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:6/16/2017)... Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon ... ... CS100i ... 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX 0998-00-3023-XX;  ... This field correction also applies to any System 98 ...
(Date:6/14/2017)... Calif. , June 14, 2017 The ... the City of Fremont and ... of the bio-pharma industry in California ... technology, enabling executive networking, and fostering workforce development. The ... development and growth of start-ups, as well as small ...
(Date:6/12/2017)... , June 12, 2017 Kineta, Inc., a biotechnology ... Kineta Vice President of R&D and Head of ... Pandemic Preparedness for the Northwest and Beyond meeting ... on June 14, 2017 from 8:30-10:30 AM PDT at the ... Dr. Bedard will be joined by other ...
Breaking Medicine Technology:
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... American Farmer, ... winning series, which is slated to air fourth quarter 2017. American Farmer airs Tuesdays ... Hansen, a Danish pharmacist, founded Chr. Hansen in Denmark in 1874 after a ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... management, financial planning, and related services to families and business owners in and ... charity drive to benefit senior citizens in the area. , Meals on Wheels ...
(Date:6/23/2017)... ... 23, 2017 , ... All-Star Insurance, a family managed agency that offers insurance ... is announcing the launch of a new charity drive to benefit women in the ... States reveal that an estimated 252, 710 new cases of invasive or high risk ...
(Date:6/23/2017)... TX (PRWEB) , ... June 23, 2017 , ... ... and business owners in the Houston area with access to asset protection and ... a regional charity event aimed at improving the lives of children with cancer ...
(Date:6/22/2017)... Rosa, CA (PRWEB) , ... June 22, 2017 , ... ... been named as a Top Doctor for 2017. Each year, research and information firm, ... country. First winning the title in 2015, this marks the 3rd time that ...
Breaking Medicine News(10 mins):