Company Plans to Meet with FDA to Discuss Filing Strategy for Approval
NEW YORK, NY, USA I October 13, 2015 I Izun Pharmaceuticals Corporation (“Izun”, the “Company”, izunpharma.com), a clinical stage company focused on developing high efficacy products based on botanical sources announced today that it has successfully completed a multicenter randomized, controlled trial comparing IZN-6D4, a topical pharmaceutical gel, to a matching active hydrogel placebo to treat diabetic foot ulcers. The study was conducted at seven centers in Israel in 82 patients.
The results of the study showed a steady and continuous improvement in wound healing over the four-week duration of the trial for the active arm. IZN-6D4 demonstrated greater than 54% wound closure at week four compared to baseline. The control group showed improvement at week one that plateaued at approximately 30% for the duration of the study. The improvement in wound healing in the active arm was significantly greater than that of the control arm at P< 0.05. IZN-6D4 accelerated wound healing and the trial demonstrated a clinically relevant effect size.
Moreover, control arm patients were given the opportunity to utilize IZN-6D4 in open label fashion for an additional month after the conclusion of the study. Those who chose to do so experienced incremental improvement in wound healing that approximated the 50% response rate results in wound healing seen in the active arm during the controlled study, thus validating the beneficial effect of IZN-6D4 in refractory wounds.
Jack Talley, Chief Executive Officer of Izun commented, “We are delighted with the outcome of this successful trial. Diabetic foot ulcers are a major medical problem that affects 6% of all diagnosed Type 2 diabetic patients annually. There is a significant unmet medical need in this area that we hope to fill. Based on our assessment of the data we intend to meet with the FDA for a presubmission meeting early next year.”
Dr. Jonathan Rosenblum, Director of the Diabetic Foot Service at Shaare Zedek Medical Center who participated as an investigator in the trial commented, “The Izun wound care gel has demonstrated excellent clinical efficacy in treating refractory wounds. The clinical benefits and ease of use could make this product a first line treatment for hard to heal wounds.”
The Company intends to meet with the FDA and other regulatory authorities to request guidance for a 510(k) or equivalent device filing with accompanying medical claims. Based on the outcome of these meetings, the company expects to be able to file for regulatory approval in 2016. Izun intends to make IZN-6D4 available for partnering in the United States, Europe and other territories.
About Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a major complication of diabetes mellitus, and a major component of the diabetic foot.
Wound healing is an innate mechanism of action that works reliably most of the time. A key feature of wound healing is stepwise repair of lost extracellular matrix that forms the largest component of the dermal skin layer. In some cases, certain disorders or physiological insult disturbs the wound healing process. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.
Current treatment of diabetic foot ulcers includes: blood sugar control, removing dead tissue from the wound, dressings, and removing pressure from the wound through techniques such as total contact casting. Surgery in some cases may improve outcomes.
DFU occurs in 15% of people with diabetes, 6% of new patients annually and precedes 84% of all diabetes-related lower-leg amputations.
About Izun Pharmaceuticals
Izun Pharmaceuticals is a US-based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing the extracted botanicals to yield polymolecular drug candidates. These patented products are designed to impact on multiple specific receptor targets. The main therapeutic focus is on agents that can reduce inflammation and accelerate healing. Izun is currently active in developing therapeutic products for a number of indications including: oral care, oncology support, wound care, women’s health care, gastrointestinal disease and dermatologic conditions. Izun uses the inherent advantage of the natural botanical sources to deliver robust clinical results with an excellent safety profile. Izun has received approval for a number of oral care products that are currently marketed. Additional clinical studies are in progress for indications that include radiation and chemotherapy-associated oral mucositis, and atrophic vaginitis.
SOURCE: Izun Pharmaceuticals
Post Views: 177
Company Plans to Meet with FDA to Discuss Filing Strategy for Approval
NEW YORK, NY, USA I October 13, 2015 I Izun Pharmaceuticals Corporation (“Izun”, the “Company”, izunpharma.com), a clinical stage company focused on developing high efficacy products based on botanical sources announced today that it has successfully completed a multicenter randomized, controlled trial comparing IZN-6D4, a topical pharmaceutical gel, to a matching active hydrogel placebo to treat diabetic foot ulcers. The study was conducted at seven centers in Israel in 82 patients.
The results of the study showed a steady and continuous improvement in wound healing over the four-week duration of the trial for the active arm. IZN-6D4 demonstrated greater than 54% wound closure at week four compared to baseline. The control group showed improvement at week one that plateaued at approximately 30% for the duration of the study. The improvement in wound healing in the active arm was significantly greater than that of the control arm at P< 0.05. IZN-6D4 accelerated wound healing and the trial demonstrated a clinically relevant effect size.
Moreover, control arm patients were given the opportunity to utilize IZN-6D4 in open label fashion for an additional month after the conclusion of the study. Those who chose to do so experienced incremental improvement in wound healing that approximated the 50% response rate results in wound healing seen in the active arm during the controlled study, thus validating the beneficial effect of IZN-6D4 in refractory wounds.
Jack Talley, Chief Executive Officer of Izun commented, “We are delighted with the outcome of this successful trial. Diabetic foot ulcers are a major medical problem that affects 6% of all diagnosed Type 2 diabetic patients annually. There is a significant unmet medical need in this area that we hope to fill. Based on our assessment of the data we intend to meet with the FDA for a presubmission meeting early next year.”
Dr. Jonathan Rosenblum, Director of the Diabetic Foot Service at Shaare Zedek Medical Center who participated as an investigator in the trial commented, “The Izun wound care gel has demonstrated excellent clinical efficacy in treating refractory wounds. The clinical benefits and ease of use could make this product a first line treatment for hard to heal wounds.”
The Company intends to meet with the FDA and other regulatory authorities to request guidance for a 510(k) or equivalent device filing with accompanying medical claims. Based on the outcome of these meetings, the company expects to be able to file for regulatory approval in 2016. Izun intends to make IZN-6D4 available for partnering in the United States, Europe and other territories.
About Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a major complication of diabetes mellitus, and a major component of the diabetic foot.
Wound healing is an innate mechanism of action that works reliably most of the time. A key feature of wound healing is stepwise repair of lost extracellular matrix that forms the largest component of the dermal skin layer. In some cases, certain disorders or physiological insult disturbs the wound healing process. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.
Current treatment of diabetic foot ulcers includes: blood sugar control, removing dead tissue from the wound, dressings, and removing pressure from the wound through techniques such as total contact casting. Surgery in some cases may improve outcomes.
DFU occurs in 15% of people with diabetes, 6% of new patients annually and precedes 84% of all diabetes-related lower-leg amputations.
About Izun Pharmaceuticals
Izun Pharmaceuticals is a US-based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing the extracted botanicals to yield polymolecular drug candidates. These patented products are designed to impact on multiple specific receptor targets. The main therapeutic focus is on agents that can reduce inflammation and accelerate healing. Izun is currently active in developing therapeutic products for a number of indications including: oral care, oncology support, wound care, women’s health care, gastrointestinal disease and dermatologic conditions. Izun uses the inherent advantage of the natural botanical sources to deliver robust clinical results with an excellent safety profile. Izun has received approval for a number of oral care products that are currently marketed. Additional clinical studies are in progress for indications that include radiation and chemotherapy-associated oral mucositis, and atrophic vaginitis.
SOURCE: Izun Pharmaceuticals
Post Views: 177
