HALSCION ANNOUNCES ENCOURAGING DATA FROM KLEAR FEASIBILITY STUDY FOR KELOID SCARS
HALSCION ANNOUNCES ENCOURAGING DATA FROM KLEAR FEASIBILITY STUDY FOR KELOID SCARS
Study Shows Promise for CelotresTM in Preventing Keloid Recurrence in Patients that Undergo Surgical Revision
Suwanee, GA, February 15, 2012-- Halscion, Inc., today announced that Brian Berman, M.D., Ph.D. will present results from the company's KLEAR Study, which evaluated the initial safety and efficacy of CelotresTM in the treatment of keloid scars adjunctive to surgical excision. The results demonstrated a significant reduction (p=0.0110) in keloid recurrence, as compared to scientific literature, following a single application of Celotres.
The presentation, "Future Treatment of Keloid Scars," will take place on Friday, February 17th during the South Beach Clinical Dermatology and Aesthetics Symposium. The purpose of the KLEAR study was to evaluate the safety and clinical feasibility of CelotresTM, an injectable hydrogel scaffold, in the prevention, reduction, or improvement of keloid scars after surgical excision. In an effort to prevent recurrence, CelotresTM, a passive device comprised of porcine gelatin stabilized with dextran, was injected into the dermal/subdermal space of the surgical wound post-excision of the existing keloid and prior to final suturing.
Twenty-six earlobe keloids (19 subjects) were treated with CelotresTM following surgical excision of an existing keloid with the objective of reducing the volume, appearance and/or symptoms associated with keloid scarring. All subjects returned for the 12-month follow-up visit. The keloid recurrence rate at 12 months for subjects treated with CelotresTM was 19.2% (5/26 keloids) vs. a scientific literature rate of 51.2%. Keloid recurrence following surgical excision has been documented to be between 45-100%. Specifically, Berman et al. (1998) presented the results of 43 patients undergoing surgical excision of keloids alone and documented a 51.2% recurrence of the keloids in an average of 6.5 months. When compared to this contemporary published rate, CelotresTM was statistically significant (p=0.0110) in preventing keloid recurrence at 12 months.
"The statistically significant difference in the keloid recurrence rate of patients treated with CelotresTM compared to the literature standard was impressive," said Dr. Brian Berman, Voluntary Professor of Dermatology at The University of Miami Miller School of Medicine and advisor to the Company. "CelotresTM has potential to be the first real solution for preventing keloid recurrence in patients that undergo surgical revision for their painful and disfiguring keloids."
During the KLEAR Study, all subjects were asked to rate pain, tenderness, itching and provide scores for a cosmetic global assessment and their individual satisfaction. At the 12 month visit, there were no reports of pain or tenderness, and with one exception, no reported itching. Despite their recurrences, all subjects including those with a keloid recurrence, were "totally satisfied" with their outcome. There were also no device-related serious adverse events associated with the use of CelotresTM.
"The positive results from the KLEAR Study are very encouraging," said Kathleen Beauchamp, President/CEO of Halscion. "This is an important step in the clinical development of CelotresTM for treatment of the most challenging of scars."
To learn more about Halscion, Inc. and CelotresTM, please visit http://www.halscion.net, send email inquiries to info@halscion.net, or contact Allison Potter with Pascale Communications at 412-228-1678 (allison@pascalecommunications.com).
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Halscion, Inc., is a privately held company based in Suwanee, Georgia, developing a novel and proprietary hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing of a wound.




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