–Positive Data on Novel Topical Peptideto be Presented at the International Gap Junction Conference 2013–
MOUNT PLEASANT, SC, USA I July 15, 2013 I FirstString Research, Inc. today announced that it will present positive data from three Phase 2 trials of GranexinTM Gel for the treatment of diabetic foot ulcers (DFUs), venous leg ulcers (VLUs) and for scar reduction at the upcoming International Gap Junction Conference (IGJC), July 13-18, 2013, in Charleston, SC. In each of the Phase 2 trials, GranexinTM Gel was well-tolerated and achieved the primary endpoint of the study with statistical significance. Patients treated with GranexinTM Gel demonstrated highly statistically significant improvements in mean percent wound closure at four and twelve weeks, as well as in incidence and time to 100% wound closure for DFUs and VLUs. A significant reduction in scar formation of surgical incisions following laparoscopic surgery was observed at the study end-point of nine months post-surgery. GranexinTM Gel contains a synthetic peptide, ACT1, which enhances wound healing through a multi-effect mechanism that promotes a healthy regenerative state in tissues.
“Based on the favorable safety data and clinical activity demonstrated in these trials of GranexinTM Gel in DFUs and VLUs, we are in the process of finalizing plans to advance the Granexin program into pivotal Phase 3 studies,” said Gautam Ghatnekar, DVM, PhD, President and CEO of FirstString. “These data reinforce our belief that GranexinTM Gel has potential to become a first-in-class topical peptide for the treatment of chronic wounds and the reduction of scar formation.”
About the Granexin Gel™ Clinical Trials
FirstString Research is scheduled to present results from three separate Phase 2 trials of GranexinTM Gel in chronic wounds and scar reduction at the International Gap Junction Conference (IGJC). Each of the Phase 2 studies was randomized, controlled, multi-center, and blinded to evaluate the safety and efficacy of GranexinTM Gel for the treatment of VLUs and DFUs; and the reduction of scarring following laparoscopic surgery. In the twelve-week studies for the treatment of VLUs and DFUs, GranexinTM Gel (100μM ACT1) was administered three times in the first week, followed by weekly application for the following eleven weeks. To date, over 300 patients have participated in Phase 1 and Phase 2 clinical evaluations of GranexinTM Gel. GranexinTM Gel application resulted in highly significant increases in mean percent wound closure at four and twelve weeks as well as incidence of 100% wound closure, along with significantly reduced time for complete wound closure. In the nine-month study for the reduction of scarring following laparoscopic surgery, GranexinTM Gel (100μM ACT1) was administered once at wound closure and 24 hours post-surgery. GranexinTM Gel demonstrated statistically significant reduction in scarring as measured by Vancouver Scar Scoring (VSS) consisting of scar vascularity, pigmentation, pliability, and height at the study end-point of nine months post-surgery. In all studies, GranexinTM Gel was safe and well-tolerated with no drug-related systemic or local adverse events. Detailed results for the Phase 2 clinical trials will be published in peer-reviewed journals.
Details of the oral presentation to be made at the IGJC are as follows:
| |
|
|
|
Date:
|
|
Tuesday, July 16, 2013 |
|
Time:
|
|
3:30-5:30pm ET |
|
Location:
|
|
Francis Marion Hotel, Charleston, SC |
|
Title:
|
|
ACT1 Scene 1: Clinical Benefits of the Connexin-Based Mimetic Peptide ACT1 |
|
Presenting Author:
|
|
Gautam Ghatnekar |
| |
|
|
About Granexin™ Gel
Granexin GelTM contains ACT1, a synthetic peptide designed to mimic the C-terminus of the gap junction protein connexin 43 (Cx43), with high binding specificity to the tight junction associated protein zona occludens (ZO-1). Gap junctions and tight junctions are found in many cells throughout the body, including epithelial cells, which make up the skin and line other organs. Gap junctions connect the cytoplasms of adjacent cells, allowing free exchange of ions and molecules. Tight junctions form barriers between cells that are virtually impermeable by fluid. ACT1 is soluble, engineered to directly translocate within cells, and interacts with ZO-1, a known binding partner of the C-terminus of Cx43. The binding of the peptide to specific Cx43 C-terminus interaction domains such as PDZ-2 on ZO-1 serves to competitively inhibit its association with the Cx43 C-terminus, resulting in stabilized gap junctions and tight junctions. ACT1 also sequesters hemichannels (extracellular communicating channels) into gap junctions. This multi-effect mechanism – reducing hemichannel activity, promoting gap junctional communication, re-enforcing tight junction integrity – tempers excessive inflammation at the site of injury and promotes a healthy regenerative response. These activities result in the promotion of chronic wound healing and reduction of scarring. The clear, odorless, easy-to-apply topical formulation is also designed to provide a localized protective barrier against microbial colonization and a moist environment to promote natural autolytic debridement of necrotic tissue surrounding a wound. GranexinTM Gel has been evaluated in three Phase 2 trials for the treatment of diabetic foot ulcers, venous leg ulcers and the reduction of scarring following laparoscopic surgery.
About FirstString Research
FirstString Reseach, a clinical stage biotech company, is leading the translation of cell-cell communication and cell-cell contact/adhesion science into a pipeline of drugs and medical applications for wound healing, scar reduction, inflammation, and complex tissue regeneratioࠀnThe company is currently advancing GranexinTM Gel, a topical formulation containing the ACT1 peptide, for the treatment of chronic wounds and scar reduction, through clinical trials, with the goal to broaden the treatment options for patients suffering from morbidities associated with acute and chronic wounds. FirstString is also conducting preclinical studies with ACT1 for additional indications having high unmet therapeutic needs in a number of therapeutic segments that include ophthalmology, CNS injuries, cardiac injuries, organ transplants, acute lung injuries, and oncology.
SOURCE: FirstString Research
Post Views: 198
–Positive Data on Novel Topical Peptideto be Presented at the International Gap Junction Conference 2013–
MOUNT PLEASANT, SC, USA I July 15, 2013 I FirstString Research, Inc. today announced that it will present positive data from three Phase 2 trials of GranexinTM Gel for the treatment of diabetic foot ulcers (DFUs), venous leg ulcers (VLUs) and for scar reduction at the upcoming International Gap Junction Conference (IGJC), July 13-18, 2013, in Charleston, SC. In each of the Phase 2 trials, GranexinTM Gel was well-tolerated and achieved the primary endpoint of the study with statistical significance. Patients treated with GranexinTM Gel demonstrated highly statistically significant improvements in mean percent wound closure at four and twelve weeks, as well as in incidence and time to 100% wound closure for DFUs and VLUs. A significant reduction in scar formation of surgical incisions following laparoscopic surgery was observed at the study end-point of nine months post-surgery. GranexinTM Gel contains a synthetic peptide, ACT1, which enhances wound healing through a multi-effect mechanism that promotes a healthy regenerative state in tissues.
“Based on the favorable safety data and clinical activity demonstrated in these trials of GranexinTM Gel in DFUs and VLUs, we are in the process of finalizing plans to advance the Granexin program into pivotal Phase 3 studies,” said Gautam Ghatnekar, DVM, PhD, President and CEO of FirstString. “These data reinforce our belief that GranexinTM Gel has potential to become a first-in-class topical peptide for the treatment of chronic wounds and the reduction of scar formation.”
About the Granexin Gel™ Clinical Trials
FirstString Research is scheduled to present results from three separate Phase 2 trials of GranexinTM Gel in chronic wounds and scar reduction at the International Gap Junction Conference (IGJC). Each of the Phase 2 studies was randomized, controlled, multi-center, and blinded to evaluate the safety and efficacy of GranexinTM Gel for the treatment of VLUs and DFUs; and the reduction of scarring following laparoscopic surgery. In the twelve-week studies for the treatment of VLUs and DFUs, GranexinTM Gel (100μM ACT1) was administered three times in the first week, followed by weekly application for the following eleven weeks. To date, over 300 patients have participated in Phase 1 and Phase 2 clinical evaluations of GranexinTM Gel. GranexinTM Gel application resulted in highly significant increases in mean percent wound closure at four and twelve weeks as well as incidence of 100% wound closure, along with significantly reduced time for complete wound closure. In the nine-month study for the reduction of scarring following laparoscopic surgery, GranexinTM Gel (100μM ACT1) was administered once at wound closure and 24 hours post-surgery. GranexinTM Gel demonstrated statistically significant reduction in scarring as measured by Vancouver Scar Scoring (VSS) consisting of scar vascularity, pigmentation, pliability, and height at the study end-point of nine months post-surgery. In all studies, GranexinTM Gel was safe and well-tolerated with no drug-related systemic or local adverse events. Detailed results for the Phase 2 clinical trials will be published in peer-reviewed journals.
Details of the oral presentation to be made at the IGJC are as follows:
| |
|
|
|
Date:
|
|
Tuesday, July 16, 2013 |
|
Time:
|
|
3:30-5:30pm ET |
|
Location:
|
|
Francis Marion Hotel, Charleston, SC |
|
Title:
|
|
ACT1 Scene 1: Clinical Benefits of the Connexin-Based Mimetic Peptide ACT1 |
|
Presenting Author:
|
|
Gautam Ghatnekar |
| |
|
|
About Granexin™ Gel
Granexin GelTM contains ACT1, a synthetic peptide designed to mimic the C-terminus of the gap junction protein connexin 43 (Cx43), with high binding specificity to the tight junction associated protein zona occludens (ZO-1). Gap junctions and tight junctions are found in many cells throughout the body, including epithelial cells, which make up the skin and line other organs. Gap junctions connect the cytoplasms of adjacent cells, allowing free exchange of ions and molecules. Tight junctions form barriers between cells that are virtually impermeable by fluid. ACT1 is soluble, engineered to directly translocate within cells, and interacts with ZO-1, a known binding partner of the C-terminus of Cx43. The binding of the peptide to specific Cx43 C-terminus interaction domains such as PDZ-2 on ZO-1 serves to competitively inhibit its association with the Cx43 C-terminus, resulting in stabilized gap junctions and tight junctions. ACT1 also sequesters hemichannels (extracellular communicating channels) into gap junctions. This multi-effect mechanism – reducing hemichannel activity, promoting gap junctional communication, re-enforcing tight junction integrity – tempers excessive inflammation at the site of injury and promotes a healthy regenerative response. These activities result in the promotion of chronic wound healing and reduction of scarring. The clear, odorless, easy-to-apply topical formulation is also designed to provide a localized protective barrier against microbial colonization and a moist environment to promote natural autolytic debridement of necrotic tissue surrounding a wound. GranexinTM Gel has been evaluated in three Phase 2 trials for the treatment of diabetic foot ulcers, venous leg ulcers and the reduction of scarring following laparoscopic surgery.
About FirstString Research
FirstString Reseach, a clinical stage biotech company, is leading the translation of cell-cell communication and cell-cell contact/adhesion science into a pipeline of drugs and medical applications for wound healing, scar reduction, inflammation, and complex tissue regeneratioࠀnThe company is currently advancing GranexinTM Gel, a topical formulation containing the ACT1 peptide, for the treatment of chronic wounds and scar reduction, through clinical trials, with the goal to broaden the treatment options for patients suffering from morbidities associated with acute and chronic wounds. FirstString is also conducting preclinical studies with ACT1 for additional indications having high unmet therapeutic needs in a number of therapeutic segments that include ophthalmology, CNS injuries, cardiac injuries, organ transplants, acute lung injuries, and oncology.
SOURCE: FirstString Research
Post Views: 198
