Navigation Links
Garnet BioTherapeutics Announces First Patient Treated in Trial of New Therapy for Improvement in Scar Appearance
Date:3/23/2010

MALVERN, Pa., March 23 /PRNewswire/ -- Garnet BioTherapeutics, Inc. ("Garnet"), a regenerative medicine company focused on developing cell based therapies, today announced that the first patient has been treated in a Phase 2 multicenter, double-blind, placebo-controlled study of its lead product candidate GBT009 at Unity Hospital in Rochester, New York.  GBT009 gives off a variety of pro-regenerative growth factors and cytokines which help repair damaged tissue and reduce inflammation, ultimately augmenting the body's ability to heal itself.  The trial will assess the safety and efficacy of GBT009 for the treatment of incisional wounds following breast reconstruction surgery.

"Recent advances in reconstructive surgery mean that women who have breast cancer today have greater choices that were not widely available 10 years ago," according to Joseph M. Serletti, MD, Chief of the Division of Plastic Surgery at the University of Pennsylvania School of Medicine, who specializes in breast reconstruction in cancer patients.  "There are definite advantages to this surgery which uses the patient's own tissue to create a natural breast reconstruction.  However, the limitation of this surgery is scarring in the area of the body where the tissue was taken.  We are excited about the potential of this novel cell therapy which meets an unmet need for patients and surgeons looking for more options to improve scar formation and repair damaged tissue," he added.  Dr. Serletti is a Principal Investigator for the study and serves as a consultant to Garnet BioTherapeutics, Inc.

There were over 79,000 breast reconstruction procedures performed by plastic surgeons in the U.S. in 2008.(i)  The transverse rectus abdominis myocutaneous (TRAM) flap is a common type of breast reconstruction that uses skin, muscle tissue and fat tissue from the lower abdomen to create a very natural looking breast.  Breast reconstruction with TRAM flap surgery is a major, invasive procedure and carries with it the possibility of significant complications, including poor wound healing.(ii)

The GBT009 clinical trial targets female patients scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique.  The goal of this study is to assess whether intradermal injections of GBT009 along full thickness abdominal incisions following surgery leads to an improvement in scar appearance.  Efficacy measures include assessments of scar appearance that will be periodically evaluated by the Investigator and patient using the Patient Observer Scar Assessment Scale (POSAS), the Manchester Scar Scale (MSS) and a Visual Analog Scale (VAS).  In addition, photographs will be taken throughout the study and an independent scar assessment panel will evaluate and rate the standardized, calibrated digital photographs.

"We are very pleased to report the first patient being enrolled in this study of GBT009.  The event marks a key milestone for women, notably breast cancer survivors, because this therapy addresses one of the least-desired attributes of our patients – the visible scars which linger as a reminder of their ordeal," explained Dr. Stephen Vega, study investigator and plastic surgeon working in Rochester, New York.

More information about the trial can be found at www.clinicaltrials.gov and the identifier is NCT01053897.

Garnet is initially developing its cell-based therapy for cosmetic and dermatologic applications where accelerated healing and reduced scarring are desirable.  The company believes that the cell-based therapy may also be applicable for treatment of burns, auto-immune disorders such as psoriasis, and in other conditions where inflammation or scar formation plays an important role in disease pathology.  In addition, Garnet has developed proprietary scalable cell manufacturing technology that has largely solved the challenge of commercial manufacturing scale-up of patient doses from a single donor source.

About Garnet BioTherapeutics

Garnet BioTherapeutics is a clinical stage regenerative medicine company based in Malvern, PA.  Garnet's cell-product GBT009 releases anti-inflammatory and pro-healing factors that accelerate healing and reduce scarring.  The company is currently targeting dermatology applications, with plans to expand into other reconstructive and cosmetic procedures as well as looking at ways to advance the technology for use in orthopedic and cardiovascular surgical procedures, burn treatment, chronic wound healing and auto-immune disorders.  For more information, please visit www.garnetbio.com.

(i) American Society of Plastic Surgeons.  2008 Reconstructive Surgery Procedures.  Statistics. http://search.plasticsurgery.org/search?q=2008+Reconstructive+Surgery+Procedures

(ii) American Cancer Society.  Breast Reconstruction After Mastectomy.  http://www.cancer.org/docroot/cri/content/cri_2_6x_breast_reconstruction_after_mastectomy_5.asp  

SOURCE Garnet BioTherapeutics, Inc.

Back to top

RELATED LINKS
http://www.garnetbio.com

'/>"/>

SOURCE Garnet BioTherapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. NASDAQ Trading for Oxygen Biotherapeutics, Inc. Shares to Begin January 15, 2010
2. Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing
3. Oxygen Biotherapeutics, Inc. Expands Board of Directors
4. Oxygen Biotherapeutics, Inc. Enrolls First Patient in Traumatic Brain Injury Clinical Trial in Switzerland
5. Northwest Biotherapeutics Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax(R) Manufacturing
6. Oxygen Biotherapeutics, Inc. Begins Shipping Cosmetic Product to Customers
7. Oxygen Biotherapeutics, Inc. Announces 1:15 Reverse Stock Split to Take Effect Nov. 9, 2009
8. Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
9. Oxygen Biotherapeutics, Inc. to Webcast Shareholder Meeting
10. Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval in Israel
11. Oxygen Biotherapeutics, Inc. Submits Milestone Achievement Notice to Vatea Fund
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
(Date:6/24/2016)... ... ... recruitment firm Slone Partners is pleased to announce the placement of Suzanne ... of North American Capital Sales at HTG Molecular . , In ... commercialization of the HTG EdgeSeq system and associated reagents in North America. , Headquartered ...
Breaking Medicine News(10 mins):