetic Shoes Market: Overview Read ... ... a disease, which is marked by high levels of blood ... The disease has become a global epidemic leading to serious ... organs of the body including eyes, kidneys, heart. However, it ...
Breaking Medicine Technology:
(Date:2/22/2017)... ... February 22, 2017 , ... ... - the Vector™ Series Multi-Cook Oven offers up to four ovens in one. ... Structured Air Technology™ for unmatched evenness in cooking. Alto-Shaam has partnered with Appliance ...
(Date:2/21/2017)... ... 2017 , ... Robins & Morton celebrated the grand opening ... 21. , The celebration began with a ribbon cutting event at 10:30 a.m., ... and tribal leadership. , Choctaw Nation Durant Regional Medical Clinic is a ...
(Date:2/21/2017)... CA (PRWEB) , ... February 21, 2017 , ... As ... United States according to the American Society of Plastic Surgeons. Some patients want to ... the functionality of their nose and improve their breathing ability. The team at ...
(Date:2/21/2017)... ... 2017 , ... American Veterinarian™, the premier multimedia provider of ... first bi-monthly issue of 2017 in February. The inaugural issue will offer expert ... , In making the announcement, American Veterinarian™ Publisher Chris Hennessy said, “We ...
(Date:2/21/2017)... California (PRWEB) , ... February 21, 2017 , ... ... world with over 50,000 participants. The connected care demonstration spanned multiple health ... the National Coordinator, roughly 30% of providers have no Health Information Exchange outside ...
Breaking Medicine News(10 mins):